[The benefit provided by new medicinal products in 2005-2006--the viewpoint of the French National Authority for Health]

Therapie. 2007 Sep-Oct;62(5):387-91. doi: 10.2515/therapie:2007068. Epub 2008 Jan 19.
[Article in French]

Abstract

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.

Publication types

  • English Abstract

MeSH terms

  • Antineoplastic Agents
  • Drug Approval / legislation & jurisprudence
  • Drug Approval / methods*
  • Drugs, Investigational*
  • France
  • Legislation, Medical
  • National Health Programs*

Substances

  • Antineoplastic Agents
  • Drugs, Investigational