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JCA is a streamlined EU-level process that evaluates the relative effectiveness and safety of new treatments compared to a range of alternative treatments. It considers a range of relevant treatments across EU member states. The resulting JCA report informs national HTA processes.

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The JCA aims to eliminate inequality across European countries, reduce redundancy in the parallel national HTA processes, increase quality of HTAs across Europe and reduce time to access for patients.

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Jan 2025 mandatory for all new oncology drugs and ATMP’s
Jan 2028 mandatory for orphan drugs
Jan 2030 all drugs registered with the EMA

The cut-off (Jan 2025) is based on the time of application sent to EMA for market authorization.

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Before the dossier submission, a scoping process determines the research question and scope for the dossier (i.e. the PICOs – Population, Intervention, Comparator, Outcomes).
HTA agencies across all EU27 countries submit their requirements for PICO parameters which are then consolidated.

If the treatment landscape differs across Europe the list of required PICOs can turn out very long which creates a high workload for manufacturers who have to provide the analyses in a short time.
The manufacturers will develop and submit the dossier including all pre-specified analyses.
The dossier contains a background section on the disease and treatment landscape and the analyses of relative effectiveness for each PICO.

Based on the submitted material the JCA will be conducted by an assessor and co-assessor and published by the European Commission.

Although the results of the JCA are non-binding, member states must give ‘due consideration’ to the JCA report, meaning the report should be part of the documentation they assess during decision making and they should not re-do any of the analyses.
Additional analyses not covered in the JCA (e.g., additional patient groups or comparators) can be requested.

Many details of the process including exact timelines are still unclear.
The implementing act that is expected to bring clarity to this issue has been delayed from Q4 2023 to Q1 2024.

Get in touch with our Access & Strategy team to discuss how the EU HTA regulation will change the pharma environment.