Two new guidance documents published for joint clinical assessments in Europe

17 Jun 2024

Written by Joanne Walker

Health technology assessment Medical devices, pharmaceuticals and vaccines News Regulation

The Member State Coordination Group on Health Technology Assessment has adopted two new guidance documents advancing joint clinical assessments in Europe under the EU Health Technology Assessment Regulation.

As implementation of the EU Health Technology Assessment Regulation (HTAR) progresses, the European Commission is swiftly providing national authorities and stakeholders with comprehensive guidance documents. These documents aim to support the effective application of the regulation, ensuring consistent and high-quality health technology assessments across the European Union. Following its ninth meeting on June 10, 2024, the Member State Coordination Group on Health Technology Assessment (HTACG) has adopted and published two new guidance for joint clinical assessments:

Guidance on outcomes for joint clinical assessments: provides advice for Member States in defining relevant outcomes during the scoping process and for assessors and co-assessors in assessing and reporting all the elements that Member States need for the national appraisal of the clinical added value of a health technology.
Guidance on reporting requirements for multiplicity issues and subgroup, sensitivity and post hoc analyses in joint clinical assessments: describes how to deal in practice with multiplicity issues and complementary analyses (such as specific subgroup analyses, specific post hoc analyses and sensitivity analyses) in JCA reports.

In addition, the Commission has provided two more updated resources:

Implementation rolling plan: detailing the key activities completed or planned by the Commission in preparation for the implementation of the HTAR.
Scientific specifications of medicinal products subject to joint clinical assessments document: clarifying the characteristics of ‘new active substance’ and ‘therapeutic indication of treatment of cancer’ to determine if a medicinal product will be subject to JCA between January 12, 2025 and January 13, 2030.