771. Deputy Cian O'Callaghan asked the Minister for Health to provide an update on the work her Department is doing to progress the pricing and reimbursement application (details supplied) for welireg (belzutifan); and if she will make a statement on the matter. [51110/26]

773. Deputy Denise Mitchell asked the Minister for Health the steps she is taking to ensure that the drug belzutifan is available and accessible to those who need it; and if she will make a statement on the matter. [51144/26]

818. Deputy Barry Heneghan asked the Minister for Health the current status of the health technology assessment and reimbursement process for the medicine belzutifan for the treatment of eligible patients with Von Hippel-Lindau (VHL) syndrome; the expected timelines for completion of the assessment and any subsequent reimbursement decision; and if she will make a statement on the matter. [51420/26]

819. Deputy Barry Heneghan asked the Minister for Health the steps her Department and the HSE are taking to facilitate timely access to belzutifan for eligible patients with Von Hippel-Lindau (VHL) syndrome, if approved for reimbursement; whether engagement has taken place, or is planned, with clinicians, patient representative organisations and other relevant stakeholders regarding access to this treatment; and if she will make a statement on the matter. [51421/26]

820. Deputy Johnny Mythen asked the Minister for Health if belzutifan will be made be available to people suffering from Von Hippel- Lindau disease; and if she will make a statement on the matter. [51422/26]

833. Deputy Naoise Ó Muirí asked the Minister for Health the status of negotiations regarding belzutifan; whether she will expedite the assessment and approval process; and if she will make a statement on the matter. [51584/26]

840. Deputy Eamon Scanlon asked the Minister for Health the steps being taken to expedite the assessment and approval of belzutifan for patients with Von Hippel–Lindau (VHL) disease to ensure timely access for eligible patients; if she will engage with clinicians and patient groups regarding barriers to access; and if she will make a statement on the matter. [51615/26]

I propose to take Questions Nos. 771, 773, 818, 819, 820, 833 and 840 together.

The Government recognises the importance of timely access for patients to new medicines and supporting those living with rare diseases in Ireland. Budgets 2021-2025 allocated €158 million for new drugs, and Budget 2026 allocated an additional €30 million. Since 2021, this funding has facilitated the introduction of 276 new medicines, including 75 medicines for rare diseases.

The Year 1 cost of a new drug comes from the allocation for new medicines, but it should be noted that once these medicines are approved for reimbursement the full cost of providing them can reach multiples of this initial cost as their uptake increases.

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 HSE has advised that it received an application for pricing and reimbursement on the 6th March 2025 from Merck Sharp & Dohme B.V (the applicant) for belzutifan (Welireg®) indicated as monotherapy for the treatment of adult patients with von Hippel-Lindau disease who require therapy for associated, localised renal cell carcinoma (RCC), central nervous system (CNS) haemangioblastomas, or pancreatic neuroendocrine tumours (pNET), and for whom localised procedures are unsuitable.

Following a Rapid Review conducted by the National Centre for Pharamacoeconomics (NCPE), a full Health Technology Assessment (HTA) was commissioned by the HSE on the 30th April 2025.

MSD submitted the materials required for the HTA to the NCPE on the 13th of November 2025 and following ongoing engagement between the NCPE and MSD, the NCPE completed its assessment on the 25th May 2026 and submitted a HTA report with a recommendation to the HSE.

The HSE Corporate Pharmaceutical Unit (CPU) is the interface between the HSE and the Pharmaceutical Industry in relation to medicine pricing and reimbursement applications. A meeting has been scheduled between the CPU and the applicant to discuss this application. These negotiations are commercially confidential.

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.

This application remains under consideration with the HSE and the HSE cannot make any comment on possible outcomes from the ongoing process.