[Evaluation of the medical value of a drug. A necessity for the Transparency Commission].
The marketing approval (AMM) is based on criteria of pharmaceutical quality, efficacy and safety of use. Before marketing, the data are collected by means of double-blind, randomized, prospective clinical trials that compare the study product to a reference product. A post-AMM assessment is needed to define the increase of the medical benefit (ASMR) and the therapeutic value of the new drugs. The quantification of the ASMR is essential for registration on the list of drugs reimbursable for those who benefit from Social Security. The evaluation of the therapeutic value and the nature of the affection treated are the criteria upon which the reimbursement ratio is chosen. After marketing, the reevaluation of the medical benefit and the drugs' usefulness may be compared to the treatment's net medical cost (direct + indirect cost--avoided cost) in cost/utility or cost/benefit studies. The Transparency Commission has worked out a scale of assessment of the ASMR which will orient recommendation, or non-recommendation, of registration on the list of reimbursable drugs as well as price fixing proposals. In the future, the Transparency Commission is to strengthen its position regarding the good use of the drug through a better prescriber information system. Thanks to the pharmaco-epidemiology and the pharmaco-vigilance data, the Transparency Commission will be able to guarantee the post-marketing follow-up of the drugs. The examination of the products' conditions of use, the reevaluation of the treatment's advantages based on the utility studies and the epidemiological surveys, and the cost-benefit studies will contribute to a medical control of health spending linked to drug consumption.
Avouac
B
B
Service de Rhumatologie, Hôpital Henri Mondor, Créteil.
D003362:Cost-Benefit Analysis; D016527:Drug Costs; D005602:France; D007356:Insurance, Pharmaceutical Services; D010600:Pharmacology / Q000706:statistics & numerical data; D010604:Pharmacy / Q000706:statistics & numerical data; D011358:Product Surveillance, Postmarketing / Q000379:methods*
L'évaluation du service médical rendu. Une nécessité pour la Commission de la Transparence.