The Programme for Government contains a suite of measures on medicines, which we aim to progress over its lifetime. Access to medicines for patients with rare diseases is the focus of a number of workstreams across the Department.
Two new Framework Agreements in principle have been reached with the Irish Pharmaceutical Healthcare Association (IPHA) and Medicines for Ireland (MFI) on the pricing and supply of medicines.
As part of these Agreements in principle, the State and MFI and IPHA have agreed to develop a future strategic partnership. This partnership will support the Department of Health in its development of proof of concept for a pilot early access programme focused on rare diseases, in line with the commitments in the Programme for Government.
The State has made considerable investments in new medicines in recent years. In 2023, over €3.2 billion was spent on medicines by the State. This represents nearly €1 in every €8 of public funding being spent on health.
Budgets 2021 to 2025 included dedicated funding for new medicines of €158 million. This has enabled the HSE to approve reimbursement for 250 new medicines or new uses for existing medicines, including 101 for treating cancer and 69 for treating rare diseases.
Budget 2026 allocated €30 million of funding available for new drugs to be allocated from the overall additional €217 million in funding allocated for medicines.
This level of investment is unprecedented in supporting patients through the availability of new and innovative medicines.
In Ireland, compassionate access schemes are entirely at the discretion of the manufacturer. There is no provision in Irish legislation for the approval of compassionate use programmes for specific groups of patients with an unmet medical need. The Minister for Health has no role or powers in this regard.
Under the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for decisions on the pricing and reimbursement of medicines and medical devices; therefore, I have asked the HSE for an update in this matter.
The HSE has advised that it is committed to providing access to as many medicines as possible, in as timely a fashion as possible, from the resources available (provided) to it.
The HSE must robustly assess applications for pricing and reimbursement to make sure that it can stretch available resources as far as possible and to deliver the best value in relation to each medicine and ultimately more medicines to Irish citizens and patients.
HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds.
There are formal processes which govern applications for the pricing and reimbursement of medicines, and new uses of existing medicines, to be funded and / or reimbursed.
The HSE considers the following criteria prior to making any decision on pricing / reimbursement in line with the Health (Pricing and Supply of Medical Goods) Act 2013:
(1) The health needs of the public,
(2) The cost effectiveness of meeting health needs by supplying the item concerned rather than providing other health services,
(3) The availability and suitability of items for supply or reimbursement,
(4) The proposed costs, benefits, and risks of the item or listed item relative to therapeutically similar items or listed items provided in other health service settings and the level of certainty in relation to the evidence of those costs, benefits and risks,
(5) The potential or actual budget impact of the item or listed item,
(6) The clinical need for the item or listed item,
(7) The appropriate level of clinical supervision required in relation to the item to ensure patient safety,
(8) The efficacy (performance in trial), effectiveness (performance in real situations) and added therapeutic benefit against existing standards of treatment (how much better it treats a condition than existing therapies) and
(9) The resources available to the HSE
In terms of the specific details of the application for pricing and reimbursement of belzutifan (Welireg®):
The HSE received a complete application for pricing and reimbursement on the 6th March 2025 from Merck Sharp & Dohme B.V (the applicant) for belzutifan (Welireg®) indicated as monotherapy for the treatment of adult patients with von Hippel-Lindau disease who require therapy for associated, localised renal cell carcinoma (RCC), central nervous system (CNS) haemangioblastomas, or pancreatic neuroendocrine tumours (pNET), and for whom localised procedures are unsuitable.
Further information on the progress of belzutifan (Welireg®) through the HSE assessment and approval processes is available via the Pricing and Reimbursement Application tracker available at: www.hse.ie/eng/about/who/cpu/ and at www.ncpe.ie/omaveloxolone-skyclarys-hta-id-24033/ . HSE application ID HSE100023 has been assigned to this application.
The application remains under consideration with the HSE. The HSE cannot make any comment on possible outcomes from the ongoing process.
