The evolution of the European Union’s Health Technology Assessment (EU HTA) is marking a pivotal phase with the roll-out of advanced methodological guidance aimed at enhancing the quality and reliability of health technology evaluations. Following the notable issuance of the preliminary draft Implementing Act on Joint Clinical Assessments (JCA), a significant milestone was achieved with the Member State Coordination Group (HTACG) — the body tasked with overseeing JCAs — giving its stamp of approval to two fundamental guidance documents. These key documents, “Methodological Guideline for Quantitative Evidence Synthesis: Direct and Indirect Comparisons” and “Practical Guideline for Quantitative Evidence Synthesis: Direct and Indirect Comparisons,” are poised to play a crucial role in navigating the intricate Population, Intervention, Comparator, and Outcomes (PICO) framework integral to assessments.
The process of Joint Clinical Assessments mandates the submission of comparative evidence of a new medication against established comparators, spanning from statistical analyses to detailed randomized trials, tailored to address specific PICO inquiries. With a pronounced focus on the caliber of evidence for assessments at the European level and its subsequent implications on national decision-making processes, grasping the essentials of generating high-quality evidence becomes indispensable. Catering to this requisite, the HTACG Subgroup for Methodological and Procedural Guidance has undertaken the initiative to publish updated methodological and practical guidelines for the synthesis of direct and indirect evidence, thereby revising and enhancing the former EUnetHTA 21 guidelines.
Setting the Bar High: New EU Health Technology Assessment Guidelines and the Path to Quality Evidence Evaluation
Elaborated within these guidelines are the methodologies applicable for direct and indirect comparisons, including those based on non-randomized evidence. The objective is clear: to ensure that the evidence presented is recognized as of high quality by assessors. Dr. Beate Wieseler, the esteemed chair of this subgroup and a prominent figure from the German Institute for Quality and Efficiency in Health Care (IQWiG), has significantly shaped these guidelines to mirror the rigorous standards of the German Health Technology Assessment framework. However, it’s crucial to acknowledge that the level of evidence acceptance and consideration ultimately lies within the purview of individual member states.
In light of these developments, pharmaceutical entities are urged to proactively delineate and compile their evidence packages in readiness for the inaugural JCA procedure. This preparation involves a strategic alignment with the newly published methodological and practical guidance encapsulated in the regulatory documents. Such proactive measures are not only a testament to the evolving landscape of EU Health Technology Assessment but also underscore the collaborative efforts aimed at ensuring the efficacy, safety, and economic viability of new health technologies within the EU.
Resource: Schönermark Kielhorn Collegen, March 25, 2024
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