Noel Grealish (Galway West, Independent)
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321. To ask the Minister for Health if he will provide an update on the availability of the drug, Fampyra under the drugs payment scheme and community drugs schemes; if the Government will approve this drug under these schemes, given that the Health Service Executive has successfully negotiated with the manufacturer, Biogen, to get the drug at a significantly reduced price; and if he will make a statement on the matter. [27130/15]

Tom Fleming (Kerry South, Independent)
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369. To ask the Minister for Health if he will provide an update regarding the provision of the multiple sclerosis drug Fampyra; when it will be made available to the numerous sufferers, including those in financial hardship; and if he will make a statement on the matter. [27382/15]

Kathleen Lynch (Cork North Central, Labour)
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I propose to take Questions Nos. 321, 353 and 369 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.

In May 2013 the HSE decided that it could not approve the reimbursement of Fampridine (Fampyra) under the GMS or other schemes as the manufacturer had failed to demonstrate or provide any formal justification for the prices proposed. The HSE decision was in line with many other European countries who have also, to date, not provided for the drug under their public health systems.

The HSE re-engaged with the company in July 2014 (and again in October 2014) seeking improved commercial offerings. The outputs of those commercial engagements were re-considered by the HSE Drugs Committee at its November 2014 meeting.

The Committee decided to seek additional detailed information from clinical experts as to how a responder only reimbursement scheme (i.e patients confirmed as positive responders to the medication) would operate for this product. The feasibility of this option is currently under consideration.