The Regulation (EU) 2021/2282 on health technology assessment (HTAR) was adopted on December 15, 2021, and took effect on January 11, 2022. Since January 12, 2025, it applies to new active substances indicated in oncology and advanced therapy medicinal products. The HTAR will extend to orphan drugs in January 2028 and to all other medicinal products in January 2030.

The HTAR aims to accelerate patient access to healthcare technologies and provide greater clarity for the pharmaceutical industry regarding clinical data requirements. However, the French National Health Authority/Haute Autorité de santé (HAS) is still assessing the regulation’s national impact.

This article outlines the current understanding of the HTAR’s effect on HTA processes in France.

HTAR Overview

The HTAR established the Member State Coordination Group, composed of Member States representatives, which oversees the coordination and adoption of the joint HTA carried out by subgroups and of the procedural guidance document. The HTAR also established four sub-groups:

• The joint scientific consultation (JSC) subgroup
• The joint clinical assessment (JCA) subgroup
• The emerging health technologies subgroup
• The methodological and procedural guidance subgroup

The HTA Information Technology platform, which is already active, the HTA Stakeholder Network, and a secretariat provided by the European Commission will support the four subgroups.

The European Commission has adopted and published the first five out of six implementing acts, which establish rules for the Member State Coordination Group on HTA and subgroups to implement their missions within the framework of the HTAR. These acts are the JCA of medicinal products, the exchange of information with the European Medicines Agency, the conflict-of-interest rules under the HTAR, the JSC for medicinal products and the JSC of medical devices and in-vitro diagnostic medical devices.

By 2025, the Member State Coordination Group on HTA plans to initiate:

• 17 JCAs for new active substances indicated for cancer and eight JCAs for advanced therapy medicinal products.
• Around 10 JSCs, i.e., five to seven JSCs for medicinal products and one to three JSCs for medical devices.

The submission window for JSCs (via the HTA Information Technology platform) for 2025 is from 3 February to 3 March 2025 for medicinal products and from 2 to 30 June 2025 for medicinal products and medical devices.

If the number of eligible applications surpasses the limit outlined in the work program, the Member State Coordination Group on HTA will prioritize drugs based on specific criteria:

• existence of unmet medical needs
• first-in-class drugs or medical devices
• possible impact on patients, public health or healthcare systems
• strong cross-border dimension
• high added value at the European Union level
• European Union priorities in clinical research

The European Commission has published a briefing document template and procedural guidance for JSC and JCA on its website.

Impact of the HTAR on French National Health Authority in France

With the European HTAR in place, procedures and clinical data evaluation will change at the national level. The HAS is expected to avoid duplicating or redoing the content of the JCA. Instead, the HAS will use the analysis developed by the JCA on the clinical data package as a basis for conducting the reimbursement process locally.

The elements that are likely to change at the national level and those that remain unchanged following the introduction of the HTAR are presented below.

Evaluation Process of the Clinical Data Package

Before the HTAR, the scientific analysis of clinical data for selected medical devices and medicinal products under centralized marketing authorization was already handled at the European level. However, companies had to submit separate clinical data dossiers at both the European and national levels.

With the HTAR, the clinical assessment at the European level remains, but pharmaceutical companies will now submit a single file based on a pre-validated PICO (Population, Intervention, Comparators, Outcomes) framework, without the need for resubmission at the national level. Despite this change, the HTAR does not entirely eliminate the national-level process. Companies must still submit a reimbursement request at the national level, accompanied by a national dossier.

Following the European-level assessment, national HTA bodies will receive comprehensive clinical data syntheses, including certainty analyses and assessments of study strengths and limitations, such as internal and external validity. If new or supplementary data emerges after the initial European submission, it can still be incorporated into the national assessment, and the HAS may also request additional information as required.

As part of this transition, updates to the HAS standard dossier matrices are anticipated, specifically in Part 10 for medicinal products and Parts 4 and 5.4 for medical devices.

Early Dialogue Process

Before the HTAR, early dialogues to clarify the type of data required for HTA were conducted exclusively at the national level. With the HTAR, this process can now take place at the European level, offering a broader framework for companies seeking guidance.

However, for medicinal products that do not participate in a JSC, early dialogue at the national level is still possible, but only under a revised process: the HAS fast-track procedure, with four submission windows per year. The HAS already published the 2025 submission timetable, with the final deadline for early dialogue requests set for October 8, 2025.

The process timeline remains structured. After submitting a request, the HAS will assess eligibility within seven days. If eligible, the applicant has 30 days to submit a briefing document. The HAS will then issue a written recommendation within 60 days, after which the applicant has 10 days to request clarifications. The HAS will send the final recommendation within 15 days.

Medical devices are not affected by this change and will continue following the existing national process.

Early Access Post-Marketing Process

With the HTAR, companies now need to submit clinical data at the European level, eliminating the need for resubmission at the national level. However, after submitting the dossier at the European level, companies must still file a national request for early access post-marketing authorization. The decision to grant early access will remain at the national level, based on the clinical data assessment provided in the JCA report. National dossiers now only need to include newly available data.

The process for early access before marketing authorization remains unchanged. Companies must still submit requests to the HAS and must include all available data.

Reimbursement Decisions

The reimbursement decision is made at the national level, based on criteria such as the medical benefit/Service Médical Rendu (SMR) and the added medical value/Amélioration du Service Médical Rendu (ASMR) in comparison to the standard of care.

The JCA will not provide an evaluation of the health technology appraisal or make decisions regarding the target population, SMR, ASMR, or the place of the technology within the therapeutic strategy. These aspects will continue to be assessed at the national level, in line with the HAS commission guidelines.

Table 1. Table summarizing the elements that are subject to change and that are not modified by the HTAR

Conclusion

The HTAR, which is now in force, means that the first drugs to be evaluated will, in principle, be those eligible for early access in France. The HAS will be involved in defining the PICOs for France and may also participate in developing the JCAs, either as an assessor or co-assessor. Changes are expected regarding early access (post-market authorization), clinical data evaluation, and early dialogues. However, no major changes are anticipated for the market access and assessment process at the national level in France. The HAS will continue to assess evidence based on its own doctrine and will determine the SMR, ASMR, and therapeutic strategy in France. New deadlines, submissions, and procedures will impact laboratories and affect the internal organization of their departments.

How Alira Health Can Help

Our Market Access team guides companies through the complexity of new requirements at the federal, national, and local level. We can help you to understand the HTAR changes and apply for an early dialogue.