health technology assessment
Insider Insights

Health Technology Assessment: HTACG provide updates


The ninth meeting of the Member State Coordination Group on Health Technology Assessment (HTACG), established by Regulation (EU) 2021/2282, took place on June 10th, 2024, in Brussels.

Key points from the meeting
  • Guidance adoption: Two guidance documents on joint clinical assessments (JCA) were adopted. These cover outcomes for JCAs and reporting requirements for multiplicity issues and subgroup, sensitivity, and post hoc analyses.
  • Joint scientific consultations: Discussion on the fourth implementing act for JSCs for medicinal products. The process and timelines were aligned with the European Medicines Agency’s scientific advice process, with flexibility for HTA bodies to conduct JSCs alone.
  • Scientific specifications for JCAs: A document outlining the products in scope for JCAs and clarifying scientific specifications for new active substances and cancer treatments was agreed upon.
  • Medical devices joint work: Information on the joint work for medical devices was presented, including selection and processes for JCA and JSC. A dedicated session on medical devices is planned for the next meeting.
  • Emerging health technologies: expected to be subject to JCAs were discussed. The subgroup will present first estimates in June 2025 and an updated report in September 2025.
  • Implementation challenges: Discussion on workload and capacities highlighted the importance of solidarity and suggested involving less experienced countries as observers to build capacity.

Explore the flash report in full detail here.

For the joint clinical assessments under the EU Health Technology Assessment Regulation, two new guidance documents are available:

Guidance for outcomes on joint clinical assessment

The guidance on outcomes for joint clinical assessments will help:

  • Member States’ authorities define the scope of the assessments
  • assessors report all the elements that Member States need for the national appraisal of the clinical added value of health technology.

Guidance on reporting requirements for multiplicity issues and subgroup, sensitivity and post hoc analyses in joint clinical assessments

The guidance on reporting requirements for multiplicity issues and subgroup, sensitivity and post hoc analyses in joint clinical assessments describes how:

  • assessors should deal in practice with multiplicity issues and complementary analyses in joint clinical assessment (JCA) reports. 

Clarification of which types of products will be included in the first wave of EU joint clinical assessment, which begins on 12th January 2025, has also been provided (key point 3). Eligibility should be relatively straightforward for ATMPs: products that meet the requirements of Regulation (EC) No 1394/2007 will be considered to fall into this category. Orphan drugs will be determined on the basis of Regulation (EC) No 141/2000.

Scientific specifications of medicinal products subject to joint clinical assessments

Stay in the know, subscribe to our newsletter

Be the first to receive exclusive content on the latest from the pharmaceutical and market access sector.