French evaluation of innovative health technologies: Early access and fundings - 09/05/25

Doi : 10.1016/j.lpm.2025.104284

Capucine Serain ^1,^{^{#
Both authors (CS and SC) have contributed equally to the article.}}, Sylvie Chevret ^2,^3,^{^{#
Both authors (CS and SC) have contributed equally to the article.}}, Yann Chambon ⁴, Vanessa Hernando ⁵, Françoise Lucet ⁶, Samuel Seksik ¹, Hassan Serrier ^7,⁸, Elodie Velzenberger Maquart ⁹, Pierre Cochat ^3,^⁎
¹ Medicines Assessment Department (SEM), Evaluation and Access to Innovation Department (DEAI), HAS, Saint-Denis La Plaine, France
² ECSTRRA Team, UMR1342, Université Paris Cité, INSERM, Paris, France
³ Transparency Committee (CT), HAS, Saint-Denis La Plaine, France
⁴ Professional Procedures Assessment Department (SEAP), Evaluation and Access to Innovation Department (DEAI), HAS, Saint-Denis La Plaine, France
⁵ Digital Health Mission (MNS), Improvement in Quality Care and Safety Department (DAQSS), Improvement Department Evaluation and Access to Innovation Department, HAS, Saint-Denis La Plaine, France
⁶ National Committee for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS), HAS, Saint-Denis La Plaine, France
⁷ Health Economic Evaluation Service, Hospices Civils de Lyon, Lyon, France
⁸ Economic and Public Health Evaluation Committee (CEESP), HAS, Saint-Denis La Plaine, France
⁹ Medical Devices Assessment Department (SED), Evaluation and Access to Innovation Department (DEAI), HAS, Saint-Denis La Plaine, France

^⁎Corresponding author.

Abstract

Background

To accelerate the availability of innovative healthcare technologies for patients with the potential for significant clinical benefits in a context of high unmet needs, derogatory programs have been elaborated. The aim of this paper is to describe the different pathways developed in France to accelerate access to innovation, efficiently handle uncertainties while controlling the risks for patients.

Methods

We first describe the different early and temporary accesses to innovation in France involving the HAS. Feedback on these pathways based on the decisions provided by the HAS up until June 2024, is summarised and discussed. Subsequent emphasis is placed on the challenges of the evaluation process.

Findings

French derogatory pathways for innovation distinguish between medicinal products, medical devices (MDs) and procedures, as well as the funding mechanism. Early funding is dedicated to MDs, in vitro diagnostic MDs and procedures. Later fast-track access is dedicated to medicinal products but also to (digital) MDs. Based on the submitted files from 2015 to 2021, the derogatory access was approved about 70% for medicinal products and 30% for MDs/procedures.

Conclusions and Relevance

While fast-track processes appear widely used and understood for medicinal products, the different pathways available for MDs and procedures remain under-used and sometimes misunderstood. Whichever the product, the main limitation factor of approval was data quality and maturity, in concordance with reports on accelerated approvals from the FDA. The main challenge is to find the right balance between rapid access to innovation and patient safety, while addressing ethical challenges posed by new therapeutic approaches.

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Keywords : Health technology assessment, France, Innovative health technology, Early access program, Fast track access

Abbreviations : AAP, ANSM, ATMP, ATU, ATUC, ATUEI, ATUN, CAV, CEESP, DMD, DTX, EU, HAS, HTA, HTD, IVD, LPPR, MA, MD, NICE