Are Member States Ready for the EU HTA Regulation?

With a January 2025 deadline for full implementation, we ask how ready member states are to comply with the EU HTA Regulation.

Last month, Lumanity’s Suzette Matthijsse and independent consultant, Neil Grubert, hosted a webinar on the EU Health Technology Assessment Regulation (EU HTA-R), 1 year and a day before the Regulation would start to apply to new oncology medicinal products and advanced therapy medicinal products. We were humbled to see the large number of attendees from all around the world (Figure 1). This really showed how involved different countries, including countries outside the EU, are in the European health technology assessment (HTA) landscape. The high level of audience engagement was also much appreciated; the attendees responded to our polling questions and submitted their own questions. This article highlights a key theme that stood out from the Q&A section: Being prepared.

Figure 1: Attendees from around the globe attended the webinar

Awareness and confidence in the EU HTA-R

To gauge awareness of the EU HTA-R in November 2022, Lumanity conducted a survey of attendees at the ISPOR Europe conference. At our webinar in January 2024, we asked some of our survey questions again to see how this awareness had changed as we approach the first implementation deadline. The results were interesting, although ‘shocking’ might be a better description. Acknowledging that we did not poll the same people as during the survey at ISPOR, the picture is quite grim as you can see from the results below:

How ready are Member States?

There was considerable interest relating to preparedness at the Member States’ level. We have been closely following ‘From Theory to Practice’ sessions hosted by the European Commission (EC) that bring together key stakeholders, including national HTA administrators who have been presenting their preparedness and challenges and opportunities in the implementation process.

Please see our interactive map below for a summary of national perspectives shared to date in terms of EU HTA-R readiness scores (out of 10), key challenges and opportunities, key changes, and local planning status. Key challenges and opportunities identified by multiple markets included:

• Potential for better collaboration
• Potential for efficiencies in the longer-term but an expected added burden in the short-term
• Resource and capacity concerns relating to contribution to Joint Scientific Consultation (JSC) and Joint Clinical Assessment (JCA) expectations in parallel to national assessment needs
• Potential for improved quality of clinical evidence package and clinical HTA
• Potential for improved and more equal access to innovative medicines across the EU
• Timeline concerns relating to expedited and / or parallel timings vs national assessment
• Outstanding lack of clarity and guidance with final methods guides and implementing acts still yet to be published and resulting inability to adequately plan at national level

Delayed implementation acts

Critical to this final point, according to the EC’s latest update to the rolling plan for implementation of the EU HTA-R, most of the implementing acts have been delayed by 3–6 months. Such delays raise questions about preparedness for the start of JCA in January 2025.

Probably the most important – and most urgent – implementing act is the one that will define the terms for JCAs of medicinal products. In previous updates, the EC indicated that this act would be published in Q4 of 2023. That deadline has now slipped to Q1 of 2024, but there are less than 5 weeks to reach that critical milestone.

The implementing acts on managing conflicts of interest and the exchange of information with the European Medicines Agency timelines have also been extended. They were previously due to be published in Q1 of 2024 but deadlines have now to Q2-Q3 of 2024. It is thus possible that these issues might not be resolved until some three months before the start of the JCA process.

Work on the three other implementing acts has not yet begun. The implementing act on JSCs for medicinal products may still be published in Q2 of 2024, as previously announced, but could slip back to Q3 of 2024. The act on JSCs for medical devices has been delayed from Q3 of 2024 to Q4 of 2024, aligning to the planned publication of the act on JCAs for medical devices (Q4 of 2024).

Having the implementing acts in place will be crucial for HTA agencies and pharmaceutical companies in terms of preparing for the start of the JCA and JSC processes, and for Member States to adequately plan at national level as flagged. The deadline for the start of JCA in January 2025 will not change so we have a busy time ahead. Please contact the Lumanity team for more information on how we can help with your own preparations and for any more detailed insights to some of the national HTA preparations reported to date.

The authors would like to thank Victoria Palmer and Norma Beavers for their support in creation of this view article.