The Social Security Financing Bill (PLFSS) for 2023, adopted today in first reading by the Senate, proposes to set up a specific financing mechanism for advanced therapy medicinal products (MTI).
This includes gene therapy medicinal products, somatic cell therapy medicinal products, cell engineered products and combined advanced therapy medicinal products (which include medical devices or active implantable medical devices).
MTI differ from other health products in that they are administered in a particular way (often in a single dose) and are very expensive (more than €2 million per patient, due to the significant research and development costs involved).
In order to take these specificities into account, Article 30 of the PLFSS for 2023 proposes to introduce, in Article L. 162-6-6 of the Social Security Code, a derogatory financing mechanism for MTI registered on the “en sus” list. This mechanism has two objectives:
- alleviate the financial burden on health institutions, which sometimes pay advances of one or more million per patient;
- share the financial risk with the manufacturer, by making payment conditional on the effectiveness of the treatment (“see to pay”).
How will MTI be priced?
It is foreseen that, when the price charged by the manufacturer exceeds a threshold set by ministerial order, the “cost of treatment” will be determined by agreement or, failing that, by decision of the CEPS.
This “treatment cost” will recover the amount paid by the health care facility and, if applicable, the amount paid by the health insurance.
On the one hand, the participation of health care institutions will be “captured” by an innovative therapy package
In order to ease the financial burden on health care institutions, an “innovative therapy package” will be defined by ministerial order. It will correspond to the maximum amount that health establishments could be required to pay to finance an MTI. It appears from parliamentary work that the government is considering an amount of 280,000 euros per patient.
Note that :
- despite the great heterogeneity of MTI (due to the type of MTI as well as the pathology concerned), a single advanced therapy package should be fixed;
- this package will not be the subject of negotiations with manufacturers (neither collectively nor individually).
On the other hand, the financing by the health insurance will be conditioned by the observed effectiveness of the treatment
If the cost of treatment is higher than the amount borne by the health care institution, additional annual payments will be made by the health insurance.
The number, amount and conditions of these payments must be defined by agreement or, failing that, by decision of the CEPS.
However, Article 30 provides that health insurance payments must :
- take into account the efficacy data of the medicinal product concerned ;
- cease in the event of treatment failure, it being specified that the following are considered as cases of failure: (i) the death of the patient and (ii) the administration of another treatment with the same therapeutic aim. In this case, the manufacturer may be required to reimburse the health insurance company for part of the sums received.
In summary :
GD Avocats advises and assists manufacturers on issues related to the reimbursement and pricing of health products. Contact us by e-mail: contact@gd-associes.com
