Pat Buckley (Cork East, Sinn Fein)
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707.To ask the Minister for Health if his attention has been drawn to the exorbitant prices being charged for melatonin which has been prescribed for adolescents, as much as €60 per month, but is not covered by the drugs payment scheme, DPS, or medical card; the reason for this; and the steps he will take to resolve the hardship being caused. [24775/24]

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 licensed 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 a 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.

Pat Buckley (Cork East, Sinn Fein)
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708.To ask the Minister for Health if his attention has been drawn to the fact that children who are prescribed fluoxetine under 30mg are not covered by the DPS or medical card scheme; the reason for this, considering 30mg tablets are not available; and the steps he will take to resolve the hardship this is causing people in mental health distress. [24776/24]

Stephen Donnelly (Wicklow, Fianna Fail)
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The HSE has statutory responsibility for medicine pricing and reimbursement decisions, under the Health (Pricing and Supply of Medical Goods) Act 2013; therefore, the matter has been referred to the HSE for attention and direct reply to the Deputy.

Pat Buckley (Cork East, Sinn Fein)
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709.To ask the Minister for Health his plans to reduce the cost of medicines related to the treatment or management of autism and ADHD given increasing diagnosis at adult ages and the prohibitive costs of treatment for many adults who do not have medical cards, given the fact that the drugs payment scheme, DPS, may not cover any of their monthly costs or only a small part. [24777/24]

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 licensed 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).

People who cannot, without undue hardship, arrange for the provision of medical services for themselves and their dependants may be eligible for a medical card under the General Medical Services (GMS) Scheme. In accordance with the provisions of the Health Act 1970 (as amended), eligibility for a medical card is determined by the HSE. Medical card eligibility is primarily based on an assessment of means and is not granted on the basis of any particular condition.

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. In circumstances where an applicant is still over the income limit for a medical card, they are then assessed for a GP visit card, which entitles the applicant to GP visits without charge.

Under the Drug Payment Scheme (DPS), no individual or family pays more than €80 a month towards the cost of approved prescribed medicines. The DPS is not means tested and is available to anyone ordinarily resident in Ireland. The DPS significantly reduces the cost burden for families and individuals with ongoing expenditure on medicines.

Individuals may also be entitled to claim tax relief on the cost of their medical expenses, including medicines prescribed by a doctor, dentist, or consultant. Relief is at the standard tax rate of 20%.