Dara Calleary (Mayo, Fianna Fail)
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583. To ask the Minister for Health if a drug (details supplied) can be added to GMS; and if he will make a statement on the matter. [11059/23]

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 under the Community Drug Schemes, in accordance with the provisions of the Health (Pricing and Supply of Medical Goods) Act 2013. Reimbursement is for licensed indications which have been granted market authorisation by the European Medicines Agency (EMA) or the Health Products Regulatory Authority (HPRA). In line with the 2013 Act and the national framework agreed with industry, a company must submit an application to the HSE to have a new medicine added to the reimbursement list.

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. 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). I, as Minister for Health, have no role in these decisions.

Semaglutide, which is marketed as Ozempic®, was approved by the HSE in 2018 for addition to the Reimbursement List for the treatment of Diabetes. Semaglutide has not been approved for reimbursement for any other indication. Controls are currently in place in relation to Semaglutide (Ozempic®) to restrict reimbursement support to the HSE approved indication of Diabetes. The HSE advise that reimbursement for Semaglutide (Ozempic®) is confined to those with eligibility under the General Medical Services Scheme (GMS) or the Long-Term Illness (LTI) scheme. This medicine is not available on the Drugs Payment Scheme.

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 licensing and reimbursement of Ozempic: www.hpra.ie/docs/default-source/Shortages-Docs/novo-nordisk---glp-1-product-range.pdf?sfvrsn=2