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Medicinal Products

Dáil Éireann Debate, Tuesday - 22 March 2022

Tuesday, 22 March 2022

Questions (847)

Pa Daly

Question:

847. Deputy Pa Daly asked the Minister for Health if he will review the situation regarding melatonin not being covered by the medical card scheme; and if he will make a statement on the matter. [14080/22]

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Written answers

The 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.

The HSE Corporate Pharmaceutical Unit (CPU) is the interface between the HSE and the Pharmaceutical Industry in relation to medicine pricing and reimbursement applications. The HSE CPU received an application for pricing / reimbursement of Melatonin (Slenyto® Prolonged-Release Tablets) on the 3rd July 2019 from Flynn Pharma 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.

On the 31st July 2019, the HSE CPU requested that Flynn Pharma submit a rapid review dossier to the NCPE for assessment. To date Flynn Pharma has not submitted a rapid review dossier to the NCPE for assessment. As it currently stands, submission of a completed rapid review dossier to the NCPE is required to progress this application, as per the formal processes governing the pricing and reimbursement of medicines.

In relation to the reimbursement of Melatonin (Circadin), the HSE advise that Melatonin (Circadin) has never been available through the Reimbursement List under the Community Drug Schemes. Melatonin (Circadin) underwent a review in 2008 and reimbursement was not recommended by the NCPE as there was insufficient evidence to support the reimbursement of this product under the Community Drug Schemes (available at www.ncpe.ie/drugs/melatonin-circadin/).

However, the HSE advise that exceptional arrangements are considered for Melatonin (Circadin) under Section 23 of the Health (Pricing and Supply of Medical Goods) Act 2013 - Supply of items not on Reimbursement List. The HSE must be satisfied that:

(a) The patient requires that item for clinical reasons, and

(b) There is no listed item which is a suitable alternative for that item in so far as that patient is concerned.

All applications for Melatonin (Circadin) under Discretionary Hardship Arrangements are reviewed on an individual patient basis under Section 23.

The medical decision to prescribe or not prescribe any treatment for an individual patient is strictly a decision for the treating clinician, in consultation with their patient. The Minister for Health has no role in this clinical decision-making process and Section 6 of the HSE Governance Act 2013 bars the Minister for Health from directing the HSE to provide a treatment or a personal service to any individual or to confer eligibility on any individual.

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