PERFORMANCE-BASED RISK SHARING AGREEMENTS:
FAD OR TREND?

Tuesday, May 18, 2010
7:00AM-8:00AM

Sponsored by RTI Health Solutions
     

Symposia are free and open to all ISPOR delegates, no pre-registration required.

Innovative performance-based risk sharing agreements have been taking place in Europe, the United States and other countries. Implementing performance-based agreements can be a strategy to receive preferential market access and help a health care system gain efficiencies. However, there is a lack of common understanding of the various methods to design and measure the performance of these agreements. Various economic frameworks for the contracts, the taxonomy of the programs, and several real-world examples will be presented from multiple countries, including the United States.

Moderator:
Kati Copley-Merriman MS, MBA, Vice President, Regulatory and Health Outcomes Strategy and Market Access, RTI Health Solutions, Ann Arbor, MI, USA

OVERVIEW OF PERFORMANCE-BASED RISK-SHARING AGREEMENTS:  A FRAMEWORK AND TAXONOMY
Speaker:  Lou Garrison PhD, Professor, Pharmaceutical Outcomes Research & Policy Program, Department of Pharmacy, University of Washington, Seattle, Washington, USA

PERFORMANCE-BASED RISK-SHARING AGREEMENTS:  A EUROPEAN PERSPECTIVE
Speaker:  Adrian Towse MA, MPhil, Director, Office of Health Economics, London, UK

Performance-Based Risk-Sharing Agreements:  A U.S. Perspective
Speaker:  Charlie Petrie PhD, Head, Outcomes Research, Clinical Development and Medical Affairs
Specialty Care, Pfizer Inc, New London, CT, USA

COMPARATIVE EFFECTIVENESS & STANDARDS OF EVIDENCE: THE INTERSECTION OF SCIENCE, POLICY, REGULATION AND BUSINESS

Tuesday, May 18, 2010
1:30PM-2:30PM

Sponsored by UBC
     

Symposia are free and open to all ISPOR delegates, no pre-registration required.

Although there have been many policy and major funding developments propelling comparative effectiveness research (CER) into the national consciousness, there has been little to no serious policy discussion addressing the sticky issue of CER evidence standards for decision making. Apparently, not only will any national “CER Institute” that may be legislated not have regulatory authority, in point of fact, it will likely be statutorily de-linked from direct (federal) policy decisions, for example Medicare coverage policy. But is it naïve to expect that federally-funded CER evidence will not ultimately play a key role in such decisions?   From technology sponsors’ point of view, the evidence bar is generally rising (even without new Federal efforts) due to payer, health plan and general clinical and societal pressures, and this includes expectation of more, better CER evidence generation for coverage decision making. The evidence standards of the above stakeholders are absolutely not clear, but those of the FDA which, of course, regulates promotional claims of prescription drugs and certain devices, are clear.  FDA standards of evidence for claims are anchored on “substantial evidence” underpinned by “adequate and well-controlled studies” which will be vastly different than studies envisioned under the CER umbrella.

So what is, could or should be the intersection between FDA promotional standards, CER evidence standards (generally) and, payer (e.g., CMS’s or private plan) coverage standards? 

In a recent provocative paper, Gottlieb and Klasmeier¹ proposed that the FDA issue guidance around its current standard of “substantial clinical experience” to provide a uniform set of standards around CER to allow other federal agencies, manufacturers, payers, physicians and patients alike to have a common understanding of the level and type of scientific evidence for responsible decision making and sanctioned promotional claims.

In this symposium, questions will be addressed, such as:

• Is a common CER evidence standard to simultaneously meet FDA requirements and health care decision maker needs desirable? If so…
• What might that standard be? 
• To what extent does the proposed “substantial clinical experience” standard make sense?
• What, if anything, would need to change (e.g., legislation? regulation? collaboration? will?) to develop a common standard?
• If a common standard is not desirable/reasonable, what needs to change for there not to be a double standard: one for manufacturers, another for everyone else?

 We invite you to join our faculty in this discussion. Please note this symposium will not be announcing any new policy

Moderator: Bryan R. Luce PhD, MBA, Senior Vice President, United BioSource Corporation, Bethesda, MD, USA

Speakers:
Scott Gottlieb MD, Resident Fellow, American Enterprise Institute, Washington, DC, USA
FDA Representative (invited), Director, Study Endpoints and Label Development, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA
Les Paul MD, Vice President, Clinical & Scientific Affairs, National Pharmaceutical Council, Reston, VA, USA
Brian Sweet BS Pharm, MBA, Chief Pharmacy Officer, Wellpoint Inc., Grand Island, NY, USA

^1. Comparative Effectiveness Research: The Need for a Uniform Standard,  S Gottlieb, M.D., C Klasmeier, American Enterprise Institute #6, June, 2009