Les médicaments d’exception : spécificité et rôle dans le cadre du bon usage des médicaments

Abstract Background In 1994, the French health care system established a special status for certain costly drugs reimbursed for ambulatory use: exception drugs. Drugs with this status are reimbursed only when prescribed for specified indications. The purpose of this study was to identify the specific characteristics of drugs with the exception status, and to understand the role of this status in proper use of drugs. Methods Drugs included in the study were analyzed using three types of data: administrative, clinical and economic. Results For most of the drugs, prescription was restrictive. For five of them, the sickness fund accepted reimbursements for fewer indications than mentioned in the marketing authorisation. For the majority, reimbursement was 100%. The exception drugs were indicated for the treatment of 15 diseases. Eighty percent of expenditures for exception drugs concerned ten drugs. Conclusion The characteristics considered in the study did not enable a specific description of the inherent features of exception drugs. This special status was established for the purpose of economic efficiency. Currently, its role in ensuring proper use of drugs is questionable.