Presentation (CTI)

OBJECTIVES: Health technology assessment (HTA) for new medicines was introduced in Ireland in 2006 and is undertaken by the National Centre for Pharmacoeconomics (NCPE). Since then, the reimbursement process has evolved substantially with the introduction of the Rapid Review (RR) in 2009 to triage medicines for HTA, price negotiations following RR (2010), and procedural reforms including submission validation and defined review timelines. This study examined trends in HTA activity, assessment outcomes, and reimbursement timelines over the first 20 years of the NCPE.
METHODS: All NCPE evaluations conducted between January 2006 and December 2025 were included. Data collected comprised indication, disease area, orphan status, RR outcome, HTA outcome, reimbursement status, and reimbursement date. Descriptive statistics and trend analyses were undertaken to examine changes in evaluation activity, assessment pathways, and time to reimbursement (TTR).
RESULTS: Between 2006 and 2025, the NCPE completed 880 evaluations, increasing from 2 HTAs in 2006 to 95 evaluations in 2025. Oncology medicines consistently represented the largest therapeutic area, while the proportion of orphan medicines increased from 0% to 36%. Overall, 328 full HTAs were conducted. The proportion of evaluations requiring HTA fell from 100% in 2006 to 25% following introduction of the RR in 2009, before increasing to 66% in 2025. Price negotiations following RR increased from 3% of evaluations in 2010 to 32% in 2025, while negotiations following HTA rose from 22% to 89%. Mean TTR increased from 182 days in 2006 to 663 days in 2025.
CONCLUSIONS: Over the past two decades, Ireland's HTA system has expanded substantially in volume and complexity, with increasing use of RR, HTA, and price negotiations. Despite process reforms, reimbursement timelines have lengthened considerably, highlighting the need for continued efforts to improve efficiency while maintaining robust evidence-based decision making