OBJECTIVES: The National Institute of Health and Care Excellence (NICE) evaluate the clinical and economic impact of new therapies to inform public reimbursement recommendations. Since July 2016, NICE can recommend oncology drugs enter the Cancer Drugs Fund (CDF) during which time they will be made available to patients whilst additional evidence is collected pending a final NICE appraisal. This research evaluates all therapies included in the newly-reformed CDF.

METHODS: NICE technology appraisals with CDF outcomes were identified from www.nice.org.uk and key information extracted (to 24-DEC-2020).

RESULTS: 39 therapies have entered the CDF (1 in 2016, 9 in 2017, 11 in 2018, 13 in 2019, and 5 in 2020). 77% were fully recommended with 23% being optimized. Only 5 drugs (13%) have exited the CDF (3 ‘recommended’, 1 ‘optimised’ and 1 marketing authorization withdrawn) after a mean of 23.6 months (range: 11.5-47.7 months). A further two (5%) FADs were published (1 not recommended, 1 restricted) but these have been withdrawn following successful appeals. Another 8 (21%) are currently in the post-CDF review process, 3 of which have had Appraisal Consultation Document (ACD) meetings and with one having published draft guidance (outcome: ‘not recommended’). The remaining 24 (62%) therapies are not currently subject to any form of appraisal and have been on the CDF for an average of 22.7 months (range: 3.7-36.9 months).

CONCLUSIONS: Although few therapies have exited the CDF to date, many more are currently at various stages of the post-CDF review process. However, perhaps the true test of the CDF is whether drugs can successfully be managed off the CDF if cost-effectiveness is not adequately demonstrated, potentially depriving patients and physicians of therapies for non-clinical reasons. The ongoing appeals for two therapies which previously had ‘not recommended’ or ‘optimized’ FADs post-CDF will be interesting to track in this regard.