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Market access for medical technologies in France

A brief overview of key market access pathways and challenges for medical devices, in-vitro diagnostic tests in France

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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. 

MTRC has experience with more than 283 projects in France

News and insights

Merged 2024 RIHN and Supplementary list for IVD tests published in France

On July 16, 2024, the French Ministry of Labor, Health and Solidarity published the merged 2024 List of acts outside the nomenclature financed under MERRI G03.

Recommendations about add-on reimbursement for medical devices in France in June 2024

The French National Authority for Health (HAS) released new recommendations about add-on reimbursement of medical devices and medical aids from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in June 2024. Twelve recommendations were published concerning the registration of medical devices or modification of registration conditions/extension of indications for the medical devices in the List of Reimbursable Products and Services (LPPR). Opinions concern cardiovascular and endocrine devices, as well as medical aids.

Introduction of new tariffs for rapid diagnostics performed in pharmacies in France

On June 18, 2024, France introduced the tariffs of €10-€15 for rapid diagnostic tests performed by pharmacists. This initiative enables pharmacists to swiftly diagnose and manage common conditions, such as Group A Streptococcal pharyngitis and urinary tract infections.

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