Dáil Éireann Debate, Thursday - 3 July 2014
185. Deputy Denis Naughten asked the Minister for Health if he will approve funds for the use of Translarna, also known as ataluren for the treatment of Duchenne muscular dystrophy in view of its approval in the UK; and if he will make a statement on the matter. [28768/14]
View answerThe first step for a medicine to be placed on the Irish market involves the manufacturer seeking an authorisation from the Health Products Regulatory Authority (HPRA) or in the case of certain medicinal products, the European Medicines Agency. A determination on the application for authorisation is based on a rigorous scientific assessment of the application against legal and regulatory requirements.
Translarna is not currently authorised in Ireland. It is awaiting a decision from the European Commission for the treatment of Duchenne Muscular Dystrophy.
Once authorised on the Irish market, the supplier must make an application to the Health Service Executive (HSE) for the product to be included on the list of products covered under the GMS and other community drug schemes. The HSE has statutory responsibility for decisions on pricing and reimbursement of medicinal products under the community drug schemes in accordance with the provisions of the Health (Pricing and Supply of Medical Goods) Act 2013.
Applications for reimbursement are considered in line with the procedures and timescales agreed by the Department of Health and the HSE with the Irish Pharmaceutical Healthcare Association for the assessment of new medicines.
In accordance with these procedures, the HSE may ask the National Centre for Pharmacoeconomics (NCPE) to conduct a pharmacoeconomic evaluation of the new product which provides detailed information on the potential budget impact of the medicine. It also assesses whether the product is cost effective at the price quoted by the company in question. The NCPE report is an important input to assist the HSE in its decision making process and informs further discussions between the HSE and the supplier. The HSE assessment process is intended to arrive at a decision on the funding of new medicines that is clinically appropriate, fair, consistent and sustainable.
