Value of Post-Registration Studies for Reimbursement Renewal

¹ Département de Pharmacologie, CHU de Bordeaux, Bordeaux, France
² Laboratoire Bristol Myers Squibb, Rueil-Malmaison, France
³ Unité d'Épidémiologie des Maladies Émergentes, Institut Pasteur, Paris, France

Received: 15 October 2008
Accepted: 20 November 2008

Abstract

Post-registration studies describe parameters of real-life clinical practice such as the treated population, conditions of treatment initiation, treatment duration, adherence, associated benefits/risks as well as the impact on treatment strategies, healthcare procedures and on public health. The results of these studies are used in particular for re-evaluation, re-registration or in applications for reimbursement. Since 1997, 134 requests for post-registration studies have been made either by the French Transparency Committee (CT) and/or the Committee for Pricing of Healthcare Products (CEPS) and the results of these studies were taken into account in the re-evaluation of Actual Benefit (AB) or Improvement in Actual Benefit (IAB). During the roundtable discussion on this subject at the National Clinical Pharmacology Meeting held at Giens (France), the difficulties in performing such studies were identified and proposals were made to predict and anticipate requests for these studies but also for the training of physicians.