David Cullinane
Question:148. Deputy David Cullinane asked the Minister for Health if he will advise on a matter raised in correspondence (details supplied). [45493/24]
View answerWednesday, 6 November 2024
Questions (148)
Written answers
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 www.ncpe.ie/drugs/melatonin-circadin/. ).
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.
The HSE have also advised that CoaguChek® meters and International Normalised Ratio (INR) self-testing strips are not reimbursable under the Community Drug Schemes (including the General Medical Services (GMS) scheme) or the Community Funded Schemes. The HSE have further advised that on very rare occasions, CoaguChek® strips were approved for reimbursement in the most exceptional circumstances under Discretionary Hardship Arrangements where it was clear that there was no other option for the patient i.e., the person was bed bound or could not travel to the INR clinic.
In regard to the Discretionary Hardship Arrangement, the processing of applications is a matter for the HSE.