Early access makes it possible to finance treatments that are presumed to be innovative and often expensive. However, once this derogatory access is withdrawn, certain products find themselves without a suitable method of funding, which makes access more difficult for patients.
These are pharmaceutical products which, although they have benefited from early access, do not satisfy the criteria for inclusion on the “en sus“ list on the basis of available data[1]. As a reminder, inclusion on the “en sus” list is subject in particular to:
- a major or important medical benefit (SMR)
- and an added medical benefit (ASMR) of level I to IV (or level V if the relevant comparator is itself included on the “en sus” list in the indication considered).
If their SMR is sufficient, these products may be included on the “hospital” list (“liste collectivités”). However, although inclusion on this list theoretically means that they can be reimbursed, in practice the cost of hospital stays prevents health establishments from purchasing expensive pharmaceutical products from these envelopes.
Article 35 of the Social Security Financing Bill (PLFSS) for 2024 therefore proposes to introduce a new temporary and derogatory reimbursement regime, in addition to hospital charges, for products that have benefited from early access.
Which products could benefit from this derogatory reimbursement regime?
Article L. 162-16-5-1-2, which the PLFSS for 2024 plans to introduce into the Social Security Code reserves the derogatory reimbursement regime for products that satisfy 3 conditions:
- the product is reserved for hospital use
- it is not included on the “en sus” list for the indication considered
- in its opinion, the Transparency Commission (CT) considered that:
- on the one hand, the product presents a certain level of SMR and ASMR in the indication considered. These levels will be defined by decree
- on the other hand, a development plan (proposed by the operator) is likely to provide the data needed to update the evaluation of the product. In this case, the CT sets the deadline by which the additional data is expected.
According to the Government, this derogatory reimbursement regime would have covered 7 products between 2022 and 2023.
What would be the derogatory reimbursement regime details?
Compensation
The PLFSS for 2024 stipulates that the product will be reimbursed on the basis of a compensation set by the ministers (without negotiation, therefore).
This will correspond to:
- if a price or tariff is known in a European country with a comparable market size: the lowest price/tariff less a discount
- if not: the compensation declared for early access, less a discount.
In both cases, the discount will be set by the ministers, depending on the opinion of the Transparency Commission (and in particular the deadline set by the Commission for providing additional data). According to the impact study on the PLFSS for 2024, the discount could be around 20%.
Paybacks
As with early access, there are two cumulative paybacks mechanisms:
- on the one hand, the annual paybacks, calculated on the basis of the sales achieved for this product in the indication concerned
- on the other hand, unwinding paybacks (with a single unwinding under this new exemption and early access scheme)
It should be noted that the PLFSS for 2024 provides for 3 cases of increase in annual paybacks:
- from the second year of authorization for the new derogatory reimbursement regime
- if the deadline set by the Transparency Commission for providing additional data is exceeded
- if a price agreement is not signed within 180 days of the request for inclusion on the “en sus” list on the basis of the new opinion from the Transparency Commission
When will this derogatory reimbursement regime end?
Lastly, it is planned that this derogatory reimbursement regime will come to an end:
- when the pharmaceutical product is included on the “en sus” list
- by ministerial order, if the new opinion of the Transparency Commission does not allow inclusion on the “en sus” list
- after a period set by decree, which may not exceed 3 years
GD Avocats advises and supports companies in their market access strategy. Contact us by e-mail: contact@gd-associes.com
[1] In theory, inclusion on the “hospital” list (“liste collectivités”) means that these pharmaceutical products can be reimbursed, but in practice the cost of hospital stays means that healthcare establishments are unable to purchase expensive pharmaceutical products from these envelopes.
