Review Of A Year Of Administrative Case Law On Market Access

After several years in which the Council of State had quashed multiple decisions on setting prices or reimbursement conditions, 2024 will be marked by a significant tightening of the criteria likely to lead to the annulment of a decision.

The principle of equal treatment must be understood to concern only "closely comparable" specialties. In practice, except in cases of exact copies, this often gives both the administration and the courts the possibility of considering that products—which necessarily differ in some ways—may be treated differently. Consequently, comparisons are made solely in relation to the indication for which registration is requested. Therefore, a drug indicated in the event of failure or ineligibility for the first line is not considered comparable to first-line drugs (CE, 17 July 2024, no. 470665).

Conversely, the Council of State upheld the refusal to list a specialty whose comparator (prescribed at the same treatment line) was itself listed on the add-on list. The Council of State validated consideration of the treatment's own constraints to conclude that, despite the severity of the disease, its medical benefit was low (CE, 17 July 2024, no. 470665). However, in doing so, the Council of State did not apply the case law it had developed simultaneously, according to which listing one product may require re-examining the conditions of listing a comparable product (CE, 15 July 2024, no. 463127). As a result, the definition of equal treatment remains fluid both in the evaluation phase and during litigation, with the judge remaining attentive to situations in which patients would be left without treatment if refusal to list one product led to the delisting of its comparator. Nevertheless, the Council of State has set a limit: A difference in toxicity profile may justify different treatment between two products, as long as it is justified and remains proportionate to the goal pursued (CE, 23 July 2024, no. 481534). In practice, this allowed the judge to justify refusing to list a combination of treatments on the add-on list, even though a comparator was already listed there. However, now that this principle has been established, it could allow differentiation from a comparator if the safety profile is different.

The Council of State has also interpreted a rarely invoked criterion for refusing to list a medical device on the list of reimbursed specialties, based on the unjustified expense it would represent for Social Security. It validated the ministers' decision to refuse listing in light of the price requested by the company and the gap between that price and the one proposed by the CEPS, without waiting for the outcome of negotiations or the adoption of a unilateral price-setting decision. Furthermore, the Council of State held that a cost-assessment criterion raised during early meetings was not proven to support treatment cost savings (CE, 8 April 2024, no. 477349). It will be interesting to see whether this principle is applied to the pharmaceutical sector. If so, it would further relativize the framework agreement provisions (and its renegotiation) on the conditions under which the president of the CEPS can set the price by unilateral decision, if the minister can, during the procedure, take an even more radical approach and refuse listing due to the difference in proposed prices.

This decision also reminds companies of the relative confidentiality of negotiations with the CEPS. Following case law that validated comparison with the net price—requiring disclosure of discount levels to competitors (CE, 9 November 2023, no. 466777)—any price proposals, as well as monitoring criteria, may be considered if they fall under the factors that may justify a refusal to provide coverage.