Written answers

Tuesday, 31 March 2015

Department of Health

Medicinal Products Availability

Photo of Caoimhghín Ó CaoláinCaoimhghín Ó Caoláin (Cavan-Monaghan, Sinn Fein)
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488. To ask the Minister for Health when the consideration by the Health Service Executive of funding the medication Regorafenib Stivarga will conclude; and if he will make a statement on the matter. [13160/15]

Photo of Kathleen LynchKathleen 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. It is not possible to say at present when a decision on the funding of this medication will be made as the HSE is currently considering the results of the assessment by the National Centre for Pharmacoeconomics as well as the commercial negotiation that they have engaged in with the pharmaceutical company Bayer to seek to address some of the concerns raised in that assessment.

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