EU joint HTA estimated activity in 2025 following the new HTA Regulation
Based on the 2025 Work Programme - Member State Coordination Group on HTA (HTACG) we can expect in 2025:
EXPECTED NUMBER OF JOINT CLINICAL ASSESSMENTS
Based on information from the Subgroup for the Identification of Emerging Health Technologies and health technology developers (HTDs), the HTACG estimates that there will be 17 joint clinical assessments (JCAs) for new cancer therapies and 8 for advanced therapy medicinal products (ATMPs) in 2025. If an ATMP has an oncology indication, it will be counted as a cancer therapy. No updates to JCAs are expected in 2025.
JOINT SCIENTIFIC CONSULTATIONS
The HTACG is planning to initiate 5-7 joint scientific consultations (JSCs) for medicines and 1-3 for medical devices in 2025. This offering will be gradually increased in the coming years. HTDs will be able to submit JSC requests during the following periods:
• 3rd February to 3rd March 2025 for medicinal products only.
• 2nd to 30th June 2025 for medicinal products and medical devices.
The submission of requests for JSCs will happen through the secure HTA IT platform, using the dedicated template for JSC requests. This template will be available in December 2024 on this webpage.
MEDICAL DEVICES
No JCAs on medical devices will be conducted in 2025, but HTDs will be able to submit requests for JSCs in the second half of the year.
HTA STAKEHOLDER NETWORK
Members of the HTA Stakeholder Network (especially patient organisations and health professionals’ associations) will be invited to propose individual experts to contribute to product-specific JCAs and JSCs and, where appropriate, provide input on the disease and therapeutic area in the context of JCAs and JSCs.
VOLUNTARY COOPERATION
Potential topics for discussion in the work stream on voluntary cooperation have been identified. Given the workload of implementing joint HTA, no work on voluntary cooperation is expected in 2025.
EVOLUTION OF JOINT HTA
The Subgroup for the Development of Methodological and Procedural Guidance (MPG SG) will gather information on lessons from JCAs and JSCs for the potential update of methodological guidance documents.
HORIZON SCANNING
The Subgroup for the Identification of Emerging Health Technologies (EHT SG) will continue to develop intelligence and strategies/methods to gather information about emerging health technologies. The subgroup’s annual report will inform the Annual Work Programme for 2026.
FREQUENCY OF MEETINGS
Meetings of the HTACG may be split into parallel sessions (one for medical devices and one for medicinal products) to allow for more detailed discussions on the two types of health technologies. The HTACG will hold two quarterly meetings in the first half of the year and may increase the frequency of meetings to monthly (in virtual format) in the second half of the year depending on the number of JCAs and JSCs initiated and the need for timely HTACG decisions.
The JCA and JSC subgroups will meet monthly, except in August. The MPG SG and EHT SG will meet every two months. If necessary, the subgroups may revise their terms of reference.
Regulation on health technology assessment Regulation (EU) 2021/2282
Health technology assessment - Key documents
Commission implementing regulations and guidance
Flash report - Member State Coordination Group on HTA (HTACG) (28 November 2024)