Pricing Negotiations of ASMR IV Drugs in France: Impact of the Latest LEEM-CEPS Framework Agreement

OBJECTIVES: On March 5^th, 2021, a new LEEM-CEPS framework agreement was signed for 3 years, setting notably the conditions under which drugs with an ASMR IV can claim a list price consistent with the prices in 4 European markets (Germany, Italy, Spain, United Kingdom). This study aimed at analyzing the impact of this agreement on ASMR IV price, and more particularly whether drugs eligible for the European Price Guarantee have benefited from a consistent French price.

METHODS: Medicines with an ASMR IV granted between January 1^st, 2020 and December 31^st, 2021 were identified from the IQVIA Transparency Commission database, only first-time assessment and extension of indication requests which prices were published 1 month after the agreement signature were eligible. French list prices were extracted from the ”Journal Officiel”, and list prices in the EU-3 + UK were extracted from PricingInsight IQVIA database. Finally, we reviewed if eligible drugs met the criteria for the European Price Guarantee and we calculated the duration of price negotiation.

RESULTS: 83 products obtained an ASMR IV between 2020 and 2021, and 16 were eligible for this analysis. At least one of the criteria for the European Price Guarantee was met by 10 drugs (62.5%), and 8 (50%) drugs had available prices in Europe. Compared to the lowest European price, 4 (25%) drugs received an equivalent list price, 2 (12.5%) drugs obtained a higher French price, and 2 (12.5%) drugs obtained a lower price, with an average discount of 1.2%. Moreover, price publication delays more than doubled for the 10 eligible drugs after the agreement (414 days on average versus 161 days in 2019).

CONCLUSIONS: This study shows that the framework agreement is applied for most eligible products, but in return we observe an increase in negotiation time, due to potential more challenging net price negotiation.