Overview of the Drug Reimbursement process
The Health Service Executive (HSE) is responsible for decisions regarding the reimbursement of new drug technologies. The Corporate Pharmaceutical Unit (CPU) of the HSE commission the NCPE to appraise new medicines following receipt of an application for reimbursement. The NCPE are commissioned to review the following classes of medicines:
- New active substances seeking reimbursement in Ireland, including those with an orphan designation from the European Medicines Agency
- New indications for currently reimbursed drugs
- Drugs which are already reimbursed by the HSE, and are associated with high expenditure or uncertain clinical benefit.
The NCPE employ a two-step process to make our recommendations in the most efficient manner and minimise time to market access for new treatments. All medicines are subjected to a preliminary Rapid Review. Companies can enter the process at any point following receipt of a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). Products with a high cost relative to potential comparators and/or those with a net impact on the drugs budget will be subjected to a formal health technology assessment (HTA). Similarly, products where there is a query in relation to the comparative clinical efficacy and/or value for money will also be selected for formal HTA.
Following formal HTA, a full appraisal report outlining NCPE conclusions and recommendations is sent to the HSE CPU to support evidence-based decision-making on reimbursement. In the case of oncology drugs a report is also sent to the National Cancer Control Programme (NCCP).
Decisions on drug reimbursement are taken by the HSE. The criteria which the HSE must consider when reaching reimbursement decisions on drugs are described in Schedule 3, Part 3 of the Health (Pricing and Supply of Medical Goods) Act 2013. The NCPE’s recommendations address three of nine criteria, including the
- Efficacy, effectiveness and added therapeutic benefit,
- Cost-effectiveness, and
- Budget impact.
Other additional criteria considered by the HSE when making reimbursement decisions include:
- Health needs of the public,
- Proposed costs, benefits and risks of the item or listed item relative to therapeutically similar items and the level of certainty in relation to the evidence of those costs, benefits and risks,
- Availability and suitability of the drug for supply and reimbursement under the current schemes,
- Clinical need for the drug,
- Availability of the appropriate level of clinical supervision to ensure patient safety, and
- Resources available to the HSE.