OBJECTIVES: For 5 years, health-economic evaluations have been assessed by CEESP for innovative products, revendicating an ASMR (improvement in medical benefit) level ≤III with an impact on the Healthcare expenditure (≥€20 million after 2 years). Since December 2017, efficiency opinions have been published on their adoption and no more when the pricing process is finalised. Our objective was to set up an overview and assess their impact on the market access of new drugs.

METHODS: All efficiency opinions available of drugs until May 31^st, 2018 and their corresponding Transparency opinions have been reviewed. The most relevant information, including types of objections, ICER and ASMR, were collected. For the new drugs, an analysis of the impact on the time period for having the funding was computed according to this information.

RESULTS: In total, 50 efficiency opinions have been published. Most of them were in the field of cancer or infectious diseases (60%). An ICER was available for 70% (n=35); among 34% (n=12) were ≤50,000€/QALY and 14% (n=5) ≥500,000€/QALY. Most of the opinions (96%) reported at least one minor objection, 86% one important objection and 40% one major objection; 32% (n=16) presenting all types of objection. Among all new drugs (74%; n=37), only 27% (n=10) obtained ASMR ≤III and around 13% the requested level of ASMR. The median time for having the funding was 273 days. A longer period was observed for drugs having ASMR≥IV or with major objections (+49.5 and +48 days respectively). All drugs without ICER needed longer time to finalize funding process (from 298 to 847 days). Six drugs were still negotiating.

CONCLUSIONS: Efficiency opinions are now part of the French requirements. According to this work, it is important to build-up a relevant market access strategy and, if needed, to respect the CEESP guidelines to optimize the reimbursement process.