Shane Curley (Fianna Fail)
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Gabhaim buíochas leis an Aire Stáit as ucht teacht isteach inniu. I thank the Minister of State for coming into the House.

Thousands of people living with type 2 diabetes remain unable to access continuous glucose monitoring, CGM, devices because Ireland has yet to undertake a health technology assessment, HTA, for its use in this patient cohort. Only recently, this House debated access to continuous glucose monitoring. In the Minister's response, it was confirmed that reimbursement cannot currently be extended because no Irish HTA has been undertaken for patients with type 2 diabetes. While that explains the current position, it also highlights the central issue that needs to be addressed, that we need to catch up to our European counterparts. If we look at some of the European countries with the highest regarded health systems, for example France, Germany and the Netherlands, not only have they carried out the HTA but they provide reimbursement for type 2 diabetes patients who get CGMs.

More than 300,000 people in Ireland are living with diabetes, almost 90% of whom have type 2 diabetes. With an ageing population, rising obesity levels and increasingly sedentary lifestyles, the prevalence of type 2 diabetes is expected to continue growing in the years ahead. Every year that a HTA is delayed is another year in which we lack the evidence needed to determine whether CGM technology should be made available to defined cohorts of people in an environment where other countries in the European Union are so far ahead of us.CGMs allow patients and clinicians to monitor glucose levels in real time, improving diabetes management and giving many patients greater confidence in managing their condition. CGMs are available for patients with type 1 diabetes, but people with type 2 diabetes remain excluded, not because the technology lacks potential but because the evidence-gathering process required to inform reimbursement decisions has not yet begun in Ireland. This is at a time when we are lagging so far behind our British and European counterparts. The HSE has also confirmed that its preferred sensor review remains ongoing, yet no timeline has been provided for its completion or publication.

Will the Minister commit to engaging with HIQA and the HSE to scope a rapid HTA for clearly defined cohorts with type 2 diabetes? If so, when will this be done? Will the Minister provide an updated timeline for the completion and publication of the HSE's preferred sensor review? I am not asking that we make a reimbursement decision today but to begin the evidence-gathering process that will allow one to be made in due course. The first step is commissioning a rapid HTA. The second is providing certainty on the preferred sensor review. Both are practical, evidence-based steps that would represent meaningful progress to better care for people living with type 2 diabetes. I would be keen to hear what the current plans are to expand access to CGMs as the disparity in patient access has been made clear to me.

Charlie McConalogue (Donegal, Fianna Fail)
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I thank Senator Curley for raising this important matter. I am taking this Commencement matter on behalf of the Minister for Health, Deputy Jennifer Carroll MacNeill.

The State acknowledges the importance of access to new and innovative medicines and medical devices for patients and is acutely aware of the challenges patients diagnosed with diabetes face. By way of background, 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 such as readers, receivers or a smart device application.

Under the Health Act 2007, the Health Information and Quality Authority, 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 for programmes and services at the specific request of the HSE or the Department of Health, which may include medical devices. Reimbursement support for CGM sensors at this point in time is based on the HIQA health technology assessment 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, which is the issue the Senator is raising today, 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.

The health technology assessment 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’s medicines management programme, in conjunction with the HSE primary care reimbursement service, and with the support of the HSE chief clinical officer, introduced an online reimbursement application system for all CGM sensors on 1 December 2023. Since the introduction of the reimbursement application system for CGM sensors, 5,439 additional individuals have been approved for reimbursement support for this technology. In December 2025, there were paid claims for CGM sensors for 22,012 individuals on the community drug schemes.

In 2025, 72% of new users of CGM sensors were commencing on a preferred CGM sensor. The HSE has identified preferred CGM products based on cost-effectiveness to manage this expenditure. A second review of CGMs is taking place, which will include an update of the preferred CGM sensors evaluation. To date, a health technology assessment 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, type 3c diabetes, monogenic forms of diabetes and so on 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. On 21 May, Diabetes Policy and Services Review: A Strategy for Better Care was launched by the Minister for Health. This is Ireland's first national strategy for diabetes and 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 and represents the development of a unified approach to its delivery. The Government is considering all recommendations of the strategy for progression.

The Senator's key ask is for a HTA to be carried out on expanding reimbursement for CGM sensors to those with diabetes other than type 1. That has not been carried out and there is therefore limited information to support extension of the reimbursement to this cohort, including the cost-effectiveness assessment and the budget impact of same. The Senator believes a HTA would inform that and enable a decision to be made. I thank him for highlighting the issue and will revert to the Minister for Health for further consideration.

Shane Curley (Fianna Fail)
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Gabhaim buíochas leis an Aire Stáit. I appreciate that. The issue we are trying to delve into is not the fact a HTA has not been carried out yet - we know the data does not exist in Ireland yet - but to get the timeline for carrying one out.

The Government has rightly placed renewed emphasis on improving diabetes care through the recently launched diabetes policy and services review. Commissioning the evidence needed to assess innovative technologies for people with type 2 diabetes would be entirely consistent with those objectives. If we are serious about delivering on that strategy, innovative technologies must be assessed using clinical evidence so that future policy decisions can be made with confidence.

This is also about ensuring health services keep up with innovation. As the number of people living with type 2 diabetes continues to grow, delaying a HTA will delay the gathering of the evidence needed to inform policy decisions. I hope the Minister will engage with HIQA and the HSE on scoping a rapid HTA for clearly defined cohorts of people with type 2 diabetes.

There are costs of not doing this. Let us look at the cost of the current situation versus what we could achieve and at the financial benefit to the State of investing in this in the short term to avoid longer term complications. I am not a medical expert but the cost implications of the health complications arising from not investing in CGMs and not having real-time data on blood sugar levels have been explained pretty clearly to me.

Charlie McConalogue (Donegal, Fianna Fail)
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From engaging with constituents of mine who manage diabetes, I know the impact CGM can deliver for them and how it ensures the most effective management of diabetes to maintain health at its optimum and prevent side effects developing over time. The Senator has laid that out carefully. Diabetes care is something the Government has been working to improve, has improved and wants to continue to develop services on.

The Minister for Health met with Diabetes Ireland in April this year and attended Diabetes Ireland's conference in May. She has been made aware of its perspectives on access to CGM sensor technology. I will refer the Senator's strong advocacy for a HTA back to the Minister and ask her to continue to engage with him on the matter.