Thomas Pringle (Donegal, Independent)
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562. To ask the Minister for Health whether the HSE primary care reimbursement service will consider including melatonin supplements on the list of medicines or aids provided under the medical card or drugs payment scheme; and if he will make a statement on the matter. [21119/23]

Stephen Donnelly (Wicklow, Fianna Fail)
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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 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 licenced 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.

The HSE advise that Melatonin (Circadin) has never been available under the Community Drug Schemes. Melatonin (Circadin) underwent a review in 2008 and reimbursement was not recommended by the NCPE (see www.ncpe.ie/drugs/melatonin-circadin/).

However, the HSE advise that an application for Melatonin can be made on an exceptional basis under Discretionary Hardship Arrangements for medical card holders. This is in accordance with Section 23 of the 2013 Act, which provides for the supply of items not on the reimbursement List. All applications under these arrangements are reviewed on an individual patient basis. The HSE must be satisfied that the patient requires the item for clinical reasons, and that there is no item on the reimbursement list which is a suitable alternative for that patient.