Evidence-Based Oncology

Bridging the gap between payer and provider perspectives

The Evolving Treatment Landscape and Innovative Payment Models in OncologyAn Expert Summit

A U G U S T 2 0 1 5

E V I D E N C E - B A S E D O N C O L O G Y

Feinberg Joseph Kiss Okon Kumapley Kolodziej

THE CLINICAL AND REIMBURSEMENT LANDSCAPE OF IMMUNO-ONCOLOGY

COVERAGE OF IMMUNO-ONCOLOGY THERAPIES

TREATMENT CONSIDERATIONS WITH IMMUNO-ONCOLOGY

ROLE OF ORAL ONCOLYTICS TO SUPPORT PALLIATIVE CARE INITIATIVES

ISSUES IN PROMOTING EARLY PALLIATIVE CARE

MEDICATION SELECTION IN THE PALLIATIVE CARE SETTING

INNOVATIVE PAYMENT MODELS IN ONCOLOGY

CONSIDERATIONS WHEN DEVELOPING AND IMPLEMENTING INNOVATIVE ONCOLOGY PAYMENT MODELS

© Managed Care &Healthcare Communications, LLC

OncologyStakeholdersSummit

From the Publ isher

The Evolving Treatment Landscape and Innovative Payment Models in OncologyAdvances in the understanding of tumor biology have led to the development of new classes of oncology medications, which provide clinicians and patients with addi-tional therapeutic options for many forms of cancer. However, substantial costs are associated with these medications, and payers are charged with developing coverage policies to ensure that their members receive appropriate, cost-effective care.

This supplement summarizes proceedings from the AJMC Oncology Stakeholders Summit, Spring 2015 series, at which experts gathered to discuss the evolving treat-ment landscape in oncology and the development of innovative payment models to help reduce the cost of care without sacrificing quality of care.

The AJMC Oncology Stakeholders Summit Insights video editorial series was designed to facilitate access to the wisdom and experience of some of the most accomplished clinicians and managed care experts in the field today. This program gathers the insights of these experts on key issues and topics in oncology, providing valuable information to physicians that they can use in their everyday practice.

Use this print resource as a quick reference for useful information on topics covered in the AJMC Oncology Stakeholders Summit, Spring 2015 series. To access the original video segments from which this print supplement was derived, visit www .ajmc.com/insights.

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PUBLISHING STAFFBrian HaugP R E S I D E N T

Nicole BeaginA S S O C I A T E E D I T O R I A L D I R E C T O R

Mary K. CaffreyM A N A G I N G E D I T O R

Surabhi Dangi-Garimella, PhDM A N A G I N G E D I T O R

David AllikasQ U A L I T Y A S S U R A N C E E D I T O R

Justin T. GallagherA S S O C I A T E P U B L I S H E R

Sara StewartD I R E C T O R O F S A L E S

Gilbert HernandezN A T I O N A L A C C O U N T S A S S O C I A T E

Gwendolyn SalasD E S I G N D I R E C T O R

Jeff D. Prescott, PharmD, RPhS E N I O R V I C E P R E S I D E N T ,

O P E R A T I O N S A N D C L I N I C A L A F F A I R S

CORPORATEMike Hennessy, SrC H A I R M A N A N D C E O

Jack LeppingV I C E C H A I R M A N

Tighe BlazierE X E C U T I V E V I C E P R E S I D E N T ,

M E R G E R S A N D A C Q U I S I T I O N S

Neil Glasser, CPA/CFEC H I E F O P E R A T I N G O F F I C E R

John MaglioneE X E C U T I V E V I C E P R E S I D E N T A N D

G E N E R A L M A N A G E R

Jeff Brown C H I E F C R E A T I V E O F F I C E R

Teresa Fallon-YandoliE X E C U T I V E A S S I S T A N T

Mike Hennessy, Sr Chairman and CEO

Contents

THE CLINICAL AND REIMBURSEMENT LANDSCAPE OF IMMUNO-ONCOLOGY3 Coverage of Immuno-Oncology Therapies

4 Treatment Considerations With Immuno-Oncology

ROLE OF ORAL ONCOLYTICS TO SUPPORT PALLIATIVE CARE INITIATIVES5 Issues in Promoting Early Palliative Care

6 Medication Selection in the Palliative Care Setting

INNOVATIVE PAYMENT MODELS IN ONCOLOGY7 Considerations When Developing and Implementing Innovative Oncology Payment Models

This section of the supplement summarizes discussions held during the Oncology Stakeholders Summit, Spring 2015 series, at which oncology experts gathered to discuss key topics related to the introduction of im-muno-oncology agents. Specific topics that were elaborated upon include payer coverage of immuno-oncology agents; the importance of balancing efficacy, toxicity, and cost; and clinical considerations regarding the use of immuno-oncology agents.

Coverage of Immuno-Oncology Therapies The advent of immuno-oncology agents has expanded the treatment armamentarium available to oncologists. Michael Kolodziej, MD, and Bruce Feinberg, DO, address some of the key issues payers face as they make coverage decisions on the new PD-1 drug class of immuno-oncol-ogy agents.

Dr Kolodziej points out that prescribing behavior has thus far reflected the indications tested during the clinical trial process and, to a lesser extent, where National Comprehensive Cancer Network (NCCN) places them in the treatment guidelines for melanoma and now non-small cell lung cancer. Similarly, payers’ coverage policies reflect approved label-ing and the NCCN recommendations. Payers’ coverage decisions are cur-rently reflective of FDA approvals and recommendations from the Nation-al Comprehensive Cancer Network (NCCN), notes Dr Kolodziej. “Payers tend to respect, at least initially, the FDA label and subsequently expert opinion like that offered by the NCCN. I would say that if a payer made a decision that was in conflict with NCCN, they’d be in a very difficult place to defend that decision.”

Dr Feinberg emphasizes that the FDA labeling and NCCN recommenda-tions restrict use of PD-1 agents to patients who experience relapse. He believes that the excitement over this drug class, on both the provider and patient levels, will drive the use of these agents earlier in treatment. The problem, according to Dr Kolodziej, is that clinical evidence on the opti-mal use of PD-1 inhibitors may lag behind actual use. The introduction

of new drug classes may require reconsid-eration of the way evidence is collected to help not only informed patient care but also coverage policy.

If they reach their fullest potential, PD-1 inhibitors may be used to target up to 30 different tumor types, says Dr Feinberg. Drs Kolodziej and Feinberg agree that a key challenge to achieving successful treatment outcomes with PD-1 inhibitors and to ap-propriate coverage decision making will be to overcome the lack of biomarkers to deter-

The Clinical and Reimbursement Landscape of Immuno-Oncology

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Participants

Bruce A. Feinberg, DO Vice President and Chief Medical OfficerCardinal Health Specialty Solutions Dublin, OH

Richard W. Joseph, MDAssistant ProfessorDivision of Medical OncologyMayo ClinicJacksonville, FL

Michael Kolodziej, MDNational Medical Director for Oncology Strategy

AetnaHartford, CT

BRUCE A. FEINBERG, DO

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mine who will most benefit from these agents.

An important issue, accord-ing to Dr Kolodziej, is whether cost could be a barrier for true breakthrough medications such as the PD-1s. Dr Kolodziej states that the goal with breakthrough therapies is to lower or reduce the barriers that patients face in receiving them.

Dr Feinberg remarks that al-though cost is a barrier for every

agent, the PD-1 agents’ high efficacy and low toxicity override, to an extent, the cost barrier. “For the clinician, there’s a value triad of efficacy, toxicity, and cost,” says Dr Feinberg. He echoes the thoughts of many payers: cost becomes the paramount dif-ferentiator in the case of multiple oncology drugs that are simi-lar in terms of improving survival, quality of life, and safety.

Treatment Considerations With Immuno-Oncology Richard W. Joseph, MD, discusses the difference in treatment outcomes for immunotherapies versus targeted therapies, and explains that while targeted therapies and immunotherapies are potential options in metastatic melanoma, most medical oncologists prefer to treat their patients with immunotherapy. “Immunotherapies are the only therapies that are going to cause long, durable remissions,” he says.

Dr Joseph highlights clinical trial results showing that mela-noma patients with NRAS mutations tend to have better re-sponse rates to immunotherapy compared with patients with wild-type NRAS. NRAS mutations may be valuable predictors of response in patients with melanoma, suggests Dr Joseph.

Dr Joseph discusses previous research that investigated whether response rates for patients treated with high-dose in-terleukin-2 varied based on whether the patient had an NRAS mutation, a BRAF mutation, or were wild-type for both NRAS and BRAF. The results showed that patients with NRAS muta-tions responded better to treatment than patients with BRAF mutations or patients who were wild-type for both NRAS and

BRAF. More recent research has demonstrated that patients with NRAS mutations also respond better when treated with other types of immunotherapies, he adds.

Although these results are exciting, there is still no defini-tive answer as to why melanoma patients with NRAS mutations respond better than patients without such mutations, remarks Dr Joseph. He is hopeful that additional studies will provide more insight into the role of NRAS mutations in melanoma. Immunotherapeutic agents have demonstrated effectiveness at delivering sustained treatment responses; however, these agents carry substantial costs. Furthermore, prolonged use of immunotherapy can increase the likelihood that a patient will experience treatment toxicities. Dr Joseph explains how clini-cal studies designed to assess appropriate duration of immu-notherapy treatment can help reduce these patient burdens.

Dr Joseph notes that clinical trials of immunotherapy in dif-ferent types of cancer have demonstrated durable response rates. Keeping patients on immunotherapy for a long period of time may not always be necessary, and studies that evaluate the appropriate duration of treatment with immunotherapeu-tic agents are needed. If cancer recurs, he adds, patients may still respond when immunotherapy is restarted.

By appropriately limiting the length of treatment with im-munotherapy based on data from clinical trials, Dr Joseph ex-plains, healthcare professionals can reduce the cost burden and the likelihood of experiencing treatment toxicities.

The oncolytic agents pembrolizumab and nivolumab have been approved for the treatment of metastatic melanoma, and a combination of ipilimumab and nivolumab is currently pend-ing approval. Dr Joseph explains that even with a higher level of toxicity, this combination therapy option is likely to become a frontline treatment option because its benefits are likely to out-weigh its risks; however, there may still be patients who are not appropriate candidates for combination therapy. “What’s going to be interesting is how to place these [single-agent therapies vs combination therapy] in the right order,” says Dr Joseph.

Although neither pembrolizumab nor nivolumab have FDA approval for the frontline therapy indication, guidelines from the NCCN recommend an anti-PD-1 agent as a preferred initial regimen, says Dr Joseph. Unfortunately, healthcare profession-

als and patients need to worry about whether frontline use of these agents will be covered by payers. Currently, coverage of first-line anti-PD-1 therapy is mixed, Dr Joseph remarks. Frontline use of anti-PD-1 ther-apy has the potential to save payers money, as these agents are more effective and less toxic than other options.

4 / 8.15 Oncology Stakeholder Summit: Insights

“I would say that if a payer made a decision that was in conflict with NCCN, they’d be in a very difficult place to defend that decision.”

–Michael Kolodziej, MD

RICHARD W. JOSEPH, MD

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Participants

Bruce A. Feinberg, DO Vice President and Chief Medical OfficerCardinal Health Specialty Solutions Dublin, OH

Brian B. Kiss, MDVice President, Healthcare TransformationBlue Cross Blue Shield of FloridaJacksonville, FL

Genevieve Kumapley, PharmD, BCOPClinical Pharmacy Specialist, OncologySaint Peter’s University HospitalNew Brunswick, NJ

Role of Oral Oncolytics to Support Palliative Care Initiatives

This section of the supplement summarizes discussions held during the Oncology Stakeholders Summit, Spring 2015 series, at which oncology experts gathered to discuss key topics related to palliative care. Specific topics that were elaborated upon include promoting multidisciplinary care and the early introduction of palliative care, cost and reimbursement con-siderations, and medication selection in the palliative care setting.

Issues in Promoting Early Palliative CarePalliative care services are poorly utilized, despite their potential ben-efits. Bruce Feinberg, DO, and Brian Kiss, MD, discuss several general is-sues related to promoting the use of palliative care services. Dr Feinberg explains that a few aspects of the problem are that palliative care ser-vices are not well defined, practice guidelines from major organizations are vague, and it is not clear who on the care team should lead oncology palliative care efforts. Dr Kiss adds that another part of the problem is that doctors tend to discuss palliative care only after active treatment options for advanced cancer have been exhausted. Palliative care discus-sions should instead happen much earlier in treatment, he states, even in the primary care setting.

It is critical that the patient’s family be involved in palliative care deci-sions, and that they try to fully understand and come to terms with their relative’s priorities, adds Dr Kiss. As many patients do not discuss their wishes regarding what should be done at the end of life, Dr Kiss stresses that their desires should be made clear early on to everyone involved.

Dr Feinberg, agrees, saying, “I always want to have someone else in the room [besides the patient] when discussing a treatment change,” he says, “mostly because patients often are in shock.” This should not nec-essarily be estranged family members, who have been absent from the patient’s affairs for several years and suddenly want to insert themselves into the patient’s decisions, cautions Dr Feinberg. However, including the key caregiver in decisions made at critical steps is very valuable, he said.

Genevieve Kumapley, PharmD, BCOP, remarks that addressing pallia-tive care early on, and in a multidisciplinary manner, helps all stakehold-ers understand the goals and preferences of the patient. As part of the team approach, members of a patient’s palliative care team discuss with the patient what tests and/or treatments will or will not be beneficial. By having these discussions and taking into account the patient’s preferences, the patient’s palliative care team can potentially decrease the overuse of healthcare resources, which may result in cost savings.

Dr Kiss believes that while palliative care can instill some cost savings, it should not be viewed as an opportunity to withdraw more expensive care. “You have to provide the care that’s necessary to assure the best

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function and pain relief for that patient at that time,” he says. Some cost savings may be real-ized by treating a patient’s end-of-life symptoms at home or in hospice instead of in a hospital, or by avoiding the use of ineffec-tive active treatment toward the end of life.

The consumption of resources in the last 30 days of life, espe-cially in end-stage cancer pa-tients, is extensive, predictable,

and avoidable, according to Dr Feinberg. Most of the costs are related to emergency department (ED) visits, intensive care unit stays, hospitalizations, and physician consultations that can be avoided if the system moves toward a patient-focused culture that more readily considers palliative care.

Collaborative programs, such as accountable care relation-ships and value-based relationships, are beginning to include patient-reported outcomes in their bonus payment agreements. However, these metrics are often defined differently from one system to another, and usually take a back seat to more straight-forward measures such as keeping patients out of the ED, ac-cording to Dr Feinberg. Even though they are not called patient-reported outcomes, as they are not direct patient reports, they provide a measure of quality of life, Dr Feinberg points out. Quality of life is enhanced if a patient can remain home, and work if they have a job, instead of being in the ED or hospital.

Because of the complexity of treatment selection and patient management in oncology, it is challenging for payers to incor-porate quality-of-life measures into coverage and reimburse-ment decisions, remarks Dr Kumapley. Although payers could simplify the process by covering only a limited number of drugs, patients with cancers for which there are few treatment options, such as pancreatic, can benefit from new options that have been approved based on quality-of-life metrics, she says.

Medication Selection in the Palliative Care SettingThe use of oral oncolytics is becoming increasingly common in cancer treatment, notes Dr Kumapley; how-ever, healthcare professionals should recog-nize that oral treatment options are associ-ated with advantages and disadvantages. For instance, for patients in rural areas who live far from healthcare facilities, oral agents may offer the advantage of ease of access. How-ever, unlike patients who receive intravenous chemotherapy in a facility under the care of healthcare professionals, patients treated with oral oncolytics take on more personal

responsibility for their care. They are likely to have to manage adverse events on their own because they have less face-to-face interaction with their healthcare professionals, she adds.

Dr Kumapley also discusses the factors that healthcare pro-fessionals consider when making decisions about whether to use oral oncolytic therapy or intravenous chemotherapy. Treat-ment guidelines, patient lifestyle factors, and patient access to treatment facilities are among the top considerations, she says.

In end-of-life care scenarios, additional considerations related to the appropriateness of oral oncolytic therapy include treat-ment costs, symptom management, and the patient’s cultural and spiritual beliefs.

The choice of intravenous versus oral medications in pallia-tive care places great importance on having a discussion about medication therapy management (MTM), most importantly a discussion related to the expense of the oral oncolytics. We want to use these medications most efficiently, points out Dr Fein-berg, and patient self-care plans must include more than just MTM to ensure adherence with the care plan.

Dr Kumapley notes the significance of introducing a self-care plan to patients who are undergoing cancer treatment. “There is a value in helping the patient understand what their antici-pated side effects are, when to expect them, and how to manage them,” says Dr Kumapley, who notes the heightened importance of proper planning in an era in which oral oncolytics have be-come primary treatment options.

If established at the beginning of treatment, a self-care plan has the potential to improve overall patient adherence, remarks Dr Kumapley.

Dr Feinberg adds that mobile health technologies, especially text-based reminders, can help patients improve adherence and persistence with oral therapy and manage side effects. Patient adherence is the key, agrees Dr Kiss, whether it is to an oncol-ogy therapy or general medical treatment. High costs burden patients and affect their adherence to treatment, remarks Dr Kumapley. For instance, patients prescribed high-cost drugs are less likely to fill their prescriptions, and although patient assis-tance programs are available to assist patients with the costs of treatment, drug benefit design should be reevaluated.

“There is a value in helping the patient understand what their anticipated side effects are, when to expect them, and how to manage them.”

–Genevieve Kumapley, PharmD, BCOP

BRIAN B. KISS, MD

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Innovative Payment Models in Oncology

This section of the supplement summarizes discussions held during the Oncology Stakeholders Summit, Spring 2015 series, at which oncology experts gathered to discuss key topics related to the development of inno-vative payment models in oncology. Specific topics that were elaborated upon include the involvement of multiple stakeholders when developing alternative payment models, the importance of using standardized qual-ity measures, and opportunities for improving accountable care organi-zation (ACO) models in oncology.

Considerations When Developing and Implementing Innovative Oncology Payment ModelsRecognition of the fact that the ever-rising growth in healthcare spend-ing is unsustainable over the long term has spurred the development of alternative reimbursement models. Michael Kolodziej, MD, and Ted Okon, MBA, discuss the inclusion of multiple stakeholders during the development of improved oncology payment models. Mr Okon remarks that the most crucial voice during the development of a payment pro-gram is the patient’s. He adds that insight from providers (ie, individual practitioners, group practices, and hos-pitals), nurses, private payers, pharma-ceutical companies, and medical device manufacturers is important. The opinions of payers, providers, and patients should be considered, and in order for a payment model to be successful, there needs to be “harmonization” among these stakehold-ers, remarks Dr Kolodziej.

Mr Okon explains that several variations of the ACO model have been established. Although these models are a “head start” in leading innovation, he suggests that there are fundamental problems that need to be addressed.

To improve ACO models in oncology, Dr Kolodziej and Mr Okon suggest the importance of providing more coordinated care, increasing commu-nication, and focusing on the needs of patients.

According to Dr Kolodziej, organizations on the private sector side may experience more success in altering the ACO care delivery model. Dr Kolodziej and Mr Okon note that more recently developed ACO models such as CMS’ Next Generation ACO model and the Community Oncol-ogy Alliance’s (COA’s) Oncology Medical Home model are transforming oncology care.

Participants

Michael Kolodziej, MDNational Medical Director for Oncology Strategy

AetnaHartford, CT

Ted Okon, MBAExecutive DirectorCommunity Oncology AllianceWashington, DC

TED OKON, MBA

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