Support for HAS Hearings and Price Negotiations

Tailored advice to meet your needs and timetable. HAS hearings and CEPS price negotiations are the critical stages at which the clinical and economic value presented in your dossiers is either recognised or challenged. Targeted support helps you anticipate objections, clarify your strategic priorities and secure the best possible pricing conditions.

Tailored Support in Discussions with French Healthcare Decision-Makers

Every situation is different: the type of product, the ASMR or ASA rating awarded, the competitive environment and the budgetary constraints of the French statutory health insurance system. We work with you to develop a negotiation strategy tailored to your timetable and specific objectives, helping you define your key arguments, potential concessions and non-negotiable conditions.

Anticipating Potential Objections from Health Authorities

Key Strategic Questions We Address with You

Is it more effective to focus discussions on the clinically relevant comparator or on the ASMR/ASA rating?

These two approaches are not mutually exclusive, but their relative importance depends on the strength of the supporting arguments in your dossier. If the comparator selected by the HAS differs from the one you have proposed, challenging this choice may create an opportunity to improve the ASMR or ASA rating. Conversely, if the comparator is firmly established, focusing the hearing on demonstrating additional clinical benefit is often more effective. We help you identify the most favourable approach before the hearing.

How can recognised organisational benefits and public health impact strengthen your position?

Documented organisational benefits — such as shorter hospital stays, simplified care pathways or a reduced workload for healthcare professionals — and demonstrable public health benefits — such as reduced morbidity and mortality at population level or the prevention of costly complications — can significantly strengthen your negotiating position beyond the individual clinical benefit recognised by the committee. These arguments must be carefully prepared and supported by objective evidence to be considered credible.

Should a net price different from the published price be negotiated with the CEPS from the outset?

This approach separates the publicly listed price from the actual net price through confidential rebates. It may be appropriate in certain circumstances, such as protecting international reference prices, maintaining premium positioning in other markets or demonstrating consistency with European pricing levels. However, it also involves trade-offs and requires careful long-term management. We help you assess whether this approach is appropriate for your situation.

When should legal proceedings be considered, and what remedies are available against an administrative decision?

Where an unfavourable decision is issued — such as a HAS assessment that may be challenged on substantive grounds or a price imposed by a unilateral CEPS decision — administrative appeals or legal proceedings may be available. The decision to pursue legal action should be carefully assessed in light of the relative negotiating positions, the timescales involved and the potential impact on future relationships with the authorities. We help you assess whether and when such action may be appropriate, and coordinate legal support where necessary.

What You Gain from Our Support

A critical review of your dossier before the hearing to identify potential weaknesses and sensitive issues
A structured hearing strategy covering key arguments, responses to anticipated objections and fallback positions
A clear pricing negotiation strategy defining the target price, potential concessions and conditions for accepting an agreement
Tailored recommendations on specific options, including net versus published pricing and potential appeals

This targeted support will help you clarify your objectives, define the next steps and secure the best possible pricing conditions.

Frequently Asked Questions

Can an assessment issued by the Transparency Committee or CNEDiMTS be challenged?

In certain circumstances, it is possible to request an administrative reconsideration by the committee itself or to bring legal proceedings before the French Council of State (Conseil d’État). The appropriateness of either approach depends on the strength of the substantive arguments and the wider strategic context.

What is the difference between a HAS hearing and a CEPS negotiation?

A HAS hearing aims to defend the product’s relative clinical value before a committee of experts, whereas CEPS negotiations aim to secure a reimbursement price through discussions with an administrative body. The objectives, stakeholders and arguments involved differ, but must remain consistent with one another.

What is the difference between the net price and the published price?

The published price is the price officially listed in the French Official Journal (Journal officiel). The net price is the effective price paid by the French statutory health insurance system after deducting confidential rebates agreed by the manufacturer during negotiations with the CEPS.

Can a price be renegotiated after it has initially been set?

Yes. Agreements with the CEPS provide mechanisms for price revisions at the initiative of either party, particularly when reimbursement listing is renewed or when the competitive environment changes.