How the French system works
Once a medicine has a marketing authorisation, the company applies to the Haute Autorité de Santé (HAS) for listing on the reimbursable lists. The Transparency Committee (Commission de la transparence, CT), a scientific committee of physicians, pharmacists, methodologists, epidemiologists and patient and user members, assesses the dossier and issues an opinion to the health and social security ministers.
The opinion carries two ratings. The service médical rendu (SMR) asks whether the medicine has enough clinical value to be covered by national solidarity, taking into account the severity of the disease, efficacy, adverse effects and place in the therapeutic strategy. The amélioration du service médical rendu (ASMR) measures the added clinical benefit over existing alternatives. Where the product falls within the criteria, the Economic and Public Health Evaluation Committee (CEESP) issues a separate efficiency opinion.[1, 2]
The CT opinion goes to the national health insurance union (UNCAM), which sets the reimbursement rate, and to the Economic Committee for Health Products (CEPS), which agrees the price with the company. Reimbursement and pricing decisions remain with the ministry, not with HAS.
The Transparency Committee opinion goes to UNCAM and the CEPS for reimbursement and price.
CEPS price agreementCriteria: an ATMP, forecast turnover of 20 million euros or more a year, excluding VAT, in the second year, or a claimed impact on care organisation.
CEPS price agreement, informed by both opinionsExemptions apply, for example for some paediatric extensions and extensions adding less than 5% to the population.
SMR, ASMR and CEPS pricing
| Rating | Levels | Main consequence |
|---|---|---|
| SMR | Important, moderate, low | Reimbursement recommended; UNCAM sets the rate in line with the level |
| SMR | Insufficient | CT recommends no reimbursement; the marketing authorisation is unaffected |
| ASMR | I major, II important, III moderate | Strongest position in the CEPS pricing discussions; triggers the efficiency assessment where the other criteria are met |
| ASMR | IV minor | Real but small progress; pricing terms are narrower than for I to III |
| ASMR | V no improvement | Adds to the therapeutic options; price discussed against comparators with the same therapeutic aim |
ASMR I is reserved for therapeutic breakthroughs in serious diseases and is rarely granted. ASMR II and III reflect a substantial or moderate effect on mortality or morbidity against available treatments. The CT can also grant a time-limited SMR conditional on further data, with re-evaluation usually within one to five years. The comparator is what the CT considers clinically relevant in French practice, and the choice is often decisive for the ASMR.
CEPS pricing: Under article L.162-16-4 of the Social Security Code, the price is set by agreement between the company and the CEPS, or otherwise by CEPS decision. It takes into account mainly the ASMR, the prices of medicines with the same therapeutic aim, forecast or observed sales volumes, the results of the medico-economic evaluation and the conditions of use.
Successive framework agreements between the CEPS and the industry association Leem link the most favourable terms, including a European price level and multi-year price stability, to ASMR I to III with an efficiency opinion, with narrower conditions for ASMR IV. The ASMR, the comparator and the CEESP conclusions therefore need to be planned together, well before the pricing discussions start.
The CEESP efficiency opinion
Under article R.161-71-3 of the Social Security Code and the HAS College decision of 23 June 2022, in force since 1 January 2023, a medico-economic evaluation is required where the company claims ASMR I, II or III and at least one of the following applies:
- the product is an advanced therapy medicinal product
- forecast turnover in the second year of marketing in the indication is 20 million euros a year or more, excluding VAT
- the company claims an impact on the organisation of care, professional practice or patients' conditions of care
Exceptions include medicines without patent or supplementary protection certificate, some paediatric extensions, and indication extensions that increase the population reached by less than 5% at two years. The CEESP critically appraises the model and budget impact analysis, reports the ICER, and grades each methodological reservation as minor, important or major. A major reservation means the deviation invalidates all or part of the economic study. The opinion is sent to the CEPS to inform pricing.
HAS methods for economic evaluation
The HAS methodological guide, validated by the CEESP in April 2020, sets the reference case:
- Perspective: collective, covering everyone affected by care; a health system perspective only if justified
- Analysis: cost-utility analysis with QALYs where quality of life is a major consequence, always accompanied by a cost-effectiveness analysis in life-years
- Utilities: EQ-5D-5L with the French value set, with paediatric instruments below age 16
- Discounting: 2.5% for costs and outcomes, declining to a 1.5% floor beyond 30 years, with sensitivity analyses at 0% and 4.5%
- Comparators: all clinically relevant interventions, with any exclusion justified; naive indirect comparisons cannot fill gaps in effect data
There is no explicit cost-effectiveness threshold in France. Results are read on the efficiency frontier, and the CEESP concludes on its confidence in the analysis. A model built for another market usually needs restructuring, not only new costs. See health economic modelling and indirect treatment comparisons.
Early access and compassionate access
Since 1 July 2021, two schemes have replaced the former ATU and RTU routes. Accès précoce is decided by HAS, with a prior binding opinion from the ANSM on efficacy and safety where the medicine is not yet authorised in the indication. All four criteria must be met: a serious, rare or disabling disease; no appropriate treatment; treatment that cannot be deferred; and a medicine presumed innovative against a clinically relevant comparator. HAS assesses within 90 days of a complete application, and the company collects data in use and reports them to HAS.[3]
Accès compassionnel sits with the ANSM and covers medicines not intended for a French marketing authorisation in the indication, through compassionate access authorisations and compassionate prescription frameworks. The presumption of innovation in an early access decision is not an ASMR, but the evidence and comparator chosen at that stage frame the later CT assessment.[4]
How the EU JCA feeds into HAS
The EU-wide phase-in dates are set out in our HTA requirements comparison. HAS states that the JCA report and other information on the EU platform will be taken into account in the national evaluation, and the report is annexed to the committee opinions when available.[5]
A national application to HAS is still required. The JCA contains no appraisal of therapeutic value and no economic evaluation, so the SMR, ASMR and CEESP opinion remain national, and HAS states that the CT doctrine is unaffected. Data already submitted at EU level is not resubmitted in the national dossier. Our EU JCA dossier work maps the JCA PICOs to the likely French comparator and the CEESP model from the start, the same logic that applies to AMNOG in Germany.
What we deliver and what assessors look for
- Evidence planning against the French comparator and the target ASMR, including early access eligibility
- Transparency Committee dossier drafting and responses
- De novo or adapted cost-utility models and budget impact analyses to the HAS reference case
- Systematic reviews, indirect treatment comparisons and network meta-analyses
- Cross-referencing between the JCA dossier and the HAS submission
- Analysis to support the CEPS pricing discussions
Assessors look for a comparator that reflects French practice, an ASMR claim the data can carry, and models without deviations from the guide that would draw an important or major reservation. A missing comparator on the efficiency frontier or an unjustified perspective weakens the economic case.
Why Evidaxia
We bring HTA experience from the assessor's side, including technical lead work at NICE, and EU-level work on JCA dossiers, PICO scoping, indirect comparisons and global model adaptation that is built to feed national processes such as the HAS assessment. We work alongside your French market access team.
References
- Haute Autorité de Santé. Choices in methods for economic evaluation [Internet]. Saint-Denis: Haute Autorité de Santé; 2020 [cited 2026 Oct]. Available from: https://www.has-sante.fr/upload/docs/application/pdf/2020-11/methodological_guidance_2020_-choices_in_methods_for_economic_evaluation.pdf
- Haute Autorité de Santé. Economic and Public Health Evaluation Committee (CEESP) [Internet]. Saint-Denis: Haute Autorité de Santé; [date unknown] [cited 2026 Oct]. Available from: https://www.has-sante.fr/jcms/c_2036304/en/economic-and-public-health-evaluation-committee
- Haute Autorité de Santé. Accès précoce à un médicament [Internet]. Saint-Denis: Haute Autorité de Santé; [date unknown] [cited 2026 Oct]. Available from: https://www.has-sante.fr/jcms/r_1500918/fr/acces-precoce-a-un-medicament
- Agence nationale de sécurité du médicament et des produits de santé. Accès compassionnel [Internet]. Saint-Denis: Agence nationale de sécurité du médicament et des produits de santé; [date unknown] [cited 2026 Oct]. Available from: https://ansm.sante.fr/vos-demarches/industriel/acces-compassionnel
- Haute Autorité de Santé. European regulation on health technology assessment [Internet]. Saint-Denis: Haute Autorité de Santé; [date unknown] [cited 2026 Oct]. Available from: https://www.has-sante.fr/jcms/p_3545447/fr/reglement-europeen-sur-l-evaluation-des-technologies-de-sante
Sources reviewed October 2026. Methods and procedures change; check the latest agency guidance before submission.