Brendan Smith (Cavan-Monaghan, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

629. 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. [18258/17]

Simon Harris (Wicklow, Fine Gael)
Link to this: Individually | In context | Oireachtas source

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.

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 – the 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.

Since receiving the last offer from Vertex for the medicine Orkambi in January the HSE have engaged in a robust evaluation process consulting with both its legal advisors and the Department of Health.

Due to the unprecedented scale of this potential investment, the HSE's objective is to ensure that access to this medicine is sustainable and delivers the best outcome for Irish patients and the Irish health service overall. I fully support the HSE in these efforts.

At the conclusion of this evaluation process the HSE identified a number of commercial and contractual issues and have proposed solutions to Vertex in order to overcome these issues.

HSE negotiators are currently in talks with Vertex on these outstanding issues.