Navigating the New European Member State Coordination Group on Health Technology Assessment Quantitative Evidence Synthesis Guidelines

Speaker(s)

Shukla P1, Paly V2, Proskorovsky I3, Hernandez LG2
1Evidera, a part of Thermo Fisher Scientific, London, LON, UK, 2Takeda Pharmaceuticals America, Inc., Lexington, MA, USA, 3Evidera, a part of Thermo Fisher Scientific, Madrid, Spain

Presentation Documents

OBJECTIVES: The establishment of a framework for the European Health Technology Assessment (HTA) process is gaining momentum. Following the release of the initial draft Implementing Act on Joint Clinical Assessments (JCA), the Member State Coordination Group on HTA (HTACG) published two pivotal guidance documents: “Methodological Guideline for Quantitative Evidence Synthesis: Direct and Indirect Comparisons” and “Practical Guideline for Quantitative Evidence Synthesis: Direct and Indirect Comparisons.” As these guidelines play an important role in addressing the PICO questions in JCAs, our aim was to review and map of these documents into a practical decision algorithm to inform JCA dossier preparation planning.

METHODS: We conducted a comprehensive review of the HTACG Quantitative Evidence Synthesis Guidelines on Direct and Indirect comparisons. Key criteria, methodological requirements, recommendations, preferences, and reporting requirements specified by HTACG were identified and used to build a step-by-step flowchart for decision processes based on specific context and level of evidence availability, presenting the information in a simplified and accessible manner.

RESULTS: The decision nodes in the flowchart are based on key factors such as number of comparator studies, type of network, validity of exchangeability assumption, possibility of anchored comparisons, and presence of full or limited individual patient data. The review covers a comprehensive suite of methodological approaches for direct comparison, indirect comparisons, population adjustment methods, and comparisons based on non-randomized evidence, highlighting which methods are considered best practice, conditionally accepted, or not advised by the HTACG.

CONCLUSIONS: The proposed decision algorithm synthesizes HTACG guidelines, providing a valuable tool for researchers and practitioners. It enhances the transparency, consistency, and credibility of evidence synthesis, aligning with HTACG's emphasis on high-quality evidence. Furthermore, it highlights outstanding challenges to be addressed in the new HTA process, particularly where the available methods to answer a specific PICO question are not advised.

Code

PT30

Topic

Study Approaches

Topic Subcategory

Meta-Analysis & Indirect Comparisons

Disease

No Additional Disease & Conditions/Specialized Treatment Areas