David Cullinane (Waterford, Sinn Fein)
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512. To ask the Minister for Health if there are plans to provide funding in budget 2023 to fund the provision of the FreeStyle Libre flash glucose monitoring system to persons with diabetes over 21 years of age based on clinical need; and if he will make a statement on the matter. [44499/22]

Stephen Donnelly (Wicklow, Fianna Fail)
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The Health Service Executive (HSE) has statutory responsibility for decisions on pricing and reimbursement of medical devices in the community drug 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 2013 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. HSE decisions on which medicines and medical items are reimbursed by the taxpayer are made on objective, scientific and economic grounds, on the advice of the National Centre for Pharmacoeconomics (NCPE).

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 (FGM) sensors. The application process is undertaken by means of a dedicated online portal, which has been operational since 3 April 2018. In line with the recommendations of the Health Technology Assessment Group, access to this product was made available to children and young adults, aged between 4 and 21 years of age. 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 requested that the NCPE carry out a full Health Technology Assessment (HTA) on Freestyle Libre, and the company, Abbott, were formally notified of this on 13 April 2021. Abbott had a scoping meeting with the NCPE in July 2021 and committed to submitting their HTA dossier by the end of October 2021. However, on 15 November 2021, Abbott informed the HSE that they would not be submitting the HTA dossier because they did not have the level of Randomized Controlled Trials (RCT) evidence that they stated was required for a full HTA process. Despite the HSE emphasising the importance of engaging with the HTA process to progress matters, the company have not submitted a HTA dossier to date. It remains open to Abbott to re-engage with the NCPE as they indicated they would in July 2021.

Recently, following a request from the HSE, the Health Information and Quality Authority (HIQA) held an initial meeting with the HSE Diabetes Clinical Programme to scope out what might be involved in undertaking a system wide HTA across diabetes care. In the absence of a full value assessment of the product to determine cost effectiveness or value for money, the HSE is not in a position to remove the current age restriction.

During the estimates process, deliberations as to the priorities to be progressed within the National Service Plan occur. It is not possible to say at this juncture whether additional funding of the FreeStyle Libre Flash Glucose Monitoring system will be provided.

David Cullinane (Waterford, Sinn Fein)
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513. To ask the Minister for Health if he will ring-fence some of the anticipated 2021 cost savings from the recent HSE medicines management programme, MMP, preferred blood glucose strips for adults with type 1 and type 2 diabetes evaluation to fund the provision of the Freestyle Libre flash glucose monitoring system to persons with diabetes over 21 years of age based on clinical need; and if he will make a statement on the matter. [44500/22]

Stephen Donnelly (Wicklow, Fianna Fail)
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As this is a service matter, I have asked the Health Service Executive to respond to the deputy directly, as soon as possible.

David Cullinane (Waterford, Sinn Fein)
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514. To ask the Minister for Health the number of applications for FreeStyle Libre that were submitted by individual hospitals for persons with diabetes over 21 years of age; the number that were approved; the number that were refused in each of the years 2017 to 2021, in tabular form; if there are plans to remove the age restriction on FreeStyle Libre; and if he will make a statement on the matter. [44501/22]

Stephen Donnelly (Wicklow, Fianna Fail)
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As this is a service matter, I have asked the Health Service Executive to respond to the deputy directly, as soon as possible.