The European Health Technology Assessment Regulation came into effect in early 2022, setting rules for health technology assessment (HTA) in the member states. The EU hopes to get efficiency gains through joint clinical assessments (JCA) organized by the Coordination Group, a newly established, formal body made of national HTA organizations.
Based on the new regulation, the JCA is limited to:
the description of the health problem and the description of current health technology,
the examination of the health technology’s technical characteristics under assessment,
the review of its relative safety and its relative clinical effectiveness.
JCAs will be carried out also for medical devices (MDs) and in vitro diagnostics (IVDs) from January 2025 with a limited scope:
In-vitro diagnostics: under IVDR class D solutions with high levels of both personal and public health risks
The Commission has the right to select further IVDs for the assessment based on the principles of “unmet medical needs,” “first-in-class,” and “EU-wide added value.”
Medical devices: under MDR class IIb active devices and Class III implantable devices, solutions of high novelty, significant major clinical impact and potential risks.
The JCA is planned to be performed by a subgroup of the Coordination Group, under the leadership of an assessor and a co-assessor from the different Member States.
After the scoping process, defining Member States’ needs and involved stakeholders, manufacturers can submit a dossier, followed by a multi-stakeholder assessment, open for public comments. Finally, the Coordination Group will endorse and publish the results. For more detailed diagnostics-specific dossier requirements, please refer to Annex II.
The final report is non-binding, which underscores Member States’ competence to draw their own conclusions and run further assessments on e.g., non-clinical, health economic aspects, potentially leading to local reimbursement decisions.
The new regulation also provides the possibility of early scientific consultations.
The coordinated JCA’s can:
foster the frequency of HTA’s for high-risk and high added value diagnostics
potentially reduce the cost of the individual country-based HTA’s
may lead to faster and more value-based reimbursement and coverage decisions
manufacturers will likely need to invest more in generating high-quality clinical validity and clinical utility evidence
build state of the art market access and clinical capabilities that work hand-in-hand with research, regulatory and commercial functions.