Consequences of Brexit: Medicines Access to Northern Ireland


Macaulay R1, Wang GD1, Leong KW2
1Precision Advisors, London, UK, 2Precision Advisors, London, LON, UK

OBJECTIVES: The Process for the Managed Entry of New Medicines was established by the Health and Social Care (HSC) Board in 2014, where technology guidance made by the National Institute for Health and Care Excellence (NICE) is adopted as policy. In advance/absence of NICE guidance, recommendations from other UK Health Technology Assessment (HTA) bodies may be applied. This research evaluates therapies reimbursed in Northern Ireland under this process.

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.

Conference/Value in Health Info

2022-05, ISPOR 2022, Washington, DC, USA




Health Policy & Regulatory, Health Technology Assessment

Topic Subcategory

Decision & Deliberative Processes, Pricing Policy & Schemes, Reimbursement & Access Policy, Systems & Structure


No Additional Disease & Conditions/Specialized Treatment Areas

Your browser is out-of-date

ISPOR recommends that you update your browser for more security, speed and the best experience on Update my browser now