I propose to take Questions Nos. 779, 807 and 878 together.
Under the Health (Pricing and Supply of Medical Goods) Act 2013, the Health Service Executive (HSE) has statutory responsibility for decisions on the pricing and reimbursement of medicines.
To commence this process, a pharmaceutical company must submit an application for a new medicine or a new use of an existing medicine, which has been granted European Medicines Agency (EMA) or Health Products Regulatory Authority (HPRA) authorisation, to the HSE’s Corporate Pharmaceutical Unit.
Applicants must continue to engage throughout 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 Act. The Act specifies nine criteria which must be considered. These include the health needs of the public and the clinical need for the medicine. All these factors, taken together, allow the HSE to make an informed decision on new medicines.
The Drugs Group is the national committee which the HSE has in place to make recommendations on the pricing and reimbursement of medicines. The membership of the HSE Drugs Group includes public interest members. Pharmacoeconomic reports are reviewed by the HSE Drugs Group along with the outputs of commercial negotiations, and any patient group submission(s) received. The HSE Drugs Group considers all of the evidence and makes a recommendation to the HSE Senior Management Team.
The decision-making authority in the HSE is the HSE Senior Management Team. The HSE Senior Management Team decides on the basis of all the demands it is faced with (across all services) whether it can fund a new medicine, or new use of an existing medicine, from the resources that have been provided to it in line with the Health (Pricing and Supply of Medical Goods) Act 2013.
In terms of the specific details of the application for pricing and reimbursement of fezolinetant (Veoza®):
• The HSE received an application for pricing / reimbursement on the 8th February 2024 from Astellas (the applicant) for fezolinetant (Veoza®) indicated for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause.
• The first step in the process is the submission of a Rapid Review dossier (a clinical and economic dossier) to the National Centre for Pharmacoeconomics (NCPE) for assessment. The HSE commissioned the Rapid Review process on the 9th February 2024.
• The NCPE Rapid Review assessment report was received by the HSE on the 12th March 2024. The NCPE advised the HSE that a full Health Technology Assessment (HTA) was recommended to assess the clinical effectiveness and cost effectiveness of fezolinetant (Veoza®) compared with the current standard of care.
• The HSE commissioned a full HTA on the 8th April 2024 as per agreed processes.
• The HTA was completed by the NCPE on the 17th April 2026. The NCPE recommends that fezolinetant be considered for reimbursement if cost effectiveness can be improved relative to existing treatments. HRT is expected to provide more benefits, than fezolinetant, in individuals who can take HRT. Thus, the HSE may wish to implement prescribing guidelines should a decision be made to reimburse fezolinetant: https://www.ncpe.ie/fezolinetant-veoza-hta-id-24005/
• 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 met with the applicant to discuss the application for fezolinetant (Veoza®) indicated for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. A proposal has been received from the applicant and is under review. The output of negotiations will be presented to the HSE Drugs Group for consideration.
The application remains under consideration with the HSE. The HSE cannot make any comment on possible outcomes from the ongoing process.
