Actual clinical benefit (SMR)

Actual clinical benefit measures the clinical value of a medicinal product in a given indication and determines whether it may be reimbursed by the national health insurance system. It is assessed by the Transparency Committee of the French National Authority for Health and rated on four levels: substantial, moderate, low or insufficient. An insufficient actual clinical benefit precludes inclusion on the list of reimbursable medicinal products in the indication concerned.

Assessment criteria

The Committee takes into account the efficacy and adverse effects of the medicinal product, its place in the therapeutic strategy in the light of other available therapies, the seriousness of the condition treated, the preventive, curative or symptomatic nature of the treatment and its public health benefit. The assessment is absolute. It concerns the medicinal product considered in itself, whereas the improvement in actual clinical benefit measures its added value compared with existing treatments. The same medicinal product may therefore have a substantial actual clinical benefit without bringing any progress.

Effects on reimbursement

The level of actual clinical benefit governs the rate of health insurance cover, set by the National Union of Health Insurance Funds within the ranges laid down by the legislation. In practice, for medicinal products dispensed in community pharmacies, a substantial actual clinical benefit gives entitlement to a 65% rate, a moderate benefit to a 30% rate and a low benefit to a 15% rate. These rates apply subject to exemptions, in particular for long-term conditions.

Reassessment and what is at stake

Actual clinical benefit is open to revision and is re-examined when the listing is renewed, in principle every five years, and may be reassessed at any time in the light of new data or the arrival of new treatments. A lower rating leads to a lower reimbursement rate, or even removal from the list, with immediate effects on sales. Generic medicinal products are in principle reimbursed on the same terms as the reference medicinal product, without any new in-depth clinical assessment.

Key points

Actual clinical benefit decides a single question: whether the medicinal product deserves to be reimbursed in the indication. The rating should be checked indication by indication, since the same medicinal product may be reimbursed in one indication and not in another. An unfavourable reassessment is best anticipated by producing new data and is argued in the adversarial phase before the Transparency Committee.

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This glossary entry is general in scope and does not constitute legal advice.

Dhenne Avocats acts in pharmaceutical patent disputes and on the medicines regulatory questions that accompany them, from the marketing authorisation to the supplementary protection certificate.

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