Pádraig Rice (Cork South-Central, Social Democrats)
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1155. To ask the Minister for Health if she will expedite approval and funding of a new drug (details supplied) to treat those living with Barakat Syndrome; and if she will make a statement on the matter. [47827/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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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 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.

There is a National Application, Assessment & Decision Process for new medicines which is underpinned by Primary Legislation (Health (Pricing and Supply of Medical Goods) Act 2013) put in place by the Oireachtas. The HSE must comply with the relevant legislation when considering investment decisions around new medicines.

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 an application for pricing and reimbursement of palopegteriparatide (Yorvipath®):

As of the 11th September 2025, a pricing and reimbursement application has not been received by the HSE for palopegteriparatide (Yorvipath®).

As outlined above, the national assessment and decision process cannot commence in the absence of a pricing and reimbursement application submission to the HSE. If the manufacturer of palopegteriparatide (Ascendis Pharma) submits a de novo application, that application will be duly progressed through the formal processes governing the pricing and reimbursement of medicines.