I propose to take Questions Nos. 567 and 591 together.
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.
The HSE received an application for the inclusion of Fampridine (Fampyra®) 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 (IPHA) 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 NCPE report is an important input to assist the HSE in its decision making process and informs further discussions between the HSE and the manufacturer of the drug. 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 €666 million in 2014, which must be achieved while protecting front line services to the most vulnerable to the greatest extent possible, the HSE has 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 evidence which demonstrates the cost effectiveness of Fampridine. The HSE will then re-consider the application to add this product to the List of Reimbursable Items, in line with the agreed procedures and timescales for the assessment of new medicines.