Dáil Éireann Debate, Tuesday - 30 June 2026
901. Deputy Conor Sheehan asked the Minister for Health for an update on the exceptional patient scheme or discretionary funding for GLP-1 medications for severe, treatment-resistant metabolic disorders, including polycystic ovary syndrome, PCOS, where insulin resistance cannot be managed by metformin; and if she will make a statement on the matter. [49594/26]
Amharc ar fhreagraThe Minister recognises the importance of providing the best care possible to patients with this condition. Women’s Health has been and will continue to be a focus of the Department. The Government has made real progress in improving the healthcare available to women in Ireland.
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 device.
In accordance with the legislation, a medicine must have a marketing authorisation (licence) to be included in the formal list of reimbursable items. Glucagon-like peptide-1 (GLP-1) receptor agonists licensed in Ireland do not currently have an EU marketing authorisation for the treatment of Polyendocrine Metabolic Ovarian Syndrome (PMOS) or similar endocrine conditions.
A pharmaceutical company can apply to the HSE for reimbursement for a specific indication (use) of a specific licensed medicine. Medicines can have more than one licensed (market authorised) indication and each indication represents a separate application.
Controls are in place within PCRS on claiming processes to ensure that only HSE approved indications are reimbursed across a range of medicines. Controls are currently in place for the GLP-1 agonists to restrict reimbursement support to the HSE approved indications. Off-label prescribing of GLP-1 agonists are not supported for reimbursement under Community Drug Schemes.
It is incumbent on a company to apply to the appropriate regulatory body for a marketing authorisation to extend the licence for a GLP-1 receptor agonist for the treatment of PMOS and then to submit a new pricing and reimbursement application for any newly approved indication to the HSE. The HSE will process any pricing and reimbursement applications as efficiently as possible.
