The French Social Security Code allows ministers to refuse the reimbursement of a healthcare product if it is likely to result in “unjustified expenditure“[1] for health insurance[2].
In recent years, ministers have applied these provisions to refuse reimbursement of healthcare products even though price negotiations with the French Economic Committee for Health Products (CEPS) had only just begun or had not yet taken place.
Following appeals against these decisions to refuse reimbursement, the Conseil d’Etat provided interesting clarifications on the power of ministers and the notion of unjustified price in the Össur France (judgment of April 8, 2024[3]) and Teva Santé (judgment of July 7, 2022[4]) cases.
The “unjustified” nature of the price, which may lead to the refusal of reimbursement, is assessed in the light of the company’s initial proposal
The Conseil d’Etat specified that, both for pharmaceutical products and medical devices (MD), the “unjustified” nature of the price is assessed in the light of the initial request made by the company, and not of the amount resulting from negotiation with the CEPS.
It therefore validated the ministers’ decisions to refuse reimbursement motivated by:
- In the Össur France case, the fact that the price envisaged by the company was 3 to 4 times higher than the one of the comparators identified by the French National Commission for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS), even though the MD provided only a minor added expected benefit (ASA IV). Yet only one round of negotiation had taken place with the CEPS, after which the company had reduced its proposal by almost 20%;
- In the Teva Santé case, the fact that the price proposed by the company represented an increase of more than 1,700% in daily treatment cost compared with the price of the most expensive comparator among those selected by the French Transparency Commission (CT), even though the pharmaceutical product provided no added medical benefit (ASMR V). In this case, there had been no negotiation on the price proposed by the company.
What is a justified price?
The Conseil d’Etat interprets the notion of justified price “in particular” with regard to the price of relevant comparators reimbursed and considering the level of ASMR or ASA of the priced product.
It should be noted that, for pharmaceutical products in specific, the price must also be justified with regard to the other legal criteria for price fixing (forecast or actual sales volumes, actual and foreseeable conditions of use, and, where applicable, the results of medico-economic analysis)[5].
To limit the risk of refusal of reimbursement, we can only recommend that the price requested should be justify, at the time of the request for reimbursement, with regard to the legal criteria for price fixing.
In each case, it will then be necessary to consider:
- the relevance of the comparator (and any arguments that might be put forward to exclude a product from the list of comparators);
- the elements likely to justify a request that is higher than the comparator’s price.
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[1] Or, in the case of pharmaceutical products, when the price proposed by the company is not justified with regard to the legal criteria set out in Article R. 163-5 of the French Social Security Code.
[2] See notably, for the “liste ville”, Article R. 163-5 of the French Social Security Code and, for the list of reimbursable products and services (LPPR), Article R. 165-4 of the same code.
[3] Conseil d’Etat, April 8, 2024, Össur France, req. n° 477349
[4] Conseil d’Etat, July 7, 2022, Teva Santé, req. n° 45530
[5] Article R. 163-5 of the French Social Security Code indeed provides that “pharmaceutical products whose price proposed by the company would not be justified with regard to the criteria provided for in I and II of Article L. 162-16-4 cannot be included on [the “liste “ville”]”.