Seán Canney (Galway East, Independent)
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354. To ask the Minister for Health if melatonin can be provided on the medical card to children with additional needs for whom it has been prescribed as the cost of accessing this is prohibitive for many families; and if he will make a statement on the matter. [26020/24]

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. Only medicines with licenced indications which have been granted market authorisation by the European Medicines Agency or the Health Products Regulatory Authority can be 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).

Slenyto (Melatonin) is licensed for the treatment of insomnia in children and adolescents aged 2-18 with Autism Spectrum Disorder (ASD) and / or Smith-Magenis syndrome, where sleep hygiene measures have been insufficient. The HSE advise that it is undergoing a pricing and reimbursement application process at the moment and that reimbursement support under the community drug schemes or any arrangement cannot be provided in advance of the conclusion of the formal processes.

The HSE advise that an application for Circadin (Melatonin) can be made on an exceptional basis under Discretionary Hardship Arrangements for medical card holders. 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

Anne Rabbitte (Galway East, Fianna Fail)
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355. To ask the Minister for Health the status of the medical cards for two children (details supplied); the reason they are being reviewed given the HSE said it would not be doing this; and if he will make a statement on the matter. [26035/24]

Stephen Donnelly (Wicklow, Fianna Fail)
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As this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.