Parliamentary Question to the Minister of State at the Department of Health (Ms Kathleen Lynch, TD)
To ask the Minister for Health if he will provide an update on the availability of fampyra; if a new application in respect of the drug has been submitted to the National Centre for Pharmaco-economics; and if he will make a statement on the matter. – Jerry Buttimer TD.
For WRITTEN ANSWER on 25/09/2014
The Health Service Executive (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.
The HSE received an application for the inclusion of Fampridine in the GMS and community drugs schemes. The application was 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 National Centre for Pharmacoeconomics (NCPE) conducted a pharmacoeconomic evaluation of Fampridine and concluded that, as the manufacturer was unable to demonstrate the cost effectiveness of Fampridine in the Irish healthcare setting, it was unable to recommend the reimbursement of the product. The report is available on the NCPE’s website (www.ncpe.ie).
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. Due to the very difficult and challenging economic environment in which the Government targeted additional savings in health expenditure of €619 million in 2014, which must be achieved while protecting front line services to the most vulnerable to the greatest extent possible, the HSE decided it was not in a position to add the drug to the List of Reimbursable Items supplied under the GMS and other community drug schemes.
It is open to the supplier, at any time, to submit a new application to the HSE incorporating new evidence which demonstrates the cost effectiveness of Fampridine. Biogen Idec’s Irish management indicated to the HSE in November 2013 that it intended to re-submit an application in April 2014. The HSE has advised it received a revised application from Biogen Idec on Friday 25th July. This application is currently being assessed in line with the agreed procedures and timescales. No further comment is possible at this time as the HSE decision making process is ongoing.