SMR and ASMR: How HAS Evaluates Medicines in France

France asks two separate questions about every new medicine. Is its clinical benefit large enough for the national health insurance to pay for it? And how much better is it than what patients already have? The answers are the SMR and ASMR ratings issued by the Haute Autorité de Santé (HAS), the French National Authority for Health, and together they shape both reimbursement and price.

Both ratings come from HAS’s Transparency Committee and are given per indication, not per molecule. For the general sequence of scoping, assessment, appraisal and decision, see our guide to the HTA process step by step.

Who decides: HAS, the Transparency Committee, CEESP, CEPS and UNCAM

HAS assesses, CEPS prices, UNCAM sets the reimbursement rate and the ministers decide. Clinical judgement, economic appraisal, price and coverage each sit with a different body.

The ministers for health and social security take the final listing decision, published in the Journal officiel. ANSM, the medicines agency, runs compassionate access and screens early access requests made before marketing authorisation.

SMR (service médical rendu): the reimbursement rating

The SMR answers one question: is the clinical benefit in this indication sufficient for the national health insurance to reimburse the medicine? An insufficient SMR means the Transparency Committee recommends against reimbursement; a sufficient SMR is graded major or important, moderate or low, and each level maps to a reimbursement rate.

The Committee’s doctrine lists five determinants: efficacy and adverse effects, the medicine’s place in the therapeutic strategy, the severity of the disease, whether treatment is preventive, curative or symptomatic, and its public health interest. One factor alone, such as weak efficacy against relevant comparators or unacceptable toxicity, can justify an insufficient SMR.

These are theoretical rates, set by UNCAM within ranges in article R160-5 of the Social Security Code. Exemptions for some patients raise them, and complementary insurers cover much of the remainder.

ASMR levels I to V: amélioration du service médical rendu and price

The ASMR rates how much a medicine improves on existing care, on a five-level scale from I (major) to V (no improvement). It is judged against clinically relevant comparators and is the main criterion in the price negotiated with CEPS.

The comparator must be clinically relevant and used in the same patients. The Committee’s doctrine expects a direct, randomised, double-blind comparison where feasible. External controls and other indirect comparisons support a higher ASMR only if of good methodological quality, and observational studies cannot replace expected randomised trials. See our guide to network meta-analysis and indirect treatment comparisons.

High ratings are rare. An IQVIA analysis of the 127 Transparency Committee opinions on first indications and extensions in 2025 found ASMR V in about half, ASMR IV in a third and ASMR I–III in 18%.

When CEESP gives an efficiency opinion

CEESP assesses cost-effectiveness only for medicines that claim a high ASMR (I, II or III) and are expected to have a significant impact on health insurance spending. Its efficiency opinion goes to CEPS to inform the price; it does not decide reimbursement.

The rules sit in article R161-71-3 of the Social Security Code, detailed by HAS decision no. 2022.0212/DC/SED/SEM of 23 June 2022, and have applied since 1 January 2023. For a first listing, extension or renewal, both conditions must be met:

1. High claimed added value: the company claims an ASMR of I, II or III.
2. Significant spending impact: the medicine is an advanced therapy medicinal product (ATMP), or forecast pre-tax sales in the second year in the indication are €20 million or more, or the company claims an impact on care organisation, professional practices or patient care.

Exemptions cover off-patent medicines without a supplementary protection certificate, paediatric extensions of reimbursed adult indications, and extensions adding less than 5% to the treated population at two years. Under the CEPS–LEEM framework agreement of 5 March 2021, a budget impact analysis is mandatory when forecast second-year sales exceed €50 million.

CEESP critiques the company’s model and reports the incremental cost-effectiveness ratio (ICER), mainly in euros per QALY, and grades methodological reservations as minor, important or major. France has no official cost-effectiveness threshold, so the opinion informs negotiation rather than producing a yes or no.

CEPS price negotiation and the European price guarantee

Once HAS has rated the medicine, the company negotiates the price with CEPS. Under the Social Security Code, the price mainly reflects the ASMR, together with any efficiency opinion, the prices of medicines with the same therapeutic aim, forecast or observed sales volumes and expected and actual conditions of use.

A medicine that brings neither an ASMR nor savings in treatment cost cannot be listed. In practice, ASMR V products are priced at a discount to the cost of the reference treatment.

The European price guarantee

Under the CEPS–LEEM framework agreement of 5 March 2021, ASMR I–III medicines qualify for a European price guarantee: a list price no lower than the lowest in the reference countries, which Simon-Kucher identifies as Germany, Italy, Spain and the United Kingdom. ASMR IV medicines qualify only with further criteria, such as medical or public health need, efficiency, a new antibiotic or orphan status. The agreement also gave ASMR I–III prices five years of stability, which could be shortened after the CEESP opinion.

That agreement was extended to 5 March 2026, and a fully revised framework agreement was signed on 28 September 2026. The terms above are those of the 2021 agreement; the new text may treat the European price guarantee differently.

France drug reimbursement: from marketing authorisation to listing, step by step

A new medicine moves from marketing authorisation to an HAS assessment, a CEPS price agreement, a UNCAM rate and a ministerial listing. The EU Transparency Directive allows 180 days for sequential pricing and reimbursement decisions; in France it often takes longer.

1. Marketing authorisation. The medicine is authorised. For medicines within the scope of the EU joint clinical assessment, the JCA runs in parallel with the EMA review.
2. Submission. The company asks HAS to evaluate the medicine for the reimbursable lists and, if eligible, files an economic dossier for CEESP.
3. Transparency Committee assessment. HAS staff and the Committee review the evidence and adopt a draft opinion on SMR and ASMR. The company can respond and ask for a hearing before the final opinion.
4. CEESP opinion. Where required, the efficiency opinion is issued in parallel and sent to CEPS and the company.
5. Price negotiation. CEPS and the company negotiate and sign a price agreement.
6. Reimbursement rate. UNCAM sets the rate, based on the SMR.
7. Ministerial decision. The ministers for health and social security list the medicine, and the decision is published in the Journal officiel.
8. Life cycle. Data collection and re-evaluation follow.

HAS describes a theoretical pathway of 90 days for its part. In 2024 the Transparency Committee’s median time for first listings and extensions was 111 days (mean 121). Price negotiation adds far more: IQVIA estimated that, for community medicines, the time from Transparency Committee opinion to reimbursement was about 415 days in 2025, up from 278 days in 2024.

Early access in France: accès précoce and compassionate access

Since 1 July 2021, France has had two derogatory routes. Early access (accès précoce) is requested by the company and authorised by HAS for presumed innovative medicines; compassionate access (accès compassionnel) is run by ANSM and is not initiated by the company.

The reform came from article 78 of the 2021 Social Security Financing Act (law no. 2020-1576 of 14 December 2020) and replaced several earlier schemes, including temporary authorisations for use (ATU). Early access is granted per indication when five conditions are met:

• the disease is serious, rare or disabling;
• there is no appropriate treatment;
• treatment cannot be deferred;
• efficacy and safety are strongly presumed from clinical trial results;
• the medicine is presumed innovative, in particular against a clinically relevant comparator.

The HAS Board decides on the Transparency Committee’s opinion. Before marketing authorisation, a positive ANSM opinion on presumed efficacy and safety is needed first. After authorisation, the company must have applied for reimbursement, or commit to apply within one month of the authorisation. Patients are followed under a protocol for therapeutic use and data collection (PUT-RD).

From 2021 to 2025, HAS issued 394 early access decisions; 152 of the 223 first requests were granted, and more than 140,000 patients were treated. The median decision time in 2024 was 87 days. A 2025 revision of the early access doctrine expects robust comparative randomised data, with indirect comparisons accepted only when properly justified.

Compassionate access serves patients without an appropriate alternative. ANSM grants named-patient authorisations (AAC), valid for one renewable year, and compassionate prescribing frameworks (CPC), valid for three renewable years, for authorised medicines used outside their indications.

Re-evaluation and the HAS Transparency Committee doctrine

An SMR or ASMR is not permanent. The Transparency Committee re-evaluates medicines or whole therapeutic classes when evidence changes, and its published doctrine sets out the principles it applies.

In 2024 the Committee issued 46 re-evaluation opinions: 17 requested by companies, 26 on its own initiative and 3 at the ministers’ request. The SMR or ASMR changed in 24 of them.

The doctrine was adopted on 2 December 2020 and revised in a version adopted on 15 February 2023. It calls every evaluation temporary by definition. The Committee can require post-registration data within at most five years, and can exceptionally grant a conditional sufficient SMR for a serious disease with unmet need and promising early data, reassessed once the data arrive. Missing quality-of-life data can weaken the ASMR in chronic, disabling or end-of-life conditions.

How EU joint clinical assessment reports feed into French HTA

Since 12 January 2025, new cancer medicines and advanced therapies are subject to an EU joint clinical assessment (JCA) alongside marketing authorisation. HAS uses the clinical evidence pooled at EU level, but SMR, ASMR, efficiency and price remain French decisions.

• Single dossier: data already submitted at EU level are not resubmitted nationally.
• New data: evidence that has appeared since the JCA must go into the national dossier, and HAS can request more.
• National doctrine: the Transparency Committee, CEESP and CNEDiMTS (the device committee) keep issuing opinions under their own principles.
• No waiting: if the JCA report is not available when the national assessment ends, the French process continues.

HAS was assessor or co-assessor on two JCAs in 2025 and chairs the JCA subgroup. The scope extends to orphan medicines in January 2028 and to all centrally authorised medicines in January 2030. For the procedure itself, see our guide to the EU joint clinical assessment; our tracker of EU JCA reports published so far follows the first results.

SMR and ASMR compared with NICE and Germany’s AMNOG

France sits between England and Germany. Like Germany, it prices mainly on a rating of added clinical benefit; unlike England, it has no official cost-per-QALY threshold and reserves formal economic evaluation for a minority of products.

NICE judges cost per QALY against a range of £25,000–£35,000 from April 2026, as our guide to the NICE technology appraisal process explains. In Germany, the G-BA determines the added benefit over an appropriate comparator, and the company negotiates a price with the statutory health insurers’ federal association within six months, with arbitration if they fail to agree; see our guide to AMNOG and the G-BA benefit assessment. In France, HAS issued 20 economic opinions on health products in 2025, against 361 opinions on medicines for reimbursement.