3239. Deputy Jen Cummins asked the Minister for Health her plans for patients to access belzutifan (welireg) for patients living with von hippel-lindau disease in Ireland. [55391/26]

3683. Deputy Pádraig Rice asked the Minister for Health the status of a drug reimbursement application (details supplied); the timeline being worked towards for a decision; and if she will make a statement on the matter. [57384/26]

4071. Deputy Rory Hearne asked the Minister for Health the steps being taken by her Department to make belzutifan available to patients with von Hippel-Lindau disease; and if she will make a statement on the matter. [59087/26]

4094. Deputy Carol Nolan asked the Minister for Health to provide an update on the status of the HSE assessment of the application for pricing and reimbursement of belzutifan (welireg) (details supplied); to outline the current stage of the application within the HSE's formal assessment and approval processes, including the engagement that has taken place with the applicant; to provide an indicative timeline for completion of the process; and if she will make a statement on the matter. [59277/26]

I propose to take Questions Nos. 3239, 3683, 4071 and 4094 together.

The Government is committed to investing in new medicines. Supported by €158 million of funding in Budgets 2021-2025, the State delivered access to 250 new medicines. 70 of these were for rare diseases. Budget 2026 allocated €217 million additional investment in medicines, including €30 million in funding for new medicines. This has, as of June 2026, delivered access to 30 new medicines, including 7 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 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 tumors (pNET), and for whom localised procedures are unsuitable.

Further information on the progress of belzutifan (Welireg®) through the HSE assessment and approval processes 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 HSE100023 has been assigned to this application.

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.