driving evidence-based health plan coverage by recognizing ......takeaway 1: little consistency in...
TRANSCRIPT
Driving Evidence-Based Health Plan Coverage by Recognizing
Gaps, Updating PracticesFebruary 13, 2020
2
Moderator
Jennifer GraffVice President, Comparative Effectiveness ResearchNational Pharmaceutical Council
3
Employees and Consumers Have Factors to Weigh When Selecting a Health Plan
Sample for Illustrative Purposes Only. DC Health Link.
Premiums, Deductibles, Estimated Costs, Doctor NetworksQuality Ratings
4
Trying to Navigate Formularies Adds Another Layer of Complexity
Sample for Illustrative Purposes Only. DC Health Link.
5
Commercially Insured Patients Encounter Variations and Restrictions in Accessing Specialty Medications
Chambers JD. Specialty Drug coverage varies across commercial health plans in the US. Health Aff 2018;37(7):1041-7.
6
“Typical” Pharmacy & Therapeutics Committee Process to Develop Formulary Coverage
AMCP Partnership Forum: Principles for Sound Pharmacy and Therapeutics (P&T) Committee Practices: What’s Next? J Manag Care Spec Pharm, 2020;26(1):48-53.
Objective Evaluation of Key Characteristics
• Clinical
• Economic
• Humanistic
Provide decision and rationale to relevant stakeholders
Voting component for formulary status
P&T review meeting(s)Safety Efficacy Cost
Preparation of formulary monograph for P&T review meeting
Research and compilation of clinical information
Request for review for one of the following:
New treatment approvalIndication approval for
existing treatmentTherapeutic category
reassessment
7
Evidence-Based Medicine Serves as the Basis for Coverage and Reimbursement
Eddy DM Clinical Decision Making: From Theory to Practice-Anatomy of a Decision JAMA 1990;263(3):441-443.
Analysis and Synthesis of
Evidence
Value Judgments
Scientific
judgments
Evidence
Information
about
Outcomes
Formulary
Coverage
Decisions
Preference
judgments
Assuming there is some evidence to evaluate, it should be possible to get reasonable, open-minded people to agree on the results of this (evidence) step – David Eddy
8
• Describe:
• Gaps between evidence and coverage policies; variation across health plans in the quantity, breadth and types evidence used to inform coverage policies.
• The challenges associated with variations in evidence and coverage policies for specialty medicines present to patients, clinicians and the health care system as a whole.
• The current state of formulary development practices and priority considerations for stakeholders.
Today’s Objectives
9
Presenters
Scott ThompsonArea PresidentGallagher Research & Insights
James Chambers, PhD, MPharm, MSc Associate Professor of MedicineThe Tufts Medical Center Institute for Clinical Research and Health Policy Studies
Jennifer Graff, PharmD Vice President, Comparative Effectiveness ResearchNational Pharmaceutical Council (Moderator)
10
Submit questions and comments via the
Questions section in the Control Panel
To Submit Questions
How to Ask a Question
To Tweet Questions
Note: We may not be able to answer all questions in the time allotted.
11
Speaker
James Chambers, PhD, MPharm, MSc Associate Professor of MedicineThe Tufts Medical Center Institute for Clinical Research and Health Policy Studies
12
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Covered – No restrictions
Covered – Restrictions
Not covered
Variation in Commercial Health Plan Decision Making
Chambers JD et al. Variation in US private health plans' coverage of orphan drugs. Am J Manag Care. 2019 Oct;25(10):508-512
13
Why Variation in Plan Decision Making?
1. Tailoring of decisions to specific populations
2. Differences in financial resources
3. Differences in contracting
4. Inconsistency in the evidence used to support decision making
14
4,811 specialty coverage decisions from
17 of the 20 largest insurance companies reviewed
207 drugs 167 conditions
Tufts Specialty Drug Evidence Coverage (SPEC) Database n=27,130 unique citations;
Is High Quality Evidence Being Used for Decision-Making?
15
Data Source
✓ 200+ specialty drugs
✓ 150+ diseases
✓ 100+ biopharma companies
✓ 4,800+ coverage decisions
✓ 27,000+ citations
16
Example Coverage Policy
17
18
Questions
1. What evidence do payers cite in their coverage policies?
2. Does cited evidence vary by health plan?
3. How consistent is the evidence plans cite in their policies?
19
Takeaway 1: Little Consistency in Evidence Cited by Commercial Plans
Chambers JD et al. Little Consistency in Evidence Cited By Commercial Plans for Specialty Drug Coverage. Health Affairs 2019;38(11).
18%
12%
10%
12%
8%
15%
Randomized
Controlled Trials
(n=1,118)
Other Clinical Study
(n=667)
Real-World Evidence
(n=492)
Evidence Synthesis
(n=378)
Economic Evaluation
(n=23)
All Evidence
Categories
(n=2748)
20
Does Cited Evidence Vary by Health Plan?Quantity of Cited Evidence
64.4
37.9
15.5
28.0
11.812.1
30.6
4.26.95.8
21.6
9.1
27.3
15.6
8.3
22.4
10.8
17.4
All Plans (number of coverage policies)
Average number of studies cited per document
Chambers JD et al. Little Consistency in Evidence Cited By Commercial Plans for Specialty Drug Coverage. Health Affairs 2019;38(11).
21
Evidence Payers Cite in Their Coverage Policies (n=27,130)
17%
15%
13%
11%
11%
11%
10%
7%4%
Randomized Controlled Trials
Guidelines
Other
FDA Label
Health Technology Assessments
Editorials & Other Reviews
Other Clinical Studies
Real World Evidence
Evidence Syntheses
Economic Evaluations
<1%
22Chambers JD et al. Little Consistency in Evidence Cited By Commercial Plans for Specialty Drug Coverage. Health Affairs 2019;38(11).
0%
20%
40%
60%
80%
100%
Evidence Types
Randomized Controlled Trials Real World Evidence FDA Label/Package Insert
Economic Evaluations Sythesis, HTA, and Guidelines Others, Editorial
Does Cited Evidence Vary by Health Plan?
23
Little Consistency in Evidence for Health Plan Coverage Policies
• Only 15% of the health plan coverage policies for the same drug and samecondition cited the same study
• Only 38% of all studies were cited by more than one plan
• Volume of evidence cited as the basis for coverage policies varied
• Ranged from 4 studies per policy at one plan to 64 studies per policy at another
• Types of evidence cited varied
• Some site RCTs; others do not cite any evidence synthesis
Chambers JD et al. Little Consistency in Evidence Cited By Commercial Plans for Specialty Drug Coverage. Health Affairs 2019;38(11).
24
1. Unclear if plans cited all the evidence they reviewed
2. Different plan committees may consider different evidence
3. Our findings might not be generalizable
4. We did not account for the quality of cited studies
Study Limitations
26
• What is most important to employers, patients, providers?
• How does the inconsistency in evidence used to inform coverage decisions impact you as a stakeholder?
• What incentives would be needed to facilitate greater consistency and transparency in evidence developed and used to guide coverage and reimbursement?
Panelist Questions
27
Presenters
Scott ThompsonArea PresidentGallagher Research & Insights
James Chambers, PhD, MPharm, MSc Associate Professor of MedicineThe Tufts Medical Center Institute for Clinical Research and Health Policy Studies
Jennifer Graff, PharmD Vice President, Comparative Effectiveness ResearchNational Pharmaceutical Council (Moderator)
What is most important to employers, patients,
providers?
29
Panelist
Scott ThompsonArea President
Gallagher Research & Insights
30ARTHUR J. GALLAGHER & CO. | AJG.COM
73%
67%
64%
60%
54%
Employers continue to navigate familiar challenges while keeping abreast of emerging issues and the implications these new dynamics will have
Importance of Trends Impacting Pharmacy Benefit Management
(percentage rating highly important)
n=107 Employers
Cost of specialty Rx biologics
Consumerism (help manage their health and make
smarter choices)
PBM transparency (from the employer perspective)
Availability of biosililars
Addressing employee compliance and adherence with
prescribed medications
© 2019 Gallagher Benefit Services, Inc. EMI Trends. All rights reserved
31ARTHUR J. GALLAGHER & CO. | AJG.COM
Approach to Health Plan Management of Specialty Medications
and Biologics that Fall Under Medical Benefit (vs. Pharmacy
Benefit)
14%11%
38%
26%
11%
Not aware ofhealth plan approach
Aware but havenot discussed or
taken action
Actively discussed Require active management
Not applicable - Moved all coverage from the
medical to pharmacy benefit
n=117 Employers
Inactive Active
© 2018 Gallagher Benefit Services, Inc. EMI Trends. All rights reserved
32ARTHUR J. GALLAGHER & CO. | AJG.COM
As employers grapple with the management of biologics, cost tops the list of worries
Concerns Pertaining to Biologics
(percentage highly concerned)
n=107 Employers
Cost to
employer
87% Cost to
employee/p
atients
64%
"Site-of-
care"
pricing
issues
63% Effectiveness
57% Patient
adherence 50% "Buy
and bill"
40%
Savings/c
opay
cards
36%
Impact of
productivity &
absenteeism
33%
© 2019 Gallagher Benefit Services, Inc. EMI Trends. All rights reserved
33ARTHUR J. GALLAGHER & CO. | AJG.COM
Employers are largely willing to make a formulary change if presented with compelling evidence, yet just 26% have received this information
n=100 Employers
Note: Does not include those who were not given an exclusion list or develop and manage their own formulary.
Employer Perspectives on PBM’s National Formulary and Exclusion Lists
(percentage strongly agreeing)
60%
49%
42%
37%
26%
20%
If presented with compelling evidence we would be willing to make a
formulary change with our PBM to cover a specific Rx
We call on third party vendors (e.g., benefits advisors/consultants) to
help us evaluate PBM drug lists
We trust our PBM to be experts and largely rely on their drug
coverage recommendations
We want to better understand how formulary decisions are made
We have been presented with clinical evidence to support making
individual Rx decisions and evaluations
We are reluctant to make formulary/exclusion list changes due to
PBM financial penalties
© 2019 Gallagher Benefit Services, Inc. EMI Trends. All rights reserved
34ARTHUR J. GALLAGHER & CO. | AJG.COM
EBCs and PBMs hold greatest influence in Rx decisions, but many also
watch employer peers for outcomes of benefit design initiatives
© 2019 Gallagher Benefit Services, Inc. EMI Trends. All rights reserved n=107 Employers
Influence of External Stakeholders on Pharmacy Benefit Decisions
58%
35%
26%
22%
21%
32%
56%
53%
62%
65%
90%
91%
79%
84%
86%
Very influential Moderalty influential
Benefits Advisor/Consultant (pharmacy
advisor if applicable)
Pharmacy Benefits Managers (PBM)
Specialty Pharmacy Provider (SPP)
Health Plan/TPA
Employer Peers
35
Panel Discussion
Scott ThompsonArea President
Gallagher Research & Insights
James Chambers, PhD, MPharm, MSc Associate Professor of MedicineThe Tufts Medical Center Institute for Clinical Research and Health Policy Studies
Jennifer Graff, PharmD Vice President, Comparative Effectiveness ResearchNational Pharmaceutical Council (Moderator)
How does the inconsistency in evidence used to inform
coverage decisions impact you as a stakeholder?
What incentives would be needed to facilitate greater
consistency and transparency?
38
0%
20%
40%
60%
80%
100%
Agence
Nationale
d'Accreditation
et d'Evaluation
en Sante'
Canadian
Medical
Association
Dutch College
of General
Practitioners
American
Diabetes
Association
Italian Society
for Diabetology
Catalan Society
of Primary Care
Scottish
Intercollegiate
Guidelines
Network
Institute for
Clinical System
Improvement
New South
Wales
New Zealand
Guidelines
Group
East London
Guidelines for
General
Practice
% of shared references across
clinical practice guidelines for care
Consistency in Evidence Evaluation is Not Unique to Plan Coverage
Burgers. Diabetes Care 2002; 25(11):1933-1939.
39
Create Carrots and Sticks for More Consistent Use of Evidence
Enhance
ProcessesDevelop Better
Evidence
Info
rmal/
Vo
lun
tary
Fo
rmal/
Str
uctu
red
P&T Model
Practices (e.g.,
RWE expert, >1
trained member)
Payer Research
Prioritization
(C-suite vs.
contracting vs.
medical)
More Complete
Reporting (e.g.,
Core Template
for Submission)
Update Good
P&T Processes
(1999)
40
21st Century Formulary Development Practices
ASHP Principles of a Sound Drug Formulary System –
(2008)
Principles of a Sound Drug Formulary System
(2000)
AMCP Principles for Sound P&T Practices
(2020)
AMCP Partnership Forum: Principles for Sound Pharmacy and Therapeutics (P&T) Committee Practices: What’s Next? J Manag Care Spec Pharm, 2020;26(1):48-53.
41
21st Century Formulary Development Practices
AMCP Partnership Forum: Principles for Sound Pharmacy and Therapeutics (P&T) Committee Practices: What’s Next? J Manag Care Spec Pharm, 2020;26(1):48-53.
42
21st Century Formulary Development Practices
AMCP Partnership Forum: Principles for Sound Pharmacy and Therapeutics (P&T) Committee Practices: What’s Next? J Manag Care Spec Pharm, 2020;26(1):48-53.
43
Questions
Scott ThompsonArea President
Gallagher Research & Insights
James Chambers, PhD, MPharm, MSc Associate Professor of MedicineThe Tufts Medical Center Institute for Clinical Research and Health Policy Studies
Jennifer Graff, PharmD Vice President, Comparative Effectiveness ResearchNational Pharmaceutical Council (Moderator)
44
Submit questions and comments via the
Questions section in the Control Panel
To Submit Questions
How to Ask a Question
To Tweet Questions
Note: We may not be able to answer all questions in the time allotted.
45
Key Takeaways
•
• Evidence A Key Part of Coverage Decisions. Not the Only Component.
• Incentives AND Infrastructure Required to Encourage Greater Transparency
Chambers JD et al. Little Consistency in Evidence Cited By Commercial Plans for Specialty Drug Coverage. Health Affairs 2019;38(11).
46
Key Takeaways
More Transparent Evidence Evaluation
Better Informed Consumers Plan Selection and Appropriate
Use
Your feedback is appreciated. Please complete the forthcoming
evaluation survey.
Thank you!