Colm Burke (Cork North-Central, Fine Gael)
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1261. To ask the Minister for Health if consideration could be given to approving all patients with type 1 diabetes mellitus to qualify for reimbursement for continuous glucose monitoring (CGM) under the community drug schemes, as many type 1 diabetes patients require CGM but are being refused reimbursement as they have not required insulin from the outset of their disease; and if she will make a statement on the matter. [3184/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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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 devices.

I have asked the HSE to provide a response and they have advised that the Health Information and Quality Authority (HIQA) published the rapid Health Technology Assessment of Continuous Glucose Monitoring (CGM) in Adults with Type 1 Diabetes Mellitus 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.

A single reimbursement application system for Continuous Glucose Monitoring (CGM) sensors came into effect on 1st December 2023. Due to the budget impact associated with these, the HSE established a single reimbursement application system for all CGM sensors on the reimbursement list. This reimbursement application system will apply to any future CGM sensors reimbursed under Community Drug Schemes.

Currently reimbursement support is available for patients with Type 1 Diabetes Mellitus, in line with HSE Circular 033/23 . Reimbursement of CGM at this point in time is for patients with Type I Diabetes Mellitus who have required insulin from the outset. Reimbursement does not extend to other cohorts who were not considered as part of the HIQA HTA. Patients treated with insulin who had recently accessed a CGM sensor under Community Drug Schemes prior to 1 December 2023 continued to have reimbursement support.

If a prescriber wishes, the outcome of a negative decision can be appealed directly via email to the HSE Medicines Management Programme at mmp@hse.ie, or a new application can be submitted via the online application system. Appeals must be made by the patient’s clinician and should include any additional information to support the unmet clinical need for CGM sensors.

Appeals are reviewed on a case-by-case basis, reviewing the information provided in the initial online application and the information in the appeal submission to the HSE Medicines Management Programme. The final reimbursement recommendation is communicated back to the clinician via email or the online application system.

John Lahart (Dublin South West, Fianna Fail)
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1262. To ask the Minister for Health to confirm the direction of travel on licensing an immunotherapy treatment (details supplied). [3189/25]