Neale Richmond (Dublin Rathdown, Fine Gael)
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1233. To ask the Minister for Health if he will allow access to the Ozempic weight loss drug for those on the drugs payment scheme without a diagnosis of diabetes; and if he will make a statement on the matter. [55558/22]

Stephen Donnelly (Wicklow, Fianna Fail)
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The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drugs schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.

HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds, on the advice of the National Centre for Pharmacoeconomics (NCPE). There are formal processes which govern applications for the pricing and reimbursement of medicines, and new uses of existing medicines, to be funded and/or reimbursed.

Medicines can only be reimbursed by the HSE when prescribed for HSE-approved indications. Ozempic (Semalgutide) is licensed by the Health Products Regulatory Authority in Ireland and indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Ozempic was approved by the HSE for addition to the Reimbursement List for the treatment of diabetes in 2018. Diabetes is one of the Long Term Illness (LTI) conditions for which eligible LTI persons can access their medicines to treat their diabetes free of charge.

Controls are in place within the Primary Care Reimbursement Service scheme management systems (and are put in place and updated as required) on claiming processes to ensure that only HSE approved indications are reimbursed across a range of medicines. Controls are currently in place for Ozempic to restrict reimbursement support to the HSE approved indication of diabetes.

I would refer the Deputy to the Health Products Regulatory Authority (HPRA) website which has recently published communication to prescribers in Ireland with regard to the licencing and reimbursement of Ozempic: www.hpra.ie/docs/default-source/Shortages-Docs/novo-nordisk---glp-1-product-range.pdf?sfvrsn=2.