626. Deputy Barry Heneghan asked the Minister for Health if she will remove the specific criteria of “insulin initiation from the start” that is preventing approximately 500-700 people with a clinical diagnosis of type one diabetes from accessing continuous glucose monitoring, which clinical evidence and recommendations overwhelmingly supports as first-choice glucose monitoring treatment for all people with type one diabetes. [66993/26]

660. Deputy Peter 'Chap' Cleere asked the Minister for Health if she will remove the specific criteria of 'insulin initiation from the start' that is preventing approximately 500-700 people with a clinical diagnosis of type one diabetes from accessing continuous glucose monitoring , which clinical evidence and recommendations overwhelmingly supports as first-choice glucose monitoring treatment for all people with type one diabetes; and if she will make a statement on the matter. [67184/26]

674. Deputy Colm Burke asked the Minister for Health whether additional funding is being considered to expand access to continuous glucose monitoring technology for people with diabetes who are currently outside the HSE reimbursement criteria. [67242/26]

676. Deputy Colm Burke asked the Minister for Health whether consideration will be given to providing access to continuous glucose monitoring systems for all people with Type 1 diabetes on the basis of current clinical need and specialist recommendation, rather than the circumstances or timing of their original diagnosis. [67239/26]

677. Deputy Colm Burke asked the Minister for Health whether she will review the current eligibility criteria for reimbursement of continuous glucose monitoring systems for people with clinically diagnosed Type 1 diabetes, particularly the requirement that a person must have required insulin from the outset; whether consideration will be given to ensuring that people whose diagnosis was delayed, atypical or initially incorrect are not excluded from access to CGM technology. [67237/26]

I propose to take Questions Nos. 626, 660, 674, 676 and 677 together.

Continuous glucose monitoring (CGM) systems provide an alternative approach to self-monitoring of blood glucose (using blood glucose test strips with an associated blood glucose meter). These CGM systems comprise of sensors, transmitters and a mechanism to display the results (readers/receivers or smart device application).

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. The HSE has advised that the HIQA Rapid HTA of Continuous Glucose Monitoring in Adults with Type 1 Diabetes Mellitus was published on 29th September 2023.

The HTA recommended the establishment of a single managed access programme for all CGM systems for all individuals with type 1 diabetes mellitus regardless of age, noting that such a system would need clearly defined criteria for access. Following on from the recommendations in this HTA, the HSE-MMP, in conjunction with the HSE-PCRS, and with the support of the HSE Chief Clinical Officer, introduced an online reimbursement application system for all CGM sensors on 1st December 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.

To date, a HTA of CGM sensors for people with type 2 diabetes mellitus or other types of diabetes has not been undertaken in Ireland. Therefore, there is limited information to support the extension of reimbursement to these patient groups, including cost-effectiveness assessment and budget impact of same.

The HSE has identified preferred CGM products based on cost-effectiveness to manage this expenditure.

The Diabetes Policy and Services Review: A Strategy for Better Care was launched on the 21st of May. It provides a detailed assessment of our current diabetes services and sets out series of recommendations and actions to improve diabetes care delivery. This includes access to diabetes technology based on clinical need, such as continuous glucose monitoring.

The HSE is currently working to develop an implementation plan for the strategy, in cooperation with my Department, to ensure that the recommendations are followed through at national level and throughout the Health Regions.