Brendan Smith (Cavan-Monaghan, Fianna Fail)
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198. To ask the Minister for Health the position regarding the availability of Orkambi for persons with cystic fibrosis; and if he will make a statement on the matter. [12455/17]

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.

Under Section 19 (4) of the 2013 Act, the HSE is prohibited from making a decision to reimburse a medicine, except in accordance with the criteria specified in Schedule 3 of the 2013 Act.

With regard to Orkambi for the treatment of cystic fibrosis patients aged 12 and older, an application to the HSE from the manufacturer was received in March 2016. The application was considered and not recommended for reimbursement at the submitted price by both the National Centre for Pharmacoeconomics (NCPE) and the HSE’s Drugs Committee. In December, the HSE Directorate took the decision not to reimburse at the submitted price. The HSE called on the company to re-enter negotiations, with a view to significantly reducing the cost of the treatment.

Further meetings were held with the manufacturer in December and early January. The discussions with the company have broadened to include Orkambi, Kalydeco and further treatments for cystic fibrosis patients. The matter is currently under consideration by the HSE Directorate and by officials in my Department.

I expect that this process will conclude in a period of weeks. However, given the scale of the investment, the potential benefits for Irish patients and the impact of this decision on the health service overall, I would call on all deputies to allow this statutory process to be concluded.

I am acutely aware that the last number of months have been a stressful and worrying time for cystic fibrosis patients and their families. However, the Government’s priority is to achieve the best outcome for Irish patients and the health system overall.