"Direct Access" Experiment in France: Potential Impact on the Pricing of Innovative Medicines

OBJECTIVES: A “direct access” program has recently been introduced in France. Similarly to previous German regulations, several products will be allowed free pricing for one year. Eligibility criteria include rating of Actual Medical Benefit (SMR) as major or important and rating of Improvement in the Actual Medical Benefit (ASMR) from major to minor. The objective was to determine the hypothetical impact of the program on the pricing of recently approved drugs in France.

METHODS: Innovative medicines approved in the European Union (EU) in 2021-2022 were identified. Products with SMR major or important and ASMR at least minor were included. Initial prices of the products in Germany were adopted as probable prices under the program in France and compared with the actual prices. Probable discounts were adopted based on the report of the Economic Committee for Health Products (CEPS).

RESULTS: In 2021-2022, 95 innovative products were approved in the EU. HAS evaluated 55 (58%) of them and 28 (29%) met SMR and ASMR requirements. Prices of 13 eligible products were found in France and Germany. A comparison of potential prices with the actual discounted prices in France showed that the potential prices were always higher than the actual prices, by 23% on average. The greatest disparity was for bimekizumab, with a 48% potential price increase and the smallest difference was for efgartigimod alfa, with a 7% higher potential price.

CONCLUSIONS: “Direct access” could accelerate access to drugs since patients will not wait until price negotiation finishes. However, the HAS assessment will still be needed and it will concern only selected products. If similar prices had been adopted under “direct access” in France as in Germany, all eligible products approved in the last two years would have had significantly higher prices. It is expected that the program will require a significant investment from the French government.