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Dáil
‹ Order of Business

Orkambi access for cystic fibrosis

Summary

Several Deputies pressed the Taoiseach on making Orkambi available, citing vigils, deaths and the pace of negotiations. The Taoiseach said the NCPE and HSE were handling the clinical and cost-effectiveness assessment, that talks with Vertex were ongoing, and that Ministers would act only on a positive recommendation.

The Fianna Fáil leader is right that any new Taoiseach will have to be approved by the House. However, given that Fianna Fáil has already pledged support, it will just be a rubber-stamping exercise.

I wish to raise the issue of the treatment of cystic fibrosis and the controversy surrounding Orkambi and whether the HSE will agree to make it available to hundreds of patients. New evidence has emerged to support the case for approving Orkambi and, according to Cystic Fibrosis Ireland, this new data shows Orkambi will save the health system even more than previously estimated. Whatever decision the HSE makes, the ultimate decision will rest with the Minister and the Government. Could the Taoiseach update the Dáil on the status of negotiations with Vertex? Many families are dependent on the outcome of this. Has the Government carried out a cost analysis on the procurement of Orkambi and the money that could be saved, as it is claimed, through a reduction in hospital admissions?

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The Deputy's time is up. On the same issue, I call Deputy O'Dea.

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The Taoiseach will recall that it is almost three months since there was a very moving demonstration outside the front gates of Leinster House. I attended a candle-lit vigil in the rain in Limerick on Friday night with parents of children suffering from cystic fibrosis. They told us that since that demonstration outside Leinster House, several children have died for want of the drug in question. When will there be a resolution of this issue and when will this drug be made available to people who are literally fighting for their lives?

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On the same issue, many of us have attended various candle-lit vigils. There will be a briefing in the House tomorrow and I gather there will be a national protest outside the complex on Wednesday next. It would be wonderful if, as a collective, we could take a decision next week to make that protest a celebration.

As we continue to procrastinate, sick children are getting sicker and some will die. My understanding, having spoken with Vertex, is that this decision is somewhere between the board of the HSE and Cabinet. We do not have to wait for a meeting to be scheduled. Can the Taoiseach not knock heads together this week with the young Minister for Health, Deputy Harris, whom he mentioned earlier, and take a decision on this matter? Vertex has put forward a proposal which includes the provision of that drug immediately to all patients and the provision of drugs that are being developed for the same price and the same agreement. There is no excuse for continuing delays.

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Enda Kenny The Taoiseach Fine Gael

I met Aisling and people from Sligo-Leitrim in Sligo recently at a candlelight vigil relating to Orkambi.

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Enda Kenny The Taoiseach Fine Gael

Deputies O'Dea and MacSharry are well aware that the Minister and the Cabinet of the day do not make the clinical decision on any drug. The HSE has re-entered talks with Vertex.

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With respect, the talks are over. It is with the board of the HSE.

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Enda Kenny The Taoiseach Fine Gael

Reports that they were ended are not correct. The fact is that the National Centre for Pharmacoeconomics, NCPE-----

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The talks are over.

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Enda Kenny The Taoiseach Fine Gael

-----which is completely independent in the way it judges the improvement in the quality of life for any drug to be given to any patient – and I regret of course, and sympathise with those, where the death of anybody has occurred, never mind children – undertook the assessment of Orkambi and noted that the drug was not considered cost-effective at a price of €160,000 per patient per year as submitted by the manufacturer.

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The matter has moved on since then.

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Enda Kenny The Taoiseach Fine Gael

It is not somewhere between the committee and the Cabinet.

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It has gone way beyond that. It is with the board.

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It has been three months.

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Enda Kenny The Taoiseach Fine Gael

If the recommendation of the NCPE is that it accepts that the price being offered or mooted by Vertex is in the interests of the patients to improve the quality of their lives-----

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We understand the system.

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Enda Kenny The Taoiseach Fine Gael

------and that comes to the Minister for Health and the Cabinet with a recommendation that is positive, that is what we will act on. We do not make the decisions.

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While considering other timelines, can the Taoiseach prioritise this issue because people are dying?

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Enda Kenny The Taoiseach Fine Gael

We do not make the decisions about the improved quality of life for any patient. I understand this and mentioned it to the people whom I met in Sligo.

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It has moved on from there. They have had their negotiations.

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Enda Kenny The Taoiseach Fine Gael

The NCPE has provided very clear guidance on a price that is considered fair and cost-effective to deal with the improvement in the quality of life.

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Enda Kenny The Taoiseach Fine Gael

Vertex needs to come back. I do not know where it is now with its offer.

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It is waiting for an answer.

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Seán Fleming Deputy Sean Fleming Fianna Fáil

The Taoiseach does not know anything about the matter. He does not know where it stands.

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Enda Kenny The Taoiseach Fine Gael

The NCPE is the independent body that will make the clinical decisions-----

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This is the old conversation from three months ago.

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Enda Kenny The Taoiseach Fine Gael

-----about this or any drug and it is not in the hands of the politicians to say whether this is a fair price.

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The Taoiseach is sitting on it. When is he going to make a decision?

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Enda Kenny The Taoiseach Fine Gael

The NCPE makes the assessment on the basis of the cost being put forward by the company-----

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The Taoiseach should check it out

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Enda Kenny The Taoiseach Fine Gael

-----in terms of the improvement of the quality of life of the children or patients as the case might be.

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