OBJECTIVES: Health technology assessment (HTA) is considered a key tool in health care policy decision making. HTA submission requirements for systematic literature reviews (SLRs) vary globally. The study’s objective was to provide a concise overview and comparison of clinical and economic evidence requirements from HTA agencies in Japan, Australia, Canada, US, UK, Scotland, France, Germany, and the new requirements published by EUnetHTA.

METHODS: Comprehensive searches of selected HTA agencies websites were performed in January 2020, extracting and comparing the most methodologically important data, to identify the most up-to-date guidelines for SLRs development used in products’ submissions.

RESULTS: Almost all national HTA agencies require transparent and reproducible SLRs of the clinical evidence. The US agency states that the process of identifying all data used in the model should be clear and systematic, yet no rigorous SLR for clinical assessment is required. Neither is it required in Canada, but the Canadian Agency for Drugs and Technologies in Health (CADTH) reviewers conduct an SLR within the dossier review. However, Japanese guidelines recommend an SLR to identify data on effectiveness, safety and quality of life. EUnetHTA has the most methodologically detailed guidelines, which addresses the needs of the majority of European HTA bodies. Most agencies require a critical appraisal of the included clinical studies, although recommended appraisal tools vary or are unspecified. SLRs of economic evidence are usually not mandatory and only two agencies require an SLR submission of economic models, economic burden, and utilities: National Institute for Health and Care Excellence (NICE) and Scottish Medicine Consortium (SMC).

CONCLUSIONS: Generally, methods used in HTA should be transparent, systematic and rigorous. Although SLR requirements vary between HTA agencies, a clinical SLR is mandatory among almost all of the analysed HTA agencies. Requirement variations of different bodies should be considered before any HTA process.