OBJECTIVES: In February 2019, the Health and Social Care (HSC) Board announced changes to the Managed Entry of New Medicines in Northern Ireland (NI), including mechanisms for commissioning therapies recommended via the NICE Highly Specialised Technologies (HST) program. Herein, we assess the time taken for therapies recommended via the HST program to be added to the NI formulary.

METHODS: Managed Entry Decisions made by the HSC Board for therapies recommended via the NICE HST program were identified on the NI Formulary and the relevant data extracted in June 2023.

RESULTS: Of the 23 therapy:indication pairings recommended via the HST, 20 corresponding additions to the NI formulary were identified (three decisions pending for NICE HST recommendations made since April 2023). The median number of HST-related additions to the NI formulary annually from 2016­­–2023 was 2 (range: 0–7). The median time for addition of therapy:indication pairings to the NI formulary was longer for therapies recommended via the HST pre- vs. post-February 2019 (594 days vs. 68 days, respectively). Overall, the median duration of delay was longest for cell therapies (n=1; 456 days), followed by small molecules (n=6; 72 days), protein-based therapies (n=7; 72 days) and gene therapies (n=6; 64 days). However, when analyses were restricted to therapy:indication pairings recommended post-February 2019, median duration of delay was independent of treatment type.

CONCLUSIONS: The delay from NICE HST decision to addition to the NI formulary has been streamlined to around 2 months since the changes implemented in 2019. However, HST-related entries to the NI formulary are caveated with, “Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis”. Therefore, pharmaceutical companies should consider conducting additional regional activities to ensure access to products recommended via the HST for patients in NI.