OBJECTIVES: The recent amendment of the Accord Cadre specifies the regulatory lead times for price negotiations with the CEPS for health products in France. In this context, the purpose of this study is to analyze the evolution of lead times for drugs market access in France in the last five years, in terms of clinical and economic evaluation.

METHODS: As French government is committed to improving patient access to innovative therapies, notably by bringing lead times closer to the 180 days set by the European directive, it appeared interesting to perform a retrospective analysis of lead times for price negotiation. Data such as Transparency Commission’s opinion dates and price publication date were extracted from French health authorities, institutions and organizations’ websites and documents, and from French legislative texts. All drugs with a Transparency Commission’s opinion published between January 2014 et January 2019 for a new indication in France were considered. They included a wide range of therapeutic areas and classes, with various levels of innovation. IQVIA performed analyses, attempting to put the price negotiation timelines into perspective with the level of ASMR and the different regulatory statuses of the drugs considered.

RESULTS: French lead times are among the longest in Europe and have kept increasing over the last years. As of June 2019, the IQVIA analyses are in process. Among other findings, preliminary results for 2018 show a mean of 319 days between Transparency Commission’s opinion and price publication. Upcoming results will allow to have more specific outcomes regarding the impact of a drug’s potential for innovation on its price negotiation timelines.

CONCLUSIONS: The shortening of price negotiation lead times for health products is considered today a priority for health actors. Corrective measures have thus been implemented and should make it possible to optimize these timelines in the future.