15 April 2025 – Since the launch of the Health Innovation 2030 plan, France is investing in the development and validation of innovative in vitro and companion diagnostics. This will support the implementation of personalised medicine approaches and accelerate the decision on reimbursement.
The development of in vitro and companion diagnostics is a key determinant in the successful implementation of PM approaches. In vitro and companion diagnostics allow clinicians to test several key aspects of a patients’ profile and adjust the prescriptions as it highlights the probability for the patient to 1) respond or not to the treatment and 2) to develop side effects. They hence ameliorate the therapeutic decisions.
Illustration created with BioRender.com by Mathias Vétillard.
In many European countries, the current regulation prevents market access for in vitro and companion diagnostics prior to their acceptation by central Health Authority and the negotiation of their market price with the government. As an example, in France in 2023, the reimbursement of health expenditures for the public and private sector was around 244 B €. The budget is justified by a “by act pricing” (“tarification à l’activité”) for medication, but also for in vitro and companion diagnostics but only for those included in a validated list, so called “Nomenclature des actes de biologie médicale”. Innovative in vitro and companion diagnostics that are not yet validated by the French Health Authority are not yet considered for reimbursement and thus are difficult to be implemented in day to day care. This delay hampers improvements of the quality and efficacy of treatments as, in principle, available therapeutic approaches are not allowed for clinical use.
Non-validated in vitro and companion diagnostics are included in a repository which lists innovative procedures (« Référentiel des actes innovants hors nomenclature », RIHN). In the vision of the Health Innovation 2030 plan, that is aiming, among other, to facilitate the incorporation of innovative in vitro and companion diagnostics in day to day care, the consideration of the RIHN repository has recently been improved by law.
Concretely, project holders of in vitro and companion diagnostics listed in the RIHN repository can request financial support for validation processes (>190M € available annually), e.g. for conducting clinical trials and other experiments, that together will allow future validation by the French Health Authority.
Since the launch of the Health Innovation 2030 plan, several in vitro and companion diagnostics, initially listed in the RIHN repository, were already successful validated. Notably, the regulatory environment regarding health innovation may be further revised, i.e. to facilitate the integration of innovative in vitro and companion diagnostics by unblocking “restrictions on the management of genetic tests in oncology”.
More information: https://sante.gouv.fr/systeme-de-sante/innovation-et-recherche/rihn
Definition and terms:
From the US Food and drug administration, Medical Devices 06/20/2023:
A companion diagnostic is a medical device, often an in vitro diagnostic, which provides information that is essential for the safe and effective use of a corresponding drug or biological product. Companion diagnostics can: 1) identify patients who are most likely to benefit from a particular therapeutic product, 2) identify patients likely to be at increased risk for serious side effects as a result of treatment with a particular therapeutic product; 3) monitor response to treatment with a particular therapeutic product for the purpose of adjusting treatment to achieve improved safety or effectiveness. If the diagnostic test is inaccurate, then the treatment decision based on that test may not be optimal.
From the European medicines agency, article 2(7) of Regulation (EU) 2017/746:
‘companion diagnostic’ means a device which is essential for the safe and effective use of a corresponding medicinal product to: (a) identify, before and/or during treatment, patients who are most likely to benefit from the corresponding medicinal product; or (b) identify, before and/or during treatment, patients likely to be at increased risk of serious adverse reactions as a result of treatment with the corresponding medicinal product.