Health Technology Assessment: two new guidance documents published

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

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

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. 

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. 

These approaches impact how different Member States consider specific methodological issues. Therefore the guidance will enable Member States to draw their conclusions on these analyses at the national level.

Both guidance documents are relevant to health technology developers' preparation of the appropriate analyses and information to be submitted to the assessment.

The Member State Coordination Group on Health Technology Assessment adopted the two guidance documents at its 9th meeting on 10 June 2024.

In addition, an information document is made available online to clarify the scientific specifications of ‘new active substance’ and ‘therapeutic indication of treatment of cancer’ to determine if a medicinal product shall be subject to JCA between 12 January 2025 and 13 January 2030.

More information

• Guidance by the Member State Coordination Group on Health Technology Assessment