Presentation (CTI)

OBJECTIVES: Ireland’s well established reimbursement process for new medicines involves evaluation by the National Centre for Pharmacoeconomics (NCPE) and price negotiation by the Health Service Executive (HSE) Drugs Group. Following HSE Drugs Group recommendation, some medicines are reimbursed under a managed access protocol (MAP). MAPs are used when: (a) the estimated budget impact is very high; (b) there is concern about off-label use; or (c) uncertainty in the clinical or cost-effectiveness evidence. The objective of this study is to characterise medicines subject to a MAP in Ireland.
METHODS: We compiled a dataset of all NCPE evaluations from 2006 to June 2025, including indication, oncology/orphan status, reimbursement decision, review and reimbursement timelines, reimbursement scheme, and MAP status.
RESULTS: Since 2006, 40 new medicines or indications have been reimbursed with a MAP. Of these, 8% were oncology and 30% orphan products. The most common reimbursement scheme was High Tech (60%), followed by Hospital (23%) and General Medicines Services (17%). MAPs were implemented following a full HTA in 68% of cases and a Rapid Review in 32%, reflecting the addition of medicines to existing MAPs e.g. for atopic dermatitis and migraine. The average time to reimbursement was 972 days for MAP medicines, compared to 500 days for those without a MAP. The longer timelines associated with MAPs reflect the complexity of reviews, development of eligibility criteria, and implementation of online application systems.
CONCLUSIONS: MAPs in Ireland are primarily applied to high-cost or high-uncertainty therapies and enable controlled reimbursement while reducing risk. However, their use is associated with prolonged access timelines, highlighting the trade-off between affordability, system oversight, and timely patient access. System streamlining and early dialogue between stakeholders may help mitigate access delays while preserving financial and clinical safeguards.