France’s new CEPS agreement brings major changes to pharma pricing across a product’s lifecycle.
France has introduced a new framework agreement governing the pricing and regulation of reimbursed medicines. Signed by the French Economic Committee for Health Products (CEPS) and four pharmaceutical industry associations, the agreement replaces the 2021 framework and applies immediately through September 30, 2030.
But the agreement was negotiated in a very different international environment from its predecessor. How far have geopolitical pressures, greater focus on pharmaceutical sovereignty, and renewed US Most Favored Nation (MFN) initiatives shaped the final compromise?
The new framework marks a significant evolution in the French pricing environment. Its underlying trade-off is clear: greater opportunities to recognize innovation and industrial investment at launch, in exchange for more structured and potentially stronger price regulation across a product’s lifecycle.
What are the key changes?
Greater flexibility at launch for innovative products:
For products rated ASMR I–III, as well as selected ASMR IV products, CEPS may now grant a temporary launch-price advantage over the relevant reference cost. Its magnitude will primarily depend on the ASMR rating. CEPS may also consider French participation in pivotal clinical trials, with at least 5% of patients recruited through French centers in line with latest AMNOG reform in Germany (i.e., clinical-trial threshold), as well as early-access status. Companies will need to distinguish clearly among the list price, temporary net launch price, and longer-term target net price.
EU list price guarantee rule:
The EU list price guarantee rule will remain valid, with increased openness to EU list price for ASMR IV at launch and, in exceptional cases, to ASMR V under strict conditions. A protected French list price may be relevant under some US MFN models, but may not be sufficient where models reference foreign net prices.
Comparator selection becomes more nuanced:
The new CEPS framework provides more detailed rules for identifying the pricing comparator, which can be a major point of discussion during negotiations. Off-patent comparators may be excluded for ASMR I–III and selected ASMR IV products in indications with no newly reimbursed drug for many years. Where no suitable clinical comparator exists, CEPS may consider a proxy comparator based on factors such as ASMR, target population, therapeutic area, and place in the treatment pathway.
Medico-economic evidence becomes part of ongoing price management:
Companies must now systematically provide the adjustable health economic model used in the Economic and Public Health Evaluation Committee (CEESP) assessment. Positive externalities may support a price advantage where they generate significant direct medical savings, but these savings must be confirmed through independently validated real-world evidence within three years. Otherwise, the price advantage may be withdrawn or recovered.
French and European manufacturing footprints and supply security become explicit pricing levers:
In the previous framework, industrial investment mainly supported list-price stability and export protections. The new framework recognizes the contribution of French or European manufacturing through a net-price advantage (magnitude is defined based on the strength of the footprint and associated supply of security it offers). The advantage is granted only once and remains conditional on satisfactory supply of the French market.
Price evolution becomes more predictable and more systematic:
The previous three- and five-year stability rules are replaced by a defined lifecycle trajectory until loss of exclusivity. The first review will generally take place after three to four years, followed by reviews every two years. An indication extension increasing the HAS-assessed target population by more than 10% will also trigger immediate renegotiation.
Post-patent regulation becomes tougher:
- Loss of exclusivity triggers existing rebates to be fully converted into list-price reductions, together with a minimum additional 10% price cut. Upon entry of a generic, biosimilar, or hybrid, this cut is increased to reach the total discount applicable under the corresponding rules.
- In retail, the base discount reaches 40% for originators compared with 20% under the previous agreement. The discount is maintained at 60% for generics and increased to 50% for biosimilars and hybrids. At the hospital level, a 40% discount applies across all categories. After two years, a 7.5% group-wide price reduction is applied followed by biennial reviews.
The orphan-specific framework is no longer included:
The dedicated clause for orphan medicines has been removed. This does not prevent product-specific arrangements, but companies can no longer rely on a standalone mechanism for orphan pricing, budget caps, or performance contracts.
The new framework also establishes a maximum 13-month negotiation period (with clock stops possible under specific conditions). If negotiations fail, the CEPS President may submit a final proposal. Refusal results in withdrawal of the reimbursement application, with a minimum six-month wait before a new application can be considered.
What does this mean for pharmaceutical companies?
The new framework increases the need to prepare not only for more complex launch negotiations, but also for recurring renegotiations throughout the lifecycle. Companies will need to anticipate what evidence, including RWE, comparator evolution, supply-security commitments, and clinical developments, can support future price reviews and help limit price erosion.
Contract design will also become more complex, with multiple dimensions to consider, including list price, temporary net launch price, longer-term target net price, and review clauses. This will require companies to align early with global teams to reconcile more dynamic price trajectories in France with typically fixed global pricing guidance. At the same time, the framework may create new opportunities for truly innovative products, including greater launch flexibility and potential protection of French list prices, which could become strategically valuable in an MFN environment.
Reach out to our team of experts at Simon-Kucher if you want to learn more about these updates.
Thanks to contributions from Charles Hoffmann-Martinot and Marine Richard!
