Insights on Joint Clinical Assessment for HTA in the EU

A CIRS-Utrecht University workshop explore different stakeholders’ early experiences of Joint Clinical Assessment (JCA), considering practical implementation of JCA outputs into national HTA decision making.

Background

Since January 2025, national HTA agencies, industry and other stakeholders have been actively adapting to a new era of Joint Clinical Assessment (JCA) of medicines under the EU HTA Regulation. The aim is to reduce duplication, improve consistency, and enhance efficiency across EU Member States. However, the successful integration of JCA outputs into national decision making remains an evolving challenge.

Building on insights from the CIRS JCA workshop in 2024, this workshop explored different stakeholders’ experiences of early JCAs in oncology and advanced therapy medicinal products (ATMPs), looking deeper at the challenges of post-JCA transition at the national level.

EU HTA agencies, industry, patient organisations, payers, academics, the European Medicines Agency and European Commission were brought together to examine how Member States are adapting their HTA processes to integrate JCA outputs into decision making. The aim was to make recommendations on how to facilitate practical implementation of JCA outputs and improve the efficiency and effectiveness of JCA.

Key learnings and recommendations from the workshop

PICO coordination

Developers require earlier and broader PICO discussions, with clearer communication of national needs.
JCA reports should transparently reflect uncertainties, such as evidence gaps for informing specific PICOs and potential lack of robust or recent clinical trials.

EMA-HTA collaboration

EMA shares major clinical objections with JCA subgroups without narrative commentary.
Operational and evidence level collaboration will continue to be strengthened through workshops, daily coordination with the HTA Secretariat, and follow up work with the HTA Coordination Group.

Capacity building

Maturing HTA agencies continue to strengthen internal JCA capability by leveraging external expertise and receiving Commission technical support to update national HTA processes and methods.
HTA Regulation training and capacity building for all stakeholders should be implemented and regularly updated.

Feedback loops

Systematic evaluation of early JCA experiences is needed to refine methods, guidance, and address recurring challenges.
Trust and transparent communication between stakeholders are key.
CIRS research will continue to quantify timelines from regulatory approval to patient access.

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