Enda Kenny (Mayo, Fine Gael) | Oireachtas source

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.

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