Driving Evidence-Based Health Plan Coverage by Recognizing ......Takeaway 1: Little Consistency in...

Driving Evidence-Based Health Plan Coverage by Recognizing

Gaps, Updating PracticesFebruary 13, 2020

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Moderator

Jennifer GraffVice President, Comparative Effectiveness ResearchNational Pharmaceutical Council

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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.

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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.

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“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

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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

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• 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

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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)

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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.

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Speaker


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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

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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

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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?

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Data Source

✓ 200+ specialty drugs

✓ 150+ diseases

✓ 100+ biopharma companies

✓ 4,800+ coverage decisions

✓ 27,000+ citations

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Example Coverage Policy

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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?

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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)

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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


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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?

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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


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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

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Thank you!

[email protected]

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• 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

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Presenters

Scott ThompsonArea PresidentGallagher Research & Insights



What is most important to employers, patients,

providers?

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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


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



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%



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



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

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Panel Discussion





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?

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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.

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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)

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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)


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Questions





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


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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!

Driving Evidence-Based Health Plan Coverage by Recognizing ......Takeaway 1: Little Consistency in...

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