OBJECTIVES: Ireland has a well-established reimbursement process for new medicines. Like other countries in Europe, the reimbursement process includes an evaluation and a price negotiation phase. Submissions are evaluated by the National Centre for Pharmacoeconomics (NCPE), while price negotiations are conducted by the Health Service Executive (HSE) Drugs Group. The outcomes and the timelines associated with the evaluation phase has been well documented for Ireland but there is a dearth of information on the price negotiation phase.

METHODS: We developed a database derived from all evaluations conducted by the NCPE from January 2015 until December 2023. This database includes data on therapeutic area, oncology/orphan status and whether the medicine was subject to a full health technology assessment (HTA). Data from the HSE Drugs Group meetings were added to the database and descriptive statistics applied.

RESULTS: A total of 579 medicines were evaluated by the NCPE over the 2015-2023 period, 43% of which were subject to price negotiations. Medicines subject to a full HTA, oncology and orphan medicines are more likely to undergo price negotiations compared to Rapid Review only, non-oncology, and non-orphan medicines (4% vs 23%, 58% vs 34%, 58% vs 38% respectively). The average time to secure the first Drugs Group meeting is 6 months, 70% of medicines require only one Drugs Group meeting and the average time from Drugs Group to reimbursement is 8 months.

CONCLUSIONS: The HSE Drugs Group plays a crucial role in the reimbursement of new medicines in Ireland, and it is essential that pharmaceutical companies seeking market access, especially those in the oncology and rare disease domains are prepared for this stage of the process and the timelines.