Liam Quaide (Cork East, Social Democrats)
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685. To ask the Minister for Health for an update on the pricing and reimbursement application process for melatonin under the community drug scheme; if melatonin will be provided under the community drug scheme to children and adolescents aged 2 to 18 years-of-age with autism spectrum disorder; and if she will make a statement on the matter. [4668/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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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 are made on objective, scientific and economic grounds, on the advice of the National Centre for Pharmacoeconomics (NCPE).

Melatonin (Slenyto®) 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 Melatonin (Circadin®), which is indicated for the short-term treatment of primary insomnia, 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 ).

However, the HSE further advise that an application for Melatonin (Circadin®) 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.