A medical breakthrough that can double life expectancy is something that we should embrace and not shy away from. The discovery and emergence of the drug, kalydeco, is regarded as the biggest single breakthrough in relation to cystic fibrosis, CF, since the discovery of the gene mutation involved in 1989. Forbes has described this drug as "The most important drug of 2012". For all those involved in the treatment of cystic fibrosis, the drug is genuinely seen as a game-changer in terms of the quality of life and life expectancy of persons with the condition. The drug received FDA approval in July last. It is now available in the United Kingdom, Germany and Canada.

It is the first drug to treat the underlying cause of the CF condition, particularly those with the G551D mutation. Some 11% of Ireland's CF population has that particular gene. Ireland has the highest occurrence of cystic fibrosis in the world. It strikes me, to say the least, as very disappointing that we are so late to the game in terms of having this drug available for those concerned, given its impact. There are very convincing arguments for this life-changing drug, but it is still not cleared for use in Ireland. In the clinical trials alone, it decreased relapses by 55% in patients.

I thank Deputy Martin.

We have known about this drug for quite some time. Over the past number of years, it has been going through the various regulatory systems and clinical trials. It could have a significant impact on inpatient attendances, etc.

Has the Minister for Health or anyone in the Government met the drug company, Vertex, or has there been any proactive engagement with a view to ensuring the availability of this drug in the marketplace? Can the Taoiseach outline to the House the steps that have been taken by the Government to ensure the availability of this drug to those with this condition?

The Minister for Health announced on 15 October last that intensive negotiations involving the Irish Pharmaceutical Healthcare Association, IPHA, the HSE and the Department of Health had reached a successful conclusion on a major deal on the cost of drugs in the State and that the deal is an important step in reducing the cost base of the health system here. That deal, with a value in excess of €400 million over the next three years, clearly means reductions in the cost of drugs for patients and a lowering of the drugs bill to the State, but also timely access for patients to new cutting-edge drugs for certain conditions, with the cost attached to that of €70 million annually and, therefore, reducing the cost base of the health system in the future.

For Deputy Martin's information, the HSE received an application for the inclusion of kalydeco, with the generic name of ivacaftor, in the GMS and community drug schemes. That application is being considered in line with the procedures which have been agreed with the Irish Pharmaceutical Healthcare Association in recent drugs agreements such as the one I mentioned. These procedures include clearly documented processes and time lines for the assessment of new medicines in as timely a fashion as possible. In accordance with those procedures, the National Centre for Pharmacoeconomics, NCPE, conducted a health technology assessment which provides detailed information on the potential budget impact of the medicine involved. It also assesses whether the medicine involved is cost effective at the price quoted by the company in question, which, at €234,000 per patient per year, is very costly.

The NCPE published its report on 21 January. That report concluded:

In view of the very high drug acquisition cost, the significant budget impact, the absence of long term clinical data and the fact that the company has failed to demonstrate the cost-effectiveness of ivacaftor, we cannot recommend reimbursement of ivacaftor at the submitted price of €234,804 per patient per annum. A mechanism such as a performance based risk sharing scheme and/or a significant reduction in price could facilitate access to ivacaftor treatment for cystic fibrosis patients with the G551D CFTR mutation.

That report is an important input to assist decision-making and it will help to inform the next stage of the process which involves further discussions between the HSE and the manufacturer of the drug.

I understand that yesterday the Cystic Fibrosis Association of Ireland stated that it accepts the need for the HSE and the drugs company to get as good a deal as possible. I also recognise the concerns of cystic fibrosis patients, a number of whom have contacted me, that a decision would be made as soon as possible. I listened to Dr. Barry speaking about this on the news the other day. He stated that were one to proceed with providing this particular treatment at this level of cost, it would take 40% of the entire budget for drugs. This is obviously an issue that the NCPE took into account in its analysis.

I repeat that the drug is projected to double life expectancy. This is not any ordinary drug coming on the market in terms of advancing incremental interventions or treatments of particular conditions. This is truly a very significant game-changer in a condition which has not witnessed such breakthroughs over a long period of time.

In the United Kingdom, for example, the regime for licensing new drugs has been far stricter with an even stronger regulatory impact than here over the years, yet it is available in the United Kingdom. The National Institute for Health and Clinical Excellence, NICE, the authority in the United Kingdom which is responsible for the licensing of drugs, has approved it. In the language coming from the NCPE, it is without question overwhelmingly for budgetary and cost reasons that this drug is being rejected, not for reasons of clinical trials or the health outcomes and impact of this drug.

All such matters require balance. I asked the Taoiseach at the outset if the Minister had met the company. From speaking about quite a number of new technologies and new drugs that became available, I am aware that last year there was a complete delay in engagement on ipilimumab and a range of other drugs.

Disappointingly, from the Taoiseach's reply I get the sense that delay will be the order of the day. In the interests of the patients and the people with the condition, here is a case that justifies the intervention of the Minister and the Government with a company and all concerned to knuckle down and make this drug available. It happened last year with ipilimumab and others when it was raised. It is important that people do not engage in a stand-off on this issue because the quality of life and life expectancy issues are so profound that it demands a proactive response from the Government, one we have not seen on this drug to date.

Patients cannot wait - 120 people.

It is not the case that delay is the order of the day here. Let me repeat what the National Centre for Pharmacoeconomics, NCPE, stated when it conducted its health technology assessment. It stated that "In view of the very high drug acquisition cost, the significant budget impact, the absence of long term clinical data and the fact that the company has failed to demonstrate the cost-effectiveness of ivacaftor", it was not willing to assess it. There was a very rapid review submission on the drug submitted on 13 August 2012. That rapid review was completed on 22 August 2012 - no delay there. A full pharmacoenomic assessment was advised. Following submission of that dossier, the NCPE group met the manufacturer on 28 November 2012 to discuss the submission and request additional information. That was received on 11 December and I have given the Deputy the result of its assessment. It states that the evaluation of the economic dossier submitted by the company estimated the annual cost at €234,804 per patient. It also estimates that 113 to 120 patients could benefit from the drug. Based on those figures, the annual budget impact would range from €23.65 million to €28.176 million. No more than anybody in here, one cannot put a price on a life-----

The Taoiseach has put a price on it.

-----and obviously it is an effective drug, but there is an issue that needs to be followed through. The next step in this process is for the HSE to meet the manufacturer of the drug in accordance with the procedures set out by IPHA. When the Minister for Health met them last year-----

Did he meet them?

-----he concluded a deal for €400 million over three years. This is a new very expensive drug with an impact for an estimated 113 to 120 patients.

We do not know the answer. Did the company meet the Minister?

Has the Minister met them?

I do not deny anyone having the right to have the best quality of life we can give them. It is a €26 million to €28 million impact on costs and obviously ceilings for this year's budget have been set. The HSE will now meet the company to see if some deal can be worked out here.

The Minister or the HSE?

I do not want to pre-empt the conclusion of that.

The Minister has not met them.

Sure, the Minister is the HSE now.

We do not even have a Food Safety Authority

That is a real pro-life issue now.