Presentation (CTI)

OBJECTIVES: With the growing number of innovative therapies entering the market, health technology assessment (HTA) submissions across Europe increasingly require robust evidence to support reimbursement decisions. This critical review aims to compare methodological guidance on economic and utility systematic literature reviews (SLRs) issued by key European HTA agencies, to inform best practices for future submissions.
METHODS: Guidance documents outlining methodological recommendations for economic SLRs (including cost, healthcare resource use [HCRU], and economic evaluations) and utility SLRs were reviewed from HTA agencies in England and Wales (NICE and SMC), France (HAS), Ireland (NCPE), Sweden (TLV), and Germany (G-BA).
RESULTS: Economic evaluation SLR is explicitly recommended by NICE, SMC, and HAS, with NICE being the only agency providing detailed guidance on search strategies and eligibility criteria. Requirements for study design, electronic databases (to be searched), and the study selection process were not specified by any of these HTA bodies. Quality assessment is recommended by NICE and HAS, both recommending the Drummond and Jefferson checklist. SLR for cost and HCRU is only required by NICE. SMC and NCPE do not mandate a formal SLR but emphasise the need for systematic, transparent, and justified approaches to identifying cost and HCRU data. Utility SLR is recommended by NICE, NCPE, and HAS, with HAS being the only agency requiring a formal quality assessment of included studies.
CONCLUSIONS: There is considerable heterogeneity in the methodological requirements for the economic and utility SLRs across European HTA bodies. The lack of standardised guidance could lead to variability in the methodology used for these SLRs. These findings highlight the importance of developing harmonised guidelines or establishing gold standards for conducting such SLRs.