the 2018 genentech oncology trend report...mar 09, 2018 · new haven, ct suggested citation ......

The 2018 Genentech

Oncology Trend Report

10th EditionPerspectives from Managed Care Organizations,

Specialty Pharmacies, Oncologists, Practice Managers, and Employers

3

THE 2018 GENENTECH ONCOLOGY TREND REPORT

EDITORIAL BOARDDean H. Gesme, MD, FACP, FACPE, FASCO

President

Minnesota Oncology

St. Paul, MN

Scott McClelland, PharmD

Vice President, Commercial and Specialty Pharmacy

Programs

Florida Blue

Jacksonville, FL

Bruce Sherman, MD, FCCP, FACOEM

Medical Director

Population Health Management,

Private Exchanges,

Conduent HR Services

Medical Director

Employers Health Coalition, Inc.

Canton, OH

Gary J. Weyhmuller, MBA, SPHR

Executive Vice President/Chief Operating Officer

National Comprehensive Cancer Network® (NCCN®)

Fort Washington, PA

Mike Seiden, MD, PhD

Chief Medical Officer

McKesson Specialty Health/US Oncology Network

The Woodlands, TX

Kevin Fitzpatrick

Chief Executive Officer

CancerLinQ

Alexandria, VA

Kim Thiboldeaux

President/Chief Executive Officer

Cancer Support Community

Washington, DC

Roy S. Herbst, MD, PhD

Ensign Professor of Medicine,

Professor of Pharmacology,

Chief of Medical Oncology

Yale Cancer Center and Smilow Cancer Hospital,

Associate Director for Translational Research

Yale Cancer Center

Yale School of Medicine

New Haven, CT

SUGGESTED CITATION2018 Genentech Oncology Trend Report. 10th ed. South San Francisco,

CA: Genentech; 2018.

TABLE OF CONTENTS

MISSION STATEMENT The mission of the 2018 Genentech Oncology Trend Report is to provide

timely and useful information on the latest cancer care trends and

developments. Updated annually, the publication is designed to serve

as a unique resource for those seeking an understanding of the issues

surrounding cancer management and practice. The content of this report

was prepared with the guidance of an editorial board and is based on

primary research of key stakeholders, as well as published literature.

Statements and opinions contained in the report do not necessarily reflect

those of Genentech or the editorial board.

Introduction ........................................................................................................

Key findings ........................................................................................................

Methodology and demographics ...................................................................

I. Where and how is oncology care provided? ..............................

II. What services are provided to patients and by whom? ............

III. How are clinical care and coverage decisions being

determined? ..........................................................................................

IV. How are care decisions being influenced/managed? ...............

V. How is quality being measured and reported? ...........................

VI. How is cost of care evolving? .......................................................

VII. High-level questions .....................................................................

References ..........................................................................................................

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MCM/012318/0011 April 2018

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INTRODUCTION

This year marks the tenth anniversary of the Genentech Oncology Trend Report. Between 2007 and now, oncology has seen tremendous changes, from a dramatic growth in innovation—45 new drug or new indication approvals in 20171 versus 8 in 20072—to the increasing emergence of value-based management. From a broader political perspective, the past ten years have seen tremendous change and pendulum swings in policy from signature legislation such as the passage of the Affordable Care Act in 2010 to a repeal of a key provision of that legislation, with the elimination of the individual mandate for health insurance coverage as part of the Tax Cut and Jobs Act of 2017.

NOTABLE DEVELOPMENTS IN CANCER CARE DURING 2017ROLLOUT OF MIPS FOR MEDICARE PART BThis year saw the initiation of the multi-year rollout of the Merit-based Incentive Payment System (MIPS) for Medicare, which is part of the new Quality Payment Program (QPP) that began in 2017. Its objective is to link payment incentives (and penalties) to performance across four categories: quality, cost, improvement activities, and advancing care information.3 Incentive payments are delayed by two years, so 2017 performance won’t affect provider payments until 2019. In addition, the magnitude of the bonus or penalty grows, ranging from –4% to +4% for

2019 and expanding to –9% to +9% in 2022 and beyond. There is a potential for an additional 10% incremental bonus for exceptional performers with those payments capped at $500 million a year. MIPS will play an increasingly important role in practice reimbursement,4 and we probe practice readiness and involvement in the program in this year’s survey.

FIRST USE OF PAY-FOR-PERFORMANCE CONTRACTS WITH CMS IN ONCOLOGYThis year saw the first approvals of a whole new treatment modality, chimeric antigen receptor T-cell (CAR-T) therapy. While clinicians are very excited by the clinical performance of the therapies, it is very expensive to produce engineered cells from each patient and the therapies have been priced above what has previously been seen in oncology (that is, list prices approaching half a million dollars per patient).5 However, an innovative pay-for-performance contract was announced in conjunction with the launch of the first CAR-T, wherein CMS would only pay for those patients who responded to the therapy within the first month.6 This marks a new era for oncology and could be the start of a trend whereby more drugs are reimbursed through these types of contract. This will be an area to watch over the coming years.

CAR-T, Chimeric antigen receptor-T cell; CMS, Centers for Medicare & Medicaid Services; MIPS, Merit-based Incentive Payment System; QPP, Quality Payment Program.

HEALTH REFORM CHANGES WITH LOSS OF INDIVIDUAL MANDATEAfter much uncertainty regarding broader healthcare reform over the course of 2017, Congress passed the Tax Cuts and Jobs Act of 2017 in late December; this included a provision to repeal the individual mandate for health insurance coverage that was part of the Affordable Care Act. It remains to be seen what the downstream impact of this change will be. The non-partisan Congressional Budget Office (CBO) estimates that it will result in four million people losing their insurance coverage in 2019, growing to 13 million by 2027.7 Furthermore, this could put significant financial pressure on exchange plans as healthier participants no longer opt for insurance, thus increasing premiums for sicker patients who do participate—such as cancer patients. The CBO estimated a 10% rise in premiums, but much is dependent on how individuals respond and how plan participation in exchanges evolves.

UNCERTAINTY ON FURTHER POLICY REFORMS FOR PRICING AND ACCESS The transition from 2017 to 2018 represented a period of great uncertainty for what further policy reforms would transpire. President Trump used his State of the Union address8 to state that “one of my greatest priorities is to reduce the price of prescription drugs,” citing the fact that US drug prices are often far higher than in other countries. President Trump has previously called for dramatic actions, such as Medicare negotiating lower drug prices or importing drugs from countries with lower prices; however, the current HHS secretary, Alex Azar, has stated the government should not directly negotiate prices.9 While the mechanisms are still unclear, President Trump believes significant changes are coming imminently: “And prices will come down substantially. Watch.”

One area of policy that does appear to be taking shape is “right to try” legislation. Again, President Trump highlighted this policy directly in his State of the Union address, with a Senate bill already passed and a companion House bill working its way through committee. This legislation seeks to allow terminally ill patients to access non-approved drugs that have passed Phase 1 FDA testing through manufacturer compassionate use programs. Already, 38 states have right-to-try legislation,10 and it is unclear what impact a federal law would have for many oncology patients. There may be unintended consequences if usage of right-to-try expands significantly, including a reduction in potential reduction of clinical trial enrollment.

POTENTIAL FOR DISRUPTIVE MARKET ENTRANTSThe US healthcare market is poised for potential significant disruption with the much-anticipated entrance of large tech players. Early 2018 saw the launch of Apple’s Health Records feature, which brings medical records to the pockets of ultimately millions of increasingly empowered consumers.11 We are seeing new types of deals and partnerships across the value chain in an attempt to bolster the prospects of incumbents within the healthcare landscape, with CVS Health acquiring Aetna for $69 billion under the imminent threat of Amazon’s entrance into the space.12 For their part, Amazon, Berkshire Hathaway, and JPMorgan Chase have teamed up to provide better and more cost-effective healthcare to their employees, though they may not limit themselves to their own employees for long.13 2018 will be a critical year to watch to see what kind of traction these non-traditional players with deep pockets and a data-first approach will be able to make in healthcare.

CHANGES TO THIS YEAR’S ONCOLOGY TREND REPORTThis report continues the tradition of in-depth and extensive reporting of notable developments in cancer treatment across key stakeholder groups, but seeks to provide a broader picture of oncology care through six key questions:

• Where and how is oncology care provided?

• What services are being provided to patients and by whom?

• How are clinical care and coverage decisions being determined?

• How are care decisions being influenced/managed?

• How is quality being measured and reported?

• How is cost of care evolving?

Through surveying managed care organizations, specialty pharmacies, oncologists, oncology practice managers, and employers, and in consultation with the independent Editorial Advisory Board, this report details how the treatment of Americans diagnosed with cancer is evolving, and highlights areas of particular disruption to the system over the coming decade.

5CBO, Congressional Budget Office; FDA, Food and Drug Administration; HHS, Health & Human Services; US, United States.

TODAY THE FIELD OF ONCOLOGY STANDS AT A CROSSROADSThere has been tremendous innovation over the past decade with the emergence of new drugs with very promising efficacy—for example, immunotherapy—along with increasing adoption of precision medicine technologies such as companion diagnostics and targeted therapy, as well as advanced monitoring techniques such as liquid biopsy.1 At the same time, stakeholders across the board remain very concerned about the escalating costs that are accompanying these innovations. Beyond the system burden, there is increasing attention being paid to the “financial toxicity” that patients may experience.

Today, one of the major levers to reduce ineffective, costly care is the deployment of clinical guidelines—and increasingly national-level guidelines: 78% of oncologists use them (up from 53% in the 2016 study year), reflecting significant growth over the study period, but adoption is not yet universal. Beyond guidelines, we are seeing the

emergence of pathways, which go beyond clinical evidence to also consider cost to the system and patient. Pathways are also coalescing around national-level systems with an uptick to 52% usage this year versus 45% in the 2016 study year, although adoption remains significantly lower as oncologists are still transitioning.

Looking forward, there are high hopes for a variety of new approaches to measuring quality and aligning incentives to performance on those quality metrics. However, to date, there have been challenges in creating changes in the behavior of oncologists; they remain laser focused on clinical efficacy (80%) and safety for patients (71%) as their primary driver of therapy selection, although cost is a leading secondary consideration—54% said patient out-of-pocket burden was a secondary consideration and 48% flagged overall cost of therapy for secondary consideration.

The oncology ecosystem is in the midst of a number of large-scale experiments around aligning care to value,2

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KEY FINDINGS FROM THE 2018 GENENTECH ONCOLOGY TREND REPORT SURVEY

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which we will track closely. Examples include the Oncology Care Model (OCM), which is part of a general move away from the fee-for-service (FFS) model toward value-based care; and the Merit-based Incentive Payment System (MIPS) for Medicare, which started to roll out this year and is part of the new Quality Payment Program (QPP) that began in 2017.3 To date, the impact of these programs has been limited though it is still early. For example, for those oncologists we surveyed who are participating in OCM, just over a third reported an improvement in cost and quality of care (36% for cost, 39% for quality) while half of oncology practice managers (OPMs) see an improvement in cost and nearly two thirds see a benefit in quality from OCM (49% and 64%, respectively).

THE NATURE OF PRACTICING ONCOLOGY IS CHANGINGIn our survey, oncologists continue to report a growing patient load with 20% citing increases in patient volume as adding to their workload. In this context, 57% of oncologists reported an increase in patient volume over the past 12 months, 8% reporting at least a 10% increase in patient volume. At the same time, oncology practices are offering more services: for example, case navigators and screening services have become almost universal. Practice reorganization is significantly reshaping the landscape: 90% of OPMs reported having recently reorganized or are considering doing so in the next two to three years.

Physicians are also more burdened by administrative tasks stemming from managing electronic health records (EHRs), which create extra reporting requirements but don’t necessarily deliver on all their promises. There are challenges with data interoperability, with more OPMs reporting using EHRs that are interoperable with practices but not with hospitals. Practices are also migrating to more comprehensive care management solutions.

Oncology’s rapid innovation also means there is significant complexity, which has driven more specialization—over a third of oncologists (38%) reported specializing in specific tumor types. This has been accompanied by greater utilization of multidisciplinary tumor boards that support individual clinician judgments: nearly a third of oncologists send half or more of their patients to these boards. Going further, we find that three-quarters of oncologists are eager to supplement their own judgment with advanced analytics tools that provide data transparency on how “patients like mine” respond to a specific drug regimen during clinical trials or in real-world settings.

PRIORITIES FOR THE FUTUREAll stakeholders feel that there has been substantial innovation in the oncology space over the past decade, but it has come with tremendous pressure on costs across the system. However, the top priorities for 2018 differed significantly across stakeholders. For managed care organizations (MCOs), top priorities were to reduce/control costs and to improve quality. Employers prioritized prevention, and said that their top initiatives were to increase cancer screening and to adopt employee wellness programs. OPMs described their top priorities as improving patient satisfaction, increasing volume of patients, and improving the quality of care. Finally, specialty pharmacies (SPs) prioritized growth.

All stakeholders agreed that better drugs and therapies were one of the top changes in cancer care over the past decade. In the coming decade, stakeholders were excited about new cancer therapies with the continued adoption and development of personalized medicine, immunotherapies, and ultimately cures for cancer.

In terms of the biggest negative changes in cancer care, cost was top of mind for all stakeholders. However, while oncologists and OPMs specifically cited rising cancer drug costs as the biggest negative change over the past decade, MCOs reported that the rising cost of cancer care (as a whole) was the biggest negative change. Rising costs are also something that all stakeholders worry about for the coming decade, although oncologists, OPMs, and SPs additionally cited increased reimbursement difficulties as a further top concern.

Oncology today has benefited from tremendous innovation in new therapeutics and diagnostics,4 but ultimately it may be the innovation in how care is delivered and reimbursed that enables quality care to be delivered sustainably to all cancer patients in America over the coming decade.

EHR, Electronic Health Record; FFS, Fee-For-Service; MIPS, Merit-based Incentive Payment System; OCM, Oncology Care Model; QPP, Quality Payment Program; OPM, Oncology Practicer Manager; MCO, Managed Care Organization; SP, Specialty Pharmacy.

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METHODOLOGY

2018 GENENTECH ONCOLOGY TREND REPORT METHODOLOGYThe 2018 Genentech Oncology Trend Report is sponsored by Genentech, a member of the Roche Group.

SURVEY DEVELOPMENTSurveys were developed to collect information from five core stakeholder groups in the United States that are responsible for the delivery and coverage of quality cancer care: managed care organizations, specialty pharmacies, oncologists, oncology practice managers, and employer health benefit sponsors.

Survey questions across the stakeholders primarily investigated the policies and services delivered by these organizations and medical practices during 2016 and 2017, and possible changes forecast for 2018 and beyond. Occasional qualitative survey questions asked stakeholders to think about policies and services over a longer timeframe (such as questions asking participants to reflect on the past ten years). Questions also required quantitative information related to purchase, coverage, and reimbursement of types of cancer agents. Surveys are updated each year to reflect changes in cancer care. This year, almost all survey questions were reworked to increase clarity. Further, several new survey questions were introduced, and a number of less relevant questions were retired.

RECRUITMENT AND FIELDINGPotential participants in the United States were sent information about the research study and the time frame for responding via email. They were assured that individual survey information and responding company and participant names would be held in strict confidence, and the final report would reflect blinded and aggregated data. Those who agreed to participate were directed to a web-based survey. The five surveys were in the field on an overlapping schedule from the fourth week of November to mid-December 2017. Respondents had to meet specific screening criteria to ensure they had the experience to respond to the survey and to ensure the integrity of their responses. Managed care organization respondents were screened based on organization type, line of business information, role, mandatory pharmacy and therapeutics committee involvement, as well as mandatory

oncology medical policy or care coverage decision-making involvement. Oncologists were screened based on mandatory oncology medical specialty (no primary care physicians, cardiologists, and so on, who are tangentially involved in cancer care). Oncology practice managers were screened based on role. Specialty pharmacy respondents were screened based on organization type and role. Employer health benefit sponsor respondents were screened based on role, number of employees in the workforce (minimum of 1,000 employees), mandatory involvement in determination of employee health benefits offered by the company, and mandatory self-insured status for either medical or pharmacy benefit. Honoraria were paid to those who submitted a completed survey.

Some of the same respondents in each stakeholder group may participate from year to year. However, each year’s sample is considered independent of the previous year’s sample. Given significant changes to the survey for this tenth edition, there was a change in the external agency retained to recruit participants, which likely introduces a greater change in the degree of overlap of responding survey participants as compared with previous years.

DATA ANALYSIS AND REPORTINGAll data were blinded and aggregated across the entire sample of respondents, as well as by specific demographic characteristics, as applicable. The data are general and did not include information about specific cancer therapies. Survey responses could not be independently verified for accuracy regarding actual operations and practices in place across the stakeholder groups represented.

The Oncology Trend Report editorial board reviewed the data analyses, resulting interpretations, and the final manuscript. Any statements and opinions contained within the report reflect the responses of the survey participants and do not necessarily reflect those of Genentech or the editorial board.

9MCO, Managed Care Organization; P&T, Pharmacy and Therapeutics

DEMOGRAPHICS

MANAGED CARE ORGANIZATIONBetween November and December 2017, 100 MCO representatives completed a survey that collected information about their organization. All survey respondents passed specific screening criteria, such that only MCO representatives who were involved in drug formulary decision making and oncology medical policy or care coverage decision making were included in the survey. Half (47%) of the survey respondents were voting members of their plan’s P&T committee; 85% of respondents were director-level or above in their organization, with 38% of respondents serving as either a pharmacy director (15%) or medical director (23%).

EXHIBIT

MANAGED CARE ORGANIZATION

POSITION WITHIN MCO% of survey respondents, N=100

1

Executive

Medical director

Pharmacy director

Clinical pharmacist/clinical program manager

Other

47%

23%

15%

11%

4%

EXHIBIT


MCOs WHO SERVE MEMBERS IN THE FOLLOWING REGIONS% of survey respondents, N=100

3

West28%

Midwest16%

National31%

South23%

Northeast16%

EXHIBIT


MCO ENROLLMENT DISTRIBUTION BY LINE OF BUSINESS AND TYPE OF BENEFIT% of survey respondents, N=100

2

Medical BenefitPharmacy Benefit

Commercial (fully insured)

Commercial (employer-sponsored/self-insured)

Exchange (ie. state health insurance exchange)

Managed Medicaid

Medicare Advantage

Responsibility to a PBM

Other (Indemnity, TRICARE, VA…etc.)

24%

29%

14%

22%

8%

16%

21%

16%

12%

20%

9%

6%

3%

10 HR, Human Resources.

EMPLOYERBetween November and December 2017, 101 employer representatives from self-insured employers with more than 1,000 employees completed a survey that collected information about their employer. All survey respondents passed specific screening criteria, such that only employer representatives who were involved in employee benefit decision making were included in the survey. The majority (85%) of survey respondents worked in HR, with 41% working in employee benefits. There was a roughly even split between employers with 1,000-5,000 employees (47%) and employers with more than 5,000 employees (53%).

EXHIBIT

EMPLOYER

LEVEL OF INVOLVEMENT IN THE DETERMINATION OF BENEFITS% of survey respondents, N=101

4

Determine the benefit design features and spending level for the health benefit plans that will be sponsored by the company

69%

Work directly with insurers, brokers, health plans, PBMs, and/or wellness vendors to request/review bids/proposals

67%

Sit on the compensation/benefits committee, which determines compensation and benefit strategies

66%

Administer the health benefit offerings approved by senior management 49%

Union negotiation and/or involvement in benefit design 36%

EXHIBIT

EMPLOYER

POSITION WITHIN EMPLOYER% of survey respondents, N=101

5

41%Manager/Director/VP Employee Benefits

Manager/Director/VP Human Resources/Personnel 34%

Manager/Director/VPTalent Management, Staffing, Diversity, or related 6%

Manager/Director/VP Wellness, or related 5%

Consultant 4%

Other 11%

EXHIBIT 7

ONCOLOGIST

ONCOLOGISTS WHO TREAT PATIENTS IN THE FOLLOWING REGIONS% of survey respondents, N=200

West27%

Midwest26%

South32%

Northeast35%

EXHIBIT 6

ONCOLOGIST

ONCOLOGIST AGE% of survey respondents, N=200

45 to 54

55 or older

44 or younger30%

35%

35%

ONCOLOGISTSBetween November and December 2017, 200 oncologists completed a survey that collected information about themselves and their practice. All survey respondents passed specific screening criteria, such that only physicians who specialized in oncology were included in the survey (no primary care physicians, cardiologists, and so on, who are tangentially involved in cancer care). The majority (62%) of oncologists surveyed practiced general oncology, and the rest (38%) specialized in treating a specific tumor type. On average, oncologists worked in a practice with 5 practice sites that employed 22 oncologists. Academic/medical center-based oncology practices employed a higher average number of oncologists (37) compared to community-based (10) or hospital-based (8) practices.

11CEO, Chief Executive Officer.

ONCOLOGY PRACTICE MANAGERBetween November and December 2017, 202 oncology practice managers completed a survey that collected information about their practice. The overwhelming majority (90%) of OPMs surveyed were practice/executive administrators or CEOs, and worked in a multisite oncology outpatient operation (75%). On average, the oncology practices of the OPMs surveyed have 8 sites and employ 23 oncologists.

EXHIBIT

ONCOLOGY PRACTICE MANAGER

OPMs WHOSE PRACTICES ARE IN THE FOLLOWING SETTINGS% of survey respondents, N=202

9

Single practice of a single-site oncology outpatient operation 25%

Single practice of a multi-site oncology outpatient operation 23%

More than one practice of a multi-site oncology outpatient operation 27%

All practices of a multi-site oncology outpatient operation 25%

EXHIBIT 8

ONCOLOGIST

ONCOLOGIST PRACTICE SETTING% of survey respondents, N=200PRACTICE SETTING % OF SAMPLES MEAN NUMBER OF SITES MEAN NUMBER OF ONCOLOGISTS

COMMUNITY-BASED 38% 5 10

Community-based solo private practice 4% 3 2

Community-based group private practice 34% 5 11

HOSPITAL-BASED 14% 3 8

Hospital-owned, non-academic practice 8% 3 7

Hospital-integrated private practice 6% 3 9

ACADEMIC/MEDICAL CENTER-BASED 48% 6 37

Physician-owned (private) 7% 6 15

Hospital/institution-owned 41% 6 40

EXHIBIT


OPMs WHOSE PRACTICES ARE IN THE FOLLOWING REGIONS% of survey respondents, N=202

10

West31%

Midwest17%

South34%

Northeast53%

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SPECIALTY PHARMACYThirty representatives from specialty pharmacies with $1 million or more of annual revenue completed a survey between November and December 2017. More than half (58%) of survey respondents were director level or above; 37% of survey respondents held a pharmacy role with 27% being pharmacy directors and 10% being pharmacy managers; 33% of survey respondents worked for an independently owned speciality pharmacy, 10% worked for a speciality pharmacy owned by a retail pharmacy chain, and 37% worked for a speciality pharmacy owned by a hospital/hospital system. On average, the specialty pharmacies of the survey respondents treated 8,919 patients in 2016, of which 4,152 were cancer patients.

EXHIBIT

SPECIALTY PHARMACY

11

POSITION WITHIN SP% of survey respondents, N=30

President

Vice President

Pharmacy Director

Other Director (e.g., Clinical Services)

Clinical staff

Other

Pharmacy Manager

17%

27%

7%

7%

23%

10%

10%

EXHIBIT

SPECIALTY PHARMACY

TOTAL REVENUES FROM SP OPERATIONS IN 2016% of survey respondents, N=30

13

More than $500M

$100-500M

$20-100M

$5-20M

$1-5M

Note ranges are non-inclusive of the bound (e.g., between $5M and less than but not equal to $10M)

10%

33%

30%

17%

10%

EXHIBIT

SPECIALTY PHARMACY

SP OWNERSHIP% of survey respondents, N=30

12

Independent

Managed health plan

Retail pharmacy chain

Group purchasing organization (GPO)

Home health care company

Integrated health care delivery system/accountable care organization

Hospital/hospital system 37%

33%

10%

10%

3%

3%

4%

EXHIBIT

SPECIALTY PHARMACY

SPs WHO SERVE PATIENTS IN THE FOLLOWING REGIONS% of survey respondents, N=30

14

West23%

Midwest30%

National27%

South13%

Northeast17%

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I. WHERE AND HOW IS ONCOLOGY CARE PROVIDED?

There is growing demand for oncology services accompanied by increasing spend and a shift in the patient payer mix toward Medicare. Accordingly, the survey looked at multiple aspects of oncology care, ranging from overall demand and spend, through oncologist specialization, to practice reorganization, digitization, and employer approaches to managing spend. Increased demand plus a greater administrative burden are inevitably boosting oncologists’ workloads (and income), while practices are responding to demand by extending business hours and expanding patient contact beyond traditional visits. Nevertheless, despite attempts by practices to keep pace with higher demand, patients are experiencing rising delays in obtaining appointments.

CONTENTSOncologist Workload ................................................................................................................................................................................

Oncologist Specialization ........................................................................................................................................................................

Practice Reorganization ...........................................................................................................................................................................

Digitization ..................................................................................................................................................................................................

Patient Payer Mix .......................................................................................................................................................................................

Cancer Spend ............................................................................................................................................................................................

Employer Cancer Focus ...........................................................................................................................................................................

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17

18

19

21

23

25

1 As reported by OPMs

From 2016 to 2017, MCO pharmacy benefit cancer

spend grew by

12%

From 2016 to 2017, MCO medical benefit cancer spend

grew by

13%

ONCOLOGIST INCOME RISING

40%of the oncologists expect their income to increse in 2018

ONCOLOGIST WORKLOAD INCREASING

63%of the oncologists experienced an increase in workload last year

PRACTICES GOING DIGITAL

97%of oncology practices use electronic health records1

14

In our survey, oncologists are reporting their workload to be greater than ever as patient volumes rise. At the same time, incomes are also climbing. In response to their increased workload, oncologists are starting to work later hours and more weekends, while practices are extending their opening hours. Despite this, the growing workload is being accompanied by longer delays for appointments.

WORKLOAD CONTINUES TO CLIMBOncologists have reported an increase in personal workload for five years in a row. A greater percentage of oncologists than ever before reported an increase in personal workload this year (63%), with 8% of oncologists saying that personal workload has increased significantly; only 1% of oncologists said that workload has decreased significantly.

The most commonly cited driver of workload (reported by 26% of oncologists) was paperwork/administrative duties (such as increased administrative tasks stemming from managing electronic health records). This was followed by increases in patient volume (20%) and changes in payment models (11%). This is consistent with the fact that 57% of oncologists reported an increase in patient volume in the past 12 months—with 8% of oncologists reporting at least a 10% increase in patient volume. On average, oncologists reported seeing close to a hundred patients (13 new patients, 55 established patients undergoing treatment, and 26 post-treatment survivorship patients) per week.

ONCOLOGIST WORKLOAD

EXHIBIT 15

ONCOLOGIST

CHANGES IN PERSONAL WORKLOAD: 5-YEAR TRENDSurvey question: How has your personal workload changed over the past 12 months?% of survey respondents

Decreased IncreasedNo change

2013 (N=200)

2014 (N=200)

2015 (N=205)

Study year

2016 (N=202)

2017 (N=200)

55%

36%

10%

48%

40%

13%

57%

35%

8%

49%

44%

7%

63%

30%

8%

EXHIBIT 16

ONCOLOGIST

ONCOLOGISTS WHO REPORTED AN INCREASE IN PERSONAL WORKLOAD OVER THE PAST 12 MONTHS% of survey respondents

63%+14% COMMONLY CITED DRIVERS OF WORKLOAD% of survey respondents

2016 study year

(N=202)

2017 study year

(N=200)

49%

Paperwork/Admin

Patient volume

Payment model

Clinical trials

New therapies

20%

11%

3%

26%

3%

EXHIBIT 17

ONCOLOGIST

AVERAGE NUMBER OF PATIENTS ONCOLOGISTS SAW IN A TYPICAL WEEKAverage # patients, N=200

Upper quartile

Lower quartileMedian MeanXX

1210

5

13

55

40

22

70

New patients per week

Established patients per week (treating)

Survivorship patients per week (post-treatment)

10

20

3026

60

50

40

30

20

10

70

94average number of patients oncologists see per week.

15

APPOINTMENT DELAYS INCREASINGInevitably, this growing workload is translating into longer delays for appointments: other than for new patients, the lead time for patient appointments has increased by one to two days, with oncology practice managers (OPMs) reporting that their practice requires an eight-day lead time for existing patients (compared with a six-day lead time in the 2016 study year). Likewise, the average lead time required for an infusion center appointment increased from five to six days this year, and the average lead time to make a survivorship program appointment increased from seven to eight days.

PRACTICES EXTEND OPENING HOURSAs workload and patient volumes increase, oncology practices are starting to hire more support staff (see Section II “Practice Staffing”) and oncologists are starting to work later hours and more weekends. For example, in the 2016 study year, roughly 20% of OPMs reported that their practice was open for more than five days a week for patient visits, and 24% for infusion services. This year, 45% of OPMs reported offering weekend patient visits and 55% reported offering weekend infusion services.

Meanwhile, there is a trend for practices to be open later in the day for visits with an oncologist, nurse practitioner, or physicians assistant: 53% of OPMs reported closing at 5 p.m. or earlier—a three-percentage-point decrease from the 2016 study year’s 56%; meanwhile, there has been a five-percentage-point increase in the share of OPMs who reported their practice being open until 6 p.m. or later (49% this year versus 44% in the 2016 study year).

EXHIBIT


AVERAGE LEAD TIMES FOR PATIENT APPOINTMENTSAverage # days

19

2016 study year (N=201) 2017 study year (N=202)

11 11

New patients

68

Established patients

5 6

Infusion center visit

7 8

Survivorship program care

INCOMES RISINGEqually, however, the increased workload was accompanied by an increase in individual net income for oncologists: 33% of oncologists estimated that their net income increased over the past year, with 12% estimating that their net income increased by at least 10%. Further, 40% of oncologists predicted an increase in their net income over the next year, with 14% predicting an increase of at least 10%.

EXHIBIT 18

ONCOLOGIST

DIRECTION OF INDIVIDUAL NET INCOME CHANGE REPORTED BY ONCOLOGISTS OVER THE PAST YEAR AND ANTICIPATED OVER THE NEXT YEAR% of survey respondents, N=200

Reported change in net income was negative (a decrease) Reported change in net income was positive (an increase)Reported no change in net income

Last year

Next year

334126

403624

6 vs 8 DAYS average number of days it takes for an existing patient to make an appointment with their oncologist (2016 study year vs 2017 study year)

49%of oncology practices don’t close until 6 p.m. or later

16

However, there seems to be a limit to how far practices are prepared to extend their opening hours to meet increased demand: the percentage of OPMs who reported that their practice were open at 7 p.m. or later remained unchanged from the 2016 study year (21%).

EXPANDED PATIENT CONTACTPractices are expanding patient contact outside of scheduled visits; almost three-quarters of OPMs reported undertaking initiatives to expand patient contact outside of scheduled visits. This was manifested in a variety of ways: 41% of OPMs reported increased contact with patients via EHR portals; 32% reported increased communication by text and email; and 29% reported hiring or assigning staff to proactively contact patients at predetermined points during treatment.

EXHIBIT 20ONCOLOGIST AND OPM RESPONSES TO INCREASED WORKLOAD

ONCOLOGIST

HOURS WORKED IN A TYPICAL WEEKAverage # hours




53 55

Total hours worked

EXTENDED PRACTICE HOURS% of respondents

45%

Offer patient visits on the weekend

55%

Offer infusion services on

the weekend

44% 49%

Close after 6 p.m.

63%

77%

Employ advanced practice providers

EXHIBIT


INITIATIVES BEING USED TO EXPAND PATIENT CONTACT OUTSIDE OF SCHEDULED VISITS

21

% of survey respondents

2016 study year (N=72)

2017 study year (N=202)

Hired staff for outreach to targeted patients deemed at high risk of complications due to disease/stage/treatment

Instituted/expanded weekend hours to accommodate walk-ins and urgent/sick care visits*

Using secure text message responses involving standardized follow-up queries to reduce number of follow-up telephone calls*

Have not undertaken any initiatives*

Increased contact via patient portal linked to EHR

Increased email and text communication

Hired/assigned staff for proactive outbound patient contact at predetermined points during treatment

Expanded schedule to accommodate walk-ins and urgent/ sickcare visits

Extended weekday hours to accommodate walk-ins and urgent/sick care visits

Designated set times during workflow to manage patient contact

Hired outsourced service for proactive outbound patient contact at predetermined points during treatment

16%

15%

23%

21%

16%32%

41%44%

32%40%

29%44%

25%32%

19%38%

7%24%

* denotes new questions for 2017 study year

3/4OPMs reported taking initiates to expand patient contact outside of scheduled visits

EHR, Electronic Health Record.

17

ONCOLOGIST SPECIALIZATION

A trend towards specialization over the past five years sees patient mixes becoming more concentrated.

PATIENT MIX MORE CONCENTRATED ON SPECIFIC TUMOR TYPESOver a third of oncologists (38%) reported specializing in specific tumor types, and a trend towards specialization over the past five years has seen 40% of general oncologists (and 64% of specialized oncologists) report that their mix of patients has become more concentrated in certain tumor types.

Only 6% of general oncologists (and 1% of specialized oncologists) reported that they are treating a wider mix of tumor types; the remainder (54% of general oncologists and 35% of specialized oncologists) reported that their mix of patients by tumor type stayed roughly the same. Among oncologists who specialized in a single tumor type, the most common specialty was breast cancer (20%), followed by lung cancer (14%), leukemia (9%), and lymphoma (9%).

ONCOLOGISTS ARE SPECIALIZING

5 out of 10 oncologists are becoming more specialized

4 out of 10 oncologists specialize in specific tumor types

EXHIBIT 22

ONCOLOGIST

ONCOLOGIST TUMOR SPECIALIZATION% of survey respondents, N=200

Practice general oncology Specialize in specific tumor types

TOP 5 SPECIALIZATIONS% of survey respondents, N=76

Breast

Lung

Leukemia

Lymphoma

Colon

20%

14%

9%

9%

8%

62% 38%

EXHIBIT 23

ONCOLOGIST

ONCOLOGISTS REPORT BECOMING MORE SPECIALIZED OVER THE PAST 5 YEARS% of survey respondents

Becoming more generalized Becoming more specialized

Overall (N=200)

Specialists (N=76)

Academic/medical center-based (N=97)

Community-based (N=75)

Generalists (N=124)

4%

6%

49%

64%

53%

45%

40%

1%

4%

4%

18

Practice reorganization is nearly ubiquitous amongst practices surveyed for this report. Many practices have or are planning to merge with other practices.

PRACTICE REORGANIZATION IS TOUCHING MOST PRACTICESNine in ten OPMs reported having recently reorganized or are considering doing so in the next two to three years—66% of OPMs surveyed have already implemented a reorganization strategy in the past two to three years, while 73% will consider a reorganization in the next two to three years.

Many of these practice reorganizations are resulting in more consolidated practices. 38% of OPMs who recently reorganized reported combining with another community practice and 26% reported selling their practice to a hospital or academic center. Further, about half (48%) of OPMs who are planning to reorganize in the next two to three years will combine with another community practice and 41% plan to sell their practice to a hospital or academic center.

PRACTICE REORGANIZATION

EXHIBIT


ONCOLOGY PRACTICE REORGANIZATION% of survey respondents, N=202

24

REORGANIZATION STRATEGIES IMPLEMENTED IN THE PAST 2-3 YEARS% of survey respondents, N=134

REORGANIZATION STRATEGIES UNDER CONSIDERATION OVER NEXT 2-3 YEARS% of survey respondents, N=148

Integrate or enter a joint venture with a hospital/academic center

Affiliate with a group purchasing organization

Join/restructure as an oncology medical home

Join or combine with another community practice

Sell practice to a hospital/academic center

Join/restructure as an oncology accountable care organization (ACO)

Affiliate with a practice management organization

54%

63%

16%

38%

26%

29%

16%

OPMs who have not

reorganized and are not considering

one

OPMs who will consider a re-org in

the next 2-3 years

OPMs who have already implemented a re-org in the last 2-3 years

10%

73%

66%

Integrate or enter a joint venture with a hospital/academic center

Affiliate with a group purchasing organization

Join/restructure as an oncology medical home

Join/restructure as an oncology accountable care organization (ACO)

Sell practice to a hospital/academic center

Join or combine with another community practice

Affiliate with a practice management organization

66%

32%

43%

44%

41%

48%

36%

66%of oncology practices re-organized between 2014–20171

PRACTICES ARE CONSOLIDATING


ACO, accountable care organization

19COE, Center Of Excellence; EHR, Electronic Health Record.

As electronic health records (EHR) usage becomes ubiquitous, oncology practices are trending towards a less siloed approach by adopting record systems that can share data between practice sites.

ELECTRONIC RECORDS NEAR UBIQUITOUSEHR usage has become nearly ubiquitous: 97% of OPMs reported that their practice used EHRs compared with 84% in the 2016 study year. Of those OPMs in an oncology practice using EHR, fewer have reported that their practices are using oncology-specific EHRs (43% versus 58% in the 2016 study year)—this suggests that oncology practices are migrating to more comprehensive care management solutions.

HOSPITAL INTEROPERABILITY DECLININGAt the same time, more oncology practice managers are reporting using EHRs that are interoperable with other practice sites, but not interoperable with hospitals. Of those practices using EHRs, the majority (70%) of OPMs reported using an EHR that is interoperable across multiple sites within a practice (up from 58% in the 2016 study year); additionally, a third reported using an EHR that is interoperable with other oncology practices. However, there has been a significant decline in EHR systems that are interoperable with hospitals. Only 10% of OPMs reported using an EHR interoperable with area hospitals, compared with the 2016 study year’s 34%; additionally, just 1% of OPMs reported using an EHR interoperable with out-of-area hospitals and centers of excellence (COEs) compared with 17% in the 2016 study year.

EXHIBIT


ONCOLOGY PRACTICES THAT USE ELECTRONIC HEALTH RECORDS

25

Use an oncology-specific EHR 2016 study year (N=104) 2017 study year (N=196)

2016 study year

(N=168)

2017 study year

(N=202)

58%

26%

84%

97%

43%

54%

% of survey respondents that use EHRs

58%

70%

29%33%

17%

1%

10%

Across multiple sites within a specific

practice

With other oncology practices

With out-of-area hospitals and COEs

With area hospital(s) outside of practice

34%

EHR INTEROPERABILITY (I.E., DATA EXCHANGE CAPABILITY) WITH OTHER DEPARTMENTS AND PRACTICES

DIGITIZATION

97%of oncology practices use electronic health records1

PRACTICES GOING DIGITAL


34% vs 10%the % of practices whose EHR is interoperable with area hospitals (2016 study year vs 2017 study year)

20

THE AGE FACTORThe physician’s age is influential in the choice of communications medium: younger oncologists (those under 45 years old) used

patient portals much more frequently than older oncologists (those over 55 years old), but older oncologists used email more frequently than younger oncologists. Interestingly there was little difference in usage of telemedicine or text messaging to communicate with patients between younger and older oncologists.

OPM EXPECTATIONSOPMs seem to have higher expectations for digital communication compared with oncologists’ reported usage, suggesting that OPMs are overly optimistic about practice digitization progress. On average, OPMs thought that a higher percentage of patients interacted digitally with practice physicians compared with the level that was reported by oncologists, and this was consistent across all digital communication channels surveyed:

• For instance, OPMs on average believed that 36% of patients used a patient portal to communicate with physicians—compared with 31% reported by oncologists.

• OPMs on average believed that 26% of patients used secure email to communicate with physicians—compared with 19% reported by oncologists.

• OPMs report that twice as many patients interact with oncologists using telemedicine (10% of OPMs versus 5% of oncologists) or texting (12% of OPMs versus 5% of oncologists) compared with what oncologists reported.

EXHIBIT 26ONCOLOGIST

DIGITAL PATIENT COMMUNICATION BY AGE OF ONCOLOGIST% of patients who communicate with their oncologists using one of the following modalities

under 45 (N=71)45-54 (N=70)55 and up (N=59)

Patient portal Secure email Telemedicine Texting

38%

30%25%

17%18%22%

6%4% 5% 6%3%

8%

Age of oncologist:

EXHIBIT 27

ONCOLOGIST ONCOLOGY PRACTICE MANAGER

OPM VS ONCOLOGIST PERCEPTION OF DIGITAL COMMUNICATION CHANNELS USE BY THEIR PATIENTSAverage of responses provided by survey participants

Oncologists (N=200) OPMs (N=202)

Patient portal Secure email Telemedicine Texting

31%

36%

19%

26%

5%

10%

5%

12%

OPMs report

2X as many patients interact with oncologists using telemedicine or texting compared with what oncologists reported

21ACA, Affordable Care Act.

The patient payer mix is trending from commercial to Medicare, creating a favorable environment for practices serving Medicare patients. The picture is less rosy for those practices serving primarily commercial patients—both because the patient payer mix is shifting away from traditional commercial plans and because commercial payers are increasing pressure to clamp down on cost (for example, through utilization of narrow networks).

SHIFTING PATIENT PAYER MIXWith aging populations and the introduction of Affordable Care Act (ACA) health exchanges, the patient payer mix has shifted from commercial payers to Medicare and health insurance exchanges.

Over the period 2012–17, OPMs reported that the percentage of their practice’s patients with commercial insurance decreased from 40% to 36%. However, this decrease happened alongside the emergence of patients using health insurance exchanges (4% of patients), so it is likely that many patients who were previously reported as using commercial insurance are now being reported as using health insurance exchanges.

There was also a very slight increase in the percentage of patients using Medicare—which rose from 43% in the 2016 study year to 45% this year.

REVENUE IMPLICATIONSThere have been differential trends in revenue for practices depending on their payor mix. OPMs whose practices serve primarily Medicare patients were 8 percentage points more likely to say that their practice revenue was expected to increase in 2017 over 2016 compared with OPMs in practices serving primarily commercial patients:

• 47% of OPMs in practices serving primarily Medicare patients (31% of all OPM survey respondents) reported an expected increase in revenue over the period 2016–17; only 39% of OPMs whose practices serve primarily commercial patients (15% of OPM respondents) reported an expected increase.

• In contrast, 35% of practices that serve primarily commercial patients expected a revenue decrease compared with only 26% of practices that serve primarily Medicare patients.

PATIENT PAYER MIX

EXHIBIT


PATIENT PAYER MIX% of patients

28


40%36%

11% 9%

43% 45%

4%<2.5% 3%

Commercial MedicaidMedicare Health insurance exchange

Charitable Care / Other

4% 3%

Self-pay/ cash pay

22

However, it’s important to keep in mind that practices that serve primarily commercial patients likely have a higher revenue baseline in comparison with practices that serve primarily Medicare patients. Thus, even though practices that serve primarily commercial patients were more likely to report an expected decline in revenue, this doesn’t indicate that practices serving primarily Medicare patients now have higher revenues than practices serving primarily commercial patients.

NARROW NETWORKSMeanwhile, payers are using narrow networks to control costs—with practices that serve mostly commercial patients being most affected. More than half of OPMs reported encountering narrow-network exclusions.

However, there are some regional differences for narrow-network exclusion prevalence: the northeast region seems to have the highest penetration of narrow networks, with 58% of OPMs reporting exclusions from narrow networks; the south appears to have the lowest penetration, with 46% of OPMs reporting exclusions from narrow networks.

It seems like practices that serve primarily commercial patients are affected disproportionately more—65% of OPMs that primarily serve commercial patients said that they were affected by narrow-network exclusions versus 52% of practices that serve primarily Medicare.

EXHIBIT


CHANGE OVER THE PAST YEAR IN PRACTICE REVENUE IN PREDOMINANTLY MEDICARE VS COMMERCIAL PRACTICES% of survey respondents

29

Mostly (>50% patients) Medicare practices (N=62) Mostly (>50% patients) commercial practices (N=31)

26%35%

27% 26%

47%39%

DecreaseNo changeIncrease

EXHIBIT


EXCLUSION FROM PAYERS’ “NARROW-NETWORKS”% of survey respondents

30

Mostly (>50% patients) Medicare (N=62)Mostly (>50% patients) Commercial (N=31)

48%

35%42%

52%

10% 13%

Not excluded; we can accept nearly any patient with

insurance

Excluded for a small number (1-20%) of covered lives in our

catchment area

Excluded for a significant

number (>20%) of covered lives in our

catchment area

EXHIBIT


NARROW-NETWORK EXCLUSION BASED ON PRACTICE GEOGRAPHY% of survey respondents

31

Midwest (N=30) Northeast (N=53) West (N=55)South (N=64)

43% 42%

55%49%

53%49%

38%44%

3%9% 8% 7%

No, we can accept nearly any patient with insurance

Yes, for a small number (1-20%) of covered lives in our catchment area

Yes, for a significant number (>20%) of covered lives in our catchment area

>50% of oncology practices have encountered narrow-network exclusions

23

The spend on cancer is already high and growing—the largest portion of medical spend was on drugs and drug administration. Meanwhile, the vast majority of specialty pharmacies report that cancer drugs represent over a fifth of their revenues. Overall, growth in spend on cancer drugs is accelerating.

CANCER MAKING UP A SIGNIFICANT PROPORTION OF HEALTHCARE COSTSOverall, approximately 16% of employer healthcare costs were for cancer treatments. Among managed care organizations, average cancer medical benefit spend grew by an average of 13% from 2016 to 2017, and made up an average of 19% of MCOs’ overall medical benefit budget.

CANCER DRUGS MAKE UP ABOUT A FOURTH OF MCO MEDICAL BENEFIT SPENDOn average, MCOs reported that 26% of MCO medical benefit spend was on drugs and drug administration. Spend on drugs is growing at a pace in line with overall cancer spend—pharmacy benefit cancer drug spending grew by an average of 12% between 2016 and 2017, and medical benefit cancer drug spending grew by an average of 14% between 2016 and 2017 (compared with an average 13% year-on-year growth in overall cancer medical benefit spend).

CANCER SPEND

OVERALL SPEND ON CANCER IS GROWINGFrom 2016 to 2017, MCO pharmacy benefit

cancer spend grew by

12%From 2016 to 2017, MCO medical benefit cancer

spend grew by

13%

EXHIBIT

EMPLOYER

PERCENT OF HEALTHCARE BUDGET REPRESENTED BY CANCERAverage % of budget

32


1 % of healthcare costs related to cancer treatments

MCO pharmacy

benefit (N=79)

Employers1 (N=101)

MCO medical benefit (N=93)

19%

21%

16%

Drug and drug administration

Physician and clinical services (i.e., non-drug)

Inpatient hospital care

Radiation therapy

Imaging

Cancer care (i.e., condition) management programs

Palliative care and hospice

Molecular/biomarker testing

Genetic testing and genetic counseling in oncology

Cancer survivorship program care

All other services

BREAKDOWN OF TOTAL MEDICAL BENEFIT CANCER SPEND

Average % of spend

19%

17%

9%

26%

7%

5%

5%

4%

3%

2%

3%

24

GROWTH IN CANCER SPEND IS REFLECTED IN SPECIALTY PHARMACY (SP) ONCOLOGY REVENUEAbout three-quarters of specialty pharmacies reported that more than 20% of their total revenues came from cancer drugs in 2016. At the same time, two-thirds (67%) of specialty pharmacies reported more than 10% revenue growth from dispensing cancer drugs.

EXHIBIT


33

Pharmacy benefit Medical benefit

CANCER DRUG SPENDING GROWTH RATEAverage % growth

1 Assessed by survey fielded in Q3 2016 and reflects MCO perception of year-over-year growth in spending, based on the information they have to date within 20162 Assessed by survey fielded in Q3 2016 and reflects MCO perception of year-over-year growth in spending, based on the information they have to date within 20163 Assessed by survey fielded in late Q4 2017 and reflects MCO perception of year-over-year growth in spending, based on the information they have to date within 2017

14%

20151 (N=103)

20162 (N=103)

20173 (N=100)

12%

14%

17%

12%

14%

EXHIBIT

SPECIALTY PHARMACY

PERCENT OF TOTAL REVENUES THAT CAME FROM CANCER DRUGS IN 2016% of survey respondents, N=30

34

81-100%

61-80%

41-60%

21-40%

1-20%

7%

6%

16%

47%

23%

EXHIBIT

SPECIALTY PHARMACY

YEAR-OVER-YEAR GROWTH (2017 VS 2016) IN REVENUE FROM DISPENSING CANCER DRUGS% of survey respondents, N=30

35

Increased 91-100%

Increased 41-50%

Increased 31-40%

Increased 21-30%

Increased 11-20%

Increased 1-10%

No change

Negative 1-10%

3%

7%

10%

13%

30%

23%

3%

7%

25PBM, Pharmacy Benefit Manager.

Most employers aren’t using any special tactics for managing cancer spend, and need help understanding alternative payment models.

MAJORITY OF EMPLOYERS OPT NOT TO EMPLOY SPECIAL MEASURES TO CONTROL ONCOLOGY SPEND Few employers reported using special tactics to manage cancer spend. Last year (2016 study year), 30% of employers adopted special benefit designs for cancer care, but this year (2017 study year) just 22% of employers did so. Even fewer employers reported taking special measures to control cancer drug costs (likely due to the fact that drug spend makes up just a fraction of cancer spend)—only 15% of employers reported using a separate PBM for specialty drugs and only 8% contract directly with oncology drug manufacturers.

EMPLOYER CANCER FOCUS

In 2016, 30% of employers adopted special benefit designs for cancer

care, but in 2017 just 22% of employers did so.

EXHIBIT

EMPLOYER

36

MEASURES USED BY EMPLOYERS TO SPECIFICALLY CONTROL ONCOLOGY SPEND% of survey respondents, N=101

Use a separate PBM specifically for cancer drugs

Use a separate PBM for specialty drugs (including cancer)

Create specific benefit designs for cancer

Contract directly with manufacturers of oncology drugs 8%

15%

22%

1%14%

26

EMPLOYERS UNDERSTAND FINANCIALS OF CANCER CARE, BUT NEED HELP UNDERSTANDING BIOSIMILARS AND ALTERNATIVE PAYMENT MODELSWhile most employers feel that they have a reasonable understanding of the financial impact of cancer treatment within their plans, they feel much less comfortable with emerging trends that are shaking up cancer spending, such as biosimilars

or alternative payment models. On the one hand, 72% of employers have good or excellent understanding of the financial impact incurred by employees undergoing cancer treatment; on the other hand, fewer than half of employers have a good or excellent understanding of biosimilars or alternative payment models. This suggests that employers need help understanding biosimilars and alternative payment models and currently rely on MCOs to make decisions in their best interests.

Fewer than

50% of employers have a good understanding of biosimilars/alternative payment models

EXHIBIT

EMPLOYER

EMPLOYER UNDERSTANDING OF TOPICS RELATED TO CANCER CARE% of survey respondents, N=101

1 <50% answered “good or “excellent” 2 >70% answered “good” or “excellent”

37

Poor Fair ExcellentGood

Biosimilars

Quality of cancer care

Differential costs by site of service

Cancer cost trend relative to other disease trends (e.g., diabetes, cardiovascular disease, back pain)

Workforce burden resulting from employees who are serving as caregivers to family members with cancer

Cost trend in cancer specialty drugs as a driver of the company’s total health care spending

Diagnostic testing and personalized medicine

Cancer expenditures as a percentage of the company’s total health care spending

Alternative payment models used in cancer care (e.g., bundled payments, episodes, pathways)

Level of financial impact incurred by your employees undergoing cancer treatment or survivorship care

21%

36%

23%

20%

22%

23%

13%

19%

19%

23%

23%

15%

11%

11%

10%

8%

8%

6%

5%

4%

15%

17%

19%

27%

23%

28%

32%

29%

25%

28%

27%

24%

44%

34%

41%

36%

40%

44%

48%

44%

Represent opportunities to educate employers1

Employers feel generally comfortable with understanding2

This section examines various aspects of the oncology services being provided to patients, including: uptake of specialized cancer insurance; the effect of the growing trend for in-practice dispensing; survivorship, palliative, and advance care planning; and clinical trials. Among the expanded range of support services available to cancer patients, case navigators and screening services are almost universal, while the vast majority of employers offer or plan to offer second-opinion services. However, supplemental insurance doesn’t seem to be the decided mechanism for employers to increase access.

II. WHAT SERVICES ARE BEING PROVIDED TO PATIENTS AND BY WHOM?

CONTENTSExpanded Services to Support Cancer Patients ................................................................................................................................

Expanded Coverage & Access ...............................................................................................................................................................

In-Office Infusions & Drug Dispensing ..................................................................................................................................................

Survivorship, Palliative, and Advance Care Planning ..........................................................................................................................

Practice Staffing ........................................................................................................................................................................................

Clinical Trials ...............................................................................................................................................................................................

28

31

34

37

40

42

27

CARE ACCESS IS REGULARLY MONITORED

89%of MCOs say they monitor/measure their members’ ability to access cancer care

1 As reported by oncologists who offer in-office dispensing


IN-OFFICE SERVICES GAINING POPULARITY

59%of patients are provided in-office dispensing for the first script of oral drugs by oncologists1

1 out of 3oncology practices say that their infusion chairs are completely full for most of the day2

28

MCO reimbursement policy is reducing palliative/survivorship care services and clinical trial participation. Meanwhile, a number of cancer support services are expanding: oncology case navigators and cancer-screening services are almost universally offered—consistent with MCOs taking a more holistic approach towards cancer care.

PALLIATIVE/SURVIVORSHIP CARE AND CLINICAL TRIALSOncologists and OPMs mostly align with each other when reporting the services offered by their practices; however, there are two areas that stand out where the numbers diverge—palliative/survivorship care and clinical trials.

• A greater percentage of oncologists reported offering palliative (70%) and survivorship care (63%) versus OPMs (56% and 51%, respectively).

• 73% of oncologists reported that their practice offers clinical trials compared with 59% of OPMs.

EXPANDED SERVICES TO SUPPORT CANCER PATIENTS

EXHIBIT


SERVICES PROVIDED BY ONCOLOGY PRACTICE OR HOSPITAL% of survey respondents

38

ONCOLOGIST

OPMs (N=202)Oncologists (N=200)

85%

86%

73%

68%

63%

51%

64%

54%

53%

45%

49%

40%

42%

40%

73%

59%

70%

56%

53%

52%

63%

64%

51%

43%

43%

40%

41%

34%

29%

27%

Clinical trials

In-office infusions

Pain management

Palliative care

Survivorship care

Advanced care planning

Radiation therapy

Nutrition counseling

Physical therapy

Smoking cessation

Behavioral/mental health counseling

Occupational therapy

Respiratory therapy

Speech therapy

Prehabilitation services

Community-based (N=76)

Academic/medical-center-based (N=96)

SERVICES PROVIDED% of survey respondents

Clinical trials

Palliative care

Survivorship care

74%

47%

86%

49%

88%

53%

29AMC, Academic Medical Center.

This divergence mirrors the split between oncologists based in academic medical centers and community-based private practice oncologists. Palliative and survivorship care is offered by 86% and 74% of AMC-based oncologists versus only 49% and 47% of community-based private practice oncologists. There is also a large gap for clinical trials, with 88% of AMC-based oncologists versus 53% of community oncologists offering clinical trials to their patients.

Looking at MCO reimbursement practices, we see a likely contributor to this divergence, with “clinical trial participation” and “survivorship care plan preparation” being the two services for which the lowest percentage of MCOs said they offered reimbursement (14% and 15%, respectively). Seemingly, community-based oncologists and practices with OPMs are responding to economic realities and more actively restrict their services to what is reimbursed.

Notably, MCOs that said they offer their members survivorship programs were much more likely to reimburse survivorship care plan preparation for their members—32% of MCOs that offer survivorship programs said they reimburse survivorship care plan preparation compared with just 9% of MCOs which said they don’t.

Palliative and survivorship care is offered by 86% and 74%

of AMC-based oncologists versus only 49% and 47% of community-based

private practice oncologists. There is also a large gap for clinical trials,

with 88% of AMC-based oncologists versus 53% of community

oncologists offering clinical trials to their patients.

EXHIBIT


SERVICES MCO PROVIDE TO MEMBERS WITH CANCER OR AT HIGH RISK FOR CANCER% of survey respondents, N=100

39

Case managers/care navigators

Cancer screening and early detection programs

Patient satisfaction surveys

Individualized, high-touch case management

Patient education materials on your website

Second-opinion consult programs

Treatment cost estimators

General mobile health apps

Financial counseling

Transparency tools to show estimated costs and/or quality by procedure by provider

Survivorship programs

Reimbursement for extraordinary travel costs

Cancer-specific mobile apps

Reimbursement for regular travel costs

96%

84%

71%

71%

67%

62%

43%

41%

38%

31%

25%

24%

23%

15%

EXHIBIT


40

SERVICES REIMBURSED BY MCOs

% of survey respondents, N=100

Clinical trial participation 14%

Survivorship care plan preparation 15%

Prehabilitation assessments and interventions 15%

Oral oncology drug education and adherence monitoring 20%

E-communication with patients (e.g., e-mails, texting) 23%

Practice-based pharmacy services 30%

End of treatment summary preparation 31%

Advance care planning (ACP) 34%

Patient care monitoring during active monitoring phase following treatment

44%

Telemedicine visits (e.g., remote follow-up) 46%

New patient treatment planning 52%

Oncology care coordination 57%

Patient care management during treatment 60%

32%

MCOs that offer

survivorship programs

(N=25)

MCOs that don’t offer

survivorship programs

(N=75)

9%

MCO REIMBURSEMENT OF SURVIVORSHIP CARE PLAN PREPARATION% of survey respondents

30

• 79% of employers either offer personalized nurse navigators to their employees diagnosed with cancer or are considering offering this service within the next two to three years.

Cancer-screening services are almost universally offered and are being highly publicized:

• 84% of MCOs offer cancer-screening services to their members with cancer or those who are at high risk for cancer.

• Indeed, 100% of employers are using at least one channel or incentive (such as social media, company intranet reminders, paid medical days off) to educate employees about cancer screening/early detection—59% are using five or more channels/incentives.

Meanwhile, 86% of employers either currently offer or are planning on offering second-opinion services as part of their benefit package, and 62% of MCOs offer this service for their members with cancer or for individuals who are at high risk for cancer.

Equally, a number of cancer support services are expanding: oncology case navigators and cancer-screening services are almost universal.

Oncology case navigators are becoming ubiquitous offerings for cancer patients:

• 96% of MCOs said that they offer case navigators for members with cancer or high risk for cancer.

EXHIBIT 41CANCER SCREENING/EARLY DETECTION SERVICES


MCOs THAT OFFER CANCER SCREENING/ EARLY DETECTION PROGRAMS1 % of survey respondents, N=100

EMPLOYER

EMPLOYERS THAT PROMOTE SCREENING% of survey respondents, N=101

EMPLOYER

NUMBER OF CHANNELS/INCENTIVES EMPLOYERS USE TO PROMOTE SCREENING% of survey respondents, N=101

84%

100%9%

50%

41%

More than 105 to 101 to 4

1 For members with cancer or at high risk for cancer

EXHIBITSECOND-OPINION SERVICES

42


SECOND-OPINION CONSULT PROGRAMS OFFERED BY MCO1


1 For members with cancer or at high risk for cancer

EMPLOYER

SECOND-OPINION SERVICES OFFERED AS PART OF THE EMPLOYER BENEFIT PACKAGE% of survey respondents, N=101

62%

11%14% 75%

Yes YesConsidering in next 2-3 yearsNo

100% of employers are using at least one channel or incentive (such as social media or paid medical days off) to promote cancer screening

31

Most MCOs are deploying programs to monitor access to care. Supplemental cancer insurance is on the decline.

MCOs IMPLEMENTING NUMEROUS APPROACHES TO MONITOR ACCESS TO CAREThe majority of MCOs have programs in place to monitor access to care, with only 11% of MCOs saying they don’t measure cancer care access for their members. Most MCOs (62%) reported assigning case managers to help coordinate care with high-cost patients, and have programs in place that support case managers. MCOs also heavily utilize feedback: 53% reported issuing patient satisfaction surveys, and another 42% reported issuing provider satisfaction surveys.

EXPANDED COVERAGE & ACCESS

CARE ACCESS IS REGULARLY MONITORED

89%of MCOs say they monitor/measure their members’ ability to access cancer care

EXHIBIT


PROGRAMS MCOs USE TO MONITOR/MEASURE THE TIMELINESS AND ADEQUACY OF ACCESS TO CANCER CARE% of survey respondents, N=100

43

Geo access tracking of distance traveled to nearest practice by service area

Case management assignment to high-cost patients to coordinate care

Member services patient satisfaction surveys and access inquiries

Monitor in-network access and out-of-network exceptions

Grievance department tracks access complaints from members/family caregivers

Provider satisfaction survey

Case management questionnaires

Case/care managers have access thresholds that trigger intervention(s)

Prior authorization process monitors travel distance for service

Providers alert MCOs to access issues for follow-up

Track time from diagnosis to treatment

Provider-to-patient ratio

Member/patient “likely to recommend” percentages (e.g., Net Promoter Score)

No specific measures for cancer care access at this time

No access issues to cancer care in my service area

37%

62%

53%

51%

42%

42%

40%

39%

39%

27%

26%

23%

20%

11%

10%

32

• The proportion of employers who aren’t offering supplemental cancer insurance, but are discussing it as an option increased to 23% (from 11%) over the same period.

Overall, the percentage of employers that either offer or are discussing offering supplemental cancer insurance remains roughly unchanged between the 2016 study year and 2017 study year. This indicates that the same percentage of employers know about supplemental cancer insurance as an option to increase access, but fewer are actually offering it, and more are considering or evaluating it as an option.

EXHIBIT

EMPLOYER

SUPPLEMENTAL CANCER INSURANCE OFFERED TO EMPLOYEES% of survey respondents

44

2017 study year (N=101)2016 study year (N=101) Yes, standard benefit, 2017 study yearYes, elective option, 2017 study year

-9%

Under discussionSupplemental cancer insurance not offered

Supplemental cancer insurance is offered

33% 34%

23%

52%

43%

11%

32%

11%

Upper quartile


EMPLOYEE OPT-IN RATE TO SUPPLEMENTAL CANCER INSURANCE% of employees, N=31

20%

15%

10%

5%

15%

5%

19%

14%

SUPPLEMENTAL CANCER INSURANCE PROVISION DECLININGHowever, supplemental insurance doesn’t seem to be the decided mechanism for employers to increase access:

• The percentage of employers that offer supplemental cancer insurance to employees declined to under one third - 32% (from 52%) - between 2016 and 2017 study years. Meanwhile, during 2017, 11% of employers reported providing supplement cancer insurance as part of standard benefits package.

33

LOW UPTAKE OF SUPPLEMENTAL COVERAGEThis could be due to the fact that employee supplemental cancer insurance uptake is low. Among employers that offered supplemental cancer insurance for purchase, an average of only 14% of employees decided to purchase additional coverage.

CENTERS OF EXCELLENCE COVERAGE HIGH AMONG LARGER EMPLOYERSAbout one-third of employers ensure that their employees have coverage with specific centers of excellence for high-cost or high-stakes cancer treatments. This percentage is noticeably higher for employers that have 5,000 employees or more (39%) compared with employers that have between 1,000 and 5,000 employee (23%).

1/3 of employers ensure their employees have coverage with centers of excellence for high-cost or high-stakes cancer treatments

EXHIBIT

EMPLOYER

ENSURE THAT EMPLOYEES HAVE COVERAGE WITH CENTERS OF EXCELLENCE FOR HIGH-COST OR HIGH-STAKES CANCER TREATMENTS% of survey respondents

45

5,000+ employees (N=54)1,000-5,000 employees (N=47)

Considering adding in the next 2-3 yearsNo Yes

58%

39%

22%

19%

39%

23%

Among employers that offered supplemental cancer insurance

for purchase, an average of only 14% of employees

decided to purchase additional coverage.

34

In-office infusions continue to dominate, while in-practice oral drug dispensing has tripled in four years; however, MCOs are moving to restrict distribution. Meanwhile, oncologists tend to consider oral oncology drug education to be their responsibility rather than the pharmacist’s.

DOMINANCE OF IN-OFFICE INFUSIONS PERSISTS; PRACTICES REPORTING HEAVY UTILIZATIONThe vast majority of oncologists and OPMs reported offering in-practice infusions (85% and 86%, respectively). Of OPMs in practices that offer in-practice infusions, 95% reported that their infusion chairs are full for some parts of the day—a third (32%) of OPMs reported that their infusion chairs are full for most of day, and they need to refer patients elsewhere.

RATE OF IN-PRACTICE ORAL DRUG DISPENSING REMAINS HIGH, BUT ONLY FOR THE FIRST SCRIPTIn-practice oral drug dispensing remains high. This year 59% of OPMs reported offering in-practice drug dispensing (consistent with the 2016 study year’s 58%). Furthermore, another 15% of practices are investigating offering in-practice oral drug dispensing. However, while dispensing practices are typically able to fill the first script of an oral drug in office for patients, only about 40% of patients are able to receive subsequent refills in-practice.

IN-OFFICE INFUSIONS & DRUG DISPENSING

EXHIBIT


LEVEL OF UTILIZATION OF INFUSION CHAIRS% of survey respondents, N=171 (OPMs who offer in-office infusions)

46

32%

63%

5%

We are nearly full most of the day and we sometimes need to refer patients elsewhere

We almost always have slots available at the time that is preferred by patients

We are full for a few hours each day, but always have slots available if patient can be flexible

... while dispensing practices are typically able to fill the first script

of an oral drug in office for patients, only about 40% of patients on

average are able to receive subsequent refills in-practice.

IN-OFFICE SERVICES GAINING POPULARITY

59% of patients are provided in-office dispensing for the first script of oral drugs by oncologists1

1 out of 3oncology practices say that their infusion chairs are completely full for most of the day2

1 Average % of patients as reported by oncologists who offer in-office dispensing


35

MCOs MOVE TO RESTRICT DISTRIBUTION Oncologists see many advantages to in-office dispensing, principally patient convenience and rapid therapy startup. Nevertheless, we are seeing more MCOs move to restrict distribution: the majority of oncologists (58%) reported that payers require them to fill prescriptions at specific pharmacies.

EXHIBIT


PRACTICES THAT ENGAGE IN IN-PRACTICE DRUG DISPENSING% of survey respondents, N=202

47

59%

26%

15%

23%

3%

21%

38%

NoDid previously, but no longer

Yes, under a NPI

Currently investigatingYes, closed door pharmacy

EXHIBIT


IN-OFFICE ORAL DRUG DISPENSING% of patients that receive in-office oral drug dispensing as reported by oncologists and OPMs

48

ONCOLOGIST

Upper quartile


1 Oncologists who offer in-office dispensing of oral drugs 2 For OPMs who offer in-practice dispensing of oral drugs 3 Excluding OPMs who skipped the question

605040302010

70

9080

70%

30%

90%

59%

50%

30%

80%

Oncologist (N=106)1

OPM (N=119)2

55%

30%

15%

60%

39%

Oncologist (N=106)1

OPM (N=98)2,3

38%

20%

69%

40%

For the first scriptDeclines after first script

Ongoing after the first script

EXHIBIT 49

ONCOLOGIST

ADVANTAGES OF IN-PRACTICE DISPENSING OF ORAL ONCOLOGY DRUGS% of survey respondents, N=200

Patients prefer to get their drugs and patient education from the staff at the oncology practice

Convenient for patients

Decrease patient wait time to get the drug(s)

Better control cost of care

Control and deliver oral oncology education to patients

Monitor and improve patient adherence to therapy

Improve patient access to oral drugs due to practice’s financial counseling/resources

Improve patient safety through complete information on patient drug treatments

Control waste

Dissatisfied with the services provided by specialty pharmacies

Monitor patient side effects and need for palliative care

13%

42%

26%

24%

20%

18%

15%

15%

14%

10%

8%

NPI, National Provider Identifier

36

PATIENT EDUCATION The trend toward in-office oral drug dispensing may be adding even more burdens on oncologists. We find that 37% of oncologists see themselves as responsible for patient education of oral drugs dispensed in-office while only 19% of oncologists see the pharmacist as responsible for education. At the same time, we find that 20% of oncologists see in-practice dispensing of oral oncology drugs as enabling better oncology education for patients.

EXHIBIT 51

ONCOLOGIST

RESPONSIBILITY FOR PATIENT EDUCATION OF ORAL ONCOLOGY DRUGS DISPENSED IN-PRACTICE% of survey respondents, N=200

Oncologist 37%

Nurse 31%

Advanced practice provider (NP/PA) 22%

Pharmacist 19%

EXHIBIT 50

ONCOLOGIST

PAYER RESTRICTIONS ON DRUG PRESCRIPTIONS% of survey respondents


Payers limit ability to fill prescriptions/require prescriptions be filled by a different pharmacy

Payers don’t limit ability to fill prescriptions

58%

50%

42%

50%

OPMs (N=202)Oncologists (N=200)

37SCP, Survivorship Care Plan.

Although survivorship programs are becoming more and more prevalent in oncology care, there is divergence among oncologists and OPMs about whether these services are the primary domain of the oncology practice or of the patients’ primary care practice.

GROWING PROVISION OF SCPs

Increasingly, oncologists provide all or some of their cancer patients with a written/printed survivorship care plan (SCP): 72% of oncologists provide all or some of their cancer patients with a written/printed SCP upon discharge from active cancer treatment; 32% provide this service to all cancer patients (unchanged from 32% from the 2016 study year); another 5% plan to do so in 2018. Moreover, 42% of OPMs expect to add/expand survivorship program services over the next two to three years.

DISCONNECT BETWEEN ONCOLOGISTS AND OPMS ABOUT COORDINATING CARE WITH PRIMARY CARE PRACTICESThere appears to be a disconnect between oncologists and OPMs regarding who is primarily responsible for survivorship program care. More OPMs believe that patient survivorship care is coordinated between both the oncology practice and the patient’s primary care practice, such that both are jointly responsible for patient survivorship program care (29% of OPMs versus 15% of oncologists). However, oncologists seem to be more skeptical about sharing survivorship care responsibility with other practices. Most oncologists reported believing that their oncology practice alone was primarily responsible for providing survivorship program care (54% of oncologists versus 32% of OPMs).

A quarter of oncologists and 11% of OPMs report not providing written SCPs. Thirty one percent of oncologists and 39% of OPMs see survivorship clinics or primary care physcians as primarily responsible for providing survivorship program care. These oncology practices that do not provide SCPs may be instead relying on others to provide this care.

SURVIVORSHIP, PALLIATIVE AND ADVANCE CARE PLANNING

72% of oncologists provide cancer patients with a written/printed SCP

EXHIBIT 52

ONCOLOGIST

PROVISION OF WRITTEN/PRINTED SURVIVORSHIP CARE PLANS (SCP) UPON DISCHARGE FROM ACTIVE CANCER TREATMENT% of survey respondents

Not currently provided, but planned for 2018Not provided

Have launched a pilot program

Provide to all cancer patientsProvide to some cancer patients

Oncologist (N=200)

OPM (N=202)

25% 32%30%10%5%

11% 39%30%12% 11%


EXHIBIT


EXPANSION OF SURVIVORSHIP PROGRAM SERVICES% of survey respondents, N=202

53

Don’t expect to add or expand services in the next 2-3 years

Expect to add or expand services in the next 2-3 years

Uncertain

42%

26%

32%

EXHIBIT


ORGANIZATION PRIMARILY RESPONSIBLE FOR PROVIDING SURVIVORSHIP PROGRAM CARE % of survey respondents

54

ONCOLOGIST

ONC2PCP3SC1 ONC2 + PCP3

1 Survivorship clinic of the hospital 2 Oncology practice 3 Patient’s primary care practice

oncologist survey (N=200)

OPM survey (N=202)

17% 14% 15% 54%

22% 32%29%17%

38

TREND TOWARDS ROUTINE PALLIATIVE CARE DISCUSSIONPalliative care is being discussed more frequently: 96% of oncologists discuss palliative care options with their patients, with 34% discussing palliative

care options routinely with all cancer patients, compared with 33% in the 2016 study year.

Oncologists have started discussing palliative care sooner for patients with advanced-stage diagnosis—often within a month of the patient being diagnosed with advanced-stage cancer:

• 46% of oncologists reported consulting with patients about palliative care within a month after advanced-stage diagnosis, more than double the level in the 2016 study year (an estimated 22%).

• Only 5% reported waiting to discuss palliative care options with patients closer to end-stage/end of life (compared with 24% in the 2016 study year).

PALLIATIVE CARE DISCUSSIONS ARE BECOMING MORE COMMON

34%of oncologists discuss palliative care routinely with all patients

EXHIBIT 55

ONCOLOGIST

TIMING OF PALLIATIVE CARE CONSULT AFTER ADVANCED-STAGE DIAGNOSIS% of survey respondents

Within first month After failure of first-line therapy

When we run out of therapeutic options

When decision is made to move from

active treatment to palliation

Closer to end-stage/end of life

Other

22%

46%

6%

12%10%

12%

19%

24% 24%

5%

18%

2%


1 Excludes oncologists who answered other

39ACP, Advance Care Plan.

• 21% of oncologists have discussed palliative care options with patients with advanced cancer only if they also have a short life expectancy (a decrease compared with the 27% reported in the 2016 study year).

LOCATION MISSING FROM PALLIATIVE CARE DISCUSSIONSAlthough palliative care discussions are happening earlier and more frequently, an important aspect that’s missing from these discussions is the location of the care. A new study published in the Journal of the National Comprehensive Cancer Network (JNCCN) found that 93% of patients thought that it was important for them to choose their end-of-life care location, and 87% of patients wanted their doctor to ask them where they wanted their end-of-life care. Unfortunately, in that study only 7% of patients reported having a conversation with their doctor about end-of-life care location.1

ADVANCE CARE PLANNING (ACP) IS COMMON BUT REIMBURSEMENT HASN’T CAUGHT UPOverall, 95% of oncologists reported that someone in their practice discusses ACP with their patients—with 68% of oncologists saying that they personally have these discussions with their patients. However, of the oncologists who reported having ACP discussion with their patients, over half reported not using ACP Current Procedural Terminology (CPT) codes when billing Medicare.

Indeed, oncologists have started discussing palliative care with patients with advanced cancer, irrespective of life expectancy:

• 33% of oncologists have discussed palliative care options with all patients with advanced cancer, irrespective of life expectancy (an increase over the 26% reported in the 2016 study year).

45% of oncologists who have ACP discussions with patients don’t bill Medicare using ACP CPT codes

EXHIBIT 57

ONCOLOGIST

PATIENT ADVANCE CARE PLANNING (ACP) DISCUSSIONS% of survey respondents, N=200

No one discusses ACP with patientsSomeone else in the practice discusses ACP with patientsOncologist personally discusses ACP with patients

1 Oncologists who personally discuss advance care planning with their patients

of oncologists who personally discuss ACP68%

27%

5%

BILL MEDICARE USING THE ACP CURRENT PROCEDURAL TERMINOLOGY CODES% of survey respondents, N=135

45%

55%

No Yes

EXHIBIT 56

ONCOLOGIST

ONCOLOGISTS WHO DISCUSS PALLIATIVE CARE OPTIONS AND/OR REFER PATIENTS TO A PALLIATIVE CARE TEAM AS A PART OF THEIR CANCER TREATMENT PLANNING AND GOAL-SETTING PROCESS% of survey respondents, N=200 Do for all patientsDo for some patientsNo

Only patients with advanced

cancer

Only patients with advanced cancer & short life expectancy

Only patients in need

of chronic treatment/monitoring of disease symptoms

33% 21% 7%

of the 61% who said they do for some patients

5% 34%61%

40

Growing oncologist workloads are driving demand for more oncologists and leading to rising staffing difficulties. Practices are responding by hiring more support staff, which is creating more demand for advanced practice providers and other specialist staff.

DEMAND FOR ONCOLOGISTS FUELS STAFFING DIFFICULTIESA consequence of the reported rise in patient volumes and oncologist workloads is a high demand for oncologists, such that most OPMs have reported a significant increase in oncologist staffing difficulties: 56% of OPMs looking to hire more oncologists found it difficult to recruit/retain oncologists to their practice.

EXHIBIT


OPMs PLANNING TO HIRE MORE ONCOLOGISTS THIS YEAR% of survey respondents, N=202

58

No Yes

EXPERIENCED DIFFICULTY RECRUITING/ RETAINING ONCOLOGISTS TO THEIR PRACTICE % of survey respondents, N=172

44%

56%

of OPMs who said yes85%

15%

PRACTICE STAFFING

56% of OPMs looking to hire more oncologists found it difficult to recruit/retain oncologists

DEMAND FOR ADVANCED PRACTICE PROVIDERS IS INCREASING

78%of oncology practices hire advanced practice providers1


INCREASED DEMAND FOR APPs

One way that OPMs have responded to the combined challenge of rising oncologist workloads and staffing difficulties is by hiring APPs—nurse practitioners and physician assistants—and by delegating more responsibilities to them. This is a continuing trend: in the 2016 study year, 53% of OPMs expected to add APPs in 2017, and in the 2017 study year 78% of OPMs reported actually employing APPs (compared with 63% in the 2016 study year).

EXHIBIT


PRACTICE EMPLOYMENT OF ADVANCED PRACTICE PROVIDERS (I.E., NURSE PRACTITIONERS, PHYSICIAN ASSISTANTS)% of survey respondents, N=202

59

Don’t employ Planned for next year Employ

75%Case coordination as a result of a patient encounter

62%In-person patient encounter (e.g., scheduled or walk-in/urgent care, hospital inpatient; patient education, procedures)

32%EHR maintenance, notes, test monitoring/follow-up (e.g., lab, radiology)

PRIMARY ROLE(S) OF ADVANCED PRACTICE PROVIDERS (I.E., NPs, PAs)% of survey respondents, N=156

RATIO OF FULL-TIME EQUIVALENT ADVANCED PRACTICE PROVIDERS (APPs) PER SINGLE FULL-TIME ONCOLOGIST% of survey respondents, N=156

Less than 1 APP per oncologist

1 APP per oncologist

38%

19%

44%1.5 or more APPs per oncologist

of OPMs who said they employ

78%

2%20%

APP, Advanced Practice Provider

41

GREATER RESPONSIBILITY FOR APPs

At the same time, OPMs are giving more responsibilities to APPs. In the 2016 study year, OPMs estimated that APPs spent 41% of their time on in-person patient encounters. This year, 62% of OPMs reported that in-person patient encounters are a primary role for APPs. This view is supported by anecdotal data from OPMs, who offered the following insights:

“The advanced practice providers [provide] work-ups to diagnostics to follow-up care.”

“Increased frequency of initial new patient encounters.”

“Prescribing chemotherapy, clinical trial participation, and triaging for the oncology care model.”

“Primary care once treatment is established versus assistant care years back.”

“More independence in prescribing drugs.”

“They see more patients than they did before.”

STAFFING DIFFICULTIES BOOSTING OTHER SUPPORT-STAFF HIRESAlthough the staffing situation for APPs is easier than oncologists—it’s not by much: 42% of OPMs whose practices employed APPs said that they found it challenging to recruit/retain APPs.

This has led to OPMs hiring other specialized support staff for their practices:

• 48% of OPMs reported hiring “care navigators” to help coordinate care between their oncology practice and referring primary care physicians, as well as other multidisciplinary team members who are involved in the patients’ active treatment and survivorship follow-up care and surveillance.

• Another 16% plan to hire care navigators in 2018.

• 29% of OPMs reported hiring “medical scribes” to input data into the electronic health record at the direction of the oncologist (for example, collaborative documentation), while the oncologist interacted with the patient during the exam.

• Another 18% plan to hire medical scribes in 2018.

IMPLICATIONS GOING FORWARDAs oncologists’ workload continues to grow, we’re likely to see a growing trend towards hiring of APPs and other specialized support staff (care navigators and medical scribes) in 2018; this is likely to be accompanied by an increase in the amount of work delegated to them. The current trend we’re seeing is for more routine or administrative tasks to be delegated to non-oncologist staff members, while oncologists focus more on the clinically specialized tasks with patients.

EXHIBIT


61

1 Hospital-employed navigators 2 In-practice navigators

OPM HIRING OF SPECIALIZED SUPPORT STAFFPRACTICE EMPLOYMENT OF “CARE NAVIGATORS”% of respondents, N=179

6%26% 36%22%10%

Don’t employ HE1 HE IPIP2

16% Plan to in 2018

48% Do employ

PRACTICE EMPLOYMENT OF “MEDICAL SCRIBES”% of respondents, N=202

9%52% 18%11%9%

Don’t employ Discussing

Sub-contract

EmployPlan in 2018

18%Not now

29% Do employ

EXHIBIT


NEW ACTIVITIES THAT ADVANCED PRACTICE PROVIDERS (I.E., NPs, PAs) ENGAGE IN NOW VS 2-3 YEARS AGO

60

42% of OPMs whose practices employed APPs found it challenging to recruit/retain APPs

APP, Advanced Practice Provider; NP, Nurse Practioner; PA, Physician Assistant

42

As clinical trial activity increases, a significant majority of oncologists report that their practice or hospital offers trial participation, which they discuss with up to half their patients. However, participation varies according to practice setting, with activity primarily focused on academic medical centers (AMCs). Barriers to clinical trial participation include growing trial complexity and increasingly narrow recruitment criteria, as well as patients’ fear of being placed in the placebo arm of randomized trials.

CLINICAL TRIAL ACTIVITY ROCKETINGOncology has witnessed significant growth in clinical trial activity.2 This is supported by data showing that 35% of oncologists reported an increase in their clinical trial activity over the past five years. Further, oncologists expect this trend to accelerate with 46% expecting even more trial activity over the coming five years.

MAJORITY OF ONCOLOGISTS WORK IN A FACILITY OFFERING CLINICAL TRIALSMost (73%) oncologists surveyed said their practice or hospital offers clinical trials, while 59% of OPMs reported offering trials. Clinical trial participation seems to be mostly driven by a small percentage of highly active oncologists. The top 15% (by percentage of patients enrolled in clinical trials) of oncologists discussed trials with on average 58% of patients, referred on average 38% of patients to trials, and ultimately enrolled on average 37% of patients. All three numbers are at least three times as high as the bottom 50% of oncologists (who discussed clinical trials with on average 15% of patients, and referred and enrolled on average 9% and 2% of patients, respectively).

EXHIBIT 62

ONCOLOGIST

THE MOST ACTIVE 15% OF ONCOLOGISTS ENROLL 37% OF THEIR PATIENTS ON TRIALS COMPARED TO THE LEAST ACTIVE 50% OF ONCOLOGISTS WHO ONLY ENROLL 2% OF THEIR PATIENTS ON TRIALS1

Median of response provided by survey respondents/participants

1 Oncologists were stratified by the percentage of patients they enroll on clinical trials

% of patients with whom you discussed clinical trials

% of patients you enrolled into clinical trials

% of patients you referred to clinical trials58%

38%37%

Top 15% (N=20) Bottom 50% (N=100)

15%

9%

2%

CLINICAL TRIALS

• –

CLINICAL TRIAL ENROLLMENT EXPANDING

35%of oncologists increased clinical trial participation between 2012–2017

AMC, Academic Medical Center.

43

• –

AMC, Academic Medical Center.

PARTICIPATION DEPENDS ON PRACTICE SETTINGPart of this asymmetric clinical trial enrollment can be attributed to differences in clinical trial enrollment between practice settings. We see a very different pattern of trial participation depending on practice setting: we found that 87% of AMC-based oncologists offer clinical trials to their patients versus 51% of oncologists in community-based practices.

AMC-based oncologists seem to enroll a higher proportion of their patients into clinical trials, compared with a nationally reported cancer clinical trial enrollment rate of 3-5%.3 Among the AMC-based oncologists surveyed, the median response for proportion of patients who had a clinical trial discussion was 40% and for the proportion of patients referred to clinical trials was 20%. Patient enrollment into clinical trials was lower where the median response was 10%. Among the hospital and community-based oncologists, the median responses for proportion of patients who had a clinical trial discussion were 20% and 10%, respectively, while the median responses for patient enrollment into clinical trials were 5% and 2%, respectively.

The most significant barriers to clinical trial participation are growing trial complexity and increasingly narrow recruitment criteria, followed by patients’ fear of being placed in the placebo arm of randomized trials. This last barrier represents an opportunity to improve patient education about how oncology clinical trials differ from many other disease areas in the use of placebo, ensuring that patients with a life-threatening condition won’t receive a regimen that lacks an active agent if there is a standard of care available. Notably, lack of awareness of relevant trials or patient eligibility were seen as a significant barrier by only 19% and 16% of respondents, respectively. However, the awareness barrier becomes more acute within the community setting: here 27% and 23%, respectively reported a significant barrier versus 13% and 12%, respectively for academic-affiliated oncologists.

87% vs 51%of AMC-based vs community-based oncologists offer clinical trials to their patients

EXHIBIT 63

ONCOLOGIST

ONCOLOGISTS AT ACADEMIC CENTERS TYPICALLY ENROLL OVER TWICE AS MANY OF THEIR PATIENTS ON TRIALS AS IN THE COMMUNITYMedian of response provided by survey respondents/participants

40%

20%

10%

20%

6% 5%

Academic medical-center (N=97) Hospital (N=27) Community private practice (N=75)

5%

2%

10%

% of patients with whom you discussed clinical trials

% of patients you enrolled into clinical trials

% of patients you referred to clinical trials

44

A noteworthy share of oncologists expects participation in trials to grow: 30% of oncologists whose practices don’t currently offer clinical trials expect to increase their participation over the next five years; 51% of oncologists whose practices currently offer clinical trials expect to increase their participation.

EXHIBIT 64

ONCOLOGIST

BARRIERS TO PATIENTS PARTICIPATING IN CLINICAL TRIALS

FOR ALL PRACTICES% of survey respondents, N=200

Growing trial complexity and increasingly narrow recruitment criteria

Patient fear of being placed in placebo arm in randomized trials

Lack of appropriate incentives to patients to encourage participation

Lack of patient awareness on value of participation in clinical trials

Sites of clinical trials are too far away

Lack of awareness of relevant clinical trials

Lack of awareness that patient is eligible to participate in clinical trial

80%

80%

72%

73%

71%

66%

64%

41% 39%

44% 36%

42% 30%

45% 28%

46% 25%

47% 19%

48% 16%

80%

79%

74%

68%

76%

68%

66%

39% 41%

40% 39%

39% 35%

44% 24%

53% 23%

41% 27%

43% 23%

FOR COMMUNITY-BASED PRACTICES ONLY% of survey respondents, N=75

Significant barrierOccasional barrier

45

Here we consider the ways clinical care and coverage decisions are made, looking at how policy is being developed for pharmacy and medical benefit, the growing influence of multidisciplinary panels and tumor boards, drug interchangeability and use of biosimilars, and the role of specialty pharmacies. This section also explores the impact of innovations such as novel endpoints and real-world evidence (RWE), personalized medicine, and advanced diagnostic techniques.

III. HOW ARE CLINICAL CARE AND COVERAGE DECISIONS BEING DETERMINED?

CONTENTSPolicy Development—Pharmacy & Medical Benefit .............................................................................................................................

Surrogate Endpoints and Real-World Data ..........................................................................................................................................

Personalized Medicine & Software Support ........................................................................................................................................

Use of Multidisciplinary Panels/Tumor Boards (MDTs) .......................................................................................................................

Interchangeability ......................................................................................................................................................................................

Biosimilars ..................................................................................................................................................................................................

Specialty Pharmacy Role in Therapy Selection ...................................................................................................................................

46

50

52

55

57

59

60

MCOs RARELY DECLINE DRUG COVERAGE BASED ON COST

25%of MCOs declined to cover a pharmacy benefit drug for its approved indication due to cost

REAL-WORLD DATA INCREASINGLY IMPORTANT TO MCOs

79%of MCOs view real-world data as essential for cancer coverage and reimbursement decisions

BIOMARKER TESTING DETERMINED BY MCOs ON A CASE-BY-CASE BASIS

43%of MCOs determine biomarker testing on a case-by-case basis

COST VALUE

46

Cost inevitably has an impact on coverage. Most MCOs and employers take an integrated approach to drug coverage decisions including direct oncologist input on their pharmacy and therapeutics (P&T) committees, with just over half making coverage policy decisions based on guidelines such as those developed by the National Comprehensive Cancer Network, American Society of Clinical Oncology, and National Cancer Institute. At the same time, some newer technologies and services previously deemed experimental are becoming clinically relevant.

INTEGRATED APPROACH TO DRUG COVERAGE DECISIONSOver half (54%) of MCOs use an integrated approach towards drug coverage decisions across medical and pharmacy benefit. Additionally, 70% of employers who use the same administrator for medical and pharmacy benefit consolidate reports across both benefit types and think about them jointly.

POLICY DEVELOPMENT—PHARMACY & MEDICAL BENEFIT

EXHIBIT


INTEGRATED DRUG COVERAGE DECISION MAKING ACROSS THE MEDICAL AND PHARMACY BENEFIT% of survey respondents, N=100

65

54%

12%

34%

Medical benefit and pharmacy benefit coverage decisions are made independently by different decision makers

Have a consistent, integrated approach across medical and pharmacy benefit for all lines of business

Sometimes integrate decision-making for certain lines of business (e.g., fully insured commercial), but not others

EXHIBIT

EMPLOYER

INTEGRATED REPORTS ACROSS BENEFIT TYPES% of survey respondents, N=491

66

43%

30%

27%

Receive separate reports for pharmacy/medical benefit and think about them separately

Our health insurance administrator/PBM merges reports into a consolidated view

Receive separate reports for pharmacy/medical benefit, but merge them ourselves to create a consolidated view

1 Employers who use the same administrator for medical and pharmacy benefit

54% of MCOs use an integrated approach (across medical and pharmacy benefit) towards making drug coverage decisions

P&T, Pharmacy and Therapeutics.

ONCOLOGIST INPUTLike in the 2016 study year, the majority—85% for pharmacy benefit and 89% for medical benefit—of MCOs have direct oncologist input to their P&T committees. Of those MCOs without direct oncologist input, the majority use a simple coverage approach (such as NCCN Level IIa), which doesn’t require oncologist input.

47

EXHIBIT


ONCOLOGIST INVOLVEMENT IN THE DEVELOPMENT OF POLICIES FOR PHARMACY BENEFIT CANCER DRUG COVERAGE (E.G., PRIOR AUTHORIZATIONS)% of survey respondents, N=79 (MCOs with pharmacy benefit enrollment)

67

85% 15%

Oncologists are directly involvedOncologists are not directly involved

15%

Of the 15% who said oncologists

aren’t directly involved


are directly involved

85%

We use a cross-therapeutic area P&T committee or clinical policy unit that includes at least 1 oncologist

We have a specialized P&T committee or clinical policy unit that includes multiple practicing oncologists

We don’t limit coverage on oncology drugs

We have a simple approach (e.g., cover to NCCN Level IIa or better) to coverage that doesn’t require oncologist input

Oncology not the area of focus/ simply no oncologists on the P&T

8%

3%

4%

40%

45%


aren’t directly involved


are directly involved

EXHIBIT


ONCOLOGIST INVOLVEMENT IN THE DEVELOPMENT OF POLICIES FOR MEDICAL BENEFIT CANCER DRUG COVERAGE (E.G., PRIOR AUTHORIZATIONS)% of survey respondents, N=93 (MCOs with medical benefit enrollment)

68

89% 11%

Oncologists are directly involvedOncologists are not directly involved

11%We don’t limit coverage on oncology drugs

We have a simple approach (e.g., cover to NCCN Level IIa or better) to coverage that doesn’t require oncologist input

We don’t employ many oncologists/simply no oncologists on the P&T

1%

6%

4%

89%

We use a cross-therapeutic area P&T committee or clinical policy unit that includes at least 1 oncologist

We have a specialized P&T committee or clinical policy unit that includes multiple practicing oncologists

42%

47%

NCCN, National Comprehensive Cancer Network; P&T, Pharmacy and Therapeutics.

• Of the MCOs that usually or always defer to guidelines, the top three guidelines reviewed (which are all used by 45% of MCOs or more) are NCCN, ASCO, and NCI.

COST NOT THE MAJOR DRIVER OF DRUG COVERAGEWe have seen that cost is a major concern for MCOs. To date, however, only 25% have reported denying coverage of a pharmacy benefit drug within its approved indication, while the comparable figure for medical benefit drugs is 18%. It is worth noting that this proportion is consistent across MCOs that usually or always defer to guidelines for their policy on coverage and those that don’t—suggesting that avoiding costly oncology drugs isn’t the reason why MCOs chose to break away from following guidelines. Potentially, it could be indicative of a situation where multiple therapies have equivalent recommendations on guidelines, but a large cost differential for either list or net price.

This dynamic could be changing, however: 24% of MCOs said that, within the next three years, they plan not to cover certain medical benefit cancer drugs for an approved indication, while a smaller 16% have similar plans for

EXHIBIT


CANCER TREATMENT GUIDELINES REVIEWED AND CONSIDERED AS PART OF POLICY AND COVERAGE DECISIONS% of survey respondents (MCOs that usually/always defer to guideline)

70

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®)

ASCO Clinical Practice Guidelines

NCI Clinical Practice Guidelines in Oncology™

Cancer Clinics of Excellence (CCE)

Children’s Oncology Group

Develop our own guidelines in collaboration with network oncologists

Develop our own guidelines with MCO-employed oncologists

82%

84%

53%

53%

45%

53%

38%

43%

35%

38%

27%

12%

4%Guidelines developed independently by network oncologist

Pharmacy benefit (N=45) Medical benefit (N=49)

48

USAGE OF GUIDELINES AND VALUE FRAMEWORKS FOR COVERAGE DECISIONSIt’s pretty much an even split between MCOs that make coverage policy decisions based on guidelines and those that don’t:

• 57% of MCOs usually or always defer to guidelines for pharmacy benefit policy/coverage decisions, and 53% of MCOs for medical benefit. Only 1 or 2% of MCOs (pharmacy and medical benefit, respectively) don’t consider guidelines for policy/coverage decisions. The rest consider guidelines but make their own independent assessment.

ASCO, American Society of Clinical Oncology; NCCN, National Comprehensive Cancer Network.

Only 1 or 2% of MCOs (pharmacy

and medical benefit, respectively)

don’t consider guidelines for policy/

coverage decisions.

EXHIBIT


USE OF CANCER TREATMENT GUIDELINES (E.G., NCCN) TO INFORM POLICY AND COVERAGE DECISIONS% of survey respondents

69

Pharmacy benefit (N=79) Medical benefit (N=93)

We always defer to guidelines

We usually defer to guidelines with some exceptions

We usually do not consider guidelines when making our decisions

We consider guidelines, but make our own independent assessment

16%

18%

6

41%

35%

1%

2%

42%

43%

MCOs ARE NOT DECLINING DRUG COVERAGE BASED ON COST

25%of MCOs declined to cover a pharmacy benefit drug for its approved indication due to cost

COST VALUE

49

pharmacy benefit drugs. MCOs provided examples of these rare cases, which tend to be when there are significant price differences between available options (e.g., anti-VEGF therapies) or for new drugs where costs are very high (e.g., cell therapies).

MCOs ARE INCREASINGLY TURNING TO SPECIALISTS FOR EMERGING AREASThis year’s survey has recorded a sizeable uptick in the number of medical policy and coverage decisions involving oncologists and clinical pathologists in emerging areas such as molecular testing and advance care planning/palliative care. The survey found that:

• The percentage of MCO respondents who seek input from practicing oncologists for molecular/biomarker testing in oncology increased by 13 percentage points over the past two years—from 53% in the 2015 study year to 66% this year.

• The share of MCO respondents who seek input from practicing oncologists for genetic testing increased by 6 percentage points over the past two years—from 49% in the 2015 study year to 55% this year.

• The proportion of MCO respondents who seek input from clinical pathologists with expertise in molecular testing for molecular/biomarker testing in oncology increased by 32 percentage points over the past two years—from 31% in the 2015 study year to 63% this year.

• The percentage of MCO respondents who seek input from clinical pathologists with expertise in molecular testing for next-generation sequencing in oncology increased by 37 percentage points over the past two years—from 23% in the 2015 study year to 60% this year.

The percentage of MCO respondents who

seek input from practicing oncologists for

molecular/biomarker testing in oncology

increased by 13 percentage points over

the past two years—from 53% in the 2015

study year to 66% this year.

EXHIBIT


MCOs THAT DECLINED TO COVER AN ONCOLOGY DRUG FOR ITS APPROVED INDICATION DUE TO COST

71

UNDER THE MEDICAL BENEFIT


18%24%58%

UNDER THE PHARMACY BENEFIT


25%58% 16%

Plan to in the next 3 yearsNo Yes

EXHIBIT


MEDICAL POLICY DECISIONS THAT HAVE INPUT FROM CLINICAL PATHOLOGISTS WITH EXPERTISE IN MOLECULAR TESTING% of survey respondents

73

42%31%

63% 60%

38%

23%

Molecular/biomarker testing in oncology

Next-generation sequencing in oncology

2015 study year (N=100) 2016 study year (N=103) 2017 study year (N=88)

EXHIBIT


MEDICAL POLICY/COVERAGE DECISIONS THAT HAVE INPUT FROM PRACTICING ONCOLOGISTS% of survey respondents

72

53%59% 61%

40%32%

66%

53%49%55%

18%25% 20%

Molecular/ biomarker testing in oncology

Genetic testing and counseling

Advance care planning and pallative care

Survivorship program care

2015 study year (N=100) 2016 study year (N=103) 2017 study year (N=88)

The proportion of MCO respondents who seek input from clinical pathologists

with expertise in molecular testing for molecular/biomarker testing in oncology increased

by 32 percentage points over the past two years—from 31% in 2015 to 63% this year.

50

There is increasing utilization of surrogate endpoints for clinical trials in the context of FDA-accelerated approvals, although oncologists vary in their readiness to evaluate novel endpoints.

READINESS FOR SURROGATE ENDPOINTSOverall, most oncologists (86–87%) are at least somewhat ready to evaluate established surrogate endpoints such as response rate and time to progression. Fewer oncologists are ready to evaluate emerging endpoints: 74% of oncologists are at least “somewhat ready” for minimum residual disease and 69% feel that way for immune-related response criteria.

MCOs seem to be less ready for surrogate endpoints

compared with oncologists. Only half as many MCO respondents felt confident in reporting being “ready” for evaluating even gold-standard endpoints such as overall survival. Additionally, only 14% of MCOs reported being “ready” for immune-related response criteria, compared with 35% of oncologists. One notable exception is that MCOs match oncologists in their readiness for evaluating patient-reported outcomes—in both groups 36% reported being ready, while 72% of MCOs and 73% of oncologists feel at least “somewhat ready.”

FDA, Food and Drug Administration; ORR, Objective Response Rate; CR, Complete Response

SURROGATE ENDPOINTS AND REAL-WORLD DATA

EXHIBIT 74

ONCOLOGIST

COMFORT LEVEL/READINESS TO EVALUATE THE MEANING AND IMPORTANCE OF TRADITIONAL AND EMERGING ENDPOINTS% of respondents, N=200

Not readyKnow where to solicit outside expertise as needed

ReadySomewhat ready

Minimum residual disease

Patient reported outcomes

Immune-related response criteria

Time to progression

Response rates (ORR. CR)

Progression-free survival

Overall survival

41%33%

36%37%

35%34%

60%27%

61%25%

64%22%

67%21%

17%

17%

21%

5%

8%

7%

8%

8%

7%

7%

7%

6%

7%

4%

EXHIBIT


COMFORT LEVEL/READINESS TO EVALUATE THE MEANING AND IMPORTANCE OF TRADITIONAL AND EMERGING ENDPOINTS% of respondents, N=100

75

Not readyKnow where to solicit outside expertise as neededReadySomewhat ready

Progression-free survival

Response rates (ORR. CR)

Time to progression

Minimum residual disease

Patient reported outcomes

Immune-related response criteria

Overall survival

28%38%19%10%

30%17% 42%7%

23%45%19%7%

18%27% 39%9%

36%36%16%7%

50% 14%20%10%

35%43%11%

6%

67% vs 35%of oncologists vs MCOs who are “ready” for evaluating overall survival as an endpoint

35% vs 14%of oncologists vs MCOs who are “ready” for evaluating immune-related response criteria as an endpoint

51

REAL-WORLD DATA AND PATIENT-REPORTED OUTCOMES Real-world evidence and patient-reported outcomes are both seen as being important to most MCOs (79% and 73%, respectively).

In fact, 59% of MCOs at least somewhat agree that within five years, drugs that fail to produce real-world demonstration of their benefit will lose coverage, a significant departure from the oncology world of today.

YOUNGER ONCOLOGISTS COMFORTABLE PRESCRIBING DRUGS WITH EVIDENCE OUTSIDE OF TRADITIONAL PHASE III TRIALSFrom an oncologist perspective, most (57% of oncologists 54 years old or younger and 61% of oncologists 55 or older) are comfortable prescribing an approved drug in an off-label indication based on real-world evidence.

Younger oncologists seem more willing to prescribe drugs based on accelerated approvals: 58% of oncologists 54 years old or younger were comfortable using a drug within an FDA-approved indication based on an accelerated approval with a single clinical study (compared with 42% of oncologists 55 or older).

FDA, Food and Drug Administration; EGFR, Epidermal Growth Factor Receptor

EXHIBIT


VALUE OF REAL-WORLD DATA IN COVERAGE DETERMINATIONS CONCERNING CANCER TREATMENTS% of respondents, N=100

76

Somewhat disagreeStrongly disagree Strongly agreeSomewhat agreeUndecided

Real-world data lack the methodological rigor of randomized, controlled trials and this limits their usefulness in coverage determinations

Currently, the resources and costs to collect real-world data outweigh the benefits to guiding coverage decisions

Patient-reported outcomes and health-related quality-of-life surveys in real-world settings are an important consideration in coverage determinations

Within the next 5 years. products that are unable show benefit in real-world settings within a reasonable timeframe after launch will lose coverage

Real-world data are essential for sound coverage and reimbursement decisions about cancer treatments

10%31%29%19%11%

8%23%24%33%12%

33%40%15%8%

4%

15%44%26%9%7%

45%34%6%4%

11%

EXHIBIT 77

ONCOLOGIST

ONCOLOGISTS WHO WOULD FEEL COMFORTABLE PRESCRIBING A THERAPY THAT ONLY HAD THE FOLLOWING CLINICAL EVIDENCE AVAILABLE% of survey respondents

Marketed drug that lacks approval for this indication but new real-world evidence indicated positive outcomes

Marketed drug that lacks approval for this indication but 1-2 case studies in literature suggested positive outcomes

Marketed drug that lacks approval for this indication but targets a mutation that your patient has (e.g., EGFR)

Conditional accelerated approval based on a single study

Conditional accelerated approval that failed confirmatory trial in a subset of patients

57%61%

38%32%

52%44%

58%42%

39%25%

55 and older (N=59)54 and younger (N=141)

REAL-WORLD DATA INCREASINGLY IMPORTANT TO MCOs

79%of MCOs view real-world data as essential for cancer coverage and reimbursement decisions

52

Advanced diagnostic testing and monitoring have become important tools for nearly all oncologists, with 99% of the physicians sampled reporting use of biomarker testing in at least some of their patients.

EMERGENCE OF BIOMARKER TESTING Advanced diagnostic testing and monitoring are becoming more and more important tools for nearly all oncologists—99% of the physicians sampled reported using biomarker testing in at least some of their patients—although the newest techniques (such as liquid biopsies or minimal residual disease testing) have inevitably seen the lowest uptake. The most common procedures are FDA-approved companion diagnostic tests and lab-developed tests for specific biomarkers (with 30% and 24% of patients on average receiving these tests). This growing penetration of biomarker testing seems to be making oncologists more comfortable to go out on a limb based on patient biomarker results: half of oncologists said they are comfortable using a marketed drug that lacks approval for their patient’s indication but targets a mutation that their patient has—for example, epidermal growth factor receptor (EGFR)—in the absence of suitable alternative options.

New emerging categories of testing that move beyond a single marker for a specific drug are starting to take root, with 83% of oncologists providing multigene panels, and 70% of oncologists providing next-generation whole-genome sequencing to at least some of their patients. However, new techniques for monitoring disease or less invasive testing are still not ubiquitous, with about half of doctors reporting not using these technologies for their patients (52% and 46%, respectively).

FDA, Food and Drug Administration.

PERSONALIZED MEDICINE & SOFTWARE SUPPORT

The most common procedures are FDA-approved companion

diagnostic tests and lab-developed tests for specific biomarkers

(with 30% and 24% of patients on average receiving these tests).

EXHIBIT 78

ONCOLOGIST

USE OF PERSONALIZED MEDICINE SCREENING/TESTING TECHNIQUES% of respondents, N=200. Q: “What extent do you typically use the following tests in your practice? Enter % of patients.”

25-50%Use for 0% of patients 1-10% >50%10-25% Mean % of patients

24%

21%

17%

11%

10%

30%

16%21%39%5%20%

14%17%44%9%17%

12%10%35%15%30%

8%6%24%11%52% 8%

6%9%22%19%46% 6%

25%17%36%18% 5%

Laboratory developed tests for a specific biomarker

Multigene panel

Broad next generation/whole genome-based sequencing

Minimal residual disease testing

Liquid biopsy

FDA-approved companion diagnostic matched to therapy under consideration

53

PATIENT OUTCOMESMost oncologists (68%) believe biomarker testing is having a significant impact on patient outcomes. Novel approaches for disease monitoring and whole-genome sequencing, however, have had a more limited impact to date, with only about a fifth of oncologists believing a significant improvement in patient outcomes has resulted from their use.

LACK OF GENERAL POLICIES REGARDING BIOMARKER TESTING Surprisingly, while most oncologists recognize the impact of biomarker testing on outcomes, only a minority of MCOs has a general policy of covering these tests—even FDA-approved companion diagnostic products, which are covered by 38% of MCOs. Less surprisingly, general coverage policies for emerging categories such as multigene panels or whole-genome sequencing were much lower, with coverage by 22% and 13% of MCOs, respectively; instead, coverage for these types of test tends to be on a case-by-case basis (43% of MCOs).

EXHIBIT 79

ONCOLOGIST

ONCOLOGIST OPINION ON THE FOLLOWING TYPES OF TESTING ON PATIENT OUTCOMES% of respondents, N=200

Molecular/biomarker testing (e.g., companion diagnostics testing like HER2, KRAS)

Molecular approaches for disease monitoring (e.g., liquid biopsy)

Whole-genome sequencing

68%22%2%

5%

22%37%29%10%

19%40%32%5%

Little impactNo impact Moderate impact Significant impact

EXHIBIT


DIAGNOSTICS TESTS COVERED BY MCOs

% of respondents, N=100

80

FDA-approved companion diagnostic matched to therapy under consideration

CLIA-waived or LDT diagnostic targeting the same marker as the registrational IVD from a different supplier

CLIA-waived or LDT multigene panel

CLIA-waived or LDT whole genome NGS-based sequencing

Determined on a case-by-case basis

38%

24%

22%

13%

43%

BIOMARKER TEsTING DETERMINED BY MCOs ON A CAsE-BY-CAsE BAsIs

43%of MCOs determine biomarker testing on a case-by-case basis

FDA, Food and Drug Administration; CLIA, Clinical Laboratory Improvement Ammendments; LDT, Laboratory Developed Test; NGS, Next-Generation Sequencing; IVD, In Vitro Diagnostic.

54

DECISION-SUPPORT TOOLS IN A COMPLEX LANDSCAPEWhile creating significant impact for patients, the emergence of advanced testing and the explosion of new drug approvals is making life far more

complex for oncologists as they seek to select the appropriate personalized therapeutic for individual patients. Moreover, the growth of clinical trials (see Section II “Clinical trials”) with correspondingly complex criteria for inclusion makes matching patients to trials a challenging process. To that end, recent efforts to create computer-assisted clinical decision-support tools (such as eviti and IBM Watson) have emerged. While these types of systems are not yet mainstream, a third of oncologists reported using them. Two-thirds of the time, the tool is directly integrated with the EMR system to streamline use by the oncologist.

WHICH SOFTWARE FEATURES MATTER?As these smart software solutions evolve, there are certain features that are particularly important to oncologists. In particular, the ability to visualize a patient’s expected clinical outcome for a certain therapy based on clinical trial and real-world outcomes data is of great interest, with 74% and 73%, respectively, of oncologists rating the two features as very important. Additionally, over half of oncologists would meaningfully value software that automatically flags clinical trials for which a patient is eligible, an integrated value assessment of each therapeutic option, and predictive models that use machine-learning to recommend therapeutic options.

EMR, Electronic Medical Record.

EXHIBIT 81

ONCOLOGIST

ONCOLOGIST USE OF COMPUTER-ASSISTED CLINICAL DECISION SUPPORT TOOL (E.G., EVITI, IBM WATSON) TO MAKE RECOMMENDATIONS BASED ON PATIENT CHARACTERISTICS% of respondents, N=200

21%

12%67%

We use one but it’s not integrated into our EMR

We use one and it’s integrated into our EMR

We don’t use one

EXHIBIT 82

ONCOLOGIST

74%

73%

VERY IMPORTANT1 CLINICAL DECISION SUPPORT SOFTWARE FEATURES% of respondents, N=200

Expected clinical outcomes of each therapy choice for my patient based on the best available clinical evidence

Expected clinical outcomes of each therapy choice for my patient by analyzing real-world data from millions of prior cancer patients (analysis of patients like mine)

Automatic identification of clinical trials my patient is eligible for

An integrated value assessment for each therapy choice that includes total cost of care transparency and practice budget impact estimates

Advanced predictive model for my patient’s outcome with each therapy choice based on machine-learning (e.g., IBM Watson-like systems)

62%

52%

52%

1 Survey participants rated the factor to be at least 4/5 in terms of importance

... the ability to visualize a patient’s expected clinical outcome

for a certain therapy based on clinical trial and real-world outcomes

data is of great interest, with 74% and 73%, respectively,

of oncologists rating the two features as very important.

55

Use of multidisciplinary panels and tumor boards is becoming increasingly significant and widespread, but with a higher level of referrals from specialist oncologists.

INCREASING USE OF MDTs

As oncology care becomes more complicated we are seeing increasing use of MDTs to handle clinical decision making: 92% of oncologists reported using MDTs for at least 5% of their patients, while 28% of oncologists reported an increase in their use of MDTs within the past year. Notably, nearly a third of oncologists send half or more of their patients to these boards.

We found that specialist oncologists are especially likely to be using MDTs: 41% of specialists reported sending half or more of their patients to MDTs compared with just 24% of general oncologists.

EXHIBIT 83

ONCOLOGIST

25-50%1<5% 5-15%1 ≥50%15-25%1

PERCENT OF PATIENTS THAT HAVE THEIR TREATMENT DECISIONS MADE VIA A TUMOR BOARD OR MULTIDISCIPLINARY TEAM DISCUSSION% of respondents

1 Ranges are non-inclusive of the upper bound (e.g., between 5% and less than but not equal to 15%)

31%

24%

22%

24%

18% 41%

23% 17%8%

23% 19%10%

22% 13%5%

All oncologists (N=200)

General oncologists (N=124)

Specialist oncologists (N=76)

USE OF MULTIDISCIPLINARY PANELS/TUMOR BOARDS (MDTs)

41% vs 24%of specialist oncologists vs general oncologists who send the majority of their patients to MDTs

56

Oncologists have differing views on drug interchangeability: specialists are more likely to see significant clinical differentiation among in-class competitors than general oncologists. This in turn affects how much specialists and generalists are prepared to push back on payer steerage. Going forward, payers are likely to be taking a stronger role in guiding therapy choices based on factors such as value.

DRUG INTERCHANGEABILITYSeveral drug classes are becoming increasingly crowded, with numerous competitor drugs that use the same mechanism of action. Oncologists have differing views on the interchangeability of such drugs and by how much they would be prepared to defer to payer pressure over their choice of therapy.

About a quarter of oncologists (23%) are of the opinion that these in-class competitors have significant clinical differentiation and so would push back on payer steerage. Approximately another quarter (26%) believe these drugs to be largely clinically equivalent and would defer to payer preference. The majority—about half (51%)—feel there are minor clinical difference; thus, while they may have particular preferences for a given patient, they would defer to significant payer pressure.

Notably, specialists are much more likely to see significant clinical differences between these intra-class competitors (33% of specialists versus 17% of general oncologists). However, 83% of general oncologists would defer to payers with pressure. This emerging paradigm of highly competitive classes that lack significant clinical differentiation in the minds of oncologists potentially opens the door to payers taking a stronger role in guiding therapy choice based on factors such as value. This will be even more important for classes of drugs that will serve as anchors for expensive combination regimens, the costs of which will be more challenging for payers to bear. It will also likely be most effective in settings where generalists treat the majority of patients.

INTERCHANGEABILITY

ONCOLOGISTS WILLING TO TREAT SAME-MOA DRUGS AS INTERCHANGEABLE

7 out of 10 specialist oncologists are willing to treat same-MOA drugs as interchangeable

8 out of 10 general oncologists are willing to treat same-MOA drugs as interchangeable

EXHIBIT 84

ONCOLOGIST

VIEW ON DRUGS THAT USE THE SAME MECHANISM OF ACTION% of survey respondents, N=200

General oncologists are particularly deferential to payer preferences. Almost a third of them consider most in-class drugs as clinically equivalent and would select therapy based on payer preferences

17%54%29%

33%46%21%

General oncologist (N=124)

Specialist oncologist (N=76)

Usually clinically equivalent; would select therapies based on non-clinical factors like payer preferences

Have minor clinical differences; would defer to payer/pathways if significant pressure applied Have significant clinical differences

MOA, Mechanism Of Action.

57

In our survey, biosimilars are seen broadly by office practice managers, managed care organizations, and specialty pharmacies as having a positive effect on profitability. However, oncologists—while open to considering biosimilars—are more cautious. In this context, a majority of MCOs will try to drive biosimilar use via lower patient co-pays.

IMPACT ON BOTTOM LINEOffice practice managers, managed care organizations, and specialty pharmacies expect biosimilars to have a meaningful impact on their bottom line in 2018:

• 49% of OPM respondents expect biosimilars to increase practice profitability in 2018 by at least 3%; 14% believe that biosimilars will increase practice profitability by at least 10%.

• Most SP respondents (73%) are actively planning to take advantage of oncology biosimilars, as they believe biosimilars will have a meaningful impact on their business.

• Most MCOs (61%) believe that biosimilars will have at least a 5% impact on total oncology drug spend over the next five years, and about half (49%) of MCO respondents plan to drive biosimilar use in 2018.

BIOSIMILARS

EXHIBIT


EXPECTED IMPACT FROM BIOSIMILARS IN 2018 ON OVERALL PRACTICE ECONOMICS% of survey respondents, N=179

85

Significant negative driver (>10% decrease in practice profitability)

Moderate negative driver (3-10% decrease in practice profitability)

We do not expect to adopt any biosimilars in 2018

Minimal impact (+/-2% increase in practice profitability)

Moderate positive driver (3-10% increase in practice profitability)

Significant positive driver (>10% increase in practice profitability)

14%

35%

37%

6%

6%1%

EXHIBIT


MCO EXPECTED APPROACH TO BIOSIMILARS IN 2018% of survey respondent, N=95

86

We plan to wait and see how pricing evolves before taking meaningful action

We plan to negotiate rebates with manufacturers of the reference product

We expect to drive use of biosimilars in newly treated patients

We expect to drive use of biosimilars in all patients

24%

25%

16%

35%

49% of MCOs expect to drive biosimilar use in patients

58

ONCOLOGISTS WILLING TO ADOPT BIOSIMILARS FOR NEW PATIENTSOncologists seem fairly willing to adopt biosimilars: a cumulative 73% of oncologists would be willing to prescribe biosimilars for new patient starts or in most

any setting, and 76% of oncologists would be willing to use biosimilars for non-FDA-approved indications if the biosimilar is deemed interchangeable—in fact, 40% of oncologists would use biosimilars for non-FDA-approved indications even without interchangeability designation. Only 21% of oncologists reported that they would only use biosimilars if required by payers.

However, few oncologists are willing to switch existing patients over to biosimilars: 43% of oncologists said they would prefer not to switch existing patients onto biosimilars and 18% would only use biosimilars for supportive care.

Nevertheless, 2018 biosimilar adoption among oncologists may be slower than the rate that OPMs, MCOs, and SPs expect. They might like biosimilars in theory, but most aren’t willing to jump right in to using them. Only 30% of oncologists said they would use biosimilars as soon as they are available. About half of oncologists said they would use biosimilars only several months after they are available, and only if there was positive anecdotal experience.

Most MCOs seem to be taking the soft approach towards biosimilar usage. Only 13% of MCOs that plan to drive biosimilar use in 2018 expect to do so by excluding branded products from the formulary—most (53%) will try to drive biosimilar use via lower patient co-pays.

ONCOLOGISTS WILLING TO ADOPT BIOSIMILARS WITHOUT PAYER PRESSURE

2 out of 10 oncologists will only use biosimilars if required by payers

7 out of 10 oncologists are willing to prescribe biosimilars for new patient starts or in most any setting

43% of oncologists would prefer not to switch existing patients onto biosimilars

EXHIBIT 87

ONCOLOGIST

ONCOLOGIST COMFORT WITH USING BIOSIMILARS% of respondents, N=200

43%

31%18%

9%

I am comfortable starting new patients on biosimilars, but would prefer not to switch existing patients from reference drugs to biosimilars

I am very comfortable prescribing biosimilars in place of the reference product in almost any setting

I prefer not to use biosimilars

I am comfortable using biosimilars for supportive care, but am unlikely to use them in high-stakes settings (e.g., with curative intent)

EXHIBIT 88

ONCOLOGIST

ONCOLOGIST TIMING OF BIOSIMILAR USE% of respondents, N=200

After they have been available for several months and there is positive anecdotal experience

Only if they are required by payers

As soon as they are available

49%

30%21%

Most MCOs seem to be taking

the soft approach towards

biosimilar usage. Only 13% of

MCOs that plan to drive biosimilar

use in 2018 expect to do so by

excluding branded products from

the formulary—most (53%) will try

to drive biosimilar use via lower

patient co-pays.

59

Specialty pharmacies are increasingly supporting patients and oncologists by recommending drugs that are cheaper or better covered by insurance—and oncologists tend to be responding positively.

GROWING INFLUENCE OF SPECIALTY PHARMACIESWith rising patient out-of-pocket costs (see Section VI), specialty pharmacies are now playing an influential role in oncology therapy selection: 90% of specialty pharmacies reported playing a role in therapy selection, and 51% of SPs reported suggesting an alternative cancer product back to the physician for at least 15% of their cancer drug referrals.

EXHIBIT

SPECIALTY PHARMACY

ROLE OF SP IN THE SELECTION OF THERAPIES% of survey respondents, N=30

89

70%

60%

60%

53%

40%

13%

10%

40%

We suggest alternative products that may be preferred/covered by payers

We suggest alternative products with lower out-of-pocket costs

We suggest alternative products with fewer drug-drug interactions

We suggest alternative products with better efficacy or safety

We suggest alternative products in cases of supply shortages

We suggest alternative products we have in inventory that will have fewer delays

No role, we dispense what the physician prescribes

We suggest alternative products that may have enhanced services

EXHIBIT

SPECIALTY PHARMACY

SPECIALTY PHARMACY DRUG SUGGESTIONS

90

Upper quartile


60%50%40%30%20%

10%

70%80%90%

20%15%10%

17%

FREQUENCY OF SUGGESTING AN ALTERNATIVE PRODUCT BACK TO ONCOLOGIST’S CANCER DRUG REFERRAL% of drug referrals, N=27

60%50%40%30%20%

10%

70%80%90% 90%

80%

50%

68%

% of drug referrals, N=27

FREQUENCY OF ONCOLOGIST ACCEPTING THE RECOMMENDATION AND CHANGING THE DRUG

... 51% of SPs reported suggesting

an alternative cancer product back

to the physician for at least 15%

of their cancer drug referrals.

SPECIALTY PHARMACY ROLE IN THERAPY SELECTION

60

SP COST-FOCUSED ROLE RECEIVED POSITIVELY BY ONCOLOGISTSNote, however, that this role appears to be heavily focused on cost. The top two most popular ways in which SPs played a role in therapy selection were by:

1. Suggesting alternative products that are preferred/covered by payers—70% of all SPs surveyed

2. Suggesting alternative products with lower OOP costs—60% of all SPs surveyed

OOP, Out-Of-Pocket.

At the same time, oncologists seem to be listening: SPs reported that the majority of the time (on average, 68% of the time), oncologists accept the new product recommended by the SP.

SPs ARE EXPANDING CONTRACTS WITH MANUFACTURERS FOR DATA AND SERVICESSPs are exploring a variety of services to drug manufacturers: 70% of SPs are providing data and a similar number are providing compliance/adherence services, with contracts covering on average 13 drugs; a small subset (40%) have manufacturer contracts that provide payments for increased market share of the preferred drug, covering on average 18 cancer drugs.

SPs ACTING AS GATEKEEPERSIf SPs continue to recommend drugs that are cheaper for patients or are better-covered by their health insurance, and oncologists continue to listen to such recommendations, then SPs will become increasingly important gatekeepers, deciding which oncology prescriptions go through and which ones get changed.

ONCOLOGISTS LISTENING TO SP DRUG SUGGESTIONS

68%of the time, oncologists listen when a SP recommends a new drug

70% of SPs provide data to drug manufacturers

EXHIBIT

SPECIALTY PHARMACY

SPs THAT CONTRACT WITH DRUG MANUFACTURERS FOR THE FOLLOWING SERVICES% of survey respondents, N=30

91

Average # of drugs SPs have contracts forXX

Data

Compliance and adherence services

Increase market share for preferred drugs

Manage patient-services hub programs

Side effect management services

70%

70%

40%

53%

60%

13

13

18

12

10

Care decisions are influenced and managed in multiple ways. Here we explore mechanisms for drug management, alternative payment models, the move towards value-based care via the Oncology Care Model, the increasing use of cancer treatment guidelines by oncologists, adoption of pathways developed by external sources, shared decision making between oncologists and patients via value assessment frameworks, and information sources for oncologist decision making, including the influence of specialty pharmacies.

CONTENTSDrug Management ....................................................................................................................................................................................

Alternative Payment Models ....................................................................................................................................................................

Oncology Care Model ...............................................................................................................................................................................

Guidelines ...................................................................................................................................................................................................

Pathways .....................................................................................................................................................................................................

Value Assessment Frameworks .............................................................................................................................................................

Oncologist Decision Making ...................................................................................................................................................................

Specialty Pharmacy ..................................................................................................................................................................................

62

65

67

69

71

75

76

79

IV. HOW ARE CARE DECISIONS BEING INFLUENCED/MANAGED?

61

USE OF QUANTITY LIMITS DECLINING

92% vs 78%The percent of MCOs using drug quantity limits declined by 14 percentage points

2016 study year

2017 study year


PRACTICES RAPIDLY ADOPTING MIPS

1 out of 2oncology practices participate in MIPS1

Another

24%of practices plan to participate this year1

ONCOLOGISTS USING GUIDELINES

78%of oncologists use cancer treatment guidelines

ONCOLOGISTS USING PATHWAYS

52%of oncologists use cancer pathways

62

Although traditional utilization management tools (such as step editing or quantity limits) remain common among MCOs for controlling oncology drug spend, they tend to be less restrictive in denying coverage for on-label drug uses than other specialty areas (such as rheumatoid arthritis). While we see signs that MCOs may increase utilization of these restrictions, overall MCOs are shifting away from limiting drug quantity, and shifting towards moving more of the risk onto providers.

TRADITIONAL UTILIZATION MANAGEMENT REMAINS HIGHUse of traditional utilization management tools—such as prior authorizations, formulary tiering, and step editing—remains common.

Prior authorization/precertification. In the 2016 study year, 91% of MCOs said they used prior authorization/precertification. This year that number remains almost unchanged at 90%.

Formulary tiering. In the 2016 study year, 77% of MCOs said they used formulary tiering to control oncology spend. This year, that number remains high at 74%.

Step editing. Both in the 2016 study year and this year, 67% of MCOs said they used step editing to control oncology spend.

DRUG MANAGEMENT

EXHIBIT


MCO USAGE OF ONCOLOGY DRUG MANAGEMENT TOOLS% of survey respondents

92


Prior authorizations/precertification

91%

90%

Formulary tiers with differential patient copays/co-insurance

77%

74%

Step edits/therapy

67%

67%

Quantity limits

92%

78% – 14%

There has been a move away from reimbursement based on the price of the drug towards a system that provides a maximum upper-bound cost for MCOs—effectively shifting the risk to providers. There has been a sizeable decrease in the percentage of oncology medical benefit drugs that are reimbursed based on average sales price (ASP), average wholesale price (AWP), or wholesale acquisition cost (WAC):

• ASP—in the 2016 study year, 51% of branded oncology medical benefit drugs were reimbursed based on ASP; this year, the ASP reimbursement figure has dropped to 21%.

• AWP—28% of branded oncology medical benefit drugs were reimbursed based on AWP in the 2016 study year; this year, the figure has fallen to 21%.

• WAC—10% of branded oncology medical benefit drugs were reimbursed based on WAC in the 2016 study year; this year, the corresponding figures have drifted down to 7% (hospitals) and 9% (private practices).

RISE IN MAC, CAPITATION AGREEMENTS, AND RISK SHARINGAt the same time, there has been a corresponding increase in the share of oncology medical benefit drugs that are reimbursed based on some kind of upper bound in cost for MCOs: just 1% of branded oncology medical benefit drugs were reimbursed based on maximum allowable cost (MAC) in the 2016 study year; this figure had risen to 11% this year. The percentage of branded oncology medical benefit drugs reimbursed via capitation agreements was too low to display as a separate category in the 2016 study year; however, this year, 12% of branded oncology medical benefit drugs in hospitals and 13% of private practices were reimbursed based on such agreements.

63

SHIFTING REIMBURSEMENT APPROACHOne utilization management tool that has seen a reduction in usage is quantity limits. In the 2016 study year, 92% of MCOs reported using quantity limits, but this year only 78% reported using them. The decline in use of quantity limits has been accompanied by a change in the way branded oncology medical benefit drugs are reimbursed.

EXHIBIT


BRANDED ONCOLOGY MEDICAL BENEFIT PRODUCT REIMBURSEMENT% of products

93


-30%

ASP-based AWP-based WAC-based Maximum allowable cost

28%

21%

10% 8%

51%

21%

1%

11%+10%

UsE OF QUANTITY LIMITs DECLINING

92% vs 78%

The percent of MCOs using drug quantity limits

2016 study year

2017 study year

There has been a move away

from reimbursement based on

the price of the drug towards

a system that provides a

maximum upper-bound cost

for MCOs—effectively shifting

the risk to providers.

1% vs 11%of branded oncology medical benefit drugs reimbursed based on maximum allowable cost (2016 study year vs 2017 study year)

ASP, Average Sale Price; AWP, Average Wholesale Price; MAC, Maximum Allowable Cost; WAC, Wholesale Acquisition Cost.

• 46% of MCOs reported that they use capitation agreements with providers.

• 23% of MCOs said they implement financial incentives for lowering total cost of care, where the risk is double-sided.

64

Additionally, the majority of MCOs have adopted a variety of risk-sharing reimbursement approaches:

• 60% of MCOs said they use bundled/episode-based payments with oncology providers—34% use bundled/episode-based payments where drug costs are included in the bundled payment.

EXHIBIT


ALTERNATIVE PAYMENT MODELS USED WITH ONCOLOGY PROVIDERS% of survey respondents, N=93

94

Both

With reimbursement of drugs at cost

Including drug costs

Bundled/episode-based payments 60%19%15%26%

Single sided riskDouble

sided risk

Capitation agreements with providers

Incentives for adherence to pathways

Care-management fees (with reimbursement of drugs at cost)

Incentives for lowering total cost of care

46%

42%

35%

13%10% 36%13%

60% of MCOs use bundled/episode-based payments with oncology providers

65

Alternative payment models—as opposed to traditional fee for service—have caught the imagination of all players in the sector, as healthcare organizations look for opportunities to improve care while reducing costs.

APM PENETRATIONAll stakeholders are exploring APMs—although oncologists tend to be less familiar with specific reimbursement models. Approximately half of employers are using APMs for oncology care; meanwhile, 50% of OPMs and 43% of oncologists also reported being reimbursed through APMs; however, about a third of providers (19% of OPMs and 31% of oncologists) don’t even know if they are being reimbursed through APMs.

APMs are by no means universal: a quarter of OPMs using APMs reported that less than 5% of their revenue currently comes from such models. However, there is a small group of practices (6% as reported by OPMs and 8% of oncologists) that receive over 20% of their reimbursement through an APM.

APM, Alternative Payment Model; E&M, Evaluation & Management.

EXHIBIT 95

ONCOLOGIST

PRACTICES RECEIVING ALTERNATIVE PAYMENTS FROM PAYERS


YesNo – all our payments are traditional fee for service Unsure/unable to provide informed answer

OPM% of survey respondents, N=202

50%31%

19%

ONCOLOGISTS% of survey respondents, N=200

43%26%

31%

61%

34%51%

31%38%

28%34%

27%40%

25%25%

32%21%

Bundled payments (e.g., episode-of-care-based)60%

Value-based quality performance incentives

Management fees for specific clinical services (i.e., not including traditional E&M…etc.)

Global payments (i.e., full capitation/risk sharing)—no quality incentives

Shared savings payments

Payments for pathways adherence

Global payments (i.e., partial capitation/risk sharing)—no quality incentives

Oncologist (N=88)OPM (N=100)

TYPES OF ALTERNATIVE PAYMENTS TO TRADITIONAL FEE FOR SERVICE RECEIVED FROM PAYERS% of survey respondents

% OF TOTAL COLLECTED REVENUE IN 2017 THAT CAN BE ATTRIBUTED TO ALTERNATIVE PAYMENT MODELS% of survey respondents 11-20% More than 20%Less than 5%Unsure 5-10%

OPM (N=100) 24% 32% 25% 6%13%

Oncologist (N=88) 31%31% 19% 11% 8%

ALTERNATIVE PAYMENT MODELS

50% of oncology practices use APMs

...there is a small group of practices (6% as reported by OPMs

and 8% of oncologists) that receive over 20% of their

reimbursement through an APM.

66

BUNDLED PAYMENTSBundled payments are often an organization’s first step into APMs and they tend to dominate the current landscape, accounting for approximately 60% of APMs used by OPMs and oncologists.

INCENTIVES FOR APMs

Financial incentives are split for APMs: 24% of OPMs said their practices receive upside only, and 35% of OPMs said their practice is subject to both financial upside and downside. Performance incentives tend to be linked with quality: only 12% of OPMs involved in APMs reported not having quality-linked performance incentives.

MERIT-BASED PAYMENTSMeanwhile, 51% of practices in 2017 are already participating in the merit-based incentive payment system, while another quarter plan to participate by 2018 as the program penalties and incentives ramp up.

APM, Alternative Payment Model; MIPS, Merit-based Incentive Payment System.

EXHIBIT


96

INCENTIVES TIED TO PERFORMANCEINVOLVEMENT IN PERFORMANCE INCENTIVES FOR ACHIEVEMENT OF QUALITY GOALS

Yes, upside onlyYes, upside and downsideNo, but we have downside risk if we don’t meet themNo, we do not use performance incentives based on quality metrics

24%

40%

13%

23%

28%

9%

14%

26%

24%

Yes, we are participating in MIPS as a group

No, we are not participating in MIPS now, but expect to in 2018No, we do not have plans to register for MIPS

Yes, all of our clinicians are participating in MIPS as individualsYes, some of our clinicians are participating in MIPS as individuals

PARTICIPATION IN THE MERIT-BASED INCENTIVE PAYMENT SYSTEM IN 2017% of survey respondents, N=124 (exluding OPMs who were unsure) % of survey respondents, N=200

PRACTICES RAPIDLY ADOPTING MIPS


1 out of 2oncology practices participate in MIPS1

24%of practices plan to participate this year1

Another

67FFS, Fee-For-Service; OCM, Oncology Care Model.

The Oncology Care Model (OCM) is part of a general move away from the fee-for-service (FFS) model toward value-based care. Developed by the Center for Medicare and Medicaid Innovation, OCM is an episode-based payment system—as a multipayer model it combines FFS payments for established services, monthly payments for additional care under a structured guideline, and performance-based payments measured against quality metrics and benchmarks. The OCM pilot is designed for discrete instances of care, especially those involving chemotherapy; however, despite incentives built into the program, many oncologists remain to be convinced about the impact on cost and quality.

PROGRESS ON IMPLEMENTING OCMProgress on implementing the Oncology Care Model has so far been mixed: 24% of surveyed oncologists and 15% of OPMs are participating in the OCM pilot. However, it appears that OCM implementation has hit a few stumbling blocks: for example, one-third of oncologists reported that they aren’t even notified that a specific patient is an OCM patient. Moreover, practices often don’t communicate to oncologists what they should be doing for OCM patients—35% of oncologists reported that their practice provides no guidance on how to treat OCM patients differently, and 28% of oncologists only received broad guidance. “In reality, I have noticed little difference in the treatment of OCM patients versus non-OCM patients,” was a typical view from this category of oncologists.

ONCOLOGY CARE MODEL

EXHIBIT


PRACTICES PARTICIPATING IN THE ONCOLOGY CARE MODEL (OCM) PILOT% of survey respondents

97

ONCOLOGIST

59% of oncologists either aren’t sure, or aren’t made aware when treating an OCM patient. A typical quote from oncologists was: “In reality, I have noticed little difference in the treatment of OCM patients versus non-OCM patients.”

15%

OPM (N=202)

Oncologist (N=200)

24%LEVEL OF GUIDANCE ON HOW TO TREAT OCM DIFFERENTLY% of survey respondents, N=51

25%35%

28%

41%

28%

31%

AWARENESS WHEN TREATING AN OCM PATIENT% of survey respondents, N=51

Never

Sometimes

Am always aware

None

Received broad guidance

Received very specific guidance

24% of oncologists are participating in the OCM pilot

Moreover, practices often don’t communicate to oncologists what they should be doing for

OCM patients—35% of oncologists reported that their practice provides no guidance on

how to treat OCM patients differently, and 28% of oncologists only received broad guidance.

68

Consequently, it is not surprising that approximately a third of oncologists believe there has been no impact on cost (37%) and quality (33%).

Despite this, OPMs are more optimistic—although 23% still believe there has been no impact on cost, and 16% feel there has been no impact on quality.

OCM, Oncology Care Model.

EXHIBIT 98

ONCOLOGIST

OCM PROGRAM BENEFITS% of survey respondents, N=51 (Oncologists participating in OCM)

Too early to tellNo, not at all Yes, somewhat Yes, significantly

Lowered cost of care

Increased quality of care

12%24%

8%31%

37%

33%

27%

27%

Lowered cost of care

EXHIBIT


OCM PROGRAM BENEFITS% of survey respondents, N=31 (OPMs participating in OCM)

99

Too early to tellNo, not at all Yes, somewhat Yes, significantly

Increased quality of care

29% 10%39%

16%48%

23%

16% 19%

1/3 of oncologists don’t believe that OCM participation has lowered cost of care or improved quality of care

69

Possibly due to increased practice consolidation, a significant proportion of oncologists are being encouraged by their practice to use cancer treatment guidelines developed by prominent oncology organizations. This has led to a sharp uptick in the percentage of oncologists who use cancer treatment guidelines, and suggests that such clinical practice guidelines may play an increasingly significant role in how oncologists approach patient treatment.

MORE ONCOLOGISTS EMBRACING TREATMENT GUIDELINESThere’s been a sharp jump in the number of oncologists who use cancer treatment guidelines: in the 2016 study year, 53% of surveyed oncologists said they used cancer treatment guidelines; this year, that number had jumped to 78%.

GUIDELINE UPTAKE DRIVERS This trend is potentially driven by increased oncology practice consolidation—large oncology practices may wish to standardize the care provided across their entire organization; also, larger oncology practices are better equipped to take advantage of opportunities to share cost savings with MCOs. Only 8% of oncologists who work in a practice with ten or more sites reported that they don’t use guidelines and aren’t planning on using guidelines in 2018. In contrast, a higher proportion (18%) of oncologists who work in a practice with fewer than ten sites reported that they don’t use guidelines and aren’t planning on using guidelines in 2018.

EXHIBIT 100

ONCOLOGIST

USE OF CANCER TREATMENT GUIDELINES% of survey respondents 2016 study year (N=202) 2017 study year (N=200)

47%

22%

53%

78%

of oncologists who said yes

USAGE PROMPTED BY% of survey respondents, N=156

Practice Payer

Don’t use guidelines Use guidelines Required to use byEncouraged to use by

19%3%

74%

4%

19%

EXHIBIT 101

ONCOLOGIST

USE OF CANCER TREATMENT GUIDELINES% of survey respondents Practices with less than 10 sites (N=176) Practices with 10 or more sites (N=24)

Don’t use guidelines Plan to use in 2018 Use guidelines

18%

8%

4%

13%

78%79%

GUIDELINES

70

ONCOLOGY ORGANIZATIONS INCREASINGLY INFLUENTIALThis trend suggests that cancer treatment guidelines developed by prominent oncology organizations will become an increasingly important

source of influence regarding oncologists’ approach to patient treatment. Among those who use or plan to use guidelines, oncologists are progressively turning towards NCCN and ASCO clinical practice guidelines and away from guidelines developed internally. For example, this year 84% of oncologists said they were using NCCN guidelines compared with 62% in the 2016 study year; nearly twice as many oncologists said they used ASCO guidelines this year compared with the 2016 study year—up to 53% this year from 28% in the 2016 study year; and only 19% of oncologists said they used internally developed guidelines this year compared with 29% in the 2016 study year.

FREQUENCY OF REVIEWAmong oncologists who use or plan to use guidelines, 85% reported reviewing cancer treatment guidelines at least once a quarter, and well over a third (39%) reported reviewing cancer treatment guidelines at least once a week.


ONCOLOGISTS USING GUIDELINES

78%of oncologists use cancer treatment guidelines

EXHIBIT


SOURCE(S) OF GUIDELINES USED% of survey respondents

102


NCCN Clinical Practice Guidelines

ASCO Clinical Practice Guidelines

Internally developed

62%

84%

28%

53%

29%

19%

-10%

+25%

+22%

EXHIBIT 103

ONCOLOGIST

FREQUENCY OF REVIEWING CANCER TREATMENT GUIDELINES% of survey respondents, N=166

Only when I hear about changes

QuarterlyMonthly AnnuallyI have visibility into guidelines for every

patient visit via our EMR

Weekly

10%

23%23%

5%

16%

22%

29% vs 19%of oncologists who use internally developed cancer treatment guidelines (2016 study year vs 2017 study year)

71

Pathways usage is on a similar trend to guideline usage, with a general uptick that is likely driven by practice consolidation, alongside a move towards pathways developed by external sources such as the NCCN.

PATHWAY USAGE TRENDSThere has been an uptick—albeit smaller than the trend towards guidelines usage—in the proportion of oncologists who use pathways: 52% this year versus 45% in the 2016 study year. Again, as with guidelines usage, this uptick could be driven by practice consolidation—a higher percentage of practices with numerous sites use pathways compared with practices with fewer sites. The survey data indicates that only 29% of oncologists in practices with ten or more sites reported that their practice doesn’t use cancer treatment pathways and doesn’t plan to use any in 2018. In contrast, 38% of oncologists in practices with fewer than ten sites reported that their practice doesn’t use cancer treatment pathways and has no plans to do so in 2018.

MOVE TOWARDS EXTERNAL SOURCES OF PATHWAYSOnce again, as with cancer treatment guidelines, oncologists are shifting away from internally developed pathways and towards external sources, such as the NCCN Value Pathway. This year, the proportion of oncologists who said they use NCCN Value Pathways grew by 8 percentage points, with 43% reporting that they have done so this year versus 35% in the 2016 study year. At the same time, the proportion of oncologists who said they use hospital/cancer center pathways increased by 6 percentage points, with 25% reporting that they did so this year versus 19% in the 2016 study year. Meanwhile, the percentage of oncologists who said they use internally developed pathways decreased by 11 percentage points, with 44% reporting that they did so in the 2016 study year versus 33% 2017 study year.

NCCN, National Comprehensive Cancer Network.

PATHWAYS

ONCOLOGISTS USING PATHWAYS

52%of oncologists use cancer pathways

EXHIBIT 104

ONCOLOGIST

USE OF CANCER TREATMENT PATHWAYS% of survey respondents 2016 study year (N=202) 2017 study year (N=200)

72%

7%

18%3%

48%

55%52%

45%

of oncologists who said yes


Don’t use pathways Use pathways Required to use byEncouraged to use by

Practice Payer

44% vs 33%of oncologists who use internally developed cancer pathways (2016 study year vs 2017 study year)

72

PATHWAY ADOPTION LIKELY TO CONTINUE TO GROW IN FUTUREPathways are currently used by 78% of MCOs, with 35% of MCOs having a specific preferred pathway for their network oncologists. Among MCOs that encourage their network oncology providers to use a specific pathway, NCCN Value Pathways were the most common preferred approach (37% of MCOs), followed by internally developed (17%), and AIM Specialty Health (11%) pathways. MCOs are bullish on cancer treatment pathways and/or guidelines to improve cost and quality of care, and sentiment among MCOs is illustrated by the following data: 66% of MCOs surveyed agree that pathways are here to stay; 66% of MCOs surveyed agree that the full value of pathways has yet to be realized; moreover, 17% of MCOs strongly agree that this is the case. In addition, about a third of MCOs have seen improvements in cost and quality of care from cancer treatment pathways.

NCCN, National Comprehensive Cancer Network.

EXHIBIT 105

ONCOLOGIST

SOURCE OF PATHWAY(S) USED% of survey respondents

35%

43%

19%

25%

44%

33%

NCCN Value Pathways Hospital/cancer center Internally developed


EXHIBIT


MCOs WHO ENCOURAGE NETWORK ONCOLOGY PROVIDERS TO USE A PREFERRED ONCOLOGY PATHWAY% of survey respondents, N=100

106

We allow our network oncologists to select their preferred pathwayWe have a pathway that we ask our network oncologists to follow

We do not currently incorporate pathways into our oncologymanagement program

New Century Health

Value Pathways Powered by NCCN (McKesson/US Oncology)

AIM Specialty Health

Cardinal pathways program

Internally developed

35%22%

43%

REASON FOR NOT ENCOURAGING SPECIFIC PATHWAYS% of survey respondents, N=65

Lack of resources

Objections to use by network oncologists

Have not evaluated which pathway is the best for different cancers

Too expensive/not worth the expected savings or quality improvement

No mechanism to monitor compliance

15%

52%

28%

9%

29%

SOURCE OF PATHWAY(S) USED% of survey respondents, N=35

9%

Hospital/cancer center3%

11%

Via Oncology™ Pathways3%

Group purchasing organization/distributor3%

Oncology practice management firm6%

eviti, Inc.3%

6%

17%

37%

MCOs are bullish on cancer treatment pathways and/or guidelines

to improve cost and quality of care

73

We found that 58% of MCOs are using some form of incentive to drive adoption among oncologists through various programs:

Financial—40% of MCOs surveyed share cost savings to incentivize pathway/guideline use, while 22% offer bonus payments.

Reducing the admin burden—36% offer faster prior authorization processing to incentivize pathway/guideline use, while 27% offer expedited reimbursement processing and utilization reviews to incentivize pathway/guideline use.

However, OPMs seem to have much higher expectations about pathway adoption compared with what oncologists are reporting: for example, a larger percentage of OPMs reported that their practice uses cancer treatment pathways compared with oncologists; 67% of OPMs said their practice uses cancer treatment pathways versus 52% of oncologists; and a greater proportion of OPMs reported that their practice informs patients when a pathway applies to them—57% of OPMs compared with 45% of oncologists.

EXHIBIT


LEVEL OF AGREEMENT WITH THE FOLLOWING STATEMENTS RELATED TO CANCER TREATMENT PATHWAYS% of survey respondents, N=100

107

Agree Strongly agreeDisagree UndecidedStrongly disagree

Discussion and consideration of clinical trials should be a required on-pathway element

The pathway development process should mirror the transparent and consensus-based guidelines development process

The full value of pathways is yet to be realized

Pathways are here to stay and are an integral tool for alternative payment mechanisms (e.g., bundled payments)

Controlling our own pathway would enable us as an MCO to negotiate with drug manufacturers

Oncologists do not need financial incentives to make treatment decisions based on evidence, but should be paid a fee for their time

Pathways should aim to be as narrow as possible to ensure consistency of care

Cost containment should not be the central organizing principle for clinical pathways

On-pathway treatment selection should be considered automatically authorized or certified

Pathways should aim to be as broad as possible to ensure physicians can select the appropriate therapy for each patient

It should be possible to create a single or national pathway for each type of cancer/stage which all payers can adopt

34% 57% 10%6%

27% 54% 19%2%

25%2%

7% 49% 17%

27%2%6% 57% 9%

26% 50% 7%4%

5%

33% 35% 8%7% 17%

18% 37% 12%4% 20%

30%3% 45% 13%21%

31% 39% 9%18%3%

27% 41% 8%19%2%

25% 43% 8%16%6%

EXHIBIT


INCENTIVES OFFERED BY MCOs TO ONCOLOGISTS TO ENCOURAGE USE OF CANCER TREATMENT GUIDELINES AND/OR PATHWAYS% of survey respondents, N=100

108

Share of cost savings

Faster processing of PA/precertifications

Reduced prior authorization (PA) or precertification requirementsExpedited utilization reviews and reimbursement processing

Per-member monthly fee

Preferred provider status within the network

Improved/higher evaluation & management (E&M) reimbursement

Initiation fee

Lump sum bonus payments (i.e., individual or group)

Improved/higher drug reimbursement for the oncologist

Do not incentivize oncologists to use treatment pathways

40%

36%

32%

27%

21%

27%

19%

14%

22%

17%

42%

E&M, Evaluation & Management; PA, Prior Authorization.

74

PATHWAY ADHERENCEOPMs have several options for guiding oncologists to meet their expectations: they can more strictly enforce pathway adherence—currently, pathway adherence isn’t strictly enforced—and also make pathway adherence less confusing.

Of the oncologists who use pathways, 35% reported adherence not being enforced—in stark contrast to just 16% of OPMs who reported not enforcing adherence. This disconnect may be partially explained by the greater proportion of OPMs who said they enforced adherence to pathways by sharing compliance reports (37%) compared with oncologists (29%). Perhaps, more OPMs than oncologists believe that sharing compliance reports with the practice is a good way to enforce pathway enforcement. Interestingly, few OPMs reported using more stringent tools for enforcing pathway compliance—only 24% of the OPMs surveyed reported tying individual physician payment to compliance.

OPMs have an opportunity to make pathway adherence less confusing. For instance, there is a disconnect between OPMs and oncologists about what to do when working with multiple pathways—one example being different patients with different providers. In this context, 13% of oncologists said they’re not always sure which pathway to use for which patient. Although 39% of OPMs said oncologists could check with staff to figure out which pathway to use, only 12% of oncologists said they do so. Equally, while 44% of OPMs said oncologists could check EMR notifications to understand which pathway to use, only 12% of oncologists said that they do so.

EMR, Electronic Medical Record.

24% of oncology practices tie individual physician payment to pathway compliance

EXHIBIT 109

ONCOLOGIST

ENFORCEMENT OF ADHERENCE TO GUIDELINES, PATHWAYS, OR VALUE FRAMEWORKS (AS APPLICABLE)% of survey respondents


Oncologist1 (N=103) OPM1 (N=135)

1 Oncologists and OPMs who reported using pathways

Practice reports regarding compliance are shared with peers

Individual physician payment is tied to compliance

Group (i.e., practice) payment is tied to compliance

Discussion during tumor boards

Requires peer review (i.e., by another physician at your practice)

IT system’s step edit requires internal approval on exception before you can proceed

Adherence is not enforced16%

29%

19%

13%

15%

35%

12%

14%

37%

24%

26%

16%

17%

12%

EXHIBIT 110

ONCOLOGIST

ONCOLOGIST INFORMATION SOURCES WHEN WORKING WITH MULTIPLE PATHWAYS% of survey respondents


Oncologists (N=103) OPMs (N=105)

I’m not always sure which pathway should be used

for which patient

Check with staff Check EMR notification Always use the same pathway

Check for an email/note

12%

39%

13% 12%

44%

8%13%

6% 4%

75

As part of efforts to ensure optimal value, there has been a push towards shared decision making between oncologists and patients regarding treatment options.

Value assessment frameworks enable providers and patients to jointly evaluate efficacy, safety, and the affordability of the various treatment options. Almost half (44%) of oncologists either use value assessment frameworks (22%) or plan to use them in 2018 (22%). Of those who use or plan to use value assessment frameworks, the majority use NCCN Evidence Blocks (65%) or ASCO Value Framework (29%).

MCOs are also significantly leveraging external value assessment frameworks for their policy decisions. About half of MCOs use these frameworks as primary or an important secondary input for policy decision making (52% for medical benefit and 43% for pharmacy benefit).


EXHIBIT 111

ONCOLOGIST

USE OF VALUE ASSESSMENT FRAMEWORKS% of survey respondents, N=200

56%22%

22%


Encouraged to use by 70%

2%

Required to use by 23%

5%

Don’t usePlan to use in 2018Use

Practice Payer

EXHIBIT 112

ONCOLOGIST

SOURCE(S) OF VALUE ASSESSMENT FRAMEWORKS USED% of survey respondents, N=44

Memorial Sloan Kettering Cancer Center DrugAbacus

NCCN Evidence Blocks

ASCO Value Framework (v2.0)

Institute for Clinical and Economic Review Value Assessment Framework

65%

29%

5%1%

VALUE ASSESSMENT FRAMEWORKS

22% of oncologists use value assessment frameworks

76

Clinical decisions around therapies have to take into account factors such as efficacy, safety, and affordability, as they concern both patients and payers. However, cost is not usually the primary concern for physicians, who are more focused on efficacy and safety, and most likely to be guided by traditional clinical and RWE data. As the complexity of the treatment landscape grows, information is increasingly coming from multiple sources—especially collaboration with peers and specialty pharmacies—but few oncologists consider manufacturer representatives to be a primary source of information about new therapies.

ONCOLOGISTS FOCUS ON DATA NOT COSTWhen it comes to selecting therapies, oncologists are mostly concerned with the data—both clinical evidence and RWE: 80% of oncologists said therapy efficacy is a primary consideration; 71% of oncologists said therapy safety is a primary consideration; and 47% of oncologists said real-world evidence is a primary consideration.

However, from an oncologist’s perspective cost is a leading secondary consideration when they prescribe therapies: 54% of oncologists said patient out-of-pocket burden was a secondary consideration while 48% flagged overall cost of therapy for secondary consideration. This places cost on par with supportive care requirements (49%) and convenience of formulation (46%) as the major secondary factors for oncologists.

DTC, Direct To Consumer; RWE, Real-World Evidence; WAC, Wholesale Acquisition Cost.

ONCOLOGIST DECISION MAKING

ONCOLOGISTS CHOOSING THERAPIES BASED ON REAL-WORLD EVIDENCE

47%of oncologists view real-world evidence as a primary consideration during therapy selection

EXHIBIT 113

ONCOLOGIST

LEVEL OF INFLUENCE OF THE FOLLOWING FACTORS ON ONCOLOGIST THERAPY SELECTION DECISION-MAKING% of survey respondents, N=200

Primary consideration Top 4 primary considerationsSecondary considerationTop 4 secondary considerationsConsidered, but rarely impacts choices

Efficacy 7%13% 80%

Safety 8%21% 71%

Real-world evidence 16%34% 47%

Guideline placement 22%39% 35%

Overall cost of therapy 33%48% 16%

Patient out-of-pocket burden 22%54% 23%

Convenience/formulation 33%46% 18%

Practice economics 35%42% 12%

Supportive care requirements 35%49% 11%

Drug being “on pathway” 31%42% 18%

Value Assessment Framework scoring 33%40% 12%

PAs/other challenges in reimbursement 37%41% 11%Patient requests (e.g., based on DTC ads)

44%35% 9%

List Price (WAC) of drug 39%34% 9%

Manufacturer-provided patient services 37%37% 6%

77

PAYER RESTRICTIONSOncologists are facing increasing restrictions from payers regarding the therapies they can prescribe to patients, and these are continuing to intensify at a faster rate than ever before. For example, 53% of oncologists reported that the volume of restrictions payers placed on oncology treatment decisions had increased in the past 12 months—compared with 43% in the 2016 study year; 23% of oncologists said the volume of restrictions had increased moderately or significantly, but just 8% of oncologists reported that the volume of restrictions payers placed on oncology treatment decisions reduced in the past 12 months—a substantial drop compared with the 53% recorded in the 2016 study year.

At the same time, 90% of oncologists reported not being able to prescribe their first choice of therapy to at least one of their patients. Of that 90%, oncologists reported not being able to prescribe their first choice of therapy for an average of 21% of their patients due to payer reimbursement challenges (for example, the need for prior authorization), and for an average of 19% of their patients due to the drug not being on pathway.

... from an oncologist’s perspective cost is a leading secondary

consideration when they prescribe therapies: 54% of oncologists

said patient out-of-pocket burden was a secondary consideration

while 48% flagged overall cost of therapy for secondary

consideration.

EXHIBIT 115

ONCOLOGIST

ONCOLOGISTS WHO WERE LIMITED BY PAYERS FROM PRESCRIBING THEIR TOP-CHOICE THERAPY TO A PATIENT (IN THE LAST YEAR)% of survey respondents, N=200

No Yes

10% 90% 22%

20%

45%

54%

55%

% of oncologists who weren’t limited by the below considerations for any of their patients

REASON FOR INABILITY TO PRESCRIBE TOP-CHOICE THERAPYAverage # of patients, N=181

Preferred drug has high out-of-pocket burden

Payer reimbursement challenge (e.g., prior authorization)

Drug not on pathway

Drug only available via limited distribution network

Supply shortage

20%

21%

19%

16%

14%

EXHIBIT 114

ONCOLOGIST

CHANGE IN THE VOLUME OF RESTRICTIONS PLACED ON ONCOLOGY TREATMENT DECISIONS BY PAYERS (OVER THE LAST 12 MONTHS)% of survey respondents, N=200

30%

41%

17%

6%

5%3%

Increased significantly

Decreased moderately

Increased slightly

No change

Increased moderately

Decreased slightly

53% report restrictions increased

8% report restrictions decreased

53% of oncologists saw an increase in the volume of payer restrictions in the past 12 months

78

INFORMATION SOURCESOncologists obtain most of their information about new therapies and changes to standards of care from scientific sources such as conferences, guideline updates, and professional journals. For instance, 63% of oncologists said that one of their primary sources of information about new therapies and changes to standards of care is live clinical

conferences/congresses (such as ASCO, ASH). Almost as many—61%—said that a primary source for this information is guideline updates (for example, NCCN). However, fewer than half—45%—turn to journals and publications as one of their primary information sources. This number drops to 34% when looking only at community private practice oncologists. Dinner/speaker programs, however, are key sources of information for 22% of community oncologists (versus only 7% for AMC-based physicians).

In sharp contrast, very few oncologists consider manufacturer representatives to be a primary source of information about new therapies: just 12% said that one of their primary information sources about new therapies and changes to standards of care is manufacturer sales representatives. The figure is even lower for manufacturer medical representatives—4%. This low percentage is consistent across both the community and academic setting. However, there is an interesting split where general oncologists cite manufacturer representatives as a top three information source much more often than do specialists (15% versus 5% for sales representatives and 6% versus 1% for medical representatives). Furthermore, oncologists in practices that don’t offer in-practice infusions are a lot more likely to cite manufacturer representatives as a top three source of information than oncologists in practices that do (19% versus 10% for sales representatives and 13% versus 2% for medical representatives).

AMC. Academic Medical Center; ASCO, American Society of Clinical Oncology; ASH, American Society of Hematology; CME, Continuing Medical Education; NCCN, National Comprehensive Cancer Network.

63% of oncologists view live clinical conferences/congresses as a primary source of information about new therapies and changes to standards of care

EXHIBIT 116

ONCOLOGIST

TOP THREE PRIMARY SOURCES OF INFORMATION FOR NEW THERAPIES AND CHANGES TO STANDARDS OF CARE% of survey respondents, N=200

63%

61%

Live conferences/congresses (e.g., ASCO, ASH)

45%

34%

Guidelines updates (e.g., NCCN)

Journals/publications

Online services (e.g. UpToDate)

Dinner/speaker programs

Colleagues

Medical news sites (e.g., Onclive)

Manufacturer medical representatives

Continuing medical education programs (CME)

Manufacturer sales representatives

14%

23%

13%

4%

22%

12%

EXHIBIT 117

ONCOLOGIST

ONCOLOGISTS FOR WHOM MANUFACTURER SALES REPRESENTATIVES ARE A TOP THREE SOURCE OF PRIMARY INFORMATION ABOUT NEW THERAPIES AND CHANGES TO STANDARDS OF CARE% of survey respondents

Generalist

Specialist

Academic/medical-center based

Community-based

Provides in-practice infusions

Doesn’t provide in-practice infusions

BY SPECIALIZATION% of survey respondents, N=200

BY ENVIRONMENT% of survey respondents, N=172

BY INFUSION SERVICES% of survey respondents, N=200

15%

5%9%

12% 10%

19%

3x as many general oncologists view drug manufacturer sales representatives as a primary source of information about new therapies and changes to standards of care compared to specialists

Specialty pharmacies are increasingly influencing oncologist decision making. Meanwhile, the growing importance of value-based contracts sees SPs frequently contracting with drug manufacturers to carry out compliance and adherence services.

INTERACTION BETWEEN SPS AND ONCOLOGISTSIncreasingly, specialty pharmacies are influencing oncologist decision making. This year, 37% of oncologists said that specialty pharmacies occasionally or frequently influence their treatment decisions.

From the SP perspective, oncology practices are a critical source of patients with two-thirds of their cancer patient referrals resulting from physician offices choosing their pharmacy (67%). Only about 19% of referrals result from being preferred by a certain payer (19%).

VALUE-BASED CONTRACTS AND MARKET SHARESPs are commonly being used for value-based contracts and increasing drug market share. In terms of value-based contracts, 30% of SPs reported contracting with drug manufacturers for performing compliance and adherence services, and almost half (47%) reported receiving performance incentives based on metrics such as adherence and market share. Regarding increasing market share, 30% of SPs reported contracting with drug manufacturers to increase market share for preferred cancer drugs, while 56% of SPs reported having a sales force that calls on oncology practices. However, 67% of SPs reported that they were excluded from a manufacturer’s network for more than 10% of oncology drugs—17% reported that they were excluded from manufacturers’ networks for more than 40% of oncology drugs.

EXHIBIT

SPECIALTY PHARMACY

CANCER PATIENT REFERRAL SOURCESAverage % of referrals, N=30

118

67%

13%

19% The drug manufacturer recommends your SP (i.e., via a hub or enrollment form)

Physicians offices prefer and choose your specialty pharmacy

Your SP is preferred by a certain payer

EXHIBIT

SPECIALTY PHARMACY

SP EXCLUSION FROM THE DRUG MANUFACTURER NETWORK% of survey respondents, N=30

119

21-30%

31-40%

11-20%

1-10%

Excluded from manufacturers’ network for no oncology drugs

Excluded from manufacturers’ network >40% of oncology drugs

30%

20%17%

17%

3%

13%

79

SPECIALTY PHARMACY

2/3 of SP cancer patient referrals are due to physician preferences/choice

67% of SPs reported that they were excluded from a manufacturer’s network for more than 10% of oncology drugs

80

Data on quality of care is increasingly important. Here we explore quality metrics and which organizations track them, what this information is used for, and the breadth and comprehensiveness of reports. We examine how such information is shared amongst stakeholders, as well as the progress being made in automating the capture of quality data. Last but not least, we look at the impact of this data.

CONTENTSQuality Report Content ............................................................................................................................................................................

Report Utilization and System Integration ............................................................................................................................................

Report Impact ............................................................................................................................................................................................

81

85

87

V. HOW IS QUALITY BEING MEASURED AND REPORTED?


MOST ONCOLOGY PRACTICES TRACK SOME QUALITY MEASURES

73%of oncology practices

track patient outcomes/survival1

72%of oncology practices

track oncologist pathway/guideline

compliance1

19% vs 32%of their network oncology providers (2016 study year vs this year)

MCOs give quality performance incentives to

MORE MCOs ARE PROVIDING QUALITY PERFORMANCE INCENTIVES

81

Both employers and MCOs are either tracking or interested in tracking several measures of quality such as admissions, adherence guidelines, and outcomes data. MCOs are further ahead in their tracking efforts compared with employers, and will likely push for more and improved quality tracking. At the same time, SPs routinely collect patient outcomes data, and many are planning on rolling out new quality and outcomes initiatives.

QUALITY MEASURESEmployers and MCOs are tracking a variety of quality measures—some of the top quality metrics being tracked by both are hospital admissions/emergency room visits, adherence to guidelines/best practices, and outcomes data. Interestingly, while employers and MCOs reported similar levels of tracking for hospital admissions, far fewer employers than MCOs reported tracking additional metrics such as adherence to guidelines or outcomes data, despite the fact that employers are interested in monitoring these metrics. Presumably this represents an attractive opportunity for MCOs to pass along these quality measures to employers.

Hospital admissions/emergency room visits: 93% of surveyed employers either track (75%) or are interested in tracking (18%) employee hospital admissions and emergency room visits; 81% of the MCOs surveyed track member hospital admissions and ER visits.

Adherence to guidelines/best practices: 92% of employers surveyed either track (37%) or are interested in tracking (55%) adherence to guidelines/best practices; the corresponding figure for MCOs is 67%.

Outcomes data (survival): 90% of surveyed employers either track (31%) or are interested in tracking (59%) employee outcomes (survival); two-thirds (64%) of surveyed MCOs track member outcomes (survival).

ER, Emergency Room.

QUALITY REPORT CONTENT

... some of the top quality metrics being tracked by both

[employers and MCOs] are hospital admissions/emergency room visits,

adherence to guidelines/best practices, and outcomes data

EXHIBIT


MEASURES OF QUALITY TRACKED% of survey respondents, Number MCOs = 100; Number employers = 101, Number OPMs = 157

120

ONCOLOGY PRACTICE MANAGEREMPLOYER

Currently track Interested in tracking

OP

Ms

Em

ploy

ers

MC

Os

OP

Ms

Em

ploy

ers

MC

Os

OP

Ms

Em

ploy

ers

MC

Os

OP

Ms

Em

ploy

ers

MC

Os

Hospital admissions/

emergency room visits

Adherence to guidelines/ best

practices

Patient satisfaction Outcomes data (survival)

93%

18%

54%55% 59%

75%

37% 34% 31%

72%67%

92% 90%

64%74%

81%88%

77%

92%

73%

A large proportion of practice managers have themselves reported tracking quality metrics—a likely consequence of MCOs’ requirement for quality data and quality-linked reimbursement programs: 74% of OPMs track hospital admissions/ER visits, 73% track outcomes/survival, and 72% track pathway/guideline compliance.

That said, MCOs are likely to push further for more quality tracking, and for better quality metrics from their network of oncology providers. This is because a significant minority—25%—of providers still do not share quality metrics, according to MCOs. To address this, managed care organizations have started offering financial incentives to their network of oncology providers to encourage the submission of quality metrics. About half (48%) of the MCOs surveyed offer financial incentives to providers in their network in exchange for quality metrics (for example, an implementation or infrastructure fee), covering an average of one third of their network providers.

82

QUALITY DATA TREND SPILLING OVER TO ONCOLOGY PRACTICESFurther, managed care organizations’ drive to track quality information is beginning to be reflected in oncology practices.

ER, Emergency Room.

ONCOLOGY PRACTICES INCREASINGLY TRACKING QUALITY MEASURES


74%of oncology practices track hospital admissions/ER visits1

73%of oncology practices track patient outcomes/survival1

72%of oncology practices track oncologist pathway/guideline compliance1

Regularly generate and monitor quality reports

Don’t regularly generate and monitor quality reports

22%

78%

FREQUENCY OF GENERATING/DISTRIBUTION QUALITY REPORTS% of survey respondents, N=157

QUALITY MEASURES TRACKED% of survey respondents, N=157

Quarterly

Annually

Monthly

54%

4%

41%

Patient satisfaction

Compliance with documented pain management procedures

Rate of hospitalization/ER visits

Outcomes (e.g., 3-year survival rates by tumor type)

Pathway/guideline compliance

Overall cost of care (e.g., average cost per episode)

End of life measures (e.g., % prescribed chemotherapy in last 2 weeks of life, enrolled in hospice less than 3 days before death)

Usage/cost of adjacent services (e.g., labs, radiology)

92%

75%

74%

73%

72%

69%

62%

60%

EXHIBIT


OPM QUALITY REPORTS% of survey respondents, N=202

121

83

... managed care

organizations have started

offering financial incentives

to their network of oncology

providers to encourage the

submission of quality metrics.

About half (48%) of the MCOs

surveyed offer financial

incentives to providers

in their network in exchange

for quality metrics...

To improve quality reporting, MCOs will push for more comprehensive and meaningful reports. Currently, they aren’t satisfied with the breadth of quality measures from 47% of their network of oncology providers, and see many gaps among the quality measures reported by providers. Responding to the question “What are the biggest gaps in the quality measures reported by your network oncology providers?” MCOs offered a number of suggestions relating to outcomes, consistency, comparative data, and so on:

“Follow-up after first dose.”

“Specific measures relating to outcomes.”

“Time/efforts involved in quality measure reporting.”

“Consistent reporting. More specific or narrow age group demographics needed. Would like to see comparisons among different industries.”

IMPORTANCE OF OUTCOME INFORMATION TO SPs

Patient outcome information is also increasingly important to specialty pharmacies. Like in the 2016 study year, SPs are continuing to routinely collect oncology patient outcome data, and many are planning on rolling out new quality and outcomes initiatives. Although focused on outcomes—100% of SPs surveyed are collecting some form of oncology patient outcome data—the majority of SPs are also collecting data on adherence (90% of SPs) and side effects (67% of SPs). Meanwhile, half of them collect data on medication switch rates and/or reasons, while 40% collect response rates data.

EXHIBIT


MCOs OFFERING NETWORK ONCOLOGY PROVIDERS AN IMPLEMENTATION OR INFRASTRUCTURE FEE IN EXCHANGE FOR SUBMITTING QUALITY METRICS% of providers, N=100

122

Upper quartile


NETWORK ONCOLOGY PROVIDERS WHO ARE OFFERED A FEE % of providers, N=48

25%

15%

50%

60%

10%

20%

30%

40%

50%

33%

48%52%

EXHIBIT


BIGGEST GAPS IN THE QUALITY MEASURES REPORTED BY NETWORK ONCOLOGY PROVIDERS

123

47%MCOs aren’t satisfied with the breadth of quality measures from

of their network oncology providers

100% of SPs are collecting some form of oncology patient outcome data

84

Regarding their plans to roll out new quality/outcomes initiatives, 43% of surveyed SPs said they were planning to do so in the next 12 months. These are some of the issues they are considering:

“30-day readmissions, relapse rates, data dashboard, patient satisfaction surveys.”

“… Metrics such as progression-free survival, complete response rates, partial response rates, duration of response, event free survival…”

“Percentage of patients who had drug-drug interactions checked by the pharmacist.”

“Reporting with support of data on clinical lab values.”

EXHIBIT

SPECIALTY PHARMACY

QUALITY/OUTCOMES MEASUREMENT AND REPORTING INITIATIVES THAT ARE PLANNED IN THE NEXT 12 MONTHS

124

EXHIBIT

SPECIALTY PHARMACY

TYPES OF OUTCOMES OR REAL-WORLD-DATA ROUTINELY COLLECTED REGARDING ONCOLOGY PATIENTS% of survey respondents, N=30

125

Adherence (e.g., medication possession ratio)

Patient out-of-pocket costs after PAP financial support

Time-to-fill

Side-effect data/AE data

Patient satisfaction with SP services

Laboratory data

Patient satisfaction with treatment

Medication switch rates and/or reasons

Quality-of-life data/patient reported outcomes

Adjunctive therapy needs

Response rates

Remission rates

Pharmacoeconomic data

Survival data (e.g., overall, progression-free)

Pain scores

Tumor progression data

Medication discontinuation rates and/or reasons

90%

70%

70%

67%

67%

60%

60%

50%

43%

40%

40%

40%

37%

27%

20%

13%

73%

PAP, Patient Assistance Program; AE, Adverse Event

85

Sharing quality and outcome data among different stakeholders has become common. Meanwhile, oncology practices are expanding patient contact beyond scheduled visits as part of their drive to boost the quality of care.

REPORT SHARINGWith more and more entities tracking quality, this has led to quality/outcome data/report sharing among different healthcare stakeholders. Many providers are establishing dynamic data sharing with managed care organizations: MCOs reported that 22% of providers have established real-time data linkages, while an additional 33% of providers submit quality data periodically. Among surveyed employers, 69% receive reports on the cost and quality of cancer care provided to their employees; about 60% of oncologists said they receive reports with quality metrics for themselves or their practice.

The vast majority—90%—of those receiving reports said that they received a quality report at least once a quarter. Quality/outcome data have started making their way towards SPs as well: they reported that 36% of physicians and 25% of MCOs share patient outcome data with them.

EXHIBIT


FREQUENCY OF QUALITY REPORTS% of survey respondents, N=100

126

Providers share continuously via real-time data links

Providers submit quality measures periodically (quarterly/annually)

Providers review quality measures during contract negotiations

Providers do not share quality measures

22%

33%

19%

25%

REPORT UTILIZATION AND SYSTEM INTEGRATION

QUALITY REPORTS BEING SHARED WITH EMPLOYERS AND ONCOLOGISTS

6 out of 10 oncologists receive quality reports about themselves or their practice

7 out of 10 employers receive cost/quality reports about their employees’ cancer care

86

SYSTEM INTEGRATIONWhile there has been progress in automating the capture of all this quality data—with 20% of OPMs reporting that their quality metrics are automatically integrated into the EHR—a quarter (24%) of practices still have to put significant manual effort into tracking metrics and producing quality reports.

EHR, Electronic Health Record.

EXHIBIT

EMPLOYER

EMPLOYER ACCESS TO HEALTH ADMINISTRATOR CANCER COST AND QUALITY REPORTS% of survey respondents, N=99

127

31%

54%

15%

69%

We receive a detailed report at least once a year on the cost and quality of cancer

We receive reports that do not break out cancer care specifically

We receive a high-level report, but it focuses mostly on cost and volumes as opposed to quality

EXHIBIT

SPECIALTY PHARMACY

PROPORTION OF CANCER PATIENTS FOR WHOM PATIENT OUTCOMES DATA ARE SHARED% of patients, N=30

128

50%

40%

30%

20%

10%

60%

70%

80%

90%Upper quartile


From physicians From MCOs

10%

48%

25%

0%

20%

58%

0%

36%

EXHIBIT


LEVEL OF BURDEN FOR COLLECTING QUALITY METRICS% of survey respondents, N=157

129

20%

56%

24%

It is all automatically pulled and reported from the EMR or other automation tools

Most data is available in the EMR but requires manual analysis to generate the reports

Requires a significant amount of manual collection and analysis

24% of oncology practices have to put significant manual effort into tracking metrics and producing quality reports

87

It turns out, however, that sending quality reports isn’t enough to inspire change from oncologists…

DISCONNECT BETWEEN MCOs AND ONCOLOGISTSWe find that 77% of OPMs reported setting specific goals or targets for the quality metrics that they track. In addition, 79% of oncologists who receive quality reports are provided with reports specific to them—that is, not just reports for the practice as a whole. However, 66% of oncologists said that quality reports don’t change the way they treat their patients as a result. Possibly this is because quality reports aren’t actionable enough or don’t contain the right information. For example, there’s a disconnect between what MCOs care about in terms of quality metrics and what oncologists have visibility into. Fewer than half of oncologists who receive quality reports have visibility into three of the top four quality metrics most frequently tracked by MCOs:

Rate of hospitalization/ER visits—only 37% of oncologists have visibility into this metric, even though 63% of MCOs track it.

Pathway/guideline compliance—just 36% of oncologists have visibility into such data, even though 64% of MCOs track them.

Outcomes/survival metrics—35% of oncologists have visibility into this information, even though 65% of MCOs track it.

ER, Emergency Room.

REPORT IMPACT

... there is a disconnect between what MCOs care about in terms of

quality metrics and what oncologists have visibility into. Fewer than half of

oncologists who receive quality reports have visibility into three of the top

four quality metrics most frequently tracked by MCOs.

EXHIBIT


TOP QUALITY MEASURES THAT MCOs TRACK AND ONCOLOGISTS CAN SEE% of survey respondents

130

ONCOLOGIST

Hospital admissions/emergency room visits

Patient satisfaction Adherence to guidelines/best practices

Outcomes (survival)

63%

37%

53%

47%

64%

36%

65%

35%

MCOs track (N=100) Oncologists have visibility into (N=117)

LINKING QUALITY TO COMPENSATIONQuality metrics are increasingly driving financial performance and remuneration—with better access to quality data, MCOs have started ramping up efforts to tie financial compensation to quality of care. In the 2016 study year, MCOs reported giving quality performance incentives to 19% of their network oncology providers; this year, the figure had almost doubled—MCOs reported having quality incentive contracts with 32% of their network.

Yet it is possible that oncologists don’t understand how quality metrics can impact their financials. Over half of oncologists said they were aware about a connection between quality metrics and financial metrics, but were unclear how quality metrics would affect their own compensation. Accordingly, there’s a big financial incentive for OPMs to distribute more actionable quality reports to oncologists in order to educate them more clearly about the financial impact of quality metrics.

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Further, the majority (70%) of oncologists who receive quality reports said that quality reports don’t break out by patient segment–so they can’t see metrics for only certain payers, or for only patients with whom the practice has APMs.

APM, Alternative Payment Model.

EXHIBIT 131

ONCOLOGIST

REPORT BREAK-OUTS BY PATIENT SEGMENTS


Oncologist (N=115) 70% 15%15%

OPM (N=157) 11% 25%64%

Segment by payer Segment patients involved in APMsNo

EXHIBITQUALITY REPORT FINANCIAL INCENTIVES

132

MANAGED CARE ORGANIZATION ONCOLOGIST

32%

19%

2017 study year (N=100)2016 study year (N=103) Know how improving specific quality metrics could increase my compensation and by how much

Know improving specific quality metrics would increase practice’s overall reimbursement from payers, but unclear connection to my personal compensation

Know there’s a connection, but it’s not clear

Not aware of any connection

22% 23% 32% 22%

MCOs THAT TIE QUALITY GOALS WITH FINANCIAL INCENTIVES WITH THEIR NETWORK ONCOLOGY PROVIDERS% of providers, N=100 % of survey respondents, N=117

CLARITY OF THE CONNECTION BETWEEN QUALITY METRIC PERFORMANCE AND FINANCIAL IMPACT

19% vs 32%of their network oncology providers (2016 study year vs this year)

MCOs give quality performance incentives to

70% of oncologists who receive quality reports don’t receive breakouts by patient segment

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The growing cost of care is having a significant impact on patients, payers, employers, and providers, prompting mounting concern about the effects of financial toxicity on patients. Rising costs are increasingly causing low-income patients to delay or discontinue treatment, and practice managers are turning to various mechanisms to support patients with some degree of success. However, this may be leading to an unexpected outcome—the proportion of patients who pay all their out-of-pocket drug costs is declining.

VI. HOW IS COST OF CARE EVOLVING?

CONTENTSFinancial Toxicity to Patients ....................................................................................................................................................................

Patient Support for Cost Burden ............................................................................................................................................................

90

93


MANY SPs SCREENING ALL PATIENTS FOR FINANCIAL TOXICITY

37%of SPs screen all their patients for financial toxicity

MCOs THINKING ABOUT REDUCING OR WAIVING PATIENT OOP COSTS

45%of MCOs are very concerned about growing oncology OOP costs and think MCOs should waive/lower such costs

ONCOLOGY PRACTICES OFFERING PAYMENT PLANS

59%of oncology practices offer payment plans to patients who struggle to pay the cost of treatment1

ONCOLOGY PRACTICES DIRECTING PATIENTS TOWARDS DRUG MANUFACTURER ASSISTANCE PROGRAMS

27%of drug-treated cancer patients applied to a drug manufacturer patient assistance program1

47%of patients who applied to such programs received assistance1

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Increasing awareness of the financial toxicity effect of growing out-of-pocket (OOP) expenses is prompting concern among both payers and providers. Rising OOP costs are having a significant impact on managed care organizations, oncology practices, and specialty pharmacies.

CONCERN AMONG MCOs

MCOs are almost unanimously concerned about growing out-of-pocket costs for their members. There seems to be growing sentiment among MCOs that they should take action with regard to lowering oncology OOP costs; however, it is unclear how such actions can be reconciled with their financials.

• Nearly all (94% of) MCOs are concerned that growing OOP costs may result in their members not receiving the highest-quality care.

• Although just under half (45%) of MCOs believe that they should waive or lower out-of-pocket costs for oncology patients, a quarter of MCOs noted that these higher OOP costs help them address the growing cost of care.

OPMs REPORTING RISING INSTANCES OF DELAYED OR DISCONTINUED TREATMENTEqually, concern among OPMs about higher OOP costs is also rising, and is especially pronounced among OPMs in practices that serve primarily low-income patients (that is, patients who earn less than $40,000 a year).

This concern is being fueled by the rising number of low-income patients who delay or discontinue treatment:

• In the 2016 study year, about a third (38%) of OPMs reported occasional or frequent delays or discontinuation of treatment as a consequence of affordability issues. This year, 83% of OPMs reported patients delaying or discontinuing treatment due to affordability.

OOP, Out-Of-Pocket.

FINANCIAL TOXICITY TO PATIENTS

MCOs THINKING ABOUT REDUCING OR WAIVING PATIENT OOP COSTS

45%of MCOs are very concerned about growing oncology OOP costs and think MCOs should waive/lower such costs

EXHIBIT


LEVEL OF MCO CONCERN THAT MEMBERS MAY NOT RECEIVE THE HIGHEST QUALITY CARE BECAUSE OF GROWING OUT-OF-POCKET COSTS% of survey respondents, N=100

133

71% of MCOs very concerned about growing OOP costs

23%

45%

26%

6%

Moderately concerned Very concerned and believe MCOs should waive or lower

OOP costs

Very concerned but higher OOP help address

rising cost of care

Not concerned

83% of oncology practices encountered patients who delayed/discontinued treatment due to affordability

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• Over half (54%) of OPMs said that more than a quarter of their patients are low-income; moreover, 16% said that over half of their patients are low-income.

• Overall, OPMs reported an average of 18% of their patients discontinuing or delaying treatment due to affordability (a similar figure to that reported by SPs); however, among practices that serve primarily low-income patients—that is, over 50% of their patients are low-income—this figure jumps to 26%.

Practices look to support low-income patients who struggle with the cost of payment in a number of ways, ranging from offering a payment plan to not collecting drug copayments, which we discuss in the next section.

EXHIBITPATIENT FINANCIAL TOXICITY

134

SPECIALTY PHARMACY ONCOLOGY PRACTICE MANAGER

37%

18%

33%

SCREEN ALL PATIENTS FOR FINANCIAL TOXICITYDELAY/DISCONTINUE EXPENSIVE TREATMENTS DUE TO COST

% of respondents, N=29 Average % of patients, N=30 Average % of patients, N=82LOW INCOME PATIENTS (<$40K/YEAR)

EXHIBIT


OPMs WHO HAVE HAD AT LEAST ONE PATIENT IN THEIR PRACTICE DISCONTINUE OR DELAY TREATMENT EITHER DUE TO AN INABILITY TO PAY INSURANCE PREMIUMS OR OUT-OF-POCKET (OOP) EXPENSES FOR TREATMENT/DRUGS% of respondents, N=10 (excluding OPMs who don’t know or cannot discuss)

135

83%27%

No Yes

26%

18%All other practices (N=75)

Practices that serve primarily low- income patients (<$40k/year) (N=8)

PERCENT OF PATIENTS THAT HAVE DONE SOAverage % of patients

OOP, Out-Of-Pocket.

SPs SCREENING FOR FINANCIAL TOXICITYAs in the 2016 study year, most (if not all) specialty pharmacies are screening patients for financial toxicity: 37% of SPs screen all patients for financial toxicity; the rest don’t screen every patient, but are

usually made aware of financial toxicity when out-of-pocket drug payments are high. The figures from the specialty pharmacies mirror the data from the OPMs: on average SPs reported that a fifth of patients discontinuing high-cost drugs (those costing over $5,000 a month) were doing so primarily because of financial considerations.

MCOs HAVE SPECIAL COST-SHARING BENEFIT DESIGNS FOR ONCOLOGYAlmost half of MCOs (43%) now have special patient cost-sharing benefit designs for oncology. Most of these benefit designs play into the patients’ favor—likely a response to growing patient out-of-pocket costs in oncology. For instance, 84% of MCOs that have special oncology cost-sharing benefit designs reported that oral oncology parity laws have limited their ability to charge patients their typical cost shares for pharmacy-benefit oncology products. Another 37% reported waiving deductibles for oncology products, while 19% reported waiving copays.

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MANY SPs SCREENING ALL PATIENTS FOR FINANCIAL TOXICITY

37%of SPs screen all their patients for financial toxicity

37% of MCOs that have special oncology cost-sharing benefit designs waive deductibles for some patients/products

19% of MCOs that have special oncology cost-sharing benefit designs waive copays for some patients/products

EXHIBIT


MCOs WITH SPECIFIC PATIENT COST-SHARING BENEFIT DESIGNS FOR ONCOLOGY (COMPARED TO OTHER THERAPEUTIC AREAS)% of survey respondents, N=100

136

of those who said yes

57% 43%

No Yes

Different OOP max for oncology

Waive copays for oncology products

Waive deductibles for oncology products

Adhere to oral oncology parity laws, which limits our ability to charge patients our typical cost shares for some pharmacy-benefit oncology products

12%

19%

37%

84%

% of survey respondents, N=43TYPE OF DIFFERENCE

With rising OOP costs, patients have increasingly turned towards support programs to help recover treatment costs.

OPMs TURNING AWAY FROM NOT COLLECTING COPAYMENTSRather than simply not collecting drug copayments from patients who struggle to pay, OPMs have trended towards engaging more and more patient support tactics to help patients make payments.

In the past year, there’s been a decrease in the percentage of OPMs who don’t collect drug copayments from low-income patients struggling to make payments: this proportion has dropped by a third from 18% in the 2016 study year to 12% this year.

At the same time, practices are increasingly turning to ways of supporting patients to make payments.

TYPES OF SUPPORTAn increasing proportion of OPMs are offering payment plans; meanwhile, the percentage of OPMs who refer patients to specialists who can help solve payment problems is also growing:

• There has been a 13-percentage-point increase in the number of OPMs who offer payment plans to struggling patients, from 46% of OPMs in the 2016 study year to 59% this year.

• At the same time, there has been a 15-percentage-point increase in referrals of struggling patients to financial counselors—up from 42% in the 2016 study year to 57% this year.

• There has also been a 10-percentage-point increase in referrals of struggling patients to social workers—up from 38% in the 2016 study year to 48% this year.

In addition to employing patient-support tactics, providers are increasingly factoring in cost to the patient when prescribing drugs—29% of OPMs reported changing patients to a lower-cost therapy when they struggle to pay.

93OOP, Out-Of-Pocket.

PATIENT SUPPORT FOR COST BURDEN

18% vs 12%of oncology practices don’t collect drug copayments from low-income patients struggling to make payments (2016 study year vs this year)

ONCOLOGY PRACTICES OFFERING PAYMENT PLANS

59%of oncology practices offer payment plans to patients who struggle to pay the cost of treatment1


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MANUFACTURERS’ PATIENT-ASSISTANCE PROGRAMSAlthough drug manufacturers are becoming a sizeable source of patient support, they may come under scrutiny from plan sponsors.

A large proportion of patients apply to and receive support from drug manufacturer patient-assistance programs:

• On average, OPMs reported that 27% of drug-treated cancer patients applied to a drug manufacturer patient-assistance program.

• Of the patients who applied, OPMs reported that on average 47% of patients received assistance.

• SPs reported that on average 35% of patients on expensive cancer drugs (over $5,000 per month) receive help from a manufacturer’s patient-assistance program.

That said, employers are starting to scrutinize drug manufacturer patient-assistance programs such as copay cards: 28% of employers reported working with benefit consultants to either limit the impact of copay cards or to increase copays. Given that many patients are receiving financial support from drug manufacturers, employers are in some ways treating increasing copays as a way to reduce the net price that is ultimately collected by drug makers. However, this is putting a significant squeeze on patients who may not be eligible for the assistance programs.

EXHIBIT


TACTICS UNDERTAKEN FOR LOW-INCOME PATIENTS STRUGGLING WITH THE COST OF THERAPY% of survey respondents

137

2017 study year (N=202)2016 study year (N=195)

1 Excluding OPMs who weren’t allowed to say or didn’t know

Refer to manufacturer patient assistance & copay/coupon foundations

56%

57%

Refer to a private, charitable foundation

41%

46%


Apply

27%

Receive support

of who those apply

47%Average % of patients, N=86

PATIENTS THAT APPLY TO AND RECEIVE SUPPORT FROM DRUG MANUFACTURER PATIENT-ASSISTANCE PROGRAMS

% of survey respondents, N=101STANCE ON COPAY CARDS

Working to limit/prevent their impact

Increasing our plans’ copays

Nothing

72%

18%10%

EMPLOYER

Refer to a financial counselor42%

57%

+15%

Refer to a social worker38%

48%

+10%

Do not collect drug copayment

18%

12% -6%

Offer a payment plan 46%

59%

+13%

ONCOLOGY PRACTICES DIRECTING PATIENTS TOWARDS DRUG MANUFACTURER ASSISTANCE PROGRAMS


27%of drug-treated cancer patients applied to a drug manufacturer patient assistance program1

47%of patients who applied to such programs received assistance1

28% of employers are changing their benefits design in response to copay cards

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What is top of mind for the various stakeholders concerned with cancer care? This section looks at changes in the evolving cancer care landscape—the positives (for example, innovation) and negatives (such as cost)—from the perspective of specific stakeholder groups, as well as their top priorities for 2018.

CONTENTSCross Stakeholder Summary .................................................................................................................................................................

Managed Cared Organization ................................................................................................................................................................

Employer ....................................................................................................................................................................................................

Oncologist .................................................................................................................................................................................................

Oncology Practice Manager ..................................................................................................................................................................

Specialty Pharmacy .................................................................................................................................................................................

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100

102

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VII. HIGH-LEVEL QUESTIONS

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CROSS STAKEHOLDER SUMMARY

All stakeholders feel that there has been substantial innovation in the space over the past decade, but it has come with tremendous pressure on costs across the system.

TOP PRIORITIES FOR 2018 Top priorities for 2018 differed significantly across stakeholders. For MCOs, top priorities were to reduce/control costs and to improve quality. Employers prioritized prevention, and said that their top initiatives were to increase cancer screening and to adopt employee wellness programs. OPMs described their top priorities as improving patient satisfaction, increasing volume of patients, and increasing the quality of care. Finally, SPs prioritized growth.

BIGGEST POSITIVE CHANGES IN CANCER CAREAll stakeholders surveyed agreed that better drugs and therapies were one of the top changes in cancer care over the past decade. In the coming decade, stakeholders were excited about new cancer therapies such as personalized medicine, immunotherapies, and cures for cancer. Among the new therapies, MCOs were excited about personalized medicine—a procedure that has been used in cancer care for a while, whereas oncologists were excited about immunotherapy—a more recent development in cancer care. This suggests that oncologists are more excited by cutting-edge therapies whereas MCOs are more excited by therapies that have gained significant traction in the market.

BIGGEST NEGATIVE CHANGES IN CANCER CARECost was top of mind for all stakeholders, with survey respondents saying that rising costs were one of the biggest negative changes in cancer care over the past decade. Interestingly, oncologists and OPMs specifically cited rising cancer drug costs as the biggest negative change over the past decade, whereas MCOs said that the rising cost of cancer care (as a whole) was the biggest negative change. Rising costs were also something that all stakeholders worried about in the coming decade, although oncologists, OPMs, and SPs additionally cited increased reimbursement difficulties as a further top concern.

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THE MANAGED CARE ORGANIZATION PERSPECTIVEManaging cost of care and improving quality tracking are top of mind for MCOs.

TOP PRIORITIES FOR 2018 When asked to briefly describe their top priorities for 2018, MCOs told us the following:

“Controlling total cost of care and improving quality metrics.”

“Improved patient outcomes and reducing cost per treatment.”

“Medical spend containment, patient engagement, quality outcomes.”

“Controlling cost, sharing risk with providers, increasing premiums.”

“Prescription drug cost management, quality measure reporting, and episode treatment group tracking.”

POSITIVES OVER PAST DECADE…Looking back over the past decade, MCOs think that the greatest positive changes in cancer care have been better drugs, better testing/screening, and improved patient outcomes (survival).

When asked to list the two to three biggest positive changes in cancer care over the past ten years, they responded with:

“Better drugs, better imaging equipment capabilities, increased routine screening.”

“Improved diagnostic testing, improved control of side effects, improved outcomes.”

“Oral oncology drugs, targeted therapies, improved survival rates, [and a] better understanding of molecular biology of cancer.”

“Advancement [and availability] of therapies [and] genetic testing.”

… AND NEGATIVESMCOs think that the biggest negative change in cancer care over the past decade is rising cost.

When asked to highlight the two to three biggest negative changes in cancer care over the past ten years, they said:

“Costs are crazy.”

“Cost, cost, and more costs.”

“Pharmaceutical costs are out of control; oncology specialists have an unreasonable expectation as to their contract fees; and direct-to-consumer advertising has complicated both the provider and the MCO business.”

“Increase in cost, price inflation of specialty medications, increase in price of older/generic products.”


EXHIBIT


AS AN MCO, BRIEFLY DESCRIBE YOUR TOP PRIORITIES FOR THE 2018

138

98

LOOKING TO THE FUTURE Going forward, MCOs are most excited about precision medicine and advancements in cancer pathways. Among the highlights they anticipate are:

“Better understanding of cancer genetics and targeted therapies.”

“Genetic tailoring of treatment plans.”

EXHIBIT


139

POSI

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CHA

NGES

NEGA

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CHA

NGES

LAST 10 YEARS NEXT 10 YEARS

“Personalized medicine with more specific evidence-based clinical pathways will compliment more shared decision making among providers, patients, and MCOs.”

“Genetic and biomarker testing, continued advancement of pathways, hopeful regulations on medication costs.”

Nevertheless, cost remains the primary concern of MCOs going forward, particularly if it affects access to care. They voiced their concerns about cancer care over the next ten years as follows:

“Cost because treatment will be limited to the rich and not the poor.”

“If cost [continues to] increase patients will be unable to access timely care.”

“No streamlining of costs.”

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THE EMPLOYER PERSPECTIVEIn an effort to address rising cancer care costs, employers are increasingly turning towards early detection (screening) and health/wellness (prevention) initiatives.

COST CONTAINMENT INITIATIVESWhen asked about initiatives they are working on with their health insurance administrators to address the rising cost of cancer care, employers told us:

“Reduce the risk and cost with preventative screenings and assessments.”

“Incentives for healthy choices, additional screenings, proactive treatments.”

“On-site wellness program in which 98% of the activity is face to face. We are considering additional branding of this outreach. In addition, for members diagnosed with cancer, we have engaged independent nurses associations to meet with members throughout the process.”

“Early prevention and overall health and wellness programs and early detection screening.”

CENTERS OF EXCELLENCE AND OUTCOME REPORTINGTo improve quality of care, employers are using centers of excellence and increasing quality/outcomes reporting:

“Have authorized the use of the centers of excellence including MD Anderson, Dana-Farber, Sloan Kettering, Mayo Clinic.”

“Centers of excellence directives and education from health insurer.”

“Improved reporting and better incentives for diagnosis and monitoring results.”

“Working to capture quality data in order to form a plan.”

EMPLOYER

EXHIBIT

EMPLOYER

WHAT INITIATIVES, IF ANY, ARE YOU WORKING WITH YOUR HEALTH INSURANCE ADMINISTRATORS ON TO ADDRESS THE RISING COST OF CANCER CARE?

140

EXHIBIT

EMPLOYER

WHAT INITIATIVES, IF ANY, ARE YOU WORKING WITH YOUR HEALTH INSURANCE ADMINISTRATORS ON TO IMPROVE THE QUALITY OF CANCER CARE?

141

COE, Center Of Excellence.

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ONCOLOGIST

THE ONCOLOGIST PERSPECTIVELooking back over the past decade, oncologists cite immunotherapy and targeted therapy as the greatest positive changes in cancer care, although there is plenty of progress still to make. Rising drug costs are the biggest negative.

POSITIVES OVER PAST DECADE…When asked to list the two to three biggest positive changes in cancer care over the past ten years, oncologists highlighted:

“Immunotherapy, targeted therapy, personalized medicine.”

“1) Immunotherapy; 2) Increased availability of targeted therapies for known mutations; 3) Increased recognition and identification of targets.”

“New drugs, especially availability of many targeted agents and several immuno-oncology products.”

“Explosion of new drugs, immunotherapy, and concurrent chemoradiotherapy.”

… AND PLENTY OF PROGRESS STILL BEING MADEThere’s still a lot of progress being made in immunotherapy and targeted therapies for oncology—going forward, oncologists are most excited about innovations in these therapies. The survey asked them: “In the next ten years, what are you most excited about in terms of changes to cancer care?” They picked out the following:

“More immunotherapy, more personalized medicine.”

“Use of biomarkers to enhance use of targeted therapies—both those available now, as well as those which will be available in the future.”

“More personalized therapies, including immunotherapies.”

“Targeted and genetic therapies to be released; more cures than treatments.”

COST IS A NEGATIVE ALONGSIDE INCREASED BURDENLooking back over the past decade, oncologists consider the biggest negative changes in cancer care to have been a rise in the cost of drugs and a corresponding rise in cost-containment efforts from payers. Oncologists also reported an increase in administrative work and paperwork as another big, negative change.

The survey asked oncologists: “What have been the two to three biggest negative changes in cancer care over the past ten years?” They focused on costs and administrative burden:

“Cost of drugs, worsening reimbursement.”

“Costs are skyrocketing. The number of drugs requiring prior authorizations are increasing.”

“More administrative burden, less time for patients, care is moving ‘away’ from the patient.”

“1) The cost of new drugs; 2) Poor payer reliability. We find that some private payers are ‘playing dumb.’ They reimburse well below the cost of the drug or they falsely claim the drug is investigational, or they later ask for money back because (and this happened) I am now deceased, and a host of other excuses to decline to pay according to their contract.”

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Going forward, oncologists are also most worried about the rising cost burden for cancer patients, rising drug costs, and increases in payer restrictions. Asked about what they were most worried about in terms of changes to cancer care over the next ten years, oncologists listed:

“Limitations by payers on therapeutics.”

“That some patients will not be able to afford this specialized cancer care.”

“Decreasing reimbursement and cost of drugs.”

“[Higher] cost burden to patients for novel therapeutics.”

EXHIBIT 142

ONCOLOGIST

POSI

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CHA

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102


THE OPM PERSPECTIVEImproving the quality of care, new treatments, and rising costs are front of mind for practice managers.

2018 PRIORITIESFor 2018, OPMs’ top priority is improving quality of care—the survey asked practice managers to describe their top priorities for 2018:

“Improve patient care including providing better treatments, with better efficacy and less toxicity; improve our patient and family experience when referred to academic centers for care.”

“Quality of care, improved patient outcomes.”

“Focusing on quality patient care outcomes for the community we service.”

“Patient satisfaction, clinic wait times, quality of care.”

ADVANCES OF THE PAST DECADELooking back over the past decade, OPMs think that the greatest positive changes in cancer care have been better treatment options, especially immunotherapy and targeted therapy. Asked about the two to three most positive changes, they responded with:

“Improved drug efficacy for some diagnosis, improved follow-up care and coordination of care.”

“Ability to better target therapy based on individual tumor markers. The advances in immunotherapy have been outstanding.”

COSTS AND REIMBURSEMENT ISSUES ARE BIGGEST NEGATIVES OF PAST DECADELooking back over the past decade, OPMs think that the biggest negative changes in cancer care have been a rise in cost and a decrease in reimbursement from payers. They said the following:

“Decreasing reimbursement from private and government insurance, cost of drugs, unsustainable healthcare model.”

“Increase in drug cost, decrease in payer mix, more complicated pathways (both clinical and financial).”

“Decreasing reimbursement, increasing costs, unnecessary treatments.”

GOING FORWARDFor the future, OPMs are most excited about new treatments and therapies over the next ten years. They picked out:

“New treatments being reviewed by FDA.”

“New therapies, reduced-dose radiation therapies; minimally invasive surgeries via robotic assistance, molecular tumor boards.”

EXHIBIT


AS A PRACTICE MANAGER, BRIEFLY DESCRIBE YOUR TOP PRIORITIES FOR THE 2018

143

“New and more effective treatments.”

In common with other stakeholders, however, OPMs are also most worried about rising costs causing a reduction in patient access to care, as well as reimbursement changes going forward. Among their worries about changes to cancer care, they highlighted:

“Costs that are completely out of reach for the average patient.”

“Further reductions in reimbursements and expanded federal reporting requirements.”

“Increased patient population who cannot afford the cost.”

103

EXHIBIT


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SPECIALTY PHARMACY

THE SP PERSPECTIVEBusiness issues—especially costs and financial performance—are what specialty pharmacies are focusing on. They remain excited about new therapies over the next decade but, along with other respondents, they worry about future costs.

2018 PRIORITIESIn 2018, the top priorities for SPs are to increase access to limited-distribution drugs, grow their patient base, and boost their financial performance. Responses to a question about their top priorities included:

“Increased access to limited-distribution drugs; more partnerships with manufacturers, increased sales force.”

“Improving margins, increasing access to limited-distribution drugs and payers.”

“Increase referral sources; increase patient base.”

POSITIVES OF THE PAST DECADELooking back over the past decade, SPs think that the greatest positive change in cancer care has been more treatment options—SPs specifically called out immunotherapy and targeted therapy:

“Better orals and more specific and targeted treatments.”

“Targeted therapies, biosimilar, and oral drugs.”

“The availability for more treatment options, and the acceptance by payers.”

BIGGEST NEGATIVES OF THE PAST DECADEOn the negative side, SPs consider the biggest changes in cancer care over the past decade to have been access to limited-distribution drugs and cost of care:

“Cost of therapies, access challenges for patients, limited distribution.”

“Limited-distribution drug access.”

“Cost of treatment plus cost of adequate diagnosis.”

ADVANCES TO COMEGoing forward, SPs are most excited about the prospect of targeted therapy/immunotherapy within the next ten years:

“Targeted therapy that will treat cancers with more manageable side effects.”

“Immunotherapy and advances.”

“More novel agents to market.”

EXHIBIT

SPECIALTY PHARMACY

AS AN SP, BRIEFLY DESCRIBE YOUR TOP 2-3 PRIORITIES FOR THE 2018

145

105

FUTURE WORRIESAgain, in common with other stakeholders, SPs are most worried about the cost of care and changes in reimbursement going forward. They articulated these worries as:

“Changing reimbursement landscape driven by regulatory changes.”

“Increased cost and less reimbursement.”

“Cost will keep getting higher and all patients will not have a fair chance for treatment.”

EXHIBIT

SPECIALTY PHARMACY

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INTRODUCTION

1. U.S. Food and Drug Administration, Hematology/Oncology (Cancer) Approvals & Safety Notifications, https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm279174.htm. Accessed March 9, 2018.

2. U.S. Food and Drug Administration, Hematology/Oncology (cancer) Approvals & Safety Notifications: Previous News Items, http://wayback.archive-it.org/7993/20170111231729/http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm279177.htm. Accessed March 9, 2018.

3. MIPS Overview, Quality Payment Program, Department of Health & Human Services, https://qpp.cms.gov/mips/overview. Accessed March 9, 2018.

4. Deepali Narula, Laura Medford-Davis, MD, Seema Parmar, and Edward Levine, MD, “The Quality Payment Program under MACRA: Strategic implications for providers and payers,” McKinsey on Healthcare, December 2017, https://healthcare.mckinsey.com/quality-payment-program-under-macra-strategic-implications-providers-and-payers. Accessed March 9, 2018.

5. Chimeric Antigen Receptor T-Cell Therapy for B- Cell Cancers: Effectiveness and Value, Draft Evidence Report prepared for California Technology Assessment Forum, Institute for Clinical and Economic Review, December 19, 2017, https://icer-review.org/wp-content/uploads/2017/07/ICER_CAR_T_Draft_Evidence_Report_121917.pdf. Accessed March 9, 2018.

6. Novartis receives first ever FDA approval for a CAR-T cell therapy, Kymriah™ (tisagenlecleucel, CTL019), for children and young adults with B-cell ALL that is refractory or has relapsed at least twice, August 30, 2017, https://novartis.gcs-web.com/novartis-receives-fda-approval-for-KymriahTM . Accessed March 9, 2018.

7. Congressional Budget Office Cost Estimate, Reconciliation Recommendations of the Senate Committee on Finance, November 26, 2017, https://www.cbo.gov/system/files/115th-congress-2017-2018/costestimate/reconciliationrecommendationssfc.pdf. Accessed March 9, 2018.

8. President Donald J. Trump’s State of the Union Address, January 30, 2018, https://www.whitehouse.gov/briefings-statements/president-donald-j-trumps-state-union-address/. Accessed March 9, 2018.

REFERENCES

9. Bertha Coombs, “Trump’s pick to head HHS balks at negotiating drug prices”, CNBC, January 9, 2018. https://www.cnbc.com/2018/01/09/trumps-pick-to-head-hhs-balks-at-negotiating-drug-prices.html . Accessed March 9, 2018.

10. FAQ, Right To Try, 2017, http://righttotry.org/faq/. Accessed March 9, 2018.

11. “Apple announces effortless solution bringing health records to iPhone,” Apple, January 24, 2018, https://www.apple.com/newsroom/2018/01/apple-announces-effortless-solution-bringing-health-records-to-iPhone/. Accessed March 9, 2018.

12. Michelle Fox, “Amazon is ‘scaring’ CVS, says former Aetna CEO about Aetna-CVS deal”, CNBC, December 4, 2017, https://www.cnbc.com/2017/12/04/aetna-cvs-deal-amazon-is-scaring-cvs-says-former-aetna-ceo.html . Accessed March 9, 2018.

13. Zachary Tracer and Hugh Son, “Amazon, Berkshire, JPMorgan Link Up to Form New Health-Care Company,” Bloomberg, January 30, 2018, https://www.bloomberg.com/news/articles/2018-01-30/amazon-berkshire-jpmorgan-to-set-up-a-health-company-for-staff. Accessed March 9, 2018.

KEY FINDINGS

1. Björn Albrecht, Philippe Menu, Jeff Tsao, and Kevin Webster, The next wave of innovation in oncology, September 2016, https://www.mckinsey.com/industries/healthcare-systems-and-services/our-insights/the-next-wave-of-innovation-in-oncology. Accessed March 9, 2018.

2. Sonal Shah and Greg Reh. Value-Based Payment Models in Oncology: Will They Help or Hinder Patient Access to New Treatments? American Journal of Managed Care. 2017;23(5):SP188-190.

3. Oncology Care Model, Centers for Medicare & Medicaid Services, https://innovation.cms.gov/initiatives/oncology-care/. Accessed March 9, 2018.

4. Sebastian Salas-Vega, Othon Iliopoulos, Elias Mossialos. Assessment of Overall Survival, Quality of Life, and Safety Benefits Associated With New Cancer Medicines. JAMA Oncol. 2017;3(3):382-390.

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II. WHAT SERVICES ARE BEING PROVIDED TO PATIENTS AND BY WHOM?

1. Amy Waller, Rob Sanson-Fisher, Nicholas Zdenkowski, Charles Douglas, Alix Hall, and Justin Walsh. The Right Place at the Right Time: Medical Oncology Outpatients’ Perceptions of Location of End-of-Life Care. JNCCN. 2018;16:35-41.

2. Björn Albrecht, Sandra Andersen, Keval Chauhan, Daina Graybosch, Philippe Menu, Pursuing breakthroughs in cancer-drug development, January 2018, https://www.mckinsey.com/industries/pharmaceuticals-and-medical-products/our-insights/pursuing-breakthroughs-in-cancer-drug-development. Accessed March 9, 2018.

3. Joseph M. Unger, Elise Cook, Eric Tai, and Archie Bleyer. The Role of Clinical Trial Participation in Cancer Research: Barriers, Evidence, and Strategies. ASCO Educational Book. 2016;1:185-198.

the 2018 genentech oncology trend report...mar 09, 2018 · new haven, ct suggested citation ......

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