Patrick O'Donovan (Limerick County, Fine Gael) | Oireachtas source

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.