12/20/2022

How to anticipate the 2025 EU HTA from now?

The European (EU) Regulation on Health Technology Assessment (HTA) came into force in January 2022 and will apply from January 2025 starting with oncology medicines and Advanced Therapy Medicinal Products (ATMPs). The three-year application period aims to set up the organizational framework and methodological guidelines of the common assessment and, to give health technology developers time to anticipate the requirements of the new framework.

The future scope of the EU assessment

The HTA Regulation focuses on clinical aspects of HTA, i.e., the relative clinical effectiveness and relative clinical safety of a new health technology compared with existing technologies. The pillar of the future EU HTA will be the Joint Clinical Assessments (JCAs). 

The JCA will take place in two main phases: the scoping phase (defining the assessment team and the PICO) and the assessment phase. The process allows patients and clinical experts to participate at each stage of the process under specific procedures.

Update on the future guidelines

EUnetHTA 21 is currently developing the methodological guidelines and documents of the EU JCA. Some are already published and give the opportunity to anticipate the expectations of the EU HTA assessment regarding some methodological concerns of the development plan.

For some subjects the key question of the acceptability of the methods is still under discussion (i.e. only accept methods that are acceptable to all member states, or include all commonly used methods of evidence).

StatusDocumentDate of publication
PublishedScoping process (PICO)12-09-2022
In progressPractical Guideline on Direct and Indirect ComparisonsQ4 2022 – Project plan available
PublishedMethodological Guideline on Direct and Indirect Comparisons29-07-2022
In progressEndpointsQ1 2023 – Project plan and draft deliverable available
In progressApplicability of evidenceQ4 2022 – Project plan available
In progress Validity of clinical studiesQ4 2022 – Project plan available
PublishedAssessment of High-Risk Medical Devices29-07-2022
In progressEUDAMED data reporting template / Guidance for EUDAMED-based TISP processQ4 2022
In progressJCA/CA Submission Dossier TemplateQ4 2022 – Project plan available
In progressJCA/CA Assessment Report TemplateQ4 2022 – Project plan available
Published
Procedural guidelines for appointing assessors and co-assessors
03-06-2022
PublishedHTAb technical expert working group29-07-2022
In progressProduction of JCA/CA on medical products and medical devices2 medical devices (Optilume® and Evoke®) – no medicinal product
Methodological Guidelines/JCA/Collaborative Assessements

What should health technology developers anticipate?

The scoping, including the PICO’s definition, will be crucial as the first step of the EU HTA process. From now on, health technology developers should consider the available EUnetHTA 21 methodological guidelines in all clinical developments.

To complete the EUnetHTA 21 guidelines, the French HTA body (Transparency Committee of the Haute Autorité de Santé, HAS) will publish a position paper in the BMJ Evidence-Based Medicine in early 2023.

From 2025, the EU HTA process will include the possibility of a Joint Scientific Consultation (JSC) with the EMA to advise health technology developers on the clinical study designs that provide appropriate evidence. Eight JSCs have been planned in EUnetHTA 21 and will take place by 2023. Before 2025, EUnetHTA 21 recommends using the possibilities to interact with national bodies to define the PICO, especially the comparators.

PHAROS as European healthcare consultancy group with highly experienced market access experts in all major European countries has a good knowledge of European processes and offers a global support for early consultations.

Feel free to contact us via email and we will be happy to advise you!

References

European Parliament and the Council of the European Union. Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU; 2021. Accessed Dec 12, 2022. https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32021R2282&from=EN  

European Commission. Regulation on Health Technology Assessment. Accessed Dec 12, 2022.  https://health.ec.europa.eu/health-technology-assessment/regulation-health-technology-assessment_en

European Commission. Questions and Answers: Adoption of Regulation on Health Technology Assessment. Accessed Dec 12, 2022. https://ec.europa.eu/commission/presscorner/detail/en/qanda_21_6773

European Network for Health Technology Assessment (EUnetHTA). Joint HTA Work. Accessed Dec 12, 2022. https://www.eunethta.eu/jointhtawork/

Conference on the new Regulation on Health Technology Assessment (HTA). 22 June 2022. Accessed Dec 12, 2022. https://health.ec.europa.eu/events/conference-new-regulation-health-technology-assessment-hta-2022-06-22_en

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