OBJECTIVES: Health Technology Assessments (HTAs) are a critical step in the reimbursement of new therapies in the UK. The National Institute for Health and Care Excellence (NICE) issues guidance on the development of HTA dossiers, and Evidence Assessment Groups (EAGs) provide detailed critique of submission dossiers. Key factors influencing final reimbursement decisions made by NICE were investigated in a thematic analysis.

METHODS: HTA dossiers published on the NICE website between 1^st January 2022 and 31^st December 2023 were reviewed. Therapies with negative recommendations from NICE were included in the analysis, excluding withdrawn or COVID-19 submissions. Key EAG comments and final reasons for negative recommendations were examined, including clinical data quality and methodology, cost-effectiveness, data generalisability to the NHS, comparative effectiveness, and evidence gaps.

RESULTS: A total of 16 appraisals received a negative recommendation (oncology, n=12; sleep apnoea, n=2; dermatology, n=1; depression, n=1). In oncology, reasons cited for negative recommendations included uncertainty in clinical data and methodology. Of those submissions with a negative recommendation, 25% (n=3/12) were recommended for the Cancer Drugs Fund. The two submissions in dermatology and depression had high levels of uncertainty in their clinical evidence and utility data, with limited generalisability to the NHS. Both submissions in sleep apnoea lacked robust clinical evidence and appropriate derivation of utilities, with one failing to produce probabilistic results. End of life criteria was applied to 50% of submissions (n=8/16). Due to high levels of uncertainty, all submissions were assessed against NICE’s standard willingness to pay threshold of £20,000.

CONCLUSIONS: Numerous factors influence reimbursement decisions in the UK. Although reasons for negative recommendations included high uncertainty in long-term predictions of clinical data, cost-effectiveness remains a priority in decision-making. These insights offer valuable information for companies aiming to align with NICE guidance.