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. The evaluation phase involves a Rapid Review of the clinical efficacy and budget impact to determine whether a full Health Technology Assessment (HTA) is required. Price negotiations occur following the Rapid Review to avoid a HTA and following a HTA. This study investigates the characteristics of medicines that were not reimbursed between 2006 and 2021, focusing on reasons for non-reimbursement.
METHODS: A dataset of all NCPE evaluations from 2006 to 2021 was compiled, allowing time for the reimbursement process to conclude (average 920 days). Data collected included disease area, oncology/orphan designation, review timelines, and outcomes at each evaluation stage. Medicines were categorised by HTA recommendation status and final reimbursement recommendation.
RESULTS: Of 574 medicine evaluations, 96 (17%) were not reimbursed. Oncology (27%) and endocrine (11%) treatments were the most common, and 24% were indicated for orphan conditions. Of the unreimbursed group, 78% did not complete a HTA, despite 68% having been recommended for one. An additional 21% received a “HTA not recommended” and 11% a “Reimbursement not recommended” outcome at the Rapid Review stage. Among the 21 medicines that did proceed to HTA, 67% received a negative reimbursement recommendation. Overall, only 23% of unreimbursed medicines were explicitly rejected following formal evaluation. The remaining 77% were not reimbursed due to HTA non-submission or unsuccessful price negotiations.
CONCLUSIONS: While most medicines in Ireland ultimately gain reimbursement, those that do not are predominantly excluded due to failure to submit a HTA or conclude pricing agreements—rather than negative clinical or economic assessments. Addressing barriers to HTA progression may improve access to new therapies.