Finian McGrath (Dublin Bay North, Independent) | Oireachtas source

I thank Senator Ó Ríordáin for raising this important matter and for giving me an opportunity to address it.

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. The HSE must also, under its governing legislation, manage the provision of health services within the overall resources available to it. In line with the recommendations of the HSE's health technology assessment group, the FreeStyle Libre product was made available in 2018 to children and young adults and, in some exceptional circumstances, to other patients. The health technology assessment group is a medical technology evaluation group that provides assistance to stakeholders when considering the various health technologies and innovations in the medical devices field. It includes expertise in medicine, pharmacy, health economics, devices and procurement. It reviews the clinical and cost effectiveness of innovative medical devices.

The FreeStyle Libre product is intended to be used as an alternative to current glucose monitoring methods for people who administer multiple daily injections of insulin. In contrast to self-monitoring blood glucose, this technology allows glucose readings to be taken non-invasively. Unlike continuous glucose monitoring, it does not need to be calibrated with a blood sample. On the advice of the health technology assessment group, the HSE decided that after 12 months the situation, including historical reimbursement data, would be reviewed to inform the next steps. The intention is that an update to the initial report will then be published.

In recent months, the primary care eligibility and reimbursement service of the HSE has taken steps to gather the relevant data for review by the health technology assessment group. It collated the reimbursement data on strip usage for persons approved for FreeStyle Libre, as notified to the HSE through individual pharmacy claims on a monthly basis. It liaised with the national clinical programme for diabetes and shared material received with the health technology assessment group. It collated the reasons for exceptional approvals, for example, in cases of older patients with visual impairment or dexterity issues and provided this quantitative data to the health technology assessment group for review.It provided the Diabetes Ireland survey on the use of this product to the health technology assessment group.

The HSE intends that an update to the initial report, including details of the review, will be published after the review has been completed. Although the HSE must be satisfied that the expected offset reductions in glucose monitoring ancillaries materialise, the health technology assessment process expected to be completed by year end or early next year will not focus exclusively on cost savings. The process also allows for patient experience and societal aspects of benefit to be considered, including improvements in health outcomes and the quality of life.