OBJECTIVES: Systematic literature reviews (SLR) play a crucial role in health technology assessments (HTA). However, methodological guidance, required outcomes, and reporting of the SLR is often unclear and varies considerably between European (EU) countries. An EU-wide Joint Clinical Assessment (JCA) will become mandatory for new cancer medicines and advanced therapy medicinal products from January 2025. The objective of this study was to conduct a comparative assessment of the current clinical and economic SLR methodological requirements of HTA agencies in larger European markets, as well as the requirements outlined in the proposed JCA submission dossier.

METHODS: Seven HTA agency websites (www.nice.org.uk [England], www.has-sante.fr [France], www.g-ba.de [Germany], www.zorginstituutnederland.nl [Netherlands], www.aifa.gov.it [Italy], www.aemps.gob.es [Spain], www.tlv.se [Sweden]) and the proposed JCA dossier information [www.eunethta.eu/jca]) were searched to identify any specific guidance on the use of SLRs in HTA. Relevant information was extracted and compared.

RESULTS: All seven countries and the JCA require an SLR of clinical data for the technology and its comparators. Only two countries (England and France) request an SLR of economic models for the technology. SLRs of utility, resource use, and cost data were less frequently mandated. Two countries state a clear preference for randomised controlled trials. Most countries recommend searching specific literature databases, most commonly Medline and Embase. Six countries mandate the reporting of details of included and excluded literature.

CONCLUSIONS: While all seven countries require an SLR as part of the HTA submission, a limited consensus was found in terms of SLR requirements. The JCA is not a full HTA and will streamline the clinical evidence submission only, and local agencies can continue to reach their own decisions on relative safety and efficacy. Differences between HTA agency guidance should be a consideration when carrying out an SLR for use in HTA submissions in any of the 27 European markets.