Introduced in the Senate on November 25, 2021, the bill on health innovation aims to improve the conditions of access to innovative therapies. Article 16 of the bill provides that the Economic Committee for Health Products (CEPS) will be able to set the price of certain medicinal products on the basis of a new criterion: relative therapeutic value (RTV).
Currently, certain highly innovative medicinal products and therefore difficult to compare are likely to have an Improvement of the medical service rendered (ASMR) of level IV or V, which prevents them from being included on the “en sus” list (for ASMR V) and makes price negotiations considerably more complex. In order to get around this difficulty, article 16 of the bill provides for them to be evaluated on the basis of the RTV. The RTV criterion would replace the ASMR criterion in setting the price of medicinal products (the other criteria remaining unchanged).
This would be an experiment set up for a period of five years.
After having been amended by the Senate, this measure is currently being examined by the National Assembly, in first reading. It could therefore be subject to significant changes during the next reviews in the coming weeks. However, we can already present the main lines of this measure.
Which medicinal products are affected?
Only medicinal products that meet the following three cumulative conditions would be concerned:
- there is insufficient relevant clinical data to assess the ASMR;
- the efficacy and safety of the medicinal product are presumed;
- the medicinal product meets a major therapeutic need with respect to existing alternatives.
How to measure the RTV?
Article 16 of the bill provides that the conditions under which the CEPS can/should take into account the RTV to set the price of the medicinal product would be specified by decree in the Council of State.
However, it appears from the work of the HAS/Leem interface committee of January 23, 2018 that the proposed criteria for assessing the RTV could be (i) the quantity of effect (both in terms of efficacy, quality of life and tolerance), taking into account the severity of the disease; (ii) the relevance of the effect; (iii) the quality of the demonstration; and (iv) the place in the therapeutic strategy.
What price…and what rebats?
Article 16 of the bill provides that the RTV would be re-evaluated periodically (and at least once every two years) on the basis of clinical and real-life data provided by the company operating the medicinal product.
Therefore, the price of the medicinal product would also be re-evaluated periodically.
In this respect, it is planned that, in the event of a downward price revision, the company operating the medicinal product will have to pay the CNAM the difference between the amounts reimbursed and the amounts that would have resulted from the application of the revised price. This mechanism is similar to the settlement rebats that apply in early access and direct access (see our article of November 18, 2021).
Obligations relating to the transmission of data
Since the RTV and the price must be re-evaluated periodically, Article 16 of the proposed law provides that manufacturers will be required to submit clinical and real-life data on a regular basis.
The presentation of these data will condition the registration of the medicinal product on the “city” list and on the “en sus” list.
While this new initiative to improve the financing of innovative medicinal product is welcome, it remains to be seen what opportunities and constraints it represents in relation to existing mechanisms (notably early access, direct access and certain provisions of the framework agreement).
GD Avocats assists manufacturers with issues related to the management and pricing of healthcare products. Contact us by e-mail : contact@gd-associes.com
