OBJECTIVES: An integral part of a health technology assessment (HTA) is a systematic literature review (SLR); an unbiased, high-quality synthesis of available evidence. For many HTA agencies, guidance on data sources, methodology, required outcomes, and reporting of the SLR varies considerably. The objective of this study was to conduct a comparative assessment of the clinical and economic SLR methodological requirements of HTA agencies in different countries around the world.

METHODS: We searched eight HTA agency websites (www.pbs.gov.au [Australia], www.cadth.ca, [Canada], www.nice.org.uk [England], www.has-sante.fr [France], www.g-ba.de [Germany], www.zorginstituutnederland.nl [Netherlands], www.ace-hta.gov.sg [Singapore], www.tlv.se [Sweden]) to identify guidance on the use of SLRs in HTA. Relevant information was extracted and compared.

RESULTS: All eight countries require an SLR of clinical data for the technology and its comparators. A quality assessment of included studies and critical appraisal of randomized and non-randomized clinical trials is also requested. Only three countries (Australia, England, and France) requested an SLR of economic models for the technology, with the latter two also requiring a critical appraisal of the models. SLRs of utility, resource use, and cost data were less frequently mandated, with only NICE in England suggesting the inclusion of an SLR of utility data. The most stringent requirements were found in England and France.

CONCLUSIONS: While all eight countries require an SLR as part of the HTA submission, a limited consensus was found in terms of SLR requirements. The specific requirements for conducting SLRs in HTAs vary globally due to differences in regulatory frameworks, healthcare systems, and decision-making processes. Differences between HTA agency guidance is a consideration when carrying out an SLR for use in HTA submissions in global markets. Efficiencies in conducting SLRs that can fulfil the requirements for several HTA bodies can be made with strategic planning.