Micheál Martin (Cork South Central, Fianna Fail)
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691. To ask the Minister for Health if he or his Department is aware that funding is not available for a new cancer drug called TDM1, also known as Kadcyla; and if he will make a statement on the matter. [21588/15]

Kathleen Lynch (Cork North Central, Labour)
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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. Prior to reimbursing any medicine, the HSE considers a range of statutory criteria including clinical need, cost-effectiveness and the resources available to the HSE.

The decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds by the HSE on the advice of the National Centre for Pharmacoeconomics. They are not political or ministerial decisions.

The HSE received an application for the inclusion of Kadcyla (trastuzumab emtansine) in the GMS and community drugs schemes. The application was considered in line with the procedures and timescales agreed by the Department of Health and the HSE with the Irish Pharmaceutical Healthcare Association for the assessment of new medicines.

In accordance with these procedures, the National Centre for Pharmacoeconomics conducted a pharmacoeconomic evaluation of Kadcyla and concluded that it was unable to recommend reimbursement of the product at the price submitted by the manufacturer, Roche Products (Ireland) Ltd.

The Report by the National Centre for Pharmacoeconomics is an important input to assist the HSE in its decision making process and informs further discussions between the HSE and the supplier. No further comment can be provided at this time as the assessment process is ongoing.