OBJECTIVES: Whilst the centralized European Joint Clinical Assessment (EU JCA) procedure aims to reduce duplication and improve the quality of local HTA processes, it will impact local HTA processes and consequently patient access. This research aims to understand the impact of the EU JCA on access to innovative medicines in France.

METHODS: Published information on the HTA Regulation, JCA implementing acts and regulatory timelines were used to map timelines. These were then compared to regulatory timelines observed in France in 2023, using the Prismaccess^® database.

RESULTS: Products with pre-marketing early access program (pre-MA EAP) were available on the market on average 66 days before EC decision and corresponding pre-EAP dossiers were submitted to Transparency committee (TC) on average 156 days before CHMP opinion. The JCA report will be available 30 days after the EC decision. This coincides with the initiation of the TC assessment for products previously authorized through pre-MA EAP. In 2023, 131 TC opinions were published. The mean time between EC approval –TC submission was of 216 days. The mean TC assessment duration was 151 days. Drugs available via pre-MA EAP had a shorter TC assessment duration of 103,4 days. The Commission for Economic and Public Health Evaluation (CEESP) opinions were published on average 133 days after TC opinion. Price negotiations took on average 422 days for new products and 310 days for indication extensions in 2023.

CONCLUSIONS: While JCA should significantly reduce TC assessment, access is contingent to completion of price negotiations. For pre-MA EAP, TC submission could be done before completion of JCA. Lack of clarity on how processes will overlap may discourage pharmaceuticals companies from pursuing early access. It is still uncertain if JCA will accomplish its goal of expediting access to innovative drugs in France.