Improvement in actual clinical benefit (ASMR)

Improvement in actual clinical benefit measures the therapeutic progress a medicinal product brings compared with existing treatments in the same indication. It is assessed by the Transparency Committee of the French National Authority for Health and rated on a five-level scale, from I, major improvement, to V, no improvement. It is the first of the criteria for the pricing of reimbursable medicinal products set out in Article L. 162-16-4 of the French Social Security Code.

Scale and method

Levels I to IV correspond to a major, important, moderate or minor improvement. The Committee compares the medicinal product with a clinically relevant comparator, which may be another medicinal product or non-drug care, and assesses the quality of the evidence as much as the size of the effect. A direct head-to-head study against the reference treatment generally carries more weight than an indirect comparison. The actual clinical benefit, which judges the value of the medicinal product in itself, and the improvement, which judges its relative contribution, both appear in every opinion.

Economic consequences

Together with other criteria, the improvement in actual clinical benefit also determines access to the liste en sus for hospital medicinal products. Conversely, a medicinal product with no improvement may be included on the reimbursement list only if it generates savings in the cost of treatment.

Improvement in actual clinical benefit and patents

The rating obtained is a public indicator of the clinical value of an innovation. It informs the analysis of lifecycle strategies, since a new formulation or a new salt often obtains no improvement at all, which limits the economic appeal of evergreening in France. It is also used in assessing damages, since the price obtained thanks to the recognised improvement underpins the lost profits of the patent holder or its exclusive licensee.

Key points

Improvement in actual clinical benefit is the rating that drives the price. The trial programme should be designed very early with the comparison the Committee will adopt in mind, because an improvement that has not been demonstrated is hard to make up for at the negotiation stage. In patent litigation, the Committee’s opinion provides an objective element for measuring the value of the invention and the reality of the alleged loss.

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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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