414. Deputy John Clendennen asked the Minister for Health for an update on the reimbursement of belzutifan, for the treatment of von Hippel-Lindau (VHL) disease, by the HSE; whether the application is being assessed on the most up to date information on the performance of the drug and subsequent patient outcomes; and when a final decision is likely. [66250/26]

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.

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 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. Following a commercial meeting, the applicant submitted a commercial proposal which is currently under review.

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.

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.

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