OBJECTIVES: In France, reimbursement of drugs is based on the therapeutic value of drugs (SMR level for each indication) as assessed by HAS, going from “insufficient” (no reimbursement at all) to “weak” (15% reimbursement), “moderate” (30%) and “important” (65%). HAS and manufacturer have the right to ask for re-assessment anytime after the initial reimbursement listing; in all cases, a relisting process is compulsory every 5 years. We analyzed HAS’s reassessment and relisting activity over the year 2011, based on the hypothesis that the Mediator safety “affair” would have impacted the process. METHODS: We considered all complete procedures for relisting, re-assessments and class reviews and focused on drugs for which a HAS advice was published between Jan and Dec 2011. We compared previous and new SMR levels for each indication. RESULTS: Twenty-six drugs have gone the relisting process, corresponding to 33 different indications, out of which 31 cases were analyzable: HAS modified 14 SMRs while 17 SMRs remained unchanged. Almost 50% (6/13) of SMR initially rated as “important” were changed to “insufficient” (4) or “moderate” (2).  All initially insufficient SMR (8) were confirmed. 19 drugs have gone through re-assessment process, corresponding to 24 SMRs/indication, out of each only 21 were analyzable: 10 SMRs have been modified (only 2 increased and the rest lowered) and 11 unchanged. In 8 of these cases, the manufacturer had asked for the re-assessment. 6 full therapeutic classes have been reviewed in 2011, including Alzheimer’s and antipschychotics, resulting in a harmonization and a decrease of the SMR levels. CONCLUSIONS: Manufacturers should now ensure that reassessment and relisting dossiers in France incorporate as much of relevant clinical, safety and real-life information as possible in order to maintain the reimbursement level