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Medicinal Products

Dáil Éireann Debate, Thursday - 5 March 2026

Thursday, 5 March 2026

Questions (569)

Donna McGettigan

Question:

569. Deputy Donna McGettigan asked the Minister for Health to make acarizax available under the drug payment scheme; to recommend a course of action for a family facing unmanageable prescription charges due to having to pay for it, in addition to other medications which are on the drug payment scheme, but still cost €80; and if she will make a statement on the matter. [18051/26]

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Written answers

The HSE 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 robustly assesses 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 through the Drugs Payment Scheme. 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 house dust mite extract (Acarizax®): The HSE received a complete application for pricing and reimbursement of house dust mite extract (Acarizax®) on the 10th December 2025 from ALK-Abello (the applicant) indicated in patients (5-65 years) diagnosed by clinical history and a positive test of house dust mite sensitisation (skin prick test and/or specific IgE) with persistent moderate to severe house dust mite allergic rhinitis despite use of symptom-relieving medication. Further information on the progress of house dust mite extract (Acarizax®) through the HSE assessment and approval processes is available via the Pricing and Reimbursement Application tracker available at https://www.hse.ie/eng/about/who/cpu/ . HSE application ID HSE100082 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.

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