The Cancer Drug Development Forum (CDDF) held a live webinar on “Perspectives on the new EU Health Technology Assessment HTA Regulation 2021/2282 “ on Thursday 28 September 2023. In this webinar, Marcus Guardian and Julie Spony provided an overview of the topic followed by a Q&A session moderated by Axel Glasmacher. Here are the key takeaways:
- In 2021 the European Union approved a regulation to improve access for patients to innovative healthcare technologies in EU member states. It entered the implementation phase in 2022 and will be applied from 2025 on. The first therapeutics to be selected for review will be anticancer therapeutics
- According to the regulation a coordination group driven by the EU member states will be formed. Subgroups will perform the Joint Clinical Assessment of new medicines and issue Joint Assessment Reports that will summarize the evidence but not give recommendations for pricing or reimbursement. The EU member states remain solely responsible for the final decisions on these. It is not yet clear how the member states will process the Joint Assessment Reports and how patient and clinician expertise will be integrated at this level.
- External experts, incl. individual patient and academic experts, will be able to provide input into the product assessment. While stakeholder organisations like patient advisory groups or scientific societies can only provide input into non-product questions. This was debated in the webinar and further clarification is expected.
- In the implementation process questions remain to be answered include how to select new healthcare technologies for the joint assessment, the application modalities etc.
- The increased input from patients is seen very positively. However, there remain several open questions regarding the Conflict-of-Interest rules for patient experts, their remuneration or availability as well as the role of patient advisory groups in addition to individual patients.
- Concerns were raised regarding the challenge of harmonization of the assessment between the EU member states as previous experiences demonstrated wide variations of assessment in key parameters.
- Future applicants are advised to seek joint consultations, to closely follow the update reports on implementation on the resp. EU website, and to prepare sufficient resources for the application and for responses within the tight timelines during the assessment.
- The discussants appeal to all stakeholders to collaborate closely already during the implementation phase to achieve the joint objective of wider and faster patient access to novel healthcare technologies through a single assessment of the evidence at the EU level.