Martin Kenny (Sligo-Leitrim, Sinn Fein)
Link to this: Individually | In context | Oireachtas source

863. To ask the Minister for Health if he plans to extend the drugs payment scheme to cover the cost of ozempic semaglutide for those prescribed it off-label for reasons other than those associated with diabetes. [34207/22]

Stephen Donnelly (Wicklow, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

The Health Service Executive (HSE) has statutory responsibility for medicine pricing and reimbursement decisions, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.

In line with the 2013 Health 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. Reimbursement is for licensed indications which have been granted market authorisation by the European Medicines Agency or the Health Products Regulatory Authority.

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). The Minister for Health has no role in these decisions.

Ozempic® (semaglutide) is licensed with the Health Products Regulatory Authority (HPRA) in Ireland, and is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Ozempic® (semaglutide) was approved by the HSE for addition to the Reimbursement List for the treatment of Diabetes in 2018. Semaglutide has not been approved for reimbursement for any other indication to date.

Controls are in place within the HSE management systems on claiming processes to ensure that only HSE approved indications are reimbursed across a range of medicines. Controls are currently in place in relation to Ozempic® (semaglutide) to restrict reimbursement support to the HSE approved indication of Diabetes. Persons with Diabetes are eligible for the Long Term Illness scheme and may access Semaglutide via that eligibility. Therefore, it is not made available on the Drug Payment Scheme.