Mary Butler (Waterford, Fianna Fail)
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I warmly 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 have to test their glucose levels up to ten times a day. This can be a real inconvenience and discomfort, especially for children.

While we welcome the HSE's decision, we believe clarity is needed in respect of it. We are here today because we need the meat on the bones now. We have questions to ask. We appreciate that the Minister of State might not be able to answer them all today. We would appreciate it if the Minister of State would bring our questions back to the Minister for Health. The Minister's press release mentioned that this will be available "for children and young adults". What exactly is meant by "young adults"? That is my first specific question. According to the press release, this will not be available for children and young adults on insulin pumps. Why is this group being excluded?

Would it be possible for the Minister of State to clarify the specific criteria which must be satisfied, in line with the recommendations of the health technology assessment group, in order for reimbursements to be made in respect of children and teenagers with diabetes? How long will it take to build the application suite for reimbursement support? As the Minister of Sate is aware, FreeStyle Libre costs approximately €120 a month. This is a huge cost for families with young children and for patients who are funding this themselves each week. The sensors, which cost €60 each, last for 14 days. This means there is a monthly cost of €120, plus €6 postage and packaging costs.

Frank O'Rourke (Kildare North, Fianna Fail)
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I am delighted to speak on this issue along with my colleague, Deputy Butler, on behalf of the diabetes community of Ireland. I thank the Minister of State for coming to the Chamber to respond to this Topical Issue. I raised this matter with the Minister for Health a number of weeks ago. It was announced a few days later that FreeStyle Libre was to be included in the long-term illness scheme for adults and children. This decision is to be welcomed. I acknowledge that this is a positive development. We are looking to see whether it can be extended to all sufferers of type 1 diabetes. This would be massively important for them. There is a great deal of concern and anxiety out there at the moment. The people who are not included in the current arrangements have put together a campaign to try to impress on the Minister the importance of their case. They have gathered 13,000 signatures to that end. The Minister of State might ask the Minister whether he is willing to meet a delegation or group to accept the 13,000 signatures and to discuss this matter for a few minutes. This would allow those who are seeking to get this extended to highlight the concern that exists in this respect.

As my colleague, Deputy Butler, said, this brilliant technology is replacing the finger-prick test. It has to be inclusive for all. We need to include it for all sufferers of type 1 diabetes. It is not right to discriminate between one class and another because they are all suffering from the same condition. At the moment, there are 20,000 adults suffering from type 1 diabetes. It appears that they are not included in the long-term illness scheme for the equipment that is being made available. The HSE advocates the use of insulin pumps in preference to other technologies. There is a direct contradiction in all of this because it has said that anyone using an insulin pump will not be able to avail of this equipment. There are major problems in this regard. I acknowledge the presence of the Minister of State. I welcome the decision to extend the availability of this technology to some people. We need to work together to extend it to everyone.

Jim Daly (Cork South West, Fine Gael)
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I thank the Deputies for the opportunity to speak about the provision by the HSE of a new management device for children with type 1 diabetes. Diabetes places a substantial burden on the individual, on society and on 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 increases, diabetes-related complications represent a growing global public health and health service challenge.

In accordance with the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for decisions on pricing and reimbursement of medical devices in the community drug schemes. In February 2017, an application by the manufacturer was submitted to the primary care reimbursement service of the HSE for the reimbursement of the FreeStyle Libre flash glucose monitoring system. Glucose monitoring allows people to self-manage diabetes by making adjustments to their diet, lifestyle and treatment to reduce the risk of diabetes-related complications. Current glucose monitoring methods include self-monitoring of blood glucose, which involves 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 and does not need to be calibrated with a blood sample. The HSE health technology assessment group carried out an appraisal of the evidence submitted with this application. An expert group under the auspices of the health technology assessment group 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 has accepted its recommendations in principle and will be developing an application suite for hospital clinicians to use when proposing suitable patients for consideration of individual reimbursement support. This will be confined to children and young adults who require multiple daily injections of insulin in the first instance, with a review after 12 months.

The HSE has indicated that it will take some months to build the application suite for reimbursement support. When the application suite is ready and in place, hospitals providing a diabetic clinic service will be able to apply for the device for children and young adults, in line with the recommendation of the health technology assessment group. As patients receive approval on the application suite, pharmacies will be able to see their approval status and will be able to dispense to the patient under their long-term illness scheme eligibility.

We have made huge strides in treating and managing diabetes and I am happy to welcome the HSE’s decision to reimburse FreeStyle Libre, which will be welcome news for young people and their parents.

Mary Butler (Waterford, Fianna Fail)
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Unfortunately, there is no new information available here. It is really hard on parents of children and young adults, who received this information and were so excited with it, that there is very little detail. This will be a game changer. However, a timeframe for the roll-out is essential and is required sooner rather than later. In the long run, the Exchequer will save money because when diabetes is properly monitored and controlled, the amount of hospital care required will decrease.

I also ask the Minister of State to request the expert group under the HSE's watch to consider the additional roll-out to adults as a matter of urgency. I have no doubt they will monitor closely how it affects children and young adults but we certainly cannot have discrimination in that regard. I concur with my colleague in respect of the petition with 13,000 signatures. That is a lot of signatures and I hope the Minister will accept it from the organisers.

Frank O'Rourke (Kildare North, Fianna Fail)
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I welcome and acknowledge the Minister of State's response. To be fair, he does not have the information or details available to him to deal with the issues we have raised today. We hope that discussing the matter in the Chamber today might create the vehicle through which we could sit down with the Minister or some of his appointed officials so that we can get the detail about all of this for the people who have been included.

We continue to acknowledge that this is a good news story. This is not negative at all, but we need it to go further. What is key here is that the Minister of State ask the Minister, Deputy Simon Harris, when we can meet him and get the information from him and get a commitment from him that it will be extended to all type one diabetes sufferers. That is hugely important. The cost of this is €120 a month. That is a lot of money for people who are struggling as it is and we need to get a commitment about the roll-out for the people who are approved, but most importantly when a decision will be made for all type one diabetes sufferers. Will the Minister also come back to us and let us know if he will meet a small delegation with the 13,000 signatures to see if we can discuss this and bring clarity and definitive delivery deadlines?

Jim Daly (Cork South West, Fine Gael)
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I thank the Deputies for their constructive and positive approach; both of them are known for that so it is no surprise in this particular matter. I accept there are many more unanswered questions and their job as representatives is to get answers for those people who are very anxious about it. Deputy O'Rourke acknowledged the cost to individuals who have to pay for the device. They need more clarity and certainty.

It is a good news story and a positive development but we need to know how far it goes, how long it is going to take to roll out and when it can impact and change people's lives in such a positive way. There is no point having a wish and something that is announced. We need to have it in real practice.

I will pass on the Deputies' concerns to the Minister and reiterate their request to get the detailed answers they want, whether it is through a meeting with his officials or with himself. I will certainly pass on that request to him and will encourage the process to happen sooner rather than later so that the 13,000 people who signed the petition and many others who are impacted by this will get the clarity they deserve and the Deputies will get it on their part.

Pat Gallagher (Donegal, Fianna Fail)
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We should be moving on to the third Topical Issue in the name of Deputy Durkan, but it appears the Minister of State, Deputy Damien English, has not arrived yet. With Deputy Durkan's permission, we will go on to the next matter in the name of Deputy Tóibín.