Practical Solutions for Using
Outcomes Data to Demonstrate the Value
Proposition to Payers
Introductions
Leanne Larson, MHA
Vice President, Evidence Development
Leanne Larson, MHA
PAREXEL Consulting
Vice President, Evidence Development
 > 25 years’ experience in healthcare with extensive work in pharmaceutical
product development and marketing, clinical research, and care delivery.
PAREXEL Consulting
 Research has examined both the clinical relevance and market potential of
new drugs and devices, with a strong focus on managed-care populations.
 Industry thoughtleader in observational, late-phase, and outcomes
research, with expertise in strategy, design, implementation, and analysis
of patient registries and outcomes research programs.
 Formerly Vice President, Strategic Development at Quintiles Outcome;
Vice President, Registry Consulting at ICON; Manager, Life Sciences and
Pharmaceutical Consulting, Ernst & Young; Senior HSA at Merck
 Invited Reviewer for the Centers for Disease Control; featured speaker at
conferences sponsored by the Drug Information Association, ISPOR,
Center for Business Intelligence, and Marcus Evans
 MHA in Health Administration from Governors State University; BS in
Community Health from University of Illinois
© 2012 PAREXEL International
|
Confidential
Agenda
Changing Market Realities Require That Issues of Importance to Payers,
Such as Outcomes Data, Be Incorporated into Development Strategies
• Determining What Payers Want
• Current Payer Reliance on Outcomes Data
• Review of Payer Views on Interaction with Bio-Pharmaceutical
Manufacturers
• Structuring to Develop Actionable Outcomes Data
• Collecting Real-World Data Through a Patient Support Program
• Summary
• Questions & Answers
PAREXEL CONSULTING
“Good work… but I think we need
just a little more detail right here”
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Regulators, Payers and KOLs Agree That More Than
Regulatory Approval is Needed
US Payers are Using Outcomes Data to Make
Coverage Decisions
• BCBS to require comparative effectiveness be reviewed
for new products
• “And so even in the United States, we can approve drugs and we’ll get them
on the market, but for them to be successful, they are going to need to have
demonstrated value...”
•
• WellPoint & oral asthma drugs (real world setting)
• Janet Woodcock, M.D., Director, FDA Center for Drug Evaluation and Research, DIA Annual
Meeting, June 17, 2010
• “I think manufacturers should have discussions with CMS in Phase II.”
• Louis Jacques, M.D., Director, CMS Coverage Analysis Group, FDA/CMS Summit Meeting,
December 2010
• Robert Seidman, formerly Chief Pharmacy Officer for WellPoint
Claims data of 55,000 patients analyzed
•
QoL surveys to 800 patients
•
Front line use not FDA approved nor in clinical guidelines
•
Removed prior authorization (PA) requirement for Zyflo, Singulair, Accolate
•
Performance based agreement for Januvia & Janumet
•
If patient stays on therapy and blood sugar falls, Cigna receives larger
rebates
•
A win/win; Cigna pays less & Merck‘s volume increases
• Centers for Medicare and Medicaid Services (CMS)
• “Using Market Exclusivity Incentives To Promote Pharmaceutical Innovation”,
New England Journal of Medicine, Nov. 4, 2010
• Suggests linking incentives to demonstration of outcomes
• Understand critical issues payers face in managing a disease or
patient population
•
• Cigna & Merck
• “We’re going to see a growth in outcomes guarantees for pharmaceuticals,
and it’s very healthy.”
The New Reality: Engage Payers Early in
Development to Protect Commercial Success
Product must be as beneficial as other approved products
•
CMS decided not to cover virtual colonoscopy based on absence of clinical
data for Medicare population
•
Based on available evidence, CMS denied coverage to Warfarin genetic
testing
•
Based on AHRQ’s comparative effectiveness data CMS has denied all
requests new codes for NPWT devices
Payers Want Dialogue Around Real-World Outcomes
At What Phase Do You Think Engagement is Relevant?
• Obtain input to better design trials & and regulatory strategies
• Payers see value in having input into the drug development process
• Lower total cost of care
• Understanding drug efficacy
• Improved outcomes
• 100% of pharmacy directors and 86% of medical directors responded
being interested/very interested in providing input to manufacturers
Source: PAREXEL Analysis and Booz & Company Report of 20 National Payer Interviews, In Vivo, Sept. 2010
Booz & Company survey results
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2
A Strategic Plan to Develop Outcomes Data Aligns
with Market Needs
Outcomes Data Help Payers Create Access Policies
That Support Their Objectives
What Types of Input Would You Want to Have With Pharmaceutical
Companies During Drug Development?
Outcomes data have greater value in
the market and supports patient
access to therapy
Trial Design
Team
National Plans,
Rated 1 (least important) to 5 (very important)
4.3
4.1
3.8
3.7
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3.5
3.3
Payer &
Reimbursement
Team
Investigators
HEOR
Team
4.1
Payers
Product
Sponsor
Patients
2.8
2.4
2.3
2.2
Operations
Team
Regulators
Patient
Advocacy Team
Regulatory
Team
Coverage, Clinical trial Discussions
benefit
design input on unmet
design and
needs and
pricing input
current
treatment
Support
services
Clinical trial
Data
validation aggregation
and results
Formal
Phase II
results
review
Portfolio
review
Real-time
eligible
patient
identification
Jointly
designed
and
executed
trials
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Booz & Company survey results
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Emerging Approach: Developing Outcomes Data
via Patient Support Programs
Traditional
Observational data supports
favorable payer coverage policies
and launch success
Patient
recruitment
Patient Support Program
Intake &
Application
Processing
Patient
Reported
Outcomes
(PRO)
Product
Fulfillment
Payer
Reimbursement
Support
Innovation
Clinical Care &
Treatment
Coaching
Data Publication
&
Communication
PRO Data
Analysis
•
Supports patients throughout treatment process
•
Captures patient-specific outcomes data to support product value proposition and payer needs
•
Allows for the development of cost-effectiveness & budget-impact models
•
Communicates data to key stakeholders
•
Supports patient access to therapy across the marketplace
Summary
• Create an integrated product-development
team
• Use regulators & payers as a sounding board to understand
desired outcomes data
• De-risk by assessing the access landscape early in
development
• Properly identify & resource late-phase outcomes data
needs, including REMS
• Continually monitor & review the data needs for
commercialized products
• Develop meaningful patient-support programs to improve
outcomes and collect data
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Thank you!
Questions and Comments
Leanne Larson
Vice President, Evidence Development
PAREXEL Consulting
[email protected]
+1.847.853.4075
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