France Prepares Major Drug Pricing Reforms as CEPS Report Due July 2025
核心洞察
The French government has requested CEPS to publish a comprehensive report in July 2025 outlining policy recommendations that will shape pharmaceutical spending approaches for 2026.
Over 70% of medicines in France with ASMR IV or V ratings could face additional discounts, while 77 molecules currently receiving 15% reimbursement may be delisted entirely.
Generic and biosimilar sectors are expected to benefit from upcoming reforms, including potential changes to discount ceilings and possible exclusion from safeguard policies.
The French pharmaceutical sector faces significant regulatory changes as the Committee for Economic Evaluation of Health Products (CEPS) prepares to deliver a critical policy report in July 2025 that will reshape drug pricing and reimbursement strategies for 2026. The French government has requested this comprehensive assessment to address mounting pharmaceutical spending pressures and implement targeted cost-saving measures.
Potential Delisting of Low-Value Medicines
The upcoming reforms could result in the delisting of medicines with low clinical value ratings under France's Service Médical Rendu (搜索) (SMR) assessment system. Products currently reimbursed at the lowest tier of 15% would no longer receive reimbursement coverage, effectively removing them from the national healthcare system.
According to GlobalData (搜索)'s Price Intelligence service, 77 molecules currently face potential delisting challenges due to their 15% reimbursement status. These products typically represent non-essential and lifestyle medicines that receive low SMR ratings in cost-effectiveness assessments. Despite their lower clinical ratings, these products experience similar price impacts after launch compared to higher-rated medicines, with average first price cuts ranging between 6% and 7% across different reimbursement tiers.
Widespread Impact on Therapeutic Improvement Ratings
France's National Health Insurance Agency (CNAM (搜索)) has proposed additional cost-containment measures targeting medicines based on their Amélioration du Service Médical Rendu (搜索) (ASMR) ratings. Products rated as having "absent/no improvement" (ASMR V) or "minor" improvement (ASMR IV) would be subject to discounts compared to the net price of the cheapest available comparator.
The scope of this impact is substantial, with more than 70% of brands in France having received ASMR IV or V ratings. These medicines account for the majority of reimbursed pharmaceuticals in the French market and would therefore be directly affected by the proposed discount mechanisms.
Sector-Specific Implications
While the innovative pharmaceutical sector faces uncertainty regarding potential benefits from the reforms, the generic and biosimilar sectors are positioned to gain from the upcoming changes. Potential amendments under consideration include modifications to limit discount ceilings and possible exclusion from the current "safeguard policy" framework.
The safeguard clause, which currently caps certain pricing mechanisms, may undergo modifications rather than complete overhaul. However, the extent of changes to this policy remains unclear as CEPS continues coordinating multiple policy initiatives throughout 2025.
Timeline and Policy Coordination
CEPS has been actively coordinating various policy initiatives throughout 2025 to determine the government's approach to pharmaceutical spending in 2026. The July 2025 report represents a relatively quick turnaround for the organization but builds upon ongoing initial proposals that have provided early insights into potential reform directions.
The report will encompass progress made on recent and upcoming policy actions while providing insight into significant spending constraints expected for innovative medicines in 2026. This comprehensive assessment will serve as the foundation for implementing substantial changes to France's pharmaceutical pricing and reimbursement landscape.