Dáil Éireann Debate, Wednesday - 6 May 2026
832. Deputy Rose Conway-Walsh asked the Minister for Health whether the drug sotatercept, approved for the treatment of pulmonary hypertension in other jurisdictions, will be made available to patients in Ireland; and if she will make a statement on the matter. [31813/26]
View answerUnder 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 requested an update from the HSE on 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 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.
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 applications for pricing and reimbursement of sotatercept (Winrevair®):
• The HSE received a complete application for pricing and reimbursement on the 29th November 2024 from Merck Sharp & Dohme B.V. (the applicant) for sotatercept (Winrevair®) in combination with other pulmonary arterial hypertension (PAH) therapies, indicated for the treatment of PAH in adult patients with WHO Functional Class (FC) II to III, to improve exercise capacity (HTA ID 24041)
• Further information on the progress of sotatercept (Winrevair®) through the HSE assessment and approval processes for the above indication is available via the Pricing and Reimbursement Application tracker available at https://healthservice.hse.ie/staff/information-healthcare-workers/pcrs/corporate-pharmaceutical-unit/ HSE application ID HSE100005 has been assigned to this application.
This application remains under consideration with the HSE. The HSE cannot make any comment on possible outcomes from the ongoing process.
