OBJECTIVES: Member-state HTA bodies across the European Union (EU) have different SLR methodology requirements. EUnetHTA and JCA have recently established a new set of evidence requirements. This review updates the 2022 landscape mapping of HTA requirements for SLRs to contrast differences in requirements between JCA and country-level HTA bodies.

METHODS: Guidance from EUnetHTA and JCA, and the most up-to-date clinical SLR requirements issued by France (HAS), Ireland (NCPE), Sweden (TLV) Germany (G-BA), were reviewed. The methodological requirements extracted included search strategy, search time-period, study design, database specifications, study selection process, quality assessment and language.

RESULTS: All agencies, except TLV, provide guidance on search time-period and study design. The search time-period should not be restricted and should be undertaken within 3-6 months prior to HTA (3 months for JCA and G-BA). All agencies require inclusion of randomised controlled trials (RCTs). Non-RCTs and observational studies are accepted by NCPE, HAS, EUnetHTA and JCA (although JCA highlight limitations of observational studies), but are rarely accepted by G-BA (only in exceptional cases). HAS, G-BA, JCA and EUnetHTA specify search databases, commonly including MEDLINE®, Embase® and Cochrane® CENTRAL (JCA recommend MEDLINE® and CENTRAL®). NCPE and G-BA recommend searches in both English and non-English languages. JCA requires information, such as included studies and eligibility criteria to be listed for each Patients, Intervention, Comparator, Outcome, Study design (PICOS) combination in scope.

CONCLUSIONS: SLR requirements at pan-EU HTA/JCA level are largely aligned with member-state HTA requirements. Important differences for JCA SLRs include searches to be conducted within 3 months from submission, inclusion of non-RCTs (observational studies in specific cases) and strict reporting of methods by PICOS criteria. The extensive scope and methodological rigor required for a pan-EU JCA SLR will necessitate integration of technological advances (such as artificial intelligence) to facilitate evidence generation.