Dáil Éireann Debate, Tuesday - 19 May 2026
1228. Deputy Barry Ward asked the Minister for Health the position regarding the approvement process for a drug (details supplied) for the treatment of bronchiectasis; and if she will make a statement on the matter. [37704/26]
Amharc ar fhreagra1229. Deputy Barry Ward asked the Minister for Health the position regarding a timeline for the approval for a drug (details supplied) for the treatment of bronchiectasis; and if she will make a statement on the matter. [37705/26]
Amharc ar fhreagra1230. Deputy Barry Ward asked the Minister for Health the position regarding any engagement she has had with the HPRA in relation to the approval for a drug (details supplied) for the treatment of bronchiectasis; and if she will make a statement on the matter. [37706/26]
Amharc ar fhreagraI propose to take Questions Nos. 1228 to 1230, inclusive, together.
The State recognises the importance of timely access to innovative medicines for patients in Ireland.
Budgets 2021-2025 allocated an additional €158 million for new drugs, which has facilitated the introduction of 263 new medicines, to date. 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.
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.
Ireland is among the highest spenders on health across the EU (OECD), with the third-highest rate of State coverage of pharmaceutical expenditure in Europe.
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. The Minister has no role in decisions on pricing and reimbursement.
There is no hierarchy of disease and pricing and reimbursement applications are considered in order of application.
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. European Medicines Agency (EMA) or Health Products Regulatory Authority (HPRA) 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.
Applicants must continue to engage through-out the process to ensure that the necessary evidence is available for the HSE to carry out its statutory role as a decision-maker with respect to the reimbursement of new medicines, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.
As well as the health needs of the public, legislation requires the HSE to consider a medicine’s cost-effectiveness and budget impact when deciding if it will reimburse it. Objective, scientific methods are used to assess these factors alongside input from patients.
The HSE’s Drugs Group—its national expert committee, including public interest members—will consider all evidence, and issue a recommendation to the HSE Senior Leadership Team, which holds final decision-making authority on the reimbursement of a medicine.
With respect to brensocatib (Brinsupri®), the EMA issued marketing authorisation on 18th November 2025. Brensocatib (Brinsupri®) is a medicine used to treat non-cystic fibrosis bronchiectasis in people aged 12 years and older who had two or more exacerbations (flare-ups or worsening of symptoms) in the past 12 months.
The HSE advise that as of 15th May 2026, a pricing and reimbursement application has not been received by the HSE for brensocatib (Brinsupri®) for this indication.
