Dáil Éireann Debate, Wednesday - 22 April 2026
242. Deputy Ken O'Flynn asked the Minister for Health whether standard cost-effectiveness thresholds applied by the National Centre for Pharmacoeconomics are adjusted in the case of rare diseases; if not, whether the Minister will consider reforming these thresholds to reflect the unique clinical and ethical context of low-prevalence conditions. [29081/26]
View answerThe Government is committed to investing in new medicines. Budgets 2021-2025 allocated an additional €158 million for new drugs, which has facilitated the introduction of 263 new medicines, to date. 72 of these were for rare diseases.
Budget 2026 allocated €217 million in additional funding for drugs, with €30 million of this allocated for new drugs funding. This has, as of end of March 2026, delivered access to 13 new medicines, including 6 new medicines for cancer and 3 new medicines for rare diseases.
The Year 1 cost of a new drug comes from the allocation for new medicines, but it should be noted that once these medicines are approved for reimbursement the full cost of providing them can reach multiples of this initial cost as their uptake increases.
Under the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has sole statutory responsibility for decisions on the pricing and reimbursement of medicines and medical devices.
To commence the pricing and reimbursement process, a pharmaceutical company must submit an application for a new medicine or a new use of an existing medicine to the HSE’s Corporate Pharmaceutical Unit.
Marketing Authorisation is required for the medicine prior to submission to the HSE for reimbursement as reimbursement only applies to licensed uses (indications) of the medicine as set out by the Health Products Regulatory Authority or the European Medicines Agency.
HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds, on the advice of the National Centre for Pharmacoeconomics (NCPE) and in line with the criteria provided for in the Health (Pricing and Supply of Medical Goods) Act 2013. 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.
