Anne Rabbitte (Galway East, Fianna Fail)
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730. To ask the Minister for Health when the drug ibrutinib, Imbruvica, produced by a company (details supplied) will be available on the market for patients diagnosed with chronic lymphocytic leukaemia, CLL. [13455/16]

Simon Harris (Wicklow, Fine Gael)
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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 Health (Pricing and Supply of Medical Goods) Act 2013. Prior to reimbursing any item, the HSE considers a range of statutory criteria, including clinical need, cost-effectiveness and the resources available.

In line with the conditions of the 2016 budget sanction for the HSE, as set down by the Department of Public Expenditure and Reform, any drugs to be reimbursed over the quality-adjusted life year threshold of €45,000, including new indications, should be subject to a Government memorandum.

Reimbursement of ibrutinib remains under consideration in the context of the budgetary control process, which requires the financial implications of very expensive new drugs to be considered by Government before reimbursement can proceed.