The demands of joint HTA: to what extent will HTA agencies benefit from the JCA?

The Joint Clinical Assessment (JCA) came into effect across EU member states on January 12th, 2025, bringing a host of opportunities and challenges to existing European Health Technology Assessment (HTA) agencies.

Participating member states hope the efficiency and consistency of clinical evaluations, in parallel with regulatory processes, will be improved: allowing faster access and improved transparency in decision making between countries. Within the next year, the Member State Coordination Group on Health Technology Assessment (HTACG) estimates that it will ‘initiate 17 joint clinical assessments for medicinal products with new active substances’ (HTACG 2024). Through examining recent responses from member states, we can explore the extent to which country level HTA agencies will adapt in the era of the JCA, from issues raised around increased administrative burden and challenging timelines, to opportunities for increased transparency and faster access to medicines.

The response of the Spanish Agency for Medicines and Medical Devices (AEMPS) outlines the opportunities associated with the ‘community framework’ (AEMPS 2025). In a statement released on the 14th January, after the roll out of JCA, AEMPS remarked:

‘[The new HTA regulation will…] help national authorities make more informed and timely decisions on pricing and reimbursement of health technologies, as well as to speed up the procedure for health technology developers, contributing to faster and wider access to innovative and more patient-efficient products’ (AEMPS 2025)

A clear potential benefit of the JCA will be the greater transparency of data between individual member states through the collective use of the PICO framework. For instance, representatives of IQWiG (Germany) have advocated:

‘that the information already submitted by the pharmaceutical company at EU level can also be used for the benefit assessment in Germany. This can be done, as proposed, by referring to the relevant sections in the EU dossier. Only information that is not available from the EU procedure will then have to be submitted in the dossier for the AMNOG procedure’ (IQWiG 2025)

However, representatives from IQWiG have also expressed the importance of maintaining the transparency of their national assessment procedure. Beate Wieseler, Head of the IQWiG Medicines Assessment Department, in response to a draft bill to adapt the German national drug benefit assessment regulation, remarked:

‘After analysing the draft, we can assume that the transparency of the AMNOG procedure will be maintained. This transparency can therefore continue to contribute to good decisions for patient care’ (IQWiG 2025)

By preserving this transparency within the Pharmaceuticals Market Reorganization Act (AMNOG), IQWiG hopes to maintain the quality of patient care, through enabling doctors to assess evaluation results and thus patients to make informed health decisions.

The commitment to avoiding the duplication of data requests and analysis across European member states represents one of the key potential benefits of the JCA process for national HTA authorities, pharmaceutical manufacturers and patients. However, this could also present a challenge where differences in data requirements, or cultures of transparency, arise between HTA agencies and their implementation of the PICO framework. Over a year ago, in Ärzte Zeitung, Thomas Kaiser, Head of IQWiG, spoke about Germany’s attempt to exert influence regarding this:

‘There have certainly been attempts to enforce the secrecy of data more strongly. We know that from NICE in Great Britain, where large parts of the HTA reports have been blacked out. That won't happen. It is still unclear whether the member states will receive only the report or the entire data package in the future’ (Ärzte Zeitung 2023)

Kaiser’s comments, in addition to Weisler’s, demonstrate IQWiG’s awareness of the benefits of data transparency. They also show that European HTA agencies will have to carefully manage cultural and methodological differences as the JCA is enacted across member states.

France’s Haute Autorité de Santé (HAS) also made an announcement in January drawing attention to both the opportunities and challenges of JCA implementation. The HAS statement denotes they are excited to:

‘Reduce duplication of efforts by national HTA authorities and industry by centralising the repository of clinical data; produce public, transparent and high-quality scientific clinical reports; to provide a framework for sustainable cooperation on HTA in Europe’ (HAS 2025)

However, much like AEMPS (Spain), this enthusiasm was coupled with an awareness of the demands that implementing the JCA will involve, with the statement also acknowledging that an ‘intense preparation phase’ (HAS 2025) had been required in the run up to rollout of the JCA. This is mirrored by concerns raised by the European Federation of Pharmaceutical Industries and Associations (EFPIA), which stated last year that ‘concerns have been raised regarding the feasibility and workability of the proposed procedures, particularly in relation to transparency, predictability, and timelines.’ (EFPIA 2024). The key challenges facing European HTA authorities will be in adapting to these issues within a limited timeframe, with the JCA planned to apply to orphan drugs from 2028, and all centrally approved new medicines from 2030.

A final point of consideration regarding the demands of the JCA implementation is evident from The Swedish Dental and Pharmaceutical Benefits Agency (TLV). In their end of year report in 2024, the TLV affirmed its commitment ‘to participating in preparatory work at EU level, not least to ensure that the future system is as functional as possible’ (TLV 2024). Despite their dedication to preparing for JCA and their experience of international collaboration within the Joint Nordic HTA Bodies (JHNB) network, (the organisation overseeing HTA agency collaboration among Denmark, Finland, Norway, Iceland and Sweden), the TLV has expressed concerns over the expected increase in administrative burden resulting from the JCA. Anna Alassaad, senior coordinator at the TLV, highlighted in a recent report that preparation was ‘about adapting their national processes and working methods to meet the obligations of the regulation that concern the authority’ (TLV 2024a) and the JHNB released a report claiming they ‘have made national adaptations to comply with the HTA regulation’ (JNHB 2024). Through adapting their national HTA process, the TLV faces a significant increase in workload, which will require ‘financial compensation…in order to implement the introduction in accordance with the governing elements of the Regulation’ (TLV 2024a). In the short term, the TLV faces an increase in demands on administrative staffing, as well as implementing a new IT system to facilitate the sharing of data. In the longer term, this increased workload is likely to be further exacerbated, as more products are included in the scope of the JCA.

Recent announcements from various member states demonstrate the challenges facing national HTA agencies as the JCA is rolled out this year. Despite these challenges, many HTA agencies recognise the potential of the JCA to drive improvements in horizon scanning, the efficiency and transparency of assessment processes, accelerated decision making for patient access, and the consistent implementation of assessment methods. While announcements from several HTA agencies outline the challenges ahead; there is a consistent, though qualified, optimism regarding the potential benefits the JCA can provide.

References

ACT EU. 2025. Clinical Trials training Curriculum. [Online]. [Accessed 25 January 2025] Available from: https://accelerating-clinical-trials.europa.eu/our-work/clinical-trials-training-curriculum_en

AEMPS. 2025. AEMPS welcomes the new European Health Technology Assessment Regulation (ETS), which has come into effect on 12 January 2025. [Online]. [Accessed 24 January 2025]. Available from: https://www.aemps.gob.es/informa/la-aemps-da-la-bienvenida-al-nuevo-reglamento-europeo-de-evaluacion-de-tecnologias-sanitarias-ets-que-ha-entrado-en-aplicacion-el-12-de-enero-de-2025/#)

AEMPS. 2025a. LinkedIn Post [Online]. [Accessed 25 January 2025]  Available from: https://www.linkedin.com/posts/agencia-espa-ola-de-medicamentos-y-productos-sanitarios_clinical-trials-training-curriculum-activity-7287455387954401280-pxMl/?utm_source=share&utm_medium=member_desktop

Ärzte Zeitung. 2023. IQWiG Head of the Thomas Kaiser on the future of benefit assessment [Online]. [Accessed 29 January 2025] Available from: https://www.aerztezeitung.de/Politik/IQWiG-Ressortleiter-Thomas-Kaiser-zur-Zukunft-der-Nutzenbewertung-428147.html

EC. 2024. Health Technology Assessment - Commission adopts rules for joint scientific consultations on medicinal products for human use. [Online] [Accessed January 23 2025] Available from: https://ec.europa.eu/newsroom/sante/items/862446/en

EFPIA. 2024. Life science industry concerns over the workability of EU HTA: Europe cannot miss out on the opportunity to speed up access to innovative medicines for European patients [Online]. [Accessed 1 February 2025] Available From: https://www.efpia.eu/news-events/the-efpia-view/statements-press-releases/life-science-industry-concerns-over-the-workability-of-eu-hta-europe-cannot-miss-out-on-the-opportunity-to-speed-up-access-to-innovative-medicines-for-european-patients/

HAS. 2025. LinkedIn Article [Online]. [Accessed 25 January 2025] Available from: https://www.linkedin.com/posts/haute-autorite-de-sante_une-avanc%C3%A9e-majeure-pour-une-europe-de-activity-7284943677817274368-Ouk7/?utm_source=share&utm_medium=member_desktop

HTA CG, 2024, Annual Work Programme of 2025. [Online]. [Accessed 25 January 2025]. Available from: https://health.ec.europa.eu/document/download/9f1d2ac8-3515-4be1-9a29-db3d9ffb5201_en?filename=hta_hatcg_awp_en.pdf

IQWiG, 2025. EU-HTA: Achievements of the AMNOG received. [Online]. [Accessed 25 January 2025] Available from: https://www.iqwig.de/presse/pressemitteilungen/pressemitteilungen-detailseite_137216.html

JNHB, 2024. The Joint Nordic HTA-Bodies are well prepared for work under the EU HTA regulation [Online]. [Accessed 25 January 2025]. Available from: https://jnhtabodies.org/media/t1cny1nc/press-release-jnhb-and-htar-2025-01-13.pdf

TLV. 2024. Annual Report 2023: Preparedness questions and updated value-based pricing in focus. [Online]. [Accessed 25 January 2025] Available from: https://www.tlv.se/press/nyheter/arkiv/2024-02-22-arsredovisning-2023-beredskapsfragor-och-uppdaterad-vardebaserad-prissattning-i-fokus.html

TLV 2024a. Swedish cooperation for new EU - regulation on HTA – Health Technology Assessment. [Online]. [Accessed 24 January 2025] Available from: https://www.tlv.se/press/nyheter/arkiv/2024-12-16-svenskt-samarbete-infor-ny-eu%E2%80%8D-%E2%80%8Dforordning-om-hta---health-technology-assessment.html

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