Educational Symposium held prior to the ISPOR 14th Annual International Meeting
Symposium is free and open to all ISPOR delegates, no pre-registration required
Health technology assessment (HTA) has evolved into an important tool for supporting health care decisions. Recent legislation and guidance both in the US and abroad will have a key impact on how HTA is conducted. During this symposium, the impact of the American Recovery and Reinvestment Act’s (ARRA) comparative effectiveness research initiative on outcomes research, health technology innovation, as well as implications of ARRA on patient groups, and challenges facing the research community will be presented. In addition an update on the 2009 AMCP Format for Formulary Submission revisions (version 3.0) as a transparent and consistent mechanism for industry to communicate evidence on the benefits, risks and economic value of health technology as well as recent European HTA initiatives will be discussed.
| 5:00-5:05 |
Opening Remarks |
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 Speaker: Kim Gilchrist MD, MBA, Chair, PhRMA Health Outcomes Committee and Executive Director, Health Economics & Outcomes Research, AstraZeneca Pharmaceuticals LP, Wilmington, DE, USA |
| 5:05-5:10 |
Introduction |
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 Moderator: Richard Willke PhD, Senior Director/Group Lead, Primary Care Outcomes Research, Pfizer Inc, Peapack, NJ,USA |
| 5:10–5:30 |
An Update on the 2009 AMCP Format for Formulary Submission Revision |
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 The AMCP Format for Formulary Submissions (Format) provides a transparent and consistent mechanism for industry to communicate evidence on the benefits, risks and economic value of health technology directly to health care payers. Health plan and industry representatives, convened by AMCP, recently completed a thorough revision (version 3.0) of the Format. This session will discuss the revision process, the comments received and will present an overview of the main proposed changes to the Format.
Speaker: Sean Sullivan PhD, RPh, BS, MS, Professor and Director, University of Washington, Pharmaceutical Outcomes Research and Policy Program, Seattle, WA, USA |
| 5:30-5:50 |
Current Pan-European HTA Initiatives |
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 Speaker: Adrian Towse MA, MPhil, Director, Office of Health Economics, London, UK |
| 5:50-6:10 |
Effect of the American Recovery and Reinvestment Act’s (ARRA) Comparative Effectiveness Research on Outcomes Research |
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 The purpose of comparative effectiveness and outcomes research is to generate better evidence for clinical and coverage decision making. This presentation describes why there is a lack of evidence available for decision making, how the money from the ARRA could be used to improve the current state of evidence and infrastructure for comparative effectiveness, as well as the challenges the research community will face going forward.
Speaker: Danielle Whicher BS, MHS, Project Manager, Center for Medical Technology Policy, Baltimore, MD, USA |
| 6:10-6:30 |
Effect of the American Recovery and Reinvestment Act’s (ARRA) Comparative Effectiveness Research on Drug Development in the USA |
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 ARRA has changed the CER landscape in the US. In this presentation, the impact on industry of the current CER agenda will be discussed including potential impact on health technology innovation, how drugs are developed, and implications for patient sub-groups. The various alternatives for what a post-ARRA CER agenda might look like will also be discussed.
Speaker: Eleanor Perfetto PhD, MS, Senior Director, Reimbursement & Regulatory Affairs, Federal Government Relations, Pfizer Inc, New York, NY, USA
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| 6:10-6:30 |
Questions & Answers |
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| 7:00-7:30 |
Symposium Reception (All symposium attendees welcome) |
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14th Annual International Meeting Main Page
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