Noel Grealish (Galway West, Independent)
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445. To ask the Minister for Health if funding will be provided to enable the Cystic Fibrosis drug Orkambi to be provided under the medical card scheme and the drugs payment scheme, given its life-changing impact on sufferers; if he will enter discussions with the manufacturer, so that this drug is available early in 2016; and if he will make a statement on the matter. [45151/15]

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. 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 (NCPE). They are not political or ministerial decisions. The NCPE conducts the health technology assessment of pharmaceutical products for the HSE, and can make recommendations on reimbursement to assist the HSE in its decision-making process.

Vertex Pharmaceuticals, the manufacturer of Orkambi™, submitted a Rapid Review application for the drug to the NCPE on 26 November 2015. The company is expected to submit a full pricing and reimbursement application to the HSE/Primary Care Reimbursement Service in the immediate future.

Once this application is received, it will be considered by the HSE in line with criteria set out in the Health (Pricing and Supply of Medical Goods) Act 2013 and using the processes outlined in national pricing framework agreements.