Michael Harty (Clare, Independent)
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FreeStyle Libre is a blood glucose measuring device to help patients manage their diabetes. On 3 April this year, the device was made available to insulin-dependent diabetics between the age of four and 21. It is a new form of technology. Our question is why there is such a restriction. The system, which is attached to the skin, gives real-time readings on blood sugar. It enables patients to individualise the management of their diabetes. It helps them to adjust their treatment, particularly in regard to diet and exercise, and it tailors their treatment to their specific needs. It also gives health professionals and patients valuable information in supervising their treatment. It is cost-effective, reducing the use of expensive blood testing strips and hospital visits, and helps to reduce the emergence of complications of diabetes such as eye disease, kidney disease and heart disease.

I want to ask why this technology is restricted to those age groups between four and 21.

Joan Collins (Dublin South Central, Independent)
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On 18 April, up to 50 people representing the diabetes community presented a petition with 18,000 signatures demanding access for all to new life-changing flash glucose monitoring technology that affects 20,000 people with type 1 diabetes. The petition highlighted the fact that from 3 April 2018 the HSE has made FreeStyle Libre available to children and young adults with type 1 diabetes aged four to 21 years. They very much welcome that. However, we note that in 18 other countries this technology been allocated to all patients with type 1 diabetes. As Ms Gráinne Flynn, one of the campaign leaders, has stated:

The FreeStyle Libre provides more information than a finger prick meter about glucose levels to base our insulin dosing decisions on. This is more than just a game changer in diabetes, it empowers us to manage our diabetes better, reducing the number of dangerous low and high glucose levels.

Why was this not introduced for everyone?

Mary Butler (Waterford, Fianna Fail)
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I welcome the HSE's decision to reimburse FreeStyle Libre for children and young adults. As the Minister of State is aware, almost 190,000 people in Ireland have diabetes, which is a chronic disease that takes a lot of management. This device, which allows blood glucose levels to be monitored without invasive finger prick testing, is an absolute game-changer for anyone suffering with diabetes.

In some cases, patients must test their glucose levels up to ten times a day. While I welcome the decision to roll this out for children and young adults, it is an absolute necessity to roll it out to all type 1 diabetics to allow them to manage their illness actively in a meaningful and continuous way on the basis of real-time information as to their glucose levels.

Frank O'Rourke (Kildare North, Fianna Fail)
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I support the call to roll out the FreeStyle Libre device to all type 1 diabetes sufferers. This is a matter we have raised on a number of occasions. While we appreciate very much the fact that it has been made available to those aged up to 21 years, it is important to remember that all type 1 diabetes sufferers suffer in the same way. They all need the same treatment and access to this good modern technology which can help them to manage and control their condition. Why would we discriminate among type 1 diabetes sufferers and allocate the device to one sufferer and not another? It does not make sense and it is unfair. The Minister of State will acknowledge that. How soon can this be made available to all type 1 diabetes sufferers and why was the measure rolled out in a manner which discriminates among people suffering from this illness?

Jim Daly (Cork South West, Fine Gael)
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I thank the Deputies for the opportunity to address the issue of the management of type 1 diabetes and the FreeStyle Libre glucose monitoring device being provided by the HSE. Diabetes places a substantial burden on the individual, society and the economy. Much of this burden is attributable to short-term and long-term complications. Almost 190,000 people in Ireland have diabetes. As the prevalence of diabetes rises, diabetes-related complications represent a growing global public health and health service challenge.

Glucose monitoring allows people to self-manage diabetes by making adjustments to their diets, lifestyles and treatments to reduce the risk of diabetes-related complications. Current glucose monitoring methods include self-monitoring of blood glucose. This means finger-prick blood glucose monitoring using testing strips and electronic glucose meters, as well as continuous glucose monitoring, which needs to be calibrated with a blood sample. The FreeStyle Libre flash glucose monitoring system is intended to be used as an alternative to current methods for people who administer multiple daily injections of insulin. This innovative technology allows glucose readings to be taken non-invasively without the need to calibrate with a blood sample.

The HSE has statutory responsibility for decisions on pricing and the reimbursement of medical devices under the community drug schemes in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. In February 2017, an application by the manufacturer of the FreeStyle Libre device was submitted to the primary care reimbursement service, or PCRS, of the Health Service Executive for the reimbursement of its flash glucose monitoring system. The HSE's health technology assessment group carried out an appraisal of the evidence submitted with this application and considered the FreeStyle Libre application for addition to the reimbursement list in line with the 2013 Act. The health technology assessment group recommended that reimbursement for the device should be considered subject to certain conditions. The HSE accepted this recommendations in principle and has developed an application suite for hospital clinicians to use when proposing suitable patients for consideration of individual reimbursement support.

Continuous glucose monitoring is already available to some patients, including those whose endocrinologists have prescribed a particular type of insulin pump. The FreeStyle Libre device is now being made available under the long-term illness scheme and the criteria for approval are as follows: the patient has type 1 diabetes; the patient is aged four to 21 years; the patient uses multiple daily injections of insulin or insulin pump therapy; the patient has increased blood glucose testing requirements; the patient has frequent episodes of diabetic ketoacidosis, DKA, or hypoglycaemia which have included hospital admissions; and the patient is not pregnant. Patients must be individually approved by their hospital clinicians. I understand that adults who do not fulfil the criteria are concerned that the new technology is not available to them. While the first phase of access to this product is confined to children and young adults, the application process allows a consultant to make an application in very exceptional circumstances for a type 1 diabetic patient outside this group. There will be a review after 12 months to look at the evidence of the effectiveness of the device and to ensure that costs are in line with expectations.

We have made huge strides in treating and managing diabetes and I welcome the HSE's decision to reimburse FreeStyle Libre, which is good news for young people and their parents. The Minister for Health, Deputy Simon Harris, is aware that patients with type 1 diabetes must test their glucose levels up to ten times a day and it is his hope that this innovative device will help to minimise inconvenience and discomfort for many children and young people. The Minister must await the outcome of the review by the HSE of the effectiveness and efficiency of the FreeStyle Libre device before he is in a position to commit to its availability to all patients.

Michael Harty (Clare, Independent)
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The Minister of State has not really outlined why this has been restricted to the four to 21 years age cohort. That is the reason the issue was raised. This is a new type of technology and the future of diabetes management, not only in Ireland but worldwide. It should be made available to all patients who need it. There has been an explosion of diabetes in Irish society and many patients will transition from non-insulin dependent diabetes to insulin-dependent diabetes. As such, the Minister of State must explain when he comes back in why there is a restriction based on age.

Joan Collins (Dublin South Central, Independent)
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I repeat that. The Minister of State has not really answered the question. Why was it restricted to those aged four to 21 years? It seems there is discrimination here. It is a question of monitoring over a 12-month period. Surely, all patients should have been provided with the device for the purposes of the 12-month review. This does not make any sense and the Minister of State should reply in more detail on it. He could go back to the monitoring committee and ask it to extend this to all patients.

Mary Butler (Waterford, Fianna Fail)
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I request the expert group within the HSE to consider the additional roll-out to adults as a matter of urgency. I have no doubt the group will monitor closely how it affects children and young adults but we cannot have discrimination. My colleague, Deputy Frank O'Rourke, and I accepted a petition recently containing 19,005 signatures on behalf of people suffering from diabetes calling for equality for all sufferers. That is a lot of signatures. People are very concerned. I ask the Minister of State to explain the exceptional circumstances criteria. That is very important and I had not heard about it before.

Frank O'Rourke (Kildare North, Fianna Fail)
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I echo my colleagues' comments. I welcome the availability of FreeStyle Libre for children and young adults from age four to 21. It is an acknowledgement of how important this is for those who suffer from type 1 diabetes. However, I ask what "exceptional circumstances" means when everyone who suffers from type 1 diabetes needs the same help and support to manage the condition. It does not make any sense to have an age cut-off. When will this be reviewed and what can be done to fast-track the review so that all those who suffer from type 1 diabetes can access this equipment?

Jim Daly (Cork South West, Fine Gael)
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I assure Deputies that I will make known their strong feelings on this matter to the Department and the HSE. I will have to get Deputy Butler the detail on the exceptional circumstances ground. I suspect it is a clinical matter but I can find out exactly what it means. While I suspect GPs are aware of what is involved, I can get her the detail on what are those exceptional circumstances.

The Deputies asked why the scheme is restricted to those aged up to 21 years. This is an era of finite not infinite resources and with any scheme like this there are two aspects. There is the affordability aspect and there is also the question of ensuring something is a good and efficient product. The decision taken has been to provide for a 12-month trial period and to review the efficacy of the device at that stage to determine whether it is an efficient treatment which, in layman's terms, does what it says on the tin. As resources allow, we will progress it. We all want to see it extended to the whole population, but we have to begin somewhere as we did with the roll-out of free GP care. It is not a question of discriminating against a cohort of people, it is a question of starting somewhere. Earlier intervention with younger people was deemed to be a priority by the group looking at this.

Joan Collins (Dublin South Central, Independent)
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Can the information on the exceptional circumstances be circulated to all of us?

Jim Daly (Cork South West, Fine Gael)
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Yes.

Seán Ó Fearghaíl (Kildare South, Ceann Comhairle)
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I thank Deputy Collins. That is a good point.