OBJECTIVES: With accelerated regulatory pathways, many products now undergo Health technology assessment (HTA) evaluation with immature or non-comparative trial data. The UK cancer drugs fund (CDF) allows for a temporary period of reimbursement whilst additional data are collected to address key uncertainties in the data package. For manufacturers and patients, managed entry agreements such as the CDF provide an important access route for conditions with the highest unmet need.

METHODS: In order to understand the key requirements to gain access to the CDF, we undertook a review of recent NICE technology appraisals for oncology products.

RESULTS: From January 2023 to April 2024, we identified 43 completed oncology appraisals, of which 11 were considered for entry into the CDF. 5 out of these 11 products were recommended to be reimbursed via the CDF. The biggest drivers of inclusion were having plausible incremental cost-effectiveness ratio (ICER) estimates that were within the range that NICE consider as cost-effective, as well as additional data generation planned. The primary drivers for rejection were the absence of planned head-to-head data versus relevant comparators. Applying for reimbursement on the basis of a single-arm trial in itself did not appear to be a major driver of inclusion, as 3 out of 6 rejected, and 3 out of 5 accepted appraisals did not include any comparative trial data.

CONCLUSIONS: Despite the CDF providing a route to reimbursement for health technologies on the basis of a single-arm trial only, manufactures are still required to approach HTA with a costing strategy that allows NICE to recognize the cost-effectiveness of their product.