John McGahon (Fine Gael)
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I thank the Minister of State for coming to the House. I have raised this issue previously in Commencement debates over the years and I am taking this opportunity to do so again. Diabetes patients can only access FreeStyle Libre if they are under 18 years of age, rather than on the basis of clinical need. This product is widely available for those with diabetes up to the age of 18. Once the patient reaches this threshold, he or she is removed from this treatment, other than in exceptional circumstances, and is provided with a different treatment. This is notwithstanding the patient's familiarity with and usage of the existing FreeStyle Libre product. The removal of the patient from the treatment they know best is based solely on age considerations rather than clinical need or suitability for this product. That is the key issue here. The issue affects a significant proportion of the Irish population, including many people whom I have come across in County Louth. There is a failure to make FreeStyle Libre available for all patient cohorts, irrespective of age, and to reimburse the product more generally.

I would like to make a couple of points. Having a choice of technology is critical. It should be a case of the right technology for the right patient at the right time, or of the technology that meets the clinical needs and preferences of the patient while considering the functionality of the device. Access is not to be determined primarily by an age criterion. Currently, only a small portion of the type 1 diabetes population in Ireland aged between four and 21 years is funded for FreeStyle Libre, which accounts from approximately 14% of the type 1 diabetes population. While funding is in place for another similar-sized cohort of people with type 1 diabetes to access other continuous glucose monitoring systems, these options are considerably more costly. This leaves roughly 20,000 people who have type 1 diabetes in Ireland without access to glucose monitoring technology, which has become a standard of diabetes care right across Europe.

Ireland is behind the rest of the world in terms of diabetes care. Some 44 countries worldwide, including Great Britain and Northern Ireland, now reimburse FreeStyle Libre for intensive insulin users. However, in Ireland it has been six years since the primary care reimbursement service, PCRS, undertook a health technology assessment group appraisal of the product. All these years later, there is no further certainty or clarity for patients. The reimbursement of FreeStyle Libre for people with diabetes is significant because it allows for the remote monitoring of their condition. That is really key because it frees up much-needed doctor and hospital appointments, and leads to better management of the condition, improved outcomes and a better quality of life. Glucose monitoring systems enable individuals to monitor their blood sugar levels more closely, thereby reducing the risks and lowering the incidence of diabetes-related complications.

These technologies have become a fundamental part of diabetes care in many countries. Access to them should be considered as a real right for people living with diabetes. I do not believe that discriminating against them in terms of age makes sense. It does not make sense to me that children who commence their treatment on this device see themselves forced, at the age of 18, to simply switch over to another treatment process by virtue of their age. A survey of diabetes patients in Ireland highlighted the frustration of many people with diabetes who are unable to start, or who have to stop using, flash glucose technology to a lack of reimbursement and unaffordability. This issue impacts not only the individuals with diabetes who are unable to access this really important technology, but also their families and the wider community. As policymakers, it is our responsibility to ensure our healthcare system is providing fair and adequate access to vital medical technologies in a timely manner. With that in mind, I bring this issue to the Seanad today. I hope we can find a timely solution for all patients with diabetes in this country.

Patrick O'Donovan (Limerick County, Fine Gael)
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I am taking this Commencement matter on behalf of the Minister and Ministers of State in the Department of Health, none of whom are available today. I thank the Senator for raising this issue. The HSE has statutory responsibility for decisions on pricing and reimbursement under the community schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. In making a relevant reimbursement decision, the HSE is required under the Act to have regard to a number of criteria including clinical efficacy, the health needs of the public, cost-effectiveness, and potential or actual budget impact. The Minister for Health has no role in these decisions.

A variety of glucose-monitoring devices and sensors are available to people with eligibility for diabetes. There is a national tender arrangement in place for aids and appliances under the community-funded schemes, including continuous glucose-monitoring devices. Hospitals must apply for funding for patients when such a device is warranted. Hence, applications for the reimbursement of such devices do not go through the HSE’s PCRS. The sensors that are used with continuous glucose monitoring devices, where approved, are reimbursable under the community drug schemes, such as the medical card General Medical Services scheme, the long-term illness scheme and the drug payment scheme. These are reimbursable via the PCRS. Currently, consultant endocrinologists may apply to the HSE, on behalf of specific patients with type 1 diabetes, for reimbursement support of FreeStyle Libre flash glucose-monitoring sensors. The application process is undertaken by means of a dedicated online portal, which has been operational since 2018.In line with the recommendations of the health technology assessment group, access to the product was made available to children and young adults aged between four and 21. However, the online application process does cater for the consultant to make an application in very exceptional circumstances for a type 1 diabetes patient who is over 21 years of age. The HSE had requested that the National Centre for Pharmacoeconomics carry out a full health technology assessment, HTA, on FreeStyle Libre. Despite the HSE emphasising the importance of engaging with the HTA process, the company has not submitted a HTA dossier to date.

Following a request from the HSE, HIQA has undertaken a rapid HTA to review the evidence of the clinical and cost-effectiveness of continuous and intermittent glucose monitoring systems for adults with type 1 diabetes. The HSE is awaiting the outcome of this value assessment which is currently ongoing and is expected to be published in the coming months. FreeStyle Libre 2 sensors are undergoing formal pricing and reimbursement in line with the Health (Pricing and Supply of Medical Goods) Act 2013 for patients with type 1 diabetes. Other continuous glucose monitoring devices, such as Dexcom and Medtronic devices, are available as aids and appliances under the community-funded schemes for those with type 1 diabetes. The respective sensors are available under the community drug schemes, and there is no applicable age restriction for these.

John McGahon (Fine Gael)
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I thank the Minister of State for that. The crux of this issue is choice. As I said, it is really about having the right technology for the right person at the right time on that person's medical journey when it comes to diabetes. The concept of basing decisions on age criteria rather than clinical need is certainly an issue. I welcome the report that is going to come from the HSE in the next couple of months. Hopefully that will shed some light on the issue. Again, this should come down to clinical need rather than age criteria.

Patrick O'Donovan (Limerick County, Fine Gael)
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In principle, I do not disagree with what the Senator is saying. As I said, I will ask the Minister for Health, Deputy Stephen Donnelly, to revert to him directly.