Mary Lou McDonald (Dublin Central, Sinn Fein)
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693. To ask the Minister for Health when the drug Fampyra will be included on the drugs payment scheme, in view of the ongoing financial hardship experienced by persons who are prescribed this drug [21602/15]

John O'Mahony (Mayo, Fine Gael)
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695. To ask the Minister for Health if he will provide an update on the discussion to make Fampyra available to multiple sclerosis sufferers; and if he will make a statement on the matter. [21614/15]

Áine Collins (Cork North West, Fine Gael)
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747. To ask the Minister for Health the reason the Fampyra drug is not included in either the medical card, drug payment scheme or long-term illness scheme; and if this situation will be rectified shortly. [21759/15]

Kathleen Lynch (Cork North Central, Labour)
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I propose to take Questions Nos. 693, 695 and 747 together.

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 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.