This project aimed to identify methodological issues reported by Evidence Review Groups (ERGs) in the systematic reviews (SR) supporting single technology appraisal (STA) submissions to the National Institute for Health and Care Excellence (NICE). STA submissions contain SRs related to the clinical and cost-effectiveness of the proposed intervention and NICE require the methods for these reviews to be clearly detailed in the submission. The intention of this project was to identify methodological aspects of submissions where companies may need additional guidance or support to provide the evidence required for efficient and effective decision-making and in turn facilitate timely access to clinical innovation.

From 2019, 61 STAs were identified from the NICE website, of which 46 were included. We extracted information about the data requests or clarification questions raised by the ERG in relation to the methodological section of both the clinical and cost effectiveness SRs reported in the STA. We then categorized these data and grouped by theme to determine the most common methodological issues faced by companies. We did not assess whether comments made by the ERG were accurate or justified.

For both clinical and cost-effectiveness SRs, the most frequent clarification questions arose from the search methods section, specifically seeking information about missing intervention or comparator terms, the use of search filters and search platforms. Clarification questions were also commonly asked about the appropriateness of interventions and comparators. There were very few clarification questions asked about screening, data extraction or risk of bias assessment.

Companies looking to submit an STA should align their submission methodology to established best practice guidance for systematic reviewing to ensure their methods are fit for purpose and avoid unnecessary delays to the STA process. Consistency with the PRISMA reporting standards would help ensure that the ERG is provided with the information needed to assess the appropriateness of the STA methodology and is likely to reduce the need for clarification questions.