Pharma braces for important French drug pricing reforms pending CEPS’s report

Rising budgetary stress is a central theme in France because the nation prepares for the publication of the federal government’s 2026 Social Safety Finance Invoice (PLFSS). French Prime Minister François Bayrou has requested the Financial Committee for Well being Merchandise (CEPS) to create a report, which will likely be printed by the top of July 2025 and launched in Q3 2025, outlining its drug pricing coverage suggestions.

These coverage suggestions are more likely to be outlined by what Bayrou describes as “altering geopolitical context” and “funding dynamics” for the EU pharma sector. The setting has due to this fact triggered a possibility to re-evaluate present value setting and regulation insurance policies, with the potential for larger flexibility and better costs on account of altering enterprise situations. This precept is already beginning to be put in place. From March 2025, the CEPS has been required to think about the manufacturing location of manufacturing websites when setting costs, often called the “industrial criterion”. Whereas this coverage existed beforehand, it’s now mandated, giving preferential pricing for domestically manufactured medicines. A value premium for native manufacturing will probably enhance the generic sector, making it extra financially viable.

Traditionally, monetary viability has been a definitive battle for generic and biosimilar producers in France. Based mostly on a pattern of off-patent, generic, and biosimilar costs, these medicines are sometimes priced between 38% to 68% decrease in France, on common, when in comparison with the opposite prime European markets. Utilizing the accessible present costs from GlobalData’s Value Intelligence (POLI) & HTA service, the determine under compares the typical value per milligram per unit of pack (one pill, for instance) distinction between off-patent, generic, and biosimilar medicines which are accessible in France and the opposite 4 main European markets. The pattern from every drug kind was generated by together with merchandise which have their energy measured in milligrams and can be found in all 5 markets.

Determine 1: Common value per energy unit (euros/unit/mg) comparability of costs in France to the opposite EU5 market

Moreover, the Generic Similar Drug Affiliation (GEMME) in France has pushed for biosimilars to be excluded from the “safeguard clause” pricing coverage. This measure limits public well being spending on medicines by requiring pharmaceutical firms to contribute to well being spending as soon as the reimbursed expense exceeds a set threshold. There could also be additional optimistic information for generics and biosimilars as the federal government additionally considers reducing the low cost ceiling for generics from 40% down to twenty%–25% whereas setting a low ceiling for biosimilars.

Whereas the upcoming report from CEPS will probably have advantages for the generic/biosimilar sector, it’s unclear what potential advantages will likely be dropped at the revolutionary pharmaceutical sector. There are appeals to alter the “safeguard clause” and decrease the cap, and there are potential modifications, however it’s unlikely to be fully overhauled. It’s extra probably that different cost-saving measures will likely be thought-about. For instance, medicines with low medical worth rankings (Service Médical Rendu, SMR) may very well be delisted. Merchandise which are reimbursed on the lowest tier (15%) would due to this fact not be reimbursed.

Such measures would probably goal non-essential and way of life medicines that obtain this low SMR score of their cost-effectiveness assessments. GlobalData’s Value Intelligence (POLI) & HTA service reveals that 77 molecules are at present 15% reimbursed and will due to this fact face a delisting problem. These merchandise see a mean first value reduce much like that of merchandise with the next medical score. The typical first value reduce throughout totally different reimbursement tiers ranges between 6% and seven% for the totally different medical rankings. Due to this fact, merchandise with a low medical score see an analogous impression on value after launch in comparison with these with the next score, regardless of being extra more likely to have competitors with different remedies available on the market.

Determine 2: Common first value reduce (%) of merchandise based mostly on reimbursement stage granted

Moreover, France’s Nationwide Well being Insurance coverage Company (Caisse Nationale d’Assurance Maladie, CNAM) has set out proposals to save lots of on pharmaceutical spending. In its annual report, CNAM steered that medicines with an enchancment in precise profit (Amélioration du Service Médical Rendu, ASMR) which are rated “absent/no enchancment” (ASMR V) or “minor” (ASMR IV) needs to be topic to a reduction in comparison with the web value of the most cost effective accessible comparator. The determine under reveals the proportion of manufacturers in France by ASMR rankings granted.

Greater than 70% of manufacturers, accounting for almost all of the medicines reimbursed in France, have been granted these rankings of ASMR IV or V and would due to this fact be impacted.

Determine 3: Distribution of medicines in France by ASMR score

All through 2025, CEPS has been coordinating many coverage initiatives that can decide and affect the federal government’s strategy to pharmaceutical spending in 2026. As such, the French Authorities has requested that the CEPS publish a report later in July 2025 to stipulate its coverage suggestions. Whereas this seems to be a fast turnaround for CEPS, the continued preliminary proposals have given a sneak peek into what this report might function. The generic and biosimilar sectors are more likely to profit from upcoming reforms. Potential amendments may embody adjustments to the restrict low cost ceiling and potential exclusion from the “safeguard coverage”. It’s unclear what this report might take into account for the revolutionary sector; nevertheless, sure medicines may very well be delisted based mostly on reimbursement ranges, and additional reductions may very well be granted on web costs for merchandise with ASMR IV and V rankings. This report will embody the progress made for current and upcoming coverage actions, whereas additionally giving perception into important spending constraints for revolutionary medicines anticipated for 2026.

This text is produced as a part of GlobalData’s Value Intelligence (POLI) service, the world’s main useful resource for world pharmaceutical pricing, HTA and market entry intelligence built-in with the broader epidemiology, illness, medical trials and manufacturing experience of GlobalData’s Pharmaceutical Intelligence Heart. Our unparalleled workforce of in-house specialists displays P&R coverage developments, outcomes and knowledge analytics world wide day-after-day to present our shoppers the sting by offering important early warning alerts and insights. For a demo or additional data, please contact us right here.