Joe O'Brien (Dublin Fingal, Green Party)
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277. To ask the Minister for Health the status of his plans to provide access to 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. [21548/22]

Stephen Donnelly (Wicklow, Fianna Fail)
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The Health Service Executive (HSE) has statutory responsibility for decisions on pricing and reimbursement of medicines and medical devices under 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 Act to have regard to a number of criteria including 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.

In February 2017, the company Abbott, applied to the HSE for the reimbursement of the FreeStyle Libre flash glucose monitoring system in Ireland. The HSE’s Health Technology Assessment Group (HTAG) carried out an appraisal of the evidence submitted with this application. The HTAG is a medical technology evaluation group that includes expertise in medicine, pharmacy, health economics, devices and procurement. It reviews the clinical and cost effectiveness of innovative medical devices. It recommended that reimbursement for the device should be considered, subject to certain conditions. 

In line with the recommendations outlined by the HTAG, access to the Freestyle Libre flash glucose monitoring system was made available to children and young adults, aged 4 - 21 years, by means of an online process operable since April 2018. However, the online application process does also cater for applications in very exceptional circumstances for type 1 diabetic patients outside this age group.

In 2021, the HSE requested that the National Centre for Pharmacoeconomics (NCPE) carry out a full Health Technology Assessment (HTA) on Freestyle Libre. 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 end 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. The HSE have emphasized the importance of engaging with the HTA to progress the process.

The HSE have now written to the Health Information and Quality Authority (HIQA) to ask if it would consider a system wide HTA across diabetes care. The HSE are awaiting the outcome of this request. In the absence of a full value assessment of the product, the HSE is not in a position to remove the current age restriction.