Senator John McGahon- speech from 28 Jun 2023

Thank you very much, Lasky Earlock. Minister, thanks for coming to the House today. This is an issue that I've raised previously in commencement debates over the years, and I'd like to take that opportunity to do so again. It's in relation to FreeScile Libre, which diabetes patients can only access if they're under 18 years of age, rather than clinical need. The product is widely available for those with diabetes up to the age of 18, and once the patient reaches this threshold, they are then removed from this treatment, save for exceptional circumstances, and are provided with a different treatment. Now it's standing the patient's familiarity and usage of the existing FSL product. The removal of the patient from the treatment they know best is based solely on age considerations, and not clinical need or suitability for this product, and that's the key issue here. The issue affects the significant proportion of the Irish population, and many people that I've come across in County Lowth. The failure to make FSL available for all patient cohorts, irrespective of age, and the reimbursement of the product more generally. So, a couple of things. Having a choice of technology, first of all, is critical. The right technology for the right patient at the right time. The technology that meets the clinical needs and preferences of the patient, whilst considering the functionality of the device. So, access is not to be determined primarily with an age criteria. Currently, only a small portion of type 1 diabetes population in Ireland, aged between 4 and 21 years, are funded for Freestyle Libra, which accounts for approximately 14% of the type 1 population. While there is a funding in place for another similarly 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 with 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. 44 countries worldwide, including Great Britain and Northern Ireland, are now reimbursing Freestyle Libra for intensive insulin users. However, in Ireland, it has been 6 years since PCRs undertook a HTAG appraisal of the product, and yet, all these years later, there is no further certainty or clarity for patients. So, the reimbursement of FSL for people with diabetes is significant, as it allows for the remote monitoring of their condition. And that is what is really key about this, because it frees up much needed doctor and hospital appointments, better management of the condition, and it leads to improved outcomes, and indeed, a better quality of life in the first instance. Glucose monitoring systems enable individuals to more closely monitor their blood sugar levels, reducing the risks, and lowering the incidence of diabetes-related complications. And again, Minister, these technologies have become a very fundamental part of the diabetes care in many countries. And access to them should be considered as a real right for people living with diabetes. And discriminating against them in terms of age, I don't believe makes sense. I think children who can commence their treatment on this device, and then see themselves forced at the age of 18 to simply switch over to another treatment process by virtue of their age, I just don't think that makes sense, personally, to me. And indeed, a survey of diabetes patients in Ireland highlighted the frustration of many people with diabetes who are unable to start, or had to stop using, flash glucose technology, due to a lack of reimbursement and unaffordability. So, this issue impacts not only the individuals with diabetes who are able to access this really important technology, but also, indeed, their families and the wider community. And as policy makers, I think it's our responsibility to ensure that our healthcare system is providing very much a fair and adequate access to vital medical technologies in a timely manner. And with that in mind, I bring this to the channel today, and I hope that we can find a timely solution for all patients with diabetes in this country. Thank you, Senator. Minister O'Connor. Thank you again for taking this on behalf of the Ministers in the Department of Health, none of whom were available today. And I'd like to thank the Senator for raising it. The HSE has set a true 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, the HSE is required in 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 project impact. The Minister of Health has no role in these decisions. There are a variety of glucose-monitoring devices and sensors which are available to people with eligibility for diabetes. This is a national tender arrangement in place for aids and appliances under the community-funded scheme and includes continuous glucose-monitoring devices and hospitals must apply for funding for those patients where 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 were approved are reimbursable under the community drugs scheme, such as the medically cared GMA scheme, the long-term illness scheme and the drugs payment scheme. These are reimbursable via the PCRS. Currently, a consultant endocrinologist may apply to the HSE on behalf of specific patients with type 1 diabetes for reimbursement support of free-style 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 4 and 21. However, the online application process does cater for the consultant to make an application in very exceptional circumstances for a type 1 diabetic patient who is over 21 years of age. The HSE has requested that the National Centre for Pharma Economics carry out a full health technology assessment on free-style Libre. However, despite the HSE emphasising the importance of engaging with the HSE process, the company has not submitted a HSE dossier to date. Following a request from the HSE, the Health Information and Quality Authority has undertaken a rapid HSE 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 which is expected to be published in the coming months. Free-style Libre 2 sensors are currently undergoing pharma pricing and reimbursements in line with the Health Pricing and Supply of Medical Goods Act for 2013 for patients with type 1 diabetes and 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 and respective sensors are available under the community drug schemes and is no applicable age restriction bar these. Thank you very much Minister for that. I suppose the whole crux of this issue comes to having the choice of it. As I said, it is really about having the right technology for the right person at the right time in what is their medical journey when it comes to diabetes. I think the concept of having it based on age criteria rather than a 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 it. But again, I think this really should come down to clinical need rather than age criteria. Mr. Chairman, look, I do not disagree in principle with what the Senator is saying. And again, as I say, I will ask that the Minister for Health revert to him directly. Thank you very much.