OBJECTIVES: The UK has been a leader in managed access agreements, providing temporary reimbursement pending additional data collection to inform a final HTA submission. Currently, the reformed CDF set up in 2016 and the IMF, launched in 2022, provide consistent and transparent managed access to drugs that offer promising results. This research evaluates the success of these schemes by examining utilization trends over time since their inception.

METHODS: Publicly-available information from NICE on CDF-included drugs and cancer appraisal was screened alongside any drugs included under the IMF, with key information extracted to inform the analysis.

RESULTS: As of March of 2024, there have been a total of 57 CDF recommendations. While inclusions followed a steady figure from 2017/18 to 2019/20 (2017/18=12; 2018/19=12; 2019/20=11), these have been consistently dropping since (2020/21=7; 2021/22=8; 2022/23=2; 2023/24=4). During the same period, the total number of NICE cancer appraisals has remained between the 35 to 45 range, except for 2019/20 and 2021/22 (30 and 50 appraisals respectively). Although the 2019 COVID pandemic did impact the number and expedience of NICE evaluations, this was not evident when accounting for CDF inclusions as percentage of total cancer appraisals. Here, the same trend can be observed with a steady increase till 2019/20 with 36.7%, followed by a steady decrease till 2023/24 with 10%. Only 5 drugs were identified that were covered under the IMF, however all were interim funding between NICE recommendation and commissioning i.e. none were managed access agreements.

CONCLUSIONS: The decreasing trend in CDF utilization, alongside the lack of any managed access inclusions into the IMF, may indicate a decreasing appetite for managed access in the UK. This may reflect payer and manufacturer experiences agreements having been less than optimal and may act as a cautionary tale for utilization of managed access agreements globally.