The examination of the Social Security Financing Bill (PLFSS) for 2023 by the deputies began today.
Articles 30 (for medicinal products) and 31 (for medical devices) of the PLFSS for 2023 propose to impose the payment of rebates to manufacturers who do not seek reimbursement for all the indications for which their health product is authorized.
It should be remembered that the marketing authorization (MA) for a medicinal product and the CE marking for a medical device may cover several indications. In such a case, the manufacturer may choose to request reimbursement in France for all or some of the indications.
The government considers that these reimbursement strategies are detrimental to the community since they lead the CEPS to grant a higher price than if reimbursement had been requested for all the indications covered by the MA or the CE mark.
It is therefore proposed to insert into the Social Security Code (CSS) an article L. 162-18-2 (for medicinal products) and an article L. 165-4-2 (for medical devices), the operation of which is presented below:
When will rebates be due?
For the medicinal product, rebates would be imposed when :
- the manufacturer applies for inclusion on the “city” list (L. 162-17 of the CSS) or one of the “en sus” lists (L. 162-22-7 and L. 162-23-6 of the CSS);
- the product provides a medical service rendered in a wider range of indications than that for which the manufacturer has requested reimbursement.
For medical devices, rebates would be imposed when:
- the manufacturer applies for registration on the list of reimbursable products and services (L. 165-1 of the CSS);
- the product provides an expected service in a wider range of indications than that for which the manufacturer has requested reimbursement.
It is specified that the rebates would be due :
- for the medicinal product, until the company applies for registration on the above-mentioned lists, for indications presenting a rendered medical service;
- for medical devices, until the product is registered on the above-mentioned lists, for indications presenting an expected service.
How will the rebates be set?
The CEPS would apply a rate to the amount of the company’s turnover excluding VAT for the product concerned.
This rate would be determined :
- or according to a scale defined by ministerial order according to the size of the different target populations (assessed by the CT or the CNEDiMTS):
- for the medicinal product : the scale would be established according to the respective sizes of the target populations of the indications for which registration has not been requested and those for which the medicinal product is registered;
- for medical devices: the scale would be established on the basis of the respective sizes of the target populations of the indications for which registration presents a sufficient expected service and those for which the device is registered;
- or, “failing that”, according to a progressive scale, by sales bracket, defined by the same ministerial order. In this case, the system would be similar to that of the annual early access and compassionate rebates.
When will the mechanism be applicable?
For medicinal products, it is planned that the rebates will be due as of January 1, 2024 if the manufacturer has not, by that date, requested coverage of all the MA indications that have obtained a medical service rendered.
As a result :
- the new rebate mechanism should concern all medicinal products operated by manufacturers, regardless of the date on which they were evaluated;
- to avoid the rebate, it will be necessary to submit a request for coverage before January 1, 2024. However, it is not necessary for the rebate to be effective on this date.
However, for medical devices, there is no provision for a deferred entry into force. If the text is adopted as it stands, the mechanism could therefore apply as soon as the order setting the rebate rates is published.
In practice, the text raises several questions:
- manufacturers could be tempted to shift the strategy linked to indications from the downstream stage of management to the upstream stage of marketing authorisation or CE marking;
- what happens if they do not provide the CT or the CNEDiMTS with the data that would allow it to conclude that the medical service rendered or the expected service is sufficient?
 In contrast to the medical device provision, it is not specified whether target populations for indications for which listing has not been requested should be considered when they do not provide a medical service.
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