Proposed Methodologies For EU Joint Clinical Assessment Are Threat To ATMPs and Rare Disease Patients

The legislation

EU-level joint clinical assessments (JCAs) are similar to relative efficacy assessments and are part of the HTA Regulation ((EU) 2021/2282) aimed at increasing cooperation on heath technology assessment across Europe and reducing duplication of work to improve access to medicines. The regulation was signed off in January 2022 but does not become applicable until January 2025, when advanced therapy products will become the first medicines to be subject to a JCA. (Also see "The Implications Of The New EU HTA Regulation For Companies" - Pink Sheet, 30 March, 2022.)

Companies will be paying close attention to how the JCAs take shape: although the outcomes are not binding, HTA or pricing and reimbursement bodies in the EU member states have to take them into account in their decision making

The EUnethHTA 21 Consortium has proposed methods for conducting the JCAs set out in a number of “deliverables,” These will influence the final methods to be selected by the HTA Coordination Group, which oversees the JCAs.

However, according to ARM, the proposals “are unable to capture the full added clinical benefit of ATMPs