Joint Clinical Assessment (JCA) came into force in January 2025. One year on, real-world experience remains limited, with no JCA yet endorsed/completed.
As of early March 2026, no JCAs have been completed; 13 are ongoing and one has been discontinued. The Health Technology Assessment Coordination Group (HTACG) 2025 Annual Report indicates that tovorafenib (paediatric low-grade glioma) is the only product for which the dossier has been confirmed, and its assessment phase is currently underway. Germany’s Institute for Quality and Efficiency in Health Care (IQWiG), acting as the co-assessor for this JCA, has noted an expected completion date in Q2 2026.
2025: Forecast vs Reality
In the 2025 Annual Work Programme (AWP), HTACG had estimated that it would initiate 17 JCAs for oncology medicinal products (MPs) and 8 JCAs for advanced therapy medicinal products (ATMPs) (with any ATMPs indicated for the treatment of cancer to be counted among the 17 JCAs planned for cancer medicines), implying a total maximum of ~ 25 JCAs. However, in practice in 2025, a total of 13 JCAs were initiated (including one that was later discontinued). Thus, in the first year of JCA implementation, actual delivery fell below the initial estimates, potentially suggesting a more cautious rollout than initially anticipated.
2026 forecasts: Step change in ambition
Looking ahead, the 2026 AWP suggests a total maximum of ~ 58 JCAs for 2026, with the HTACG estimating it may potentially initiate ~ 35 JCAs for oncology MPs, ~ 15 JCAs for ATMPs, ~ 3 JCAs for variations, and ~ 5 JCAs for selected medical devices. This represents a significant step-up in projected JCA numbers, both relative to the 2025 forecasts and relative to the number of JCAs actually initiated in 2025. Consequently, 2026 may represent the first real test of JCA at scale.
Why the slow start?
- Manufacturers may have adopted a cautious, “wait-and-see” approach as the first JCAs unfold, allowing more time to navigate procedural uncertainty and to prepare accordingly.
- The substantial uncertainty that came from recent US policy developments (particularly Most Favoured Nation, MFN) may have also impacted manufacturers’ Marketing Authorisation Application / launch plans.
- A steep, system-level learning curve may be expected, both for manufacturers and Health Technology Assessment (HTA) bodies, as stakeholders begin to implement the guidance in practice during the initial wave of JCAs.
What remains to be seen?
- How the system operates in practice, including PICO (Population Intervention Comparator Outcome) consolidation and evidence interpretation
- How national HTA agencies use JCA reports within their national reimbursement frameworks
- The influence/role of assessors & co-assessors
- The impact of early choices made by manufacturers (e.g., around evidence generation, clinical trial designs)
- Whether JCA can meet its promise of accelerating HTA adoption
- The spill over effects on ex-EU markets
With multiple stakeholders still in watchful waiting mode, there remains an opportunity to push forward with scenario-based research & development planning, move ahead of the curve and achieve a competitive edge for the asset.
At GPI, we support companies in effectively translating emerging JCA expectations into their pricing & reimbursement strategies, optimising evidence generation, preparing for subsequent national access pathways and refining launch strategy.
As the first completions approach and national agencies begin to signal how they’ll use JCA outputs, the decisions manufacturers make now will shape their access trajectories for years to come.
With 58 JCAs projected for 2026, the window to get ahead is narrowing. GPI’s pricing & reimbursement specialists can map your asset against the evolving JCA landscape, before early outcomes lock in the playbook for everyone else.
Book a strategy session →
Sources: European Commission (02 March 2026). List of JCAs; European Commission (2026). HTACG Annual Report 2025; IQWiG. European HTA (Accessed 04 March 2026); European Commission (2024). HTACG Annual Work Programme (AWP) 2025; European Commission (2025). HTACG Annual Work Programme (AWP) 2026.
