Dáil Éireann Debate, Wednesday - 8 May 2024
558. Deputy Michael Collins asked the Minister for Health based on the fact that melatonin and circadin tablets which are used in the treatment of insomnia are ineffective in many patients, and that GPs are prescribing slenyto more frequently for these patients with a very high success rate; when will this drug be put on the discretionary hardship scheme. [20431/24]
View answerThe 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 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 the pricing and reimbursement application process at the moment. The HSE further advise that reimbursement support under the Community Drug Schemes or any arrangement cannot be provided in advance of the conclusion of the formal processes.
