[The benefit provided by new medicinal products in 2005-2006--the viewpoint of the French National Authority for Health].
The French National Authority for Health (HAS) assesses the actual benefit provided by medicinal products within a defined legal framework. It provides an independent scientific opinion. It aims to ensure equity, taking into account a variety of points of view as a result of close collaboration with health professionals. In 2005-2006, the mean time to process requests by the Transparency Committee was 100 days (median 77 days) and faster than in previous years. Over 30% of new medicinal products undergoing a first assessment or an assessment for an extension to indications were deemed to provide added value. This added value was marked for 25% of the products (i.e. an improvement in actual benefit ("ASMR") of I to III). Many of these products were orphan drugs and/or biotechnology products.
Bouvenot
Gilles
G
Haute Autorité de Santé, Saint Denis la Plaine, France. gilles.bouvenot@ap-hm.fr
D000970:Antineoplastic Agents; D017277:Drug Approval / Q000331:legislation & jurisprudence / Q000379:methods*; D015507:Drugs, Investigational; D005602:France; D007883:Legislation, Medical; D009313:National Health Programs
D000970:Antineoplastic Agents; D015507:Drugs, Investigational