746. Deputy Claire Kerrane asked the Minister for Health whether she intends to make a device (details supplied) reimbursable for people with diabetes type 2, as those with type 1 have access to reimbursement; and if she will make a statement on the matter. [51013/26]

The Government is committed to supporting new medicines. Budget 2026 has 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 HSE has statutory responsibility for decisions on the pricing and reimbursement of medicines and medical devices; therefore, I have asked the HSE for an update on this matter.

The Health Information and Quality Authority (HIQA) Rapid Health Technology Assessment (HTA) of Continuous Glucose Monitoring (CGM) in Adults with Type 1 Diabetes Mellitus was published on 29th September 2023. The published document can be found at: www.hiqa.ie/reports-and-publications/health-technology-assessment/rapid-health-technology-assessment-continuous

In line with the advice from HIQA and due to the budget impact associated with CGM sensors, the HSE established a single national reimbursement application system for all CGM sensors on the reimbursement list on 01/12/2023.

Reimbursement support for CGM sensors at this point in time is based on the HIQA HTA and is for patients with type 1 diabetes mellitus regardless of age, who have required insulin from the outset. Reimbursement does not extend to other cohorts such as people with type 2 diabetes who require insulin, or patients previously diagnosed with type 2 diabetes which is now classified as type 1 diabetes based on laboratory investigations such as C-peptide measurement or diabetes-specific autoantibodies. To date, a HTA of CGM sensors for people with type 2 diabetes mellitus or other types of diabetes excluded from the HTA referenced above, such as latent autoimmune diabetes in adults (LADA), type 3c diabetes, monogenic forms of diabetes etc. has not been undertaken. Therefore, there is limited information to support the extension of reimbursement to this cohort, including cost-effectiveness assessment and budget impact of same.

An application for reimbursement support of CGM sensors can be submitted for any patient, and each application is reviewed centrally by the HSE-Medicines Management Programme (MMP) on a case-by-case basis.