Medicines, medical devices and in vitro diagnostic tests each follow a distinct assessment and reimbursement listing pathway in France, involving different committees and reimbursement schemes according to the type of product. However, all three pathways share a common principle: assessing and recognising the clinical value of the product.
Healthcare Product Assessment and Reimbursement Listing in France
Medicines: Transparency Committee Assessment and Reimbursement Listings
Medicines are assessed by the HAS Transparency Committee (SMR and ASMR), then included on the list of medicines reimbursable under statutory health insurance and/or the list of medicines approved for use in healthcare institutions. Orphan medicines and targeted therapies associated with companion diagnostics require specific assessment and coordination strategies.
Medical Devices: CNEDiMTS Assessment and LPPR Listing
Medical devices are assessed by the CNEDiMTS on the basis of Expected Clinical Benefit (SA) and Improvement in Expected Clinical Benefit (ASA), before being included on the List of Reimbursable Products and Services (LPPR), either under a brand name or a generic description, depending on the level of clinical differentiation to be recognised.
In Vitro Diagnostics: CEDiag Assessment, NABM and RIHN
In vitro diagnostic tests are assessed by CEDiag, then included either in the NABM, the established reimbursement classification for medical laboratory procedures, or, for newer innovative tests, in the RIHN, a transitional framework providing hospital funding while additional clinical evidence is generated.
One Common Principle, Three Distinct Pathways
In all three cases, an assessment by the relevant HAS committee establishes the recognised clinical value of the product, which informs its inclusion in the appropriate reimbursement scheme and the applicable pricing or funding arrangements. However, the type of product — medicine, medical device or diagnostic test — determines the responsible committee, the reimbursement list and the strategic options available, such as brand-name listing, transitional RIHN funding or hospital and outpatient reimbursement lists.
Frequently Asked Questions
The Transparency Committee assesses medicines, while the CNEDiMTS assesses medical devices. In vitro diagnostic procedures are assessed through the relevant HAS diagnostic assessment pathway, involving CEDiag.
Yes, particularly in the case of a targeted therapy associated with a companion diagnostic. The medicine follows the Transparency Committee assessment pathway, while the associated test follows the relevant diagnostic assessment and reimbursement pathway, potentially involving NABM or RIHN funding. Coordinating the timelines of both processes is essential.