The French way of HTA: Between scientific rigor, independence and transparency - 09/05/25

Doi : 10.1016/j.lpm.2025.104281

Joachim Baba ¹, Nathan Guerrier ², Irena Guzina ³, Vanessa Hernando ⁴, Vassilia Ressencourt ⁵, Ivana Spasojevic ¹, Dominic Thorrington ⁶, Charlotte Masia ^1,^⁎
¹ Medicines Assessment Department (SEM), Evaluation and Access to Innovation Department (DEAI), HAS, Saint-Denis La Plaine, France
² User Engagement Department (SEU), Communication, Information and User Engagement (DCIEU), HAS, Saint-Denis La Plaine, France
³ Professional Procedures Assessment Department (SEAP), Evaluation and Access to Innovation Department (DEAI), HAS, Saint-Denis La Plaine, France
⁴ 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
⁵ Medical Devices Assessment Department (SED), Evaluation and Access to Innovation Department (DEAI), HAS, Saint-Denis La Plaine, France
⁶ Public Health Assessment and Vaccines Assessment Department (SESPEV), Evaluation and Access to Innovation Department (DEAI), HAS, Saint-Denis La Plaine, France

^⁎Corresponding author.

Abstract

Context

The Haute Autorité de Santé (HAS) is an independent body responsible for advising the government on the appropriateness of national funding for healthcare technologies and interventions. To fulfil this role, HAS evaluates their efficacy and safety, especially in comparison to existing alternatives.

Methods

We first described how the HAS is organised to carry out this mission, then outlined the different stages of the evaluation process, highlighting specific features according to the type of health technology being assessed We also reviewed the HAS's activities for 2023.

Results

The HAS relies on international methodological standards to assess health technologies and interventions, on the expertise of healthcare professionals and patient experiences, and input from various stakeholders where appropriate and necessary.

Conclusion

Through this rigorous, independent, and transparent scientific evaluation process, the HAS aims to ensure that patients have access to the best available treatments and care, and, when relevant, to the most efficient options for the French healthcare system, while guaranteeing patient safety.

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Keywords : Assessment, Evaluation, Appraisal, Health technologies, Diagnostic and therapeutic procedures, Evidence-based medicine, Comparative

Abbreviations : AMSTAR, ANSM, ASA, ASMR, ATMP, CAV, CB, CCDVR, CEDIAG, CEESP, CEPS, CNAM, CNEDiMTS, CTV, DEAI, DMD, DPI, EB, ED, EU, EUnetHTA, HAS, HT, HTA, HTD, ICER, INAHTA, JCA, LATM, LPPR, MD, PICO(TS), PRISMA, QUADAS, RoB, SA, SMR, UNCAM

Plan

Introduction

About the HAS

2.1. What is the HAS?

2.2. Organisation

HTA process and organisation: a common framework and specificities based on sectors

3.1. Pre-HTA phase: supporting the generation of evidence with high certainty of results for future HTA

3.2. Request for assessment

3.3. Assessment phase: critical analysis of available data

3.4. Appraisal and opinion phase

3.5. Contradictory phase and publication of the opinion

3.6. Post-HTA

3.7. Special cases

3.8. Key figures of the HAS

External consultations to inform evaluation

Perspectives

5.1. Forthcoming challenges at European level

5.2. Integration of environmental impact in HTA evaluation

Conclusion

CRediT authorship contribution statement

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Vol 54 - N° 2

Article 104281- juin 2025 Retour au numéro

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The French way of HTA: Between scientific rigor, independence and transparency - 09/05/25

Abstract

Context

Methods

Results

Conclusion

Plan

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