Preparation of CEPS Pricing Dossiers

The pricing dossier submitted to the French Economic Committee for Health Products (CEPS) draws on the HAS assessment and the pricing corridor established at an earlier stage to develop a coherent economic rationale — covering budget impact, international price comparisons and reimbursement conditions — with the aim of securing the best achievable negotiated price.

Building on the HAS clinical dossier, which establishes the product’s relative clinical value, the pricing dossier aims to demonstrate that the requested price is consistent with that clinical value, is financially sustainable for the French statutory health insurance system and remains aligned with international pricing practices. This dossier provides the framework for reimbursement negotiations.

Against a background of controlling statutory health insurance expenditure and keeping patients’ out-of-pocket costs low or non-existent, budget impact modelling helps establish the medium-term funding requirements for a healthcare product.

The model also provides a basis for negotiating price-volume agreements, taking into account patient numbers, average dosage or the number of units used.

For many innovative products, the CEPS takes into account prices in a group of reference European countries under the European price guarantee provisions. European pricing information is also a prerequisite when preparing a pricing dossier.

Accurate, up-to-date documentation of international prices is essential to support a price consistent with the targeted pricing corridor.

The pricing dossier is developed directly from the pricing strategy established during the initial market research. Consistency between the clinical value recognised by the HAS, the proposed price and the supporting economic rationale is essential to maintaining a strong negotiating position.

Furthermore, in accordance with the framework agreement between the CEPS and industry associations, we identify the opportunities and scope for developing an optimal negotiation strategy and sequence.

Frequently Asked Questions

What is a budget impact model?

A budget impact model estimates the additional expenditure or savings generated for the French statutory health insurance system by introducing a healthcare product over several years. It takes into account the target population or the population likely to receive treatment, the expected dosage and, where applicable, the products being replaced.

Can the pricing dossier be submitted after the HAS assessment?

No. Although the pricing dossier draws on the HAS assessment (SMR/ASMR or SA/ASA), it must be prepared in advance and submitted in parallel with the clinical dossier. Its structure and supporting arguments are anticipated through market research focused on the pricing strategy.

What is the European price guarantee clause?

This is a mechanism established under the framework agreement between pharmaceutical manufacturers and the CEPS. It governs price negotiations for innovative medicines by reference to prices in a group of European countries.

It applies upon initial reimbursement listing to healthcare products demonstrating the highest levels of incremental clinical benefit (ASMR). The CEPS also takes European prices into consideration when assessing medical devices.