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Clinical evidence requirements for LPPR List process for implants and invasive devices in France (analysis of positive recommendations)

Analysis of five HTAs and strategic recommendations for evidence generation strategy in France (February 2024)


In France, 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.

However, there is a possibility of add-on reimbursement (on top of the DRG tariff) via the LPPR List. Add-on reimbursement is possible 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.

The National Committee performs clinical assessment for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS), and price negotiation is performed by the Economic Committee on Healthcare Products (CEPS). The assessment is based on evidence from specific clinical data relating to the device subject to the application for inclusion in the LPPR and the non-specific clinical data that relates to previous products or versions from the range or competitor products.

In this White Paper, we identified evidence requirements for national add-on reimbursement via the LPPR List process based on an analysis of five recent HAS reports with positive recommendations. Cases included technologies with different levels of added clinical value (II, III, IV, and V). A review of five cases is followed by recommendations in relation to evidence generation for medical technologies in France, and factors influencing the decision-making of HAS. The analysis was performed in February 2024.

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