Brendan Griffin (Kerry South, Fine Gael)
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18. To ask the Minister for Health if the MS drug fampyra will be made available on the public system to multiple sclerosis sufferers; and if he will make a statement on the matter. [2357/15]

Kathleen Lynch (Cork North Central, Labour)
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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 decisions on which medicines are reimbursed by the taxpayer, are not political or ministerial decisions. These are made on objective, scientific and economic grounds by the Health Service Executive on the advice of the National Centre for Pharmacoeconomics.

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 conducted a pharmacoeconomic evaluation of Fampridine and concluded that, as the manufacturer was unable to demonstrate sufficient effectiveness and a fair price for 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 ().

On foot of this, the HSE decided that 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 for the inclusion of Fampridine on the community drugs schemes incorporating new evidence which demonstrates the cost-effectiveness of the drug, by offering a reduced price or both. A revised application was received by the HSE on 25th July 2014. The HSE has since been engaging with the company seeking an improved commercial offering. These engagements have been completed and the HSE is now considering the outcome of those commercial engagements. Fampridine will be assessed along with a range of other applications for reimbursement of medicines for multiple sclerosis and other diseases.