Jim Daly (Cork South West, Fine Gael) | Oireachtas source

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.

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