Advancing EU Health Technology Assessment: Key Priorities in the HTACG Draft Annual Work Programme 2026
How will the EU Health Technology Assessment framework evolve in 2026 to improve clinical evaluations for cancer treatments and advanced therapies? The EU Health Technology Assessment (HTA) initiative coordinates standardized reviews of medicines and devices across Member States, thereby boosting efficiency and patient access. The HTACG Draft Annual Work Programme 2026 outlines key priorities under the HTA Regulation, including joint clinical assessments (JCAs) and fee-free scientific consultations, while this roadmap targets JCAs for oncology products and advanced therapy medicinal products (ATMPs), with device assessments starting in June. By streamlining processes in this way, it reduces duplication and speeds up innovation delivery.
HTACG Draft Annual Work Programme 2026
The HTACG Draft Annual Work Programme 2026 focuses on joint clinical assessments for cancer therapies and ATMPs, as the plan projects 35 JCAs for new cancer treatments and forecasts 15 for ATMPs, while initial device assessments begin in June 2026. Stakeholders can expect 8-12 joint scientific consultations (JSCs) for medicines and should plan for 2-5 for devices, which supports unified HTA through hybrid meetings that enhance stakeholder input, and IT platforms will improve to drive health tech innovation.
The HTACG programme advances EU Health Technology Assessment by expanding its scope and refining methods for health innovations, such as:
- Expansion to Medical Devices: The HTACG will start about 5 JCAs on key devices, which follows the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) while aligning with HTAR Articles 7(1)(c) and (d), and the focus remains on high-impact technologies.
- Scientific Consultations and Stakeholder Involvement: JSCs stay fee-free with submission windows in January-February, April, June-July, and September-October 2026, which boosts early developer ties, and the HTA Stakeholder Network plans two in-person meetings in June and October, while patient and clinician views feed in via working groups.
- No Immediate Updates or Voluntary Assessments: 2025 JCAs are too new for 2026 updates, so voluntary work under Article 23 pauses due to workloads, and a group will study future options.
Implications
How does the 2026 HTACG programme shape health economics and research in the EU? It standardizes evaluations to aid national agencies and may cut redundant studies, while reimbursement for cancer and ATMPs could speed up since these face high costs and uneven access. In economic terms, 35-50 JCAs target oncology with shared work that lowers costs, and fee-free JSCs help early evidence so developers can align trials with EU needs.
FAQ
What is the role of EU Health Technology Assessment in coordinating cancer treatment evaluations?
EU Health Technology Assessment standardizes joint clinical assessments across Member States, as it focuses on 35 JCAs for new oncology products in 2026 to reduce duplication and improve patient access to innovative therapies (European Commission, 2024).
How will advanced therapy medicinal products be assessed under the 2026 programme?
The programme plans 15 JCAs for ATMPs that build on EMA trends and horizon scanning, while fee-free scientific consultations aid early planning to streamline approvals for cutting-edge treatments like gene therapies.
When do medical device assessments begin in the EU HTA framework?
Selected device JCAs start in June 2026 with about 5 targeted under MDR and IVDR, which marks the first expansion to devices in EU Health Technology Assessment.
