EU HTA: Successfully navigating the methodological framework

New methodological guidance documents

Mon, 2024 / 03 / 25
The development of a detailed framework for the EU HTA process is gaining traction: just shortly after the publication of the first draft Implementing Act on Joint Clinical Assessments (JCA), the Member State Coordination Group (HTACG), which will be responsible for conducting JCAs has endorsed two important additional guidance documents: “Methodological Guideline for Quantitative Evidence Synthesis: Direct and Indirect Comparisons” and “Practical Guideline for Quantitative Evidence Synthesis: Direct and Indirect Comparisons.”. Those will be of central relevance for addressing the PICO scope in the assessment.

In order to address the multitude of PICOs in a JCA, comparative evidence of the new drug against the designated comparators must be provided. In principle, a plethora of study and evidence forms, ranging from statistical comparisons to extensively planned and executed randomized trials, are possible to address a specific PICO question. However, as the quality of the presented evidence will be a central aspect of the assessment on the European level, with implications for the downstream national processes, it is crucial to understand how evidence would need to be generated to be considered of high quality. To address that need, the HTACG Subgroup for Methodological and Procedural Guidance has now issued methodological and practical guidelines for direct and indirect comparisons for quantitative evidence generation. They thereby deliver a binding update to the EUnetHTA 21 deliverables “D4.3.1 Practical Guideline Direct and Indirect Comparisons” and “D4.3.2 Methodological Guideline on Direct and indirect comparisons”.

The documents describe the requirements for methods that are to be used for direct and indirect comparisons, as well as comparisons based on non-randomized evidence, so the assessors will consider the resulting evidence to be of high quality. Since Dr. Beate Wieseler from the German IQWiG is the chair of the responsible subgroup, it comes to no surprise that many of the methodological requirements and frameworks such as indirect comparisons and meta-analyses resemble the strict expectations of the German HTA system. Nevertheless, one has to keep in mind that the decision on the degree of acceptance and “consideration” remains at the national member state.

In order to prepare optimally for the first JCA procedure, it is now not only important for pharmaceutical manufacturers to define the required evidence package based on the anticipated and simulated PICOs in advance, but also to start preparing the evidence that is likely to be required to address the assessment scope, supported by the now published details of the methodological and practical guidance from the two new regulatory documents.

If you are interested in assistance for any of these crucial preparatory steps, SKC is right by your side. We provide the necessary strategic expertise, methodological background, and medical writing performance to make jour first JCA a success. We are the market access special forces.


About the author

Ihr Ansprechpartner  Sebastian  Vinzens
Sebastian Vinzens
M.Sc. Drug Research and Development
Fon: +49 511 64 68 14 – 0
Fax: +49 511 64 68 14 18

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