The Innovative Medicines Fund or the In Need of Medicines Fund: Analysis of NICE Technology Appraisals to Explore Barriers to Managed Access Agreements

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, as an alternative to the Cancer Drugs Fund. However, it has taken two years for a treatment to be recommended via the IMF. 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, up until 19^th June 2024. Those where managed access is discussed in any of the published documentation were included in this analysis. In addition, all TAs in development were included for this analysis, assuming committee papers were published at the time of analysis.

RESULTS: As of June 2024, 20 TAs were identified where a MAA via the IMF was considered as an option. Of these, 11 of 20 have achieved reimbursement. Notably, only one (etranacogene dezaparvovec for haemophilia B, ID3812) has been recommended with managed access. The reasons for this include the company not engaging (11 of 19), no plausible potential to be cost-effective (3 of 19), data collection issues (3 of 19), and recommendation via routine commissioning meaning no need for IMF (2 of 19). Where manufacturers did not engage with a managed access proposal despite interest from NICE, the reason given was typically a commitment to routine commissioning.

CONCLUSIONS: Two years since launch, the IMF has only just received its first managed access entrant. One possible explanation for this is that manufacturers are concerned about the requirement to provide drug free of charge should a price agreement not be reached following conclusion of the managed access period. The only entrant being a one-time gene therapy supports this theory.