France's Leap Forward in IVD Reimbursement and Precision Medicine
In France, the landscape for reimbursement of in vitro diagnostics (IVD) tests is shaped by several key frameworks and lists that play pivotal roles in the market access process for these technologies. Formal test reimbursement typically involves the inclusion of the test into the standard NABM (Nomenclature des Actes de Biologie Médicale) catalog, which defines the reimbursement scope under social security. To avoid lenghty processes, which could prevent adoption from innovation, the Référentiel des actes Innovants Hors Nomenclature (RIHN) framework was created. It worked as a “close envelop” fund that would enable temporary funding, while collecting health economic data that lead to formal inclusion to the NABM and thus to reimbursement. Yet, once added to RHIN, tests did not move to NABM, creating significant pressure on the French biomarker testing system.
As part of the Health Innovation 2030 Plan the government started introducing changes in the system and incorporation of biomarker diagnostic testing. These reforms are part of France’s broader health system modernization efforts, emphasizing the need for a reimbursement system that keeps pace with medical advances, especially in areas like genomics and personalized medicine that are rapidly evolving.
On March 31, 2024, the Ministry of Labor, Health, and Solidarity published a Decree in the Official Journal of the French Republic which relates to the conditions of coverage of innovative IVD tests within the RIHN framework. This is expected to streamline the transition from RIHN framework to regular reimbursement via the NABM Nomenclature, thereby facilitating greater access to innovative diagnostics for the French population. Within this scope, RIHN is nevisioned as a pillar of innovation, facilitating early access to medical breakthroughs and ensuring that innovative diagnostics are financially supported in a transitory manner through the MERRI G03 endowment. Moreover, the Haute Autorité de Santé (HAS) has now a defined role on the process, ensuring the collection of necessary clinical and medico-economic data that will aid future evaluations and limiting inclusion in RHIN to a maximum period of 6 years.
Since the introduction of the 2030 plan, some biomarker testing have already been transferred to the NABM. For patients, this signalises the possibility of faster access to innovation, especially when exploring biomarker testing beyond CDx. For diagnostic companies, these updates represent critical information that can impact their market entry strategy, pricing, and overall stakeholder engagement in France. Companies must closely monitor these developments and adjust their approaches to align with the evolving reimbursement landscape.