SMR / ASMR (Service Medical Rendu / Amelioration du Service Medical Rendu)
SMR and ASMR are French methods used to assess how well a medicine works in real-world practice and how much it improves patient outcomes compared to existing treatments. SMR evaluates the overall medical service a drug provides, while ASMR measures the added benefit it brings.
At a glance
Use when
Assessing the clinical added value of new pharmaceuticals for reimbursement decisions in France or comparing therapeutic innovation across European markets
Avoid when
Conducting global HTA without local context adaptation; when comparative data are lacking or of low quality; in settings requiring fully harmonized EU-wide value assessment
Inputs
Clinical trial data, comparative effectiveness evidence, safety profiles, therapeutic context, standard of care information
Outputs
SMR rating (level of medical service) and ASMR rating (level of added benefit from I to V), used for reimbursement and pricing decisions
How it works
The Haute Autorité de Santé (HAS) in France uses SMR (Service Médical Rendu) to assess the clinical benefit of a medicinal product based on its therapeutic value in standard medical practice. ASMR (Amélioration du Service Médical Rendu) evaluates the incremental clinical benefit of a new drug compared to current standard therapies, using a five-level scale (I to V) from major to insufficient improvement. These assessments inform pricing, reimbursement, and coverage decisions.
- HTA domains
- Clinical Effectiveness, Patient and Social Aspects, Aspects Beyond HTA
- Assumptions
- Comparative clinical data are available; the standard of care is well-defined; improvements in clinical outcomes translate to meaningful patient benefit
- Strengths
- Structured, transparent framework for assessing added therapeutic benefit; supports evidence-based reimbursement decisions; widely used in French healthcare policy
- Limitations
- May favor drugs with marginal benefits if they target high-need populations; limited harmonization with other EU assessment systems; potential discrepancies with other national value assessment frameworks
- Also known as
- ASMR, SMR, Amélioration du Service Médical Rendu, Service Médical Rendu
Questions this answers
- › What is the clinical benefit of a new medicinal product in routine practice?
- › How much additional therapeutic value does a new drug provide compared to existing treatments?
- › Is the medicine eligible for premium pricing or reimbursement based on its added benefit?
- › Does the drug offer a significant improvement for patients with unmet medical needs?
- › How does the drug perform in terms of efficacy, safety, and patient outcomes relative to comparators?
- › What level of innovation does the drug represent within its therapeutic class?
References & sources
Similar by meaning
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