Seán Kyne (Galway West, Fine Gael)
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331. To ask the Minister for Health the status of the application received by the Health Service Executive for the inclusion of Fampridine on the community drugs scheme; when it is envisaged a decision will be made; and if he will confirm that the effectiveness of the medication on the lives of persons with multiple sclerosis is central to the decision-making process. [16788/15]

Kathleen Lynch (Cork North Central, Labour)
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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. Prior to reimbursing any medicine, the HSE considers of a range of statutory criteria including clinical need, cost-effectiveness and the resources available to the HSE.

The decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds by the HSE on the advice of the National Centre for Pharmacoeconomics. They are not political or Ministerial decisions.

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.

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 25 July 2014. The HSE has since been engaging with the company seeking an improved commercial offering and these engagements have been completed. It is not possible to say when a decision on the funding of this medication will be made as the HSE is considering the outcome of those commercial engagements as well as the outcome of discussions which the HSE has had with clinical experts regarding this drug.