Mark Ward (Dublin Mid West, Sinn Fein)
Link to this: Individually | In context

548. To ask the Minister for Health if belzutifan will be made available to people with Von Hippel-Lindau disease; the steps being taken to make this therapy available; and if she will make a statement on the matter. [50755/26]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
Link to this: Individually | In context

The Government is committed to investing in new medicines. Budgets 2021-2025 allocated an additional €158 million for new drugs, which has facilitated the introduction of 270 new medicines, to date. Budget 2026 allocated €30 million of funding available for new drugs to be allocated from the overall additional €217 million in funding allocated for medicines.

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.

In terms of the specific details of the application for pricing and reimbursement of belzutifan (Welireg®):

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.