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Key topics
There is only one key theme describing market access for medical technologies in France:
- Reimbursement: payment mechanism via DRG system, add-on reimbursement via LPPR List
There are no separate funding (approval by the payer) or health technology assessment challenges in France. HTA is integrated into reimbursement decision-making.
France has a number of innovative payment schemes for medical technologies.
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Reimbursement
Reimbursements for hospital procedures are made solely via a DRG system, which is called “Groupe Homogène de Maladies” (GHM). All hospitalizations, as well as day case procedures and ambulatory treatments, are reimbursed via DRG.
The DRG system has several components.
Diagnosis-related groups:
- Each DRG in the French system has four severity levels, from level 1 (lowest severity) to level 4 (highest severity). The severity level is determined by the length of the stay, the presence of complications, the type of procedure performed, etc. There are also DRGs for a short stay, which can cover hospital day care or one-day hospitalizations
- DRGs are determined by the combination of a procedure code (CCAM) and a diagnosis code (ICD-10).
- DRG tariffs differ between public, private not-for-profit, and private for-profit hospitals. Private for-profit hospitals have lower tariffs, but physicians practicing there receive a fee for every procedure performed, based on fees determined for each CCAM code.
Add-on reimbursement (LPPR list):
- This is an add-on reimbursement category for selected implantable (Title III) or invasive non-implantable (Title V) devices.
- The LPPR list is primarily managed by the French National Authority for Health (Haute Autorité de Santé, HAS). The industry can either make a brand-specific or a generic application to request the inclusion of its products into the LPPR catalog. Technologies for which evidence is considered sufficient are listed, and their price is determined at the national level. The price is based on the level of added value the device provides compared to the current standards of care in France.
- Clinical assessment is performed by National Committee for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS), and price negotiation is performed by Economic Committee on Healthcare Products (CEPS).
- The DRG system is approved annually. The DRG system is administered by the Technical Agency for Hospital Information (Agence technique de l'information sur l'hospitalisation, ATIH). Neither the industry nor the providers have a direct impact on the development of the DRG system. However, some lobbying groups can have an impact.
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Specifics for IVD tests
In-vitro diagnostic tests are reimbursed using a fee-for-service mechanism via NABM Nomenclature.
Innovative tests are funded by the Ministry of Solidarity and Health via RIHN and Supplementary List mechanisms.
However, in 2023, the reform of this innovation framework was announced, and in spring 2024 the authorities announced how this reform will occur. In the summer of 2024, the Ministry of Health released the 2024 List of IVD tests outside the Nomenclature (LAHN), which is the merged 2023 RIHN List and the Supplementary List, with a total of 616 tests as of July 2024. Currently, the French High Authority for Health (HAS) is evaluating expensive tests listed in the LAHN with the purpose of deciding whether these tests will be granted permanent reimbursement or will be excluded from coverage within the statutory health insurance. Cleaning the current AHN List will allow for the financing of truly innovative tests patients need.
Finally, the authorities launched a new process for the registration of new innovative tests in the RIHN List.
MTRC has experience with more than 283 projects in France
How can MTRC help?
Development of reimbursement analysis (procedure coding, payment mechanism, reimbursement tariffs, policy and HTA considerations)
Development of reimbursement strategy
Development of the health economic model in the French settings
Adaptation of the global health economic model to the French settings
Access to an educational seminar on the French reimbursement system
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