Gino Kenny (Dublin Mid West, People Before Profit Alliance)
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390. To ask the Minister for Health if his Department signed a contract with the manufacturers of Orkambi; when the drug will be made available to persons with cystic fibrosis; and if he will make a statement on the matter. [25284/17]

Simon Harris (Wicklow, Fine Gael)
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The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.

I am informed that an agreement has been confirmed, in principle, between the HSE and the manufacturer for the supply of two cystic fibrosis treatments to Irish patients. These are Orkambi (for patients aged 12 years and older) and Kalydeco (for patients aged 2-5 and certain patients aged 18 and over). The agreement will also include other treatments and age cohorts, following market authorisation in Europe for these.

HSE Leadership has confirmed to the Department of Health that, in line with their statutory responsibilities under the 2013 act, they have decided to add this treatment to the list of reimbursable products.

Both the HSE and the manufacturer are now working to finalise the contractual arrangements and complete approval processes in order to achieve this. This process is at an advanced stage and the HSE is working intensively with the company to bring the contact to a conclusion.

The expectation is that this process will conclude shortly.