I thank Senator Byrne for raising this important issue. I will be answering on behalf of the Minister for Health, Deputy Jennifer Carroll MacNeill.
The State acknowledges the importance of access to new and innovative medicines for patients and is acutely aware of the plight of patients diagnosed with diabetes. By way of background, CGM systems provide an alternative approach for self-monitoring of blood glucose. These CGM systems comprise sensors, transmitters and a mechanism to display results.
Under the Health Act 2007, HIQA has a statutory remit to evaluate the clinical and cost-effectiveness of health technologies and provide advice to the Minister for Health. HIQA conducts health technology assessments, HTAs, for programmes and services at the specific request of the HSE or the Department of Health, which may include medical devices.
The HSE has advised that HIQA’s rapid HTA of CGM in adults with type 1 diabetes mellitus was published on 29 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 medicines management programme, in conjunction with the HSE primary care reimbursement system and with the support of the HSE chief clinical officer, introduced an online reimbursement application system for all CGM sensors on 1 December 2023. At this point in time, reimbursement support for CGM sensors is based on the HIQA HTA. By the end of 2025, over 27,000 patients in Ireland were approved for reimbursement support for CGM sensors. 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. Such information would include a cost-effectiveness assessment and the budget impact of the measure. The HSE has identified preferred CGM products based on cost effectiveness to manage this expenditure. A second review of CGM sensors is taking place, which will include an update of the preferred CGM sensors evaluation.
On 21 May, the Minister for Health launched Diabetes Policy and Services Review: A Strategy for Better Care. This is Ireland’s first national strategy for diabetes. It sets out recommendations for action in relation to type 1 diabetes, type 2 diabetes, diabetes in pregnancy and paediatric diabetes. The strategy marks a major milestone in diabetes care in Ireland, representing the development of a unified approach to the delivery of diabetes care.
I again thank Senator Byrne for raising this very important issue today. I will bring her views, concerns and ideas back to the Minister for Health, Deputy Carroll MacNeill.