3939. Deputy Barry Ward asked the Minister for Health the position regarding any engagement she has had with the HSE in relation to the eligibility of a drug (details supplied) for rebate or coverage for people on the medical card; and if she will make a statement on the matter. [63611/26]

3945. Deputy Barry Ward asked the Minister for Health the position regarding any review of the eligibility of a drug (details supplied) for rebate or coverage for people on the medical card; and if she will make a statement on the matter. [63609/26]

3946. Deputy Barry Ward asked the Minister for Health if her attention has been drawn to the omission of a drug (details supplied) from coverage under the medical card; and if she will make a statement on the matter. [63608/26]

I propose to take Questions Nos. 3939, 3945 and 3946 together.

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, they have been asked to provide an update in 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

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 Leadership Team.

The decision-making authority in the HSE is the HSE Senior Leadership Team. The HSE Senior Leadership 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: 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.