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CFI concerned about status of Orkambi/Kalydeco talks

According to a statement from CFI: “On behalf of our patients, CFI calls on Minister Harris and the Government to do what they have promised to do – to make an agreement for the provision of Orkambi and Kalydeco for the 600 patients that would benefit from these two vital drug therapies.

“The negotiations for these ground-breaking drugs are now more than nine months old. There have been repeated assurances given in recent weeks which CFI has welcomed. Cystic fibrosis patients would be very grateful for the promised announcement on a final agreement.”

In a written Dail response on 9 March, Minister Harris said that, with regard to Orkambi for the treatment of CF 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.

Minister Harris added in his Dail response: “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.”

Vertex had initially proposed a price of €160,000 per patient per year for Orkambi.

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