Aengus Ó Snodaigh (Dublin South Central, Sinn Fein)
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640. To ask the Minister for Health when he will provide the drug, Orkambi, for sufferers of cystic fibrosis. [12500/16]

Seán Fleming (Laois, Fianna Fail)
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705. To ask the Minister for Health the current position relating to drug treatment for cystic fibrosis and what is currently in place to treat this; if any new drugs on the market are being considered; and if he will make a statement on the matter. [13199/16]

Simon Harris (Wicklow, Fine Gael)
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I propose to take Questions Nos. 640 and 705 together.

Orkambi (lumacaftor/ivacaftor) was licensed by the US Food and Drug Administration in July 2015 and by the European Medicines Agency in November 2015. To date, no public health service in Europe has approved it for reimbursement.

Each country has its own reimbursement approval process. The Irish process is laid down in the Health (Pricing and Supply of Medical Goods) Act 2013. Under this Act, the HSE has statutory responsibility for decisions on pricing and reimbursement of medicinal products through the community drug schemes. It is appropriate that these should not be political decisions and that a scientific and evidence-based approach is taken to determine the extent to which patients would benefit from treatment with expensive new drugs.

Prior to reimbursing a medicine, the HSE considers a range of statutory criteria, including clinical need, cost-effectiveness, and the resources available. The process for reimbursement approval of new high tech drugs in Ireland involves three steps. The first step involves a rapid review, which has been completed by the National Centre for Pharmacoeconomics (NCPE) for Orkambi. The second involves a full health technology assessment by the NCPE. This process iscurrently being undertaken in respect of Orkambi. This expert assessment evaluates whether the claims made about the benefits of a new drug are valid, and to what extent, in terms of its impact on issues including life expectancy, quality of life, reducing hospital admissions and a reduced need for transplants. The NCPE will also consider which patient groups might benefit, how the drug compares with existing treatments and if it is cost-effective at the price sought by the manufacturer.

On completion of the assessment process, the NCPE will make a report to the HSE for consideration.