Drug Reimbursement Process in Ireland

How New Medicines Are Approved for Funding in Ireland

When the European Medicines Agency (EMA) approves a new medicine, each country then decides whether to fund it through its own health service. In Ireland, that decision rests with the Health Service Executive (HSE), following an application from the pharmaceutical company.

The process at a glance

1. Application — The pharmaceutical company applies to the HSE for reimbursement. The HSE's Corporate Pharmaceutical Unit (CPU) manages the application and price negotiations.
2. Rapid Review — The National Centre for Pharmacoeconomics (NCPE) carries out a short review of how well the medicine works and what it costs. This determines whether a full Health Technology Assessment (HTA) is needed.
3. Health Technology Assessment — If a HTA is recommended, the pharmaceutical company must submit all relevant information required to complete the HTA. The NCPE completes a detailed assessment of the medicine's clinical effectiveness, safety, cost-effectiveness and budget impact. Clinicians and patient organisations are invited to make submissions.
4. Price negotiations — If the NCPE recommends that cost-effectiveness needs to be improved, the CPU negotiates with the company to agree on a fair price. Any pricing changes are discussed with the NCPE to determine the cost effectiveness.
5. HSE Drugs Group evaluation — The Drugs Group reviews all the evidence and if more information is required they can refer it to the Rare Diseases Technology Review Committee for additional patient and clinical input. The Drugs Group make their reimbursement recommendation to the HSE Senior Leadership Team.
6. Final decision — The HSE Senior Leadership Team makes the final decision: approve, refuse (with reasons), or defer — for example, if the budget for new medicines is used up.
7. Notice to refuse — If refused, the company has 28 days to submit new information before a final notice issues.

Track a medicine's progress

The HSE's pricing and reimbursement medicines tracker lets you follow the status of any application in real time, from Rapid Review to final decision: sspcrs.ie tracker

‍You can also search for the outcomes of individual NCPE assessments on the NCPE website www.ncpe.ie

‍For more full details on the reimbursement process, including all potential Rapid Review outcomes and NCPE recommendations, download the complete guide below.

‍ ‍📄Download: Drug Reimbursement Process in Ireland (PDF)