Key details unveiled ahead of EU HTA Regulation deadline

The newly adopted HTACG Annual Work Programme 2025 outlines the next strategic steps for implementing the EU Health Technology Assessment Regulation (HTAR).

As the implementation of the EU HTA Regulation (Regulation 2021/2282) approaches its January 12, 2025 deadline, significant new details have emerged regarding the scope of activities planned for 2025. These updates follow the 11th Meeting of the Member State Coordination Group on HTA (HTACG), chaired by Roisín Adams (National Centre for Pharmacoeconomics, Ireland), and co-chaired by Marco Marchetti (National Agency for Regional Healthcare Services, Italy) and Niklas Hedberg (Dental and Pharmaceuticals Benefits Agency, Sweden). At this pivotal meeting, the HTACG formally adopted the HTACG Annual Work Programme 2025 alongside several key guidance documents. These include guidance on the scoping process, procedural steps, and timelines for joint clinical assessments (JCAs) of medicinal products, and the selection criteria for joint scientific consultations (JSCs).

Key highlights of the HTACG Annual Work Program 2025

JCAs – Depending on the number of formal marketing authorization submissions to EMA, the HTACG expects to conduct 17 assessments for cancer treatments and 8 for advanced therapy medicinal products (ATMPs), focusing on medicines containing new active substances. While medical devices will not undergo JCAs in 2025, groundwork is being laid for future assessments, with the JCA subgroup taking a lead role in developing selection criteria.

JSCs – The HTACG plans to initiate 5–7 JSCs for medicinal products and 1–3 for medical devices, with consultations taking place in two submission periods: February–March and June. These initial steps are part of a gradual expansion over coming years.

Emerging health technologies (EHT) – The EHT subgroup will focus on horizon scanning to identify and monitor emerging innovations, producing an annual report to guide future HTA priorities. This report will shape the HTACG Work Program for 2026 and beyond.

Stakeholder engagement – The HTACG will actively engage with the HTA Stakeholder Network (HTA SN), which includes patient organizations and professional associations. Stakeholders will provide insights into disease areas and nominate experts to participate in assessments. Two face-to-face meetings are planned for 2025, supplemented by webinars to raise awareness about JCA and JSC processes.

Data exchange – A secure HTA IT Platform will act as the central hub for managing assessments and consultations, available to designated representatives of the HTACG, its subgroups, and members of the HTA SN. Designed to uphold confidentiality and facilitate secure collaboration, the platform will allow developers to inform the HTA Secretariat of planned marketing authorization applications. Furthermore, a new referencing tool to support the drafting of scientific reports is scheduled for pilot testing.

As the implementation of EU HTAR progresses, more and more details from the rolling plan are expected. Become a member of The Evidence Base to receive the latest news about EU HTAR straight to your inbox.