Dáil Éireann Debate, Thursday - 9 July 2026
174. Deputy Aindrias Moynihan asked the Minister for Health to provide an update on the HSE assessment of a medication (details supplied) for inclusion under the drugs payment scheme; the current stage of the process; the timeline for decision, having regard to the prolonged assessment period; the ongoing cost to patients; the impact on women unable to access HRT; and if she will make a statement on the matter. [52097/26]
View answerI wish to thank the Deputy for his question.
I recognise the importance of providing the best care possible to patients with this condition. Women’s Health has been and will be a focus of mine since taking this office. We have made real progress in improving the healthcare available to women in Ireland.
Veoza (Fezolinetant) is a treatment for moderate to severe vasomotor symptoms (VMS, e.g. hot flashes, night sweats) associated with menopause.
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.
In terms of Veoza®, Astellas, the Marketing Authorisation Holder, submitted a pricing and reimbursement application to the HSE in April 2024 and a Health Technology Assessment was commissioned by the HSE in April 2024.
A completed health technology assessment (HTA) was received by the National Centre for Pharmacoeconomics (NCPE) Astellas, on the 20th August 2025, 16 months after it was commissioned by the HSE. This was following proactive engagements by the HSE to the company encouraging the submission of a fully completed HTA.
It is important to note that 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.
Following ongoing engagement between the NCPE and the company the HTA was completed by the NCPE on the 17th April 2026 and a HTA report submitted to the HSE. The NCPE recommended that Veoza® be considered for reimbursement if cost effectiveness could be improved relative to existing treatments.
The HSE Corporate Pharmaceutical Unit (CPU) is the interface between the HSE and the Pharmaceutical Industry in relation to medicine pricing and reimbursement applications.
The HSE CPU has advised that they met with the applicant to discuss this application and have recently received a commercial proposal from the applicant.
Once the commercial negotiations are completed, the next steps in the process involve the HSE’s Drugs Group—the national expert committee, which includes public interest members. The HSE’s Drugs Group will consider all evidence, including outputs of commercial negotiations and recommendations of the NCPE, and issue a recommendation to the HSE Senior Management Team, which holds final decision-making authority on the reimbursement of a medicine.
The application remains under consideration with the HSE. The HSE cannot make any comment on possible outcomes from the ongoing process.
There are a suite of measure in place that my Department will seek to progress over the lifetime of this Government to improve the access to medicines.
