Alan Kelly (Tipperary, Labour)
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525. To ask the Minister for Health if he will consider adding the injection ozempic to the drugs payment scheme (details supplied); and if he will make a statement on the matter. [37854/24]

David Cullinane (Waterford, Sinn Fein)
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538. To ask the Minister for Health if he has considered the inclusion of ozempic in the drug payment scheme for purposes other than management of type 2 diabetes; if he has considered this in the context of its application in managing patients with insulin resistance; and if he will make a statement on the matter. [37877/24]

Stephen Donnelly (Wicklow, Fianna Fail)
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I propose to take Questions Nos. 525 and 538 together.

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 licenced 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, or to have a new indication for a medicine added to the 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.

Ozempic® (Semaglutide) is indicated for the treatment of adults with insufficiently controlled type 2 diabetes as an adjunct to diet and exercise. Ozempic® (Semaglutide) is not licensed or reimbursed for the treatment of weight management in a non-diabetic population.

Therefore, reimbursement support for Ozempic® (Semaglutide) for the licensed indication only is available to those with eligibility under the General Medical Services (GMS) Scheme or the Long-Term Illness (LTI) Scheme. Ozempic® (Semaglutide) is not available on the Drugs Payment Scheme.