Finian McGrath (Dublin North Central, Independent)
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192. To ask the Minister for Health when the drug eculizumab will be sanctioned for a person (details supplied) in County Laois. [30491/14]

Finian McGrath (Dublin North Central, Independent)
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193. To ask the Minister for Health the reason the drug eculizumab is not being sanctioned for a small number of persons with a life-limiting disease; and if he will make a statement on the matter. [30492/14]

Alex White (Dublin South, Labour)
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I propose to take Questions Nos. 192 and 193 together.

The Health Service Executive (HSE) has statutory responsibility for decisions on pricing and reimbursement of medicinal products under the community drug schemes in accordance with the provisions of the Health (Pricing and Supply of Medical Goods) Act 2013. The HSE received an application for the inclusion of Eculizumab (Brand: Soliris) in the community drugs schemes. The application was considered in line with the procedures and timescales agreed in 2012 by my Department and the HSE with the Irish Pharmaceutical Healthcare Association (IPHA).

In accordance with these procedures, the National Centre for Pharmacoeconomics (NCPE) conducted a pharmacoeconomic evaluation of Eculizumab and concluded that, at a total cost per patient per year of €437,247 and a cumulative gross budget impact over 5 years estimated at €33 million, the therapy did not represent value for money for the treatment of patients in the Irish healthcare setting. In addition, the manufacturer did not include an economic model as part of their submission and failed to demonstrate the cost-effectiveness of this therapy. Consequently, the NCPE was unable to recommend reimbursement of the product under the community drug schemes. The report is available on the NCPE's website

The NCPE report is an important input to assist the HSE in its decision making process and informs further discussions between the HSE and the manufacturer of the drug. The HSE assessment process is intended to arrive at a decision on the funding of high cost new medicines that is clinically appropriate, fair, consistent and sustainable. The HSE is now carefully considering all the issues which arise in relation to the proposed benefits and costs of this medicine and expects to reach a decision in the near future.