Caoimhghín Ó Caoláin (Cavan-Monaghan, Sinn Fein)
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To ask the Minister for Health when a decision will be made on the possible funding of kalydeco for cystic fibrosis patients; the date on which this drug will be made available; and if he will make a statement on the matter. [3546/13]

Joanna Tuffy (Dublin Mid West, Labour)
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To ask the Minister for Health when he intends to approve and supply the drug kalydeco for cystic fibrosis patients; and if he will make a statement on the matter. [3636/13]

Michael Lowry (Tipperary North, Independent)
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To ask the Minister for Health if he will fund Kalydeco for the treatment of cystic fibrosis patients; if this drug will be approved and sanctioned for the Irish market; when this drug will be made available to patients here; and if he will make a statement on the matter. [3682/13]

Alex White (Dublin South, Labour)
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I propose to take Questions Nos. 202, 208 and 211 together.

The HSE has received an application for the inclusion of Kalydeco (generic name: Ivacaftor) in the GMS and community drugs schemes which is being considered in line with the procedures agreed with the Irish Pharmaceutical Healthcare Association (IPHA). These include clearly documented processes and timelines for the assessment of new medicines in as timely a fashion as possible.

In accordance with these procedures, the National Centre for Pharmacoeconomics (NCPE) conducts a Health Technology Assessment (HTA) which provides detailed information on the potential budget impact of the medicine. It also assesses whether the medicine is cost effective at the price quoted by the company in question.

The NCPE published its report on the cost-effectiveness of Kalydeco on the 21st of January. The report concluded 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 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".

The NCPE report is an important input to assist decision making and will help inform the next stage of the process which involves further discussions with the manufacturer of the drug, in accordance with the aforementioned procedures agreed with the pharmaceutical industry. The HSE assessment process is intended to arrive at a decision on the funding of Kalydeco that is clinically appropriate, fair, consistent and sustainable. The HSE understands that patients, the Cystic Fibrosis Association of Ireland and clinicians are very anxious that a decision be made as soon as possible.

No further comment is possible at this time as the decision making process is ongoing.