On January 23, 2024, the French Economic Committee for Health Products (“CEPS”) published its activity report for 2022. It describes (i) the CEPS doctrine and (ii) its main activities in 2022 for pharmaceutical products and medical devices (“MDs”).
In terms of doctrine, we are pleased to see the publication of the elements taken into account by the CEPS to value the “industrial criterion” in pharmaceutical products pricing. On contrast, the report provides no details on the valuation of this criterion for medical devices, for which the Committee’s doctrine does not seem to have been settled.
In terms of the CEPS’s main activities in 2022, we note that pricing decisions:
- on the one hand, are adopted after periods that are still a long way from the regulatory 180 days, and that the length of price negotiations has not decreased;
- on the other hand, are the subject of increasingly frequent disputes, with a “success” rate for pharmaceutical companies approaching 65%[1].
File processing times, still a long way from the regulatory 180 days
The French Social Security Code (“CSS”) – and, in the case of pharmaceutical product, European legislation – require ministers to take a decision, within a maximum of 180 days from the date of application, on the inclusion of healthcare products on the concerned reimbursement lists (notably the “liste ville” and the List of reimbursable Products and Services (“LPPR”)), and on their price.
As indicated in the CEPS activity report for 2022, the average time taken to process files remains, as in 2021, far from this regulatory timeframe:
- For pharmaceutical products, the average processing time for applications for inclusion on the “liste ville” (excluding generic products) was 218 days in 2022. This is 48 days less than in 2021, mainly due to a reduction in the time taken to publish prices in the Journal Officiel. The length of negotiations, which had doubled in 2021, did not decrease in 2022 (remaining at 70 days[2] for branded products);
- For medical devices, the average processing time for applications for inclusion on the LPPR was 277 days in 2022, an increase of 34 days on 2021[3]. As for pharmaceutical products, the average length of negotiations continues to increase, from 66 days in 2021 to 76 days in 2022[4].
CEPS decisions increasingly challenged by pharmaceutical companies
It is recalled that CEPS decisions may be the subject of an administrative appeal (i.e. to the CEPS and/or the Minister) and/or a contentious appeal (i.e. to a judge).
In 2022, thirteen decisions were handed down by the judge in disputes brought against a decision taken by the CEPS (two of which were withdrawn). As the CEPS points out, the number of contentious appeals lodged against its decisions has increased since 2021 (thirteen appeals were lodged by pharmaceutical companies in 2022, compared with ten in 2021 and… three in 2020!)
With regards to the price of healthcare products, pharmaceutical companies can contest:
- Pricing decisions, whether set by unilateral decision of the CEPS or by agreement;
- decisions refusing price increases;
- decisions to decrease prices.
In addition to these price-related decisions, the cases ruled by the judge in 2022 concerned conventional paybacks, the reference pricing and associated paybacks in the context of a temporary authorization for use (ATU), or the M amount. It should be noted that, in nearly 65% of cases (excluding withdrawals), the judge annulled the decision taken by the CEPS:
Despite these encouraging statistics for pharmaceutical companies, it is often more relevant and less costly to integrate the legal dimension into the market access strategy at the negotiation stage.
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[1] Thirteen decisions were handed down in 2022. Of these, two were withdrawals (i.e. the judge did not rule on the legality of the contested decision). Of the remaining eleven, seven were annulments (= cases won by the pharmaceutical company) and four were rejections (= cases won by CEPS).
[2] This timeframe relates solely to the negotiation phase, and not to the investigation phase. It therefore covers only the period from the Committee’s first meeting to the signing of the amendment.
[3] Only files with an HAS recommendation and publication in the Journal Officiel are concerned here.
[4] The CEPS notes, however, that this average timeframe is affected by very specific situations, such as the need to register a specific act in the Common classification of medical acts (“CCAM”)
