How are countries implementing the EU HTA Regulation? An updated overview 

EU HTA Regulation goes live: A new era for HTA begins 

The much-awaited implementation of the regulation on health technology assessment (HTA) (Regulation (EU) 2021/2282) (EU HTA Regulation) has commenced. On 12 January 2025, the EU HTA regulation went live for oncology and advanced therapy medicinal products (ATMPs), with all new medicinal products set to be incorporated from 2030 onwards.¹ This marks a significant shift in the assessment of health technologies, as clinical evaluations will now be conducted at the EU level through the Joint Clinical Assessment (JCA), which will run in parallel with the European Medicines Agency (EMA) process. The EU HTA Regulation aims to expedite patient access, reduce duplication of efforts across Member States, and harmonise the methodologies used for clinical evaluation.  

In response to the EU HTA Regulation, EU countries are actively collaborating to enhance the evaluation of health technologies. On 21 January 2025, the EU Health and Digital Executive Agency (HaDEA) signed a four-year framework contract worth €35 million with a consortium of HTA bodies from 21 EU countries.² The consortium, led by Belgium’s INAMI-RIZIV, will conduct JCAs and joint scientific consultations (JSCs) with the goal of improving HTA quality, efficiency, and long-term sustainability across the EU. 

The JCA aims to completement, rather than replace, national pricing and reimbursement (P&R) processes by providing a framework for collaboration and information sharing. The JCA is intended to be a streamlined process in which a single submission of data addresses issues of relative effectiveness and relative safety. However, the JCA will not make value judgements or conclusions on added clinical value and is non-binding. National HTA bodies will continue to assess added benefit and value, conduct economic evaluations, potentially perform additional complementary clinical assessments, and retain full control over P&R decisions. However, they are expected to give “due consideration” to the JCA report when determining the value of health technologies and making P&R decisions.  

The success of the JCA in achieving its goal will depend on how effectively each country implements it at the national level. Therefore, just as pharmaceutical companies are adapting their organizations, processes, and ways of working to meet the new JCA requirements, national HTA bodies must also undergo significant transformations. They will need to change their ways of working and processes in different ways, depending on the presence and maturity of their existing national HTA processes: 

• Countries with mature HTA systems (e.g., France, Germany) will need to adapt their current frameworks to integrate the JCA (e.g., they will need to adapt dossier templates) 

• Countries with limited or no HTA infrastructure will need to establish new processes to effectively incorporate the JCA into their P&R decision-making 

A review of public sources, including national HTA websites for nine countries (France, Germany, Spain, Italy, Portugal, the Netherlands, Denmark, Sweden and Norway), was conducted to identify which countries have issued formal announcements, regulations, or publications outlining their plans to adapt national HTA processes in alignment with the JCA. The analysis reviews these announcements or regulatory changes, focusing on areas such as the establishment of dedicated national working groups to oversee and coordinate the implementation of the JCA. Additionally, it discusses methods for completing PICO surveys, changes to national submission or evaluation timelines for products undergoing JCA, updates to national dossier templates, and considerations on how manufacturer of products undergoing JCA will submit clinical data at a national level. 

What changes are countries making to implement the EU HTA Regulation?  

While some countries have taken proactive steps, others are still in the early stages of adaptation: 

• National group for implementation: Denmark, Sweden, and Norway, and have set up dedicated national coordination groups to oversee EU HTA implementation.^3-8 

• PICO survey completion: Norway and especially Sweden have focused on how to approach the completion of the PICO survey, including how to ensure the integration of national stakeholders’ input in the process.^6,8 

• Submission/evaluation timelines: Several countries have commented on and/or made changes to submission and evaluation timelines in response to the JCA: 
  
  – In Germany, if the JCA report is not available at the time of submission, the G-BA will pause the process for up to three months to wait for its publication and allow for its incorporation.⁹ 
  
  – In France, the national process will not be delayed if the JCA report is unavailable, meaning evaluations will proceed even in its absence.^10,11
  
  – Spain set a specific evaluation timeline for products undergoing JCA, i.e., clinical evaluation must be completed 20 days after JCA publication.¹² 
  
  – The Netherlands has recently introduced a new streamlined HTA process and, while the full assessment will only begin after the JCA report is published, the newly introduced core document (a summary of the reimbursement dossier that allows ZIN to provide preliminary feedback before the final submission) can be submitted before JCA report publication.^13,14 

• Dossier’s clinical section completion: France, Germany, and the Netherlands have confirmed that manufacturers undergoing JCA will not need to resubmit the same clinical data at the national level but can instead reference the JCA dossier and reports.^{9-11, 13,14} However, only the Netherlands has introduced a new dossier template, in which more details are given to manufacturers of products undergoing JCA. ^13,14 

• Italy and Portugal have not made any formal announcements or implemented changes to their HTA processes in response to the JCA. Discussions are ongoing among stakeholders in Italy¹⁵, and proposals from the industry have been made in Portugal.¹⁶ 
  

Conclusion  

The JCA marks a major shift in clinical evidence evaluation but does not replace national HTA assessments for P&R. Instead, it serves as a foundation that countries must integrate into their processes, prompting national HTA bodies to adapt. While some countries have issued formal guidance, others are still in discussions. Manufacturers must stay agile, tracking both JCA and evolving national HTA procedures to navigate market access effectively. As implementation progresses, further refinements are expected, requiring continuous monitoring and adaptation for long-term alignment between EU and national assessments. 

Remap can support you and your company in preparing for change, ensuring you meet JCA and local HTA requirements, and helping you thrive under the EU HTA. Explore our EU HTA resources  here. To support our clients through this complex journey, we have also developed the Remap JCA Advisor, an AI-powered tool designed to help you better understand the EU HTA processes.   

This tool aims to simplify the complexities of the JCA and JSC processes; for more information on the JCA advisor or to discuss how we can support you, email:  contact@remapconsulting.com 

Sources  

1. https://eurlex.europa.eu/eli/reg/2021/2282/oj/eng 
2. https://hadea.ec.europa.eu/news/theory-practice-implementing-eu-health-technology-assessment-regulation-2025-01-22_en  
3. https://laegemiddelstyrelsen.dk/da/tilskud/eu-hta-forordning/ 
4. https://laegemiddelstyrelsen.dk/da/tilskud/eu-hta-forordning/~/media/E82EEA9FFEFE48C8BEE4D2FBA8B37A2D.ashx 
5. 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 
6. https://www.tlv.se/download/18.16757a31939024aed155738/1734342481248/samordna_det_nationella_arbetet_med_att_genomfora_hta_forordningen_slutrapport.pdf 
7. https://www.nyemetoder.no/om-systemet/europeisk-samarbeid-htar/#arbeidsomradene-som-den-norske-arbeidsgruppa-jobber-med-1 
8. https://www.nyemetoder.no/4ad27c/siteassets/documents/internasjonalt/brukerstemmen-2024_eu-hta-forordning-htar.pdf 
9. https://www.bundesgesundheitsministerium.de/fileadmin/Dateien/3_Downloads/Gesetze_und_Verordnungen/GuV/A/AM-NutzenV-AendV_RefE.pdf 
10. https://www.has-sante.fr/jcms/p_3545447/fr/reglement-europeen-sur-l-evaluation-des-technologies-de-sante 
11. https://www.has-sante.fr/upload/docs/application/pdf/2024-10/eu_hta_-_has_-_suppport_de_webinaire.pdf 
12. https://www.sanidad.gob.es/normativa/audiencia/docs/DG_54_24_Solicitud_informacion_publica_RD_EVALUACION_TECNOLOGIAS_SANITARIAS.pdf 
13. https://www.zorginstituutnederland.nl/publicaties/publicatie/2025/01/24/nieuwe-werkwijze-beoordeling-van-geneesmiddelen 
14. https://www.zorginstituutnederland.nl/publicaties/publicatie/2025/02/14/format-farmacotherapeutisch-dossier-voor-herbeoordeling-van-geneesmiddelen 
15. https://www.sanita33.it/rubrica-a-dire-il-vero-contro-la-disinformazione-e-le-fake-news-in-ambito-salute/4306/verso-il-valore-delle-terapie-raccomandazioni-per-l-implementazione-del-regolamento-europeo-di-hta-in-italia.html 
16. https://apifarma.pt/wp-content/uploads/2024/06/Documento-de-Posicao_RegulamentoATS_Processo.pdf