OBJECTIVES: NICE launched the Innovative Medicines Fund (IMF) in June 2022, ringfencing £340m with the aim of fast-tracking non-oncology drugs addressing a high unmet need. This study analysed technology appraisals (TAs) where access via the IMF was considered, to identify themes emerging that may support uptake of managed access agreements (MAAs) outside of oncology in the UK.

METHODS: All published non-oncology TAs starting from June 2022 were analysed. Those where IMF, or MAA more generally, is discussed in any of the published documentation were included in this analysis. In addition, all TAs in development that had an expected publication date of June 2022 onwards were included. Those without a publication date were excluded on the basis that these TAs are not sufficiently advanced for IMF to have been deliberated.

RESULTS: As of June 2023, 7 TAs were identified where a MAA via the IMF was considered as an option. Of these, 5 of 7 have achieved reimbursement. Notably, of the 7 identified TAs, none of the manufacturers have either proposed access or achieved access via the IMF. The reasons for this include the manufacturer not engaging (4 of 7), not demonstrating plausible potential to be cost-effective (1 of 7), data collection issues (1 of 7), and a recommendation via routine commissioning meaning no need for IMF (1 of 7). For manufacturers choosing not to engage with IMF, the reason given was typically a commitment to routine commissioning, indicating potential concerns around entry via the IMF.

CONCLUSIONS: Whilst the CDF has proven a big success in delivering rapid access to oncology medicines, there has been a reluctance from manufacturers to engage with the IMF. This may be due to the requirement for manufacturers to provide drug free of charge indefinitely in the event of a not recommended decision following conclusion of the MAA.