Which Criteria are Considered and How are They Evaluated in Health Technology Assessments? A Review of Methodological Guidelines Used in Western and Asian Countries.

Objectives This study aimed to provide an exhaustive description of criteria and methodological recommendations for evaluating them in health technology assessment (HTA) in Western and Asian countries. Methods We conducted a system literature review of HTA-related guidelines by searching the websites of HTA agencies and related data sources. The guidelines, reports, or recommendations introducing the HTA evaluation methods, processes, decision-making frameworks, and criteria for priority setting were eligible to be included. The review was limited to guidelines from countries belonging to the European Network for Health Technology Assessment (EUnetHTA) and HTAsiaLink organisations and other countries with well-established available guidelines. Results A total of 52 guidelines from 24 countries were identified, including 13 countries from the EUnetHTA organisation, 9 countries from the HTAsiaLink organisation and 2 other countries (Canada and the USA). A strong consensus was observed among the HTA agencies on the core set of criteria including efficacy or effectiveness, cost-effectiveness, safety, and budget impact. More similarities were observed than differences in methodological recommendations for clinical and economic evaluations among the agencies. Conclusions Substantial convergence is seen in the criteria included in the HTA process, as well as the methods to evaluate and quantify them. Further efforts are needed to verify whether the criteria identified from the guidelines are incorporated in real HTA decisions, and how they are assessed and weighted in practice.