Placement: Brigham and Women’s Hospital
Mentor: Aaron Kesselheim, M.D., J.D., M.P.H., Associate Professor of Medicine, Harvard Medical School; Director of the Program on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmaeconomics, Brigham and Women’s Hospital
Project: Evidence Utilization to Support Innovative Drugs Pricing and Reimbursement Decisions in the U.S. and French Health Care Systems
Véronique Raimond, Ph.D., M.Sc., is a 2019–20 French Harkness Fellow in Health Care Policy and Practice. As a senior project manager at the French National Authority for Health, Raimond works on cost-effectiveness evaluation as a new criterion for pricing and reimbursement for innovative drugs and medical devices. She divides her work between the assessment of innovative drugs and the development of regulation methods and strategies supporting pricing and reimbursement decisions. Raimond’s research focuses on the role of economic calculation as a health regulation tool and the adoption of cost-effectiveness to regulate the price of prescription drugs. Her work has been published in health policy and health technology assessment journals including Value in Health and PharmacoEconomics. She holds an M.Sc. in health economics and Ph.D. in economics from the University Paris Panthéon-Sorbonne.
Project Overview: With an increasing number of innovative, yet expensive, drugs being developed worldwide, it’s worthwhile using the evidence produced during their evaluations to make coverage and pricing decisions. Since 2013, France has been requesting cost-effectiveness evaluations, in addition to clinical evidence, to support pricing decisions for innovative drugs. In the U.S., the evidence that supports coverage decisions, especially the role dedicated to cost-effectiveness, varies among payers. This study consists of two parts:
- To compare the evolution of prices of top-selling prescription drugs in France and in Medicare in the US and explain divergent price evolutions. To understand how to account for observed pricing differences between the markets, the study will identify key regulatory events related to each drug – including marketing approvals, clinical and cost-effectiveness opinions, and official decisions on pricing and coverage in France after marketing approval – using FDA, European Medicines Agency, and French government publications.
- To compare the types of evidence and how evidence is used in the coverage decision process in France and the U.S for car-T cell therapies. It will include a survey of the latest regulatory provisions related to the coverage and pricing of innovative drugs for federal programs and private organizations in the US and national health insurance in France. It will include a systematic review of the evaluation reports and comparative effectiveness or cost-effectiveness in the two countries. Structured qualitative interviews with key decision-makers will support a description of the coverage decisions reached on the drugs. A typology will be developed to classify decisions according to the process, such as predefined rules or negotiation, the size of the population covered, and the nature and conclusions of evidence used to support the decision. This study will contribute to the debate on innovative drug pricing and coverage policy, as well as the development of relevant evaluation and regulation frameworks supporting fair pricing schemes.