OBJECTIVES: In order to support Health Technology Assessment (HTA) co-operation across Europe, the amended Directive 2011/24/EU of the European Commission (EC) 2018 Proposal for a Regulation on joint work, by harmonising clinical outcomes domains, has been put forward. One of the joint work pillars are joint clinical assessments (JCAs), currently the EUnetHTA has published methodological guidelines to support relative effectiveness assessments (REAs). This research explores the development of a Critical Review Framework (CRF) to appraise these guidelines and applicability for JCAs.

METHODS: The CRF was developed following an iterative process. Firstly, a targeted literature search was conducted to identify current state-of-the-art HTA methods on a pilot topic (network meta-analysis). Secondly, key publications and existing guideline review frameworks, checklists and best practices were identified and reviewed.

RESULTS: Two review themes, with multiple domains in each, were developed in the CRF; the ‘General Guideline Appraisal’ domains outline key guiding questions on the scope and purpose, comprehensiveness, clarity and presentation and applicability of the reviewed guidelines (e.g., addressing practical decision making and variation in practice among HTA bodies). The ‘HTA-topic specific assessment’ domains include questions relating to the appropriateness of the guideline methods relative to the current state-of-the-art HTA methods, uncertainty characterisation and generalisability, transferability, and feasibility of the guideline methods (e.g., assessing different evidence types). Two overarching summary questions were also included to assess how the guidelines promote consistency in evidence assessment across HTA bodies in Europe, and to what extent the guidelines support predictability in the methods used in REAs.

CONCLUSIONS: The developed CRF allows an independent assessment of the existing EUnetHTA methodological guidelines with a consistent and thorough approach that is supported by insights from previously published review frameworks. The outcomes from the use of this framework may inform the public debate on methodological guidance for future JCAs.