French reimbursement of health technologies: assessment is at the heart of the procedure

Abstract

Background: In France, health technologies can be reimbursed by the national health insurance system. However, not all are eligible, and several steps are required. This article aims at deciphering the various procedures involved.

Methods: We first described the most common steps for reimbursement procedures, from authorisation to health technology assessment, including clinical evaluation and reimbursement decision. We then discussed certain specificities related to the nature of the health technologies (for example, vaccines among drugs, or digital medical devices (DMDs) among medical devices), and to the status of the procedure (derogatory vs. standard).

Findings: France benefits from several procedures aimed at reimbursing health products, and their number is increasing over time. They all share one common step, assessment, which is systematically performed from a clinical perspective and sometimes includes an organisational or an economic viewpoint, by a single actor: the French National Authority for Health (Haute Autorité de santé, HAS).

Conclusion and relevance: HAS evaluations are essential tools for informing healthcare decision-making, and ensuring that patients have access to safe, effective, and affordable treatments. The system will have to face new challenges in the coming years: the European regulation will pool certain procedural steps, there will be more self-directed DMDs on the market and new organizations set up to support innovation as well as scarce human and financial resources. Ultimately, it is all about constantly adapting to meet patients' needs, introducing new health technologies that offer added value and limited risks, while making the best possible use of available resources.

Keywords: Health technologies assessment; In vitro diagnostic medical devices; Medical devices; Medical or surgical procedures; Medicinal products.