Once the market access strategy has been defined, three key stages remain: preparing a clinical dossier for the HAS, developing a structured economic dossier for the CEPS, and preparing for price negotiations, where securing the best possible published reimbursement price is ultimately at stake.
Reimbursement Dossiers and Price Negotiations
Preparation of Clinical Dossiers (HAS)
The dossier submitted to the HAS must include a systematic literature review, an epidemiological analysis and a clinical rationale aligned with the requirements of the Transparency Committee or the CNEDiMTS. The resulting HAS assessment provides the foundation for subsequent price negotiations.
Preparation of Economic Dossiers (CEPS)
The economic dossier submitted to the CEPS draws on the HAS assessment and the pricing corridor established at an earlier stage to develop a coherent economic rationale. Budget impact modelling and national and international economic comparisons are required to support price negotiations. The requested price may also be justified through cost-effectiveness studies assessed by the HAS Health Economic and Public Health Committee.
HTA Hearings and Price Negotiations
Hearings before the HAS and negotiations with the CEPS are critical opportunities to demonstrate and defend the clinical or economic value established in each dossier. Anticipating objections, preparing key arguments and developing a fallback strategy directly influence the outcome of the negotiations.
Three Stages, One Consistent Strategy
The HAS clinical dossier, the CEPS pricing dossier and addressing the points raised during the instruction process must communicate the same value proposition, developed from the initial market research stage. Any inconsistency between these three stages — such as using a different clinical comparator in the HAS dossier and the pricing negotiation arguments — weakens the manufacturer’s position and may result in a price below the originally targeted pricing corridor.
Frequently Asked Questions
Are the clinical and economic dossiers submitted at the same time?
Yes. The clinical dossier is submitted to the HAS at the same time as the pricing dossier is submitted to the CEPS. However, following the final HAS assessment, the economic dossier must be updated to reflect any new findings or conclusions from the HAS, including the product’s position in the treatment pathway, its ASMR/ASA rating and the target population. In such cases, the manufacturer has only a few days to make the required amendments. In the event of a major disagreement, a hearing before the relevant HAS committee must be requested.
How does the HAS assessment affect price negotiations?
The HAS does not directly assess the price of a product. Instead, it evaluates its relative clinical value (ASMR/ASA) compared with a relevant comparator. Depending on the level of clinical benefit recognised and the ASMR/ASA rating awarded within the treatment pathway, price negotiations will generally be based on a cost saving (level V), price parity or a cost saving (level IV), or a price premium (levels III, II or I).