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Dáil
‹ Questions on Promised Legislation

Orkambi for cystic fibrosis

Summary

Deputy Adams raised the HSE decision not to recommend Orkambi for more than 550 cystic fibrosis patients and warned it would deeply affect families. The Taoiseach said negotiations with the drug manufacturer were continuing and had not broken down.

The programme for Government commits to tackling the most pressing challenges facing our society in terms of health provision. One of these challenges is the treatment of cystic fibrosis, CF. This morning, we learned that the HSE drug committee has not recommended the use of the drug Orkambi for more than 550 Irish cystic fibrosis sufferers. I am sure that the Taoiseach will appreciate that this will come as a huge blow to those people with this life-threatening condition. Prior to Christmas, many of us heard distressing first-hand accounts of cystic fibrosis sufferers and their families. Orkambi can dramatically improve the well-being of some sufferers - maybe hundreds of sufferers for all we know. This matter has now been referred to the executive management team in the HSE. If it does not agree to purchase the drug, the ball will rest with the Minister for Health. Can the Taoiseach confirm that negotiations with Vertex have concluded and will he set out the financial gap between Vertex and the HSE? Also, has a cost analysis been undertaken of the procurement of Orkambi versus the money that would be saved by reducing the hospitalisation of CF sufferers?

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Enda Kenny The Taoiseach Fine Gael

This is a matter of concern to significant numbers of people. I can assure the Deputy that the suggestions in some media reports that the discussions and negotiations have broken down are not true. The HSE re-entered into negotiations with Vertex, the manufacturer of Orkambi, in December following a decision by HSE leadership that it was unable to reimburse Orkambi at the price offered at that time by the company. The Deputy will be aware of this. The HSE subsequently met with Vertex in December and in January with a view to significantly reducing the cost of Orkambi for cystic fibrosis sufferers so that the State is in a position to fund the drug and provide it for Irish patients.

Following the completion of that negotiation process, I am advised the HSE's drugs committee met last week and considered the manufacturer's latest price offerings. That will now be considered by the HSE at its next available meeting. A decision on reimbursement will be made on objective, scientific and economic grounds under the 2013 Act. I hope for a conclusion to this matter. Obviously, the Minister removed the decision-making capacity from the political process. Decisions are now based on clinical and medical accuracy in light of the quality of life afforded to the patient and the extent of the improvement.

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