OBJECTIVES: Requirements for systematic literature reviews (SLRs) within a Health Technology Assessment (HTA) submission vary across the world. The objective of this study is to compare clinical and economic SLR requirements issued by eight HTA agencies in the UK (England and Wales, Wales, Scotland), Ireland, Germany, Sweden, Canada, and Australia.
METHODS: SLR requirements issued by the National Institute for Health and Care Excellence (NICE), All Wales Medicines Strategy Group (AWMSG), Scottish Medicines Consortium (SMC), National Centre for Pharmacoeconomics (NCPE), Gemeinsamer Bundesausschuss (G-BA) (Federal Joint Committee), The Dental and Pharmaceutical Benefits Agency (TLV), Canadian Agency for Drugs and Technologies in Health (CADTH), and Pharmaceutical Benefits Advisory Committee (PBAC) were compared, and a checklist of requirements was compiled.
RESULTS: SLRs of the clinical and economic evidence underpin the HTA process. However, HTA agencies vary on the specific requirements for each and the need for critical appraisal of identified clinical studies and economic analyses. NICE requirements are the most prescriptive, whereas AWMSG and TLV have few stated SLR requirements. All agencies require a clinical SLR, although AWMSG does not specify outright but requires a clinical SLR to determine economic model inputs. Four agencies require both a clinical SLR and critical appraisal of the included studies (NICE, NCPE, G-BA, and PBAC), although recommended appraisal tools vary. NICE and CADTH require both an SLR and a critical appraisal of existing economic evaluations for the intervention of interest; PBAC requires an SLR of only economic evaluations. NICE, SMC, AWMSG, and NCPE require an SLR of utility data, and only NICE and SMC specify the need for an SLR of cost and resource use data. A more detailed analysis of specific methodology requirements will be presented.
CONCLUSIONS: Although SLR requirements vary between HTA agencies, a clinical SLR is a key requirement for all eight agencies investigated.
