OBJECTIVE: Rigorous systematic literature reviews (SLRs) are common requirements within health technology assessment (HTA) reimbursement submissions globally. No national HTA agency exists in the United States (US); however, the Academy of Managed Care Pharmacy (AMCP) guidelines are generally used as standard guidance for submissions to payers within the US. We compared literature review requirements for reimbursement submissions in Europe, Canada, Australia, and the US.
METHODS: Submission guidance from eight HTA agencies – the National Institute for Health and Care Excellence (NICE; England and Wales), Scottish Medicines Consortium (SMC; Scotland), National Centre for Pharmacoeconomics (NCPE; Ireland), National Authority for Health (HAS; France), Federal Joint Committee (G-BA; Germany), Dental and Pharmaceutical Benefits Agency (TLV; Sweden), Canadian Agency for Drugs and Technologies in Health (CADTH, Canada), Pharmaceutical Benefits Advisory Committee (PBAC; Australia)– and the AMCP Format for Formulary Submissions (US) were reviewed and compared.
RESULTS: All national HTA agencies require an SLR of the clinical evidence; NICE, SMC, NCPE, HAS, G-BA, and PBAC also require a risk of bias assessment of the included clinical studies. Some agencies provide specific guidance regarding databases searched, study selection, and risk of bias checklist. Additionally, NICE, HAS, and CADTH require SLRs and critical appraisal of economic evaluations. In contrast, a rigorous SLR of neither clinical nor economic evidence with a replicable protocol is specifically mentioned in the AMCP guidance. In the AMCP format, it is the manufacturer’s responsibility to define objective criteria for study selection, explaining the exclusion of specific evidence via a search strategy or CONSORT diagram.
CONCLUSIONS: Requirements for literature reviews for reimbursement submissions vary globally. Although most national HTA agencies require rigorous clinical SLRs and some require economic SLRs, within the US, manufacturers generally define the inclusion/exclusion criteria for clinical and economic evidence submitted for review to payers.
