OBJECTIVES: In January 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) introduced the Innovative Licensing Access Pathway (ILAP), and in January 2022 the National Institute for Health and Care Excellence (NICE) replaced the end of life (EOL) criteria with a severity-based decision modifier. This analysis aims to describe the outcomes of NICE oncology single technology appraisals (STAs), including those entering Cancer Drug Fund (CDF) managed entry agreements (MEAs), following recent changes in regulatory and reimbursement processes.

METHODS: All oncology drug STAs from January 2021 to May 2023 were identified, and key information relating to reimbursement processes and decisions were extracted, including ILAP status, NICE recommendations, and EOL criteria. Severity modifier was estimated for appraisals where standard of care quality-adjusted life years (QALYs) were unredacted.

RESULTS: One hundred ten published appraisals were reviewed. Sixty-five appraisals were recommended for routine commissioning (of which 18 exited the CDF) and 13 appraisals were recommended via the CDF. Seven appraisals were not recommended, one of which was previously recommended via the CDF, and 25 appraisals were terminated. Amongst appraisals that entered into CDF MEAs, the most frequently cited clinical uncertainties related to maturity of trial data, followed by issues with uncertainties around subsequent treatments. We identified 10 ILAP therapies, of which 4 entered the CDF, 4 were recommended, 1 was not recommended and 1 was terminated. Severity modifier was estimated for 16 appraisals.

CONCLUSIONS: The full impact of changes to the UK regulatory and reimbursement landscape remains uncertain. Redactions in appraisals make it difficult to ascertain near-term implications of ILAP and NICE methods update, as ILAP status was not readily available for terminated appraisals and severity modifiers were not estimable for most appraisals. It therefore remains unclear whether drugs that entered CDF with EOL criteria would also be exiting with a similar threshold.