Caoimhghín Ó Caoláin (Cavan-Monaghan, Sinn Fein)
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673. To ask the Minister for Health the details of the medication Regorafenib (Stivarga); the cost for treatment, per year, per patient; the number of patients who require the medication; his plans to include the medication under the general medical services scheme-high-tech drugs scheme; the cost to fund this medication for all who need it; and if he will make a statement on the matter. [11813/15]

Kathleen Lynch (Cork North Central, Labour)
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The 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 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 Regorafenib in the GMS and community drugs schemes. The application is being 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 Regorafenib. The HSE is currently considering the results of that assessment and a subsequent commercial negotiation with the pharmaceutical company Bayer to seek to address some of the concerns raised in the assessment. The number of people with advanced gastrointestinal stromal tumours that may require this drug is expected to be low. As the assessment process is still ongoing it is not possible at this time to provide any further details regarding the cost of this drug.