METHODS: Managed Entry Decisions made by the HSC Board were identified, and key information extracted (23-Dec-2021).

RESULTS: 707 Managed Entry decisions were identified, an average of 84/year (range:43[2014]–115[2021]). 51% were based on NICE guidance, 48% on Scottish Medicines Consortium (SMC), and 1% on All Wales Medicines Strategy Group (AWMSG). The proportion of decisions based on NICE guidance has increased from 28%(2014) to 62%(2021). 76% of Managed Entry decisions were “Accepted” vs. 24% “Not Accepted”. 91% of Managed Entry decisions based on NICE guidance were “Accepted”, vs. 59% based on SMC, and 75% based on AWMSG. Managed Entry decisions were made on average 80 days after their respective NICE/SMC/AWMSG guidance (78 days “Accepted” vs. 85 days “Not Accepted”). This time has increased from a mean of 1 day (2014, when many decisions were made after NICE Final Appraisal Documents [FADs]) to 138 days (2021). 45 drug:indication pairings were reimbursed by NICE under the Cancer Drugs Fund (CDF), 73% were “Accepted” in Northern Ireland, 24% were accepted only after exiting the CDF onto routine commissioning.

CONCLUSIONS: Northern Ireland does not have an HTA body, instead typically recognising NICE recommendations after an average of ~5 months. However, under the Northern Ireland Protocol, there may be regulatory divergence between therapies approved in Northern Ireland (European Commission) and Great Britain (MHRA) that may significantly challenge this process.