The HAS assessment paves the way for reimbursement, but does not determine the price or reimbursement tariff. This second stage, which is equally important for the economic viability of a healthcare product, falls under the responsibility of another body: the CEPS. Understanding its role and negotiation approach is essential for successfully navigating market access in France.
The Role of the CEPS
The CEPS — the Economic Committee for Health Products (Comité Économique des Produits de Santé) — is the French interministerial body responsible for setting the prices of medicines and the reimbursement tariffs for medical devices covered by the statutory health insurance system.
Operating under the authority of the ministries responsible for Health and the Economy, the CEPS negotiates directly with manufacturers under a clear mandate: ensuring access to innovative healthcare products while controlling the impact of healthcare expenditure on public finances.
Unlike the HAS, whose assessment focuses on the product’s clinical value, the CEPS deals with economic considerations — pricing levels, reimbursement conditions and agreements with manufacturers that allow prices to be monitored and, frequently, adjusted over time.
From HAS Assessment to Price Negotiations
The CEPS price-setting process follows the assessment by the Transparency Committee or the CNEDiMTS. The ASMR or ASA rating awarded directly influences the scope for negotiation: a major to moderate improvement (levels I to III) provides access to more favourable pricing rules, including reference to European prices, while a minor improvement or no improvement generally leads to comparisons with products already reimbursed for the same indication.
The SMR or SA, meanwhile, informs reimbursement eligibility and, where applicable, the reimbursement rate.
This connection between clinical assessment and economic negotiation is central to the French system. It is therefore essential that the dossier submitted to the CEPS is closely aligned with the HAS assessment (preparation of the CEPS economic dossier).
Pricing Mechanisms: From Published Price to Net Price
Negotiations result in an official price or reimbursement tariff, published in the French Official Journal (Journal officiel). However, the actual cost borne by the statutory health insurance system — the net price — is often lower due to contractual rebates, safeguard mechanisms or risk-sharing agreements.
These mechanisms differ according to the type of healthcare product, whether a medicine or medical device. Framework agreements signed with the industry associations representing each product category establish additional rules that clarify the pricing and tariff-setting principles applied by the CEPS.
For in vitro diagnostics, economic assessment and reimbursement follow a separate pathway: inclusion and tariff-setting under the NABM classification for established medical laboratory procedures, or transitional funding through the RIHN framework for innovative procedures performed by healthcare institutions.
Negotiation Timelines
Negotiations with the CEPS generally progress following publication of the HAS assessment, although preparatory work and certain procedural steps may begin earlier. The duration varies considerably depending on the complexity of the dossier and the ASMR/ASA rating awarded: from a few months for a straightforward submission to more than a year for a product requiring an in-depth budget impact assessment or particularly challenging negotiations.
Early preparation — including a clearly defined pricing corridor, a robust economic rationale and anticipation of potential objections — can generally help shorten these timelines (support for price negotiations).
Support at Every Stage
YC-HCS supports manufacturers throughout the process: from defining the pricing corridor at an early stage, to preparing the economic dossier and developing the negotiation strategy. Contact us.