Medicinal products and medical devices
In Ireland, the Health Service Executive (HSE) is responsible for overseeing the pricing and reimbursement of medicinal products and medical devices under the Health (Pricing and Supply of Medical Goods) Act 2013. This legislation requires the HSE to maintain a Reimbursement List, which sets out the healthcare products eligible for reimbursement. Suppliers wishing to have products included on this list must follow a standardised application procedure, with exceptions for products restricted to hospital or specialist use.
While Ireland does not have a distinct approval procedure for rare disease medicines or high-tech products, cancer drugs undergo a specialised review by the National Cancer Control Programme Technology Review Committee (NCCP-TRC). If a manufacturer is not seeking reimbursement, then the HSE does not need to agree to the price before the product can be placed on the market.
The Act also sets out the criteria for reimbursement decisions, with the HSE making final decisions based on advice from the National Centre for Pharmacoeconomics (NCPE). When assessing a product’s cost-effectiveness, the NCPE will look at the product’s Incremental Cost Effectiveness Ratio (ICER) per Quality Adjusted Life Years (QALYs). If the NCPE deems a product cost-effective, the HSE may approve its addition to the Reimbursement List. The HSE can also request further review by the HSE Drugs Group, whose recommendations are considered by the HSE before a final decision is made.
While Ireland typically reimburses prescription-only products, non-prescription products including common painkillers may also be reimbursed if prescribed by a doctor. There are four main reimbursement schemes in Ireland:
General Medical Services (GMS) Scheme
This is a means-tested scheme – patients pay €1.50 per item, up to a maximum of €15 per family per month. Pharmacists are paid a dispensing fee but do not receive a mark-up fee.
Long-Term Illness (LTI) Scheme
Patients with specific long-term conditions, such as epilepsy or diabetes, receive medicines free of charge. Pharmacists receive both a mark-up fee and a dispensing fee.
Hi-Tech Scheme
Patients requiring long-term care receive expensive medicines under the Hi-Tech Scheme. If the patient has a Medical Card, or if the medicine is for a condition listed in the Long-Term Illness Scheme, then the medicine is free to the patient. Otherwise, the patient falls under the Drug Payment Scheme.
Drug Payment Scheme (DPS)
Patients pay up to €80 each month. Pharmacists receive both a mark-up and dispensing fee.
Framework agreements
Pricing and reimbursement for on-patent and originator medicines is also provided for under a supply and pricing agreement entered into between members of the Irish Pharmaceutical Healthcare Association (IPHA) and the HSE. The latest version of this agreement was entered into in October 2021 and was due to expire in September 2025. The 2021 agreement built on a prior agreement that had been in place from August 2016 and provides for:
- Increased rebate contributions regarding on-patent medicines
- More sophisticated rules relating to hybrid medicines
- Changes to the reference date for price cuts, and
- Various price reductions for off-patent medicines
A parallel agreement is also in place between the HSE and Medicines for Ireland (MFI) on behalf of the generic and bio-similar industry in Ireland. This four-year agreement runs from 1 December 2021 to 30 November 2025. Similar to the IPHA Agreement, the generic and bio-similar agreement provides for enhanced price cuts in the case of generic and bio-similar medicines.
The content of this article is provided for information purposes only and does not constitute legal or other advice.
Share this: