Willie O'Dea
Question:636. Deputy Willie O'Dea asked the Minister for Health when circadin will be available on the medical card scheme; and if he will make a statement on the matter. [53071/22]
View answerTuesday, 25 October 2022
Questions (636)
Written answers
The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drugs schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.
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). There are formal processes which govern applications for the pricing and reimbursement of medicines, and new uses of existing medicines, to be funded and/or reimbursed.
Products that are licensed will undergo a pricing and reimbursement approval process by the National Centre for Pharmacoeconomics (NCPE) on receipt of an application by the HSE from the manufacturer.
Melatonin (Circadin) underwent a review in 2008 and reimbursement was not recommended by the NCPE as there is currently insufficient evidence to support the reimbursement of this product under the Community Drugs Schemes (available at http://www.ncpe.ie/drugs/melatonin-circadin/).
Exceptional arrangements are considered 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 under Discretionary Hardship Arrangements are reviewed on an individual patient basis under Section 23. An individual reimbursement form is required to be completed and submitted by the prescribing consultant in all cases.