Martin Browne (Tipperary, Sinn Fein)
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616. To ask the Minister for Health if there are plans to expand the availability of the freestyle libre device for persons with diabetes in Ireland. [25937/22]

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 items, 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). The Minister for Health has no role in these decisions.

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 3rd 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 4 - 21 years. 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.

In order to conduct a value assessment, the HSE requested that NCPE carry out a full Health Technology Assessment (HTA) on Freestyle Libre. The company, Abbott, were formally notified of this on 13 April 2021. Abbott a scoping meeting with the NCPE in July 2021 and committed to submitting their HTA dossier for 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.

The HSE has written to Health Information and Quality Authority (HIQA) to ask if HIQA can consider a system wide HTA across diabetes care. The HSE await the outcome of this request. In the absence of a full value assessment of the product, the HSE cannot progress matters further at the moment.