Mary Lou McDonald (Dublin Central, Sinn Fein)
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307. 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. [38429/24]

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 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. 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 are made on objective, scientific and economic grounds, on the advice of the National Centre for Pharmacoeconomics (NCPE).

Ozempic® (Semaglutide) is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise; as monotherapy when metformin is considered inappropriate due to intolerance or contraindications; and in addition to other medicinal products for the treatment of diabetes. Ozempic® (Semaglutide) is not licensed for the treatment of weight management in a non-diabetic population.

Ozempic® (Semaglutide) was approved by the HSE in September 2018 for addition to the reimbursement list in accordance with its licensed indication (see ).

Controls are currently in place within the HSE's Primary Care Reimbursement Service (PCRS) in relation to Ozempic® (Semaglutide) to restrict reimbursement support to the approved indication. It is for this reason that reimbursement for Ozempic® (Semaglutide) is confined to those with eligibility under the General Medical Services Scheme (GMS) or the Long-Term Illness (LTI) scheme and is not made available on the Drugs Payment Scheme.

In accordance with the provisions of the Health Act 1970 (as amended), eligibility for a medical card under the GMS Scheme is determined by the HSE by means of a financial assessment. In certain circumstances, the HSE may exercise discretion and grant a medical card, even though an applicant exceeds the income guidelines, where he or she faces difficult financial circumstances, such as extra costs arising from illness.

The LTI Scheme was established under Section 59(3) of the Health Act 1970 (as amended). Regulations were made prescribing 16 conditions covered by the Scheme, including diabetes mellitus. There is no means test for the LTI Scheme.

Mary Lou McDonald (Dublin Central, Sinn Fein)
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308. To ask the Minister for Health if semaglutide is licenced and approved for use for insulin resistance or weight management or any other purpose in the State; if it is approved or under consideration for reimbursement in any context other than type 2 diabetes; and if he will make a statement on the matter. [38430/24]