Written answers

Tuesday, 31 March 2015

Department of Health

Medicinal Products Availability

Photo of Pat RabbittePat Rabbitte (Dublin South West, Labour)
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476. To ask the Minister for Health if the drug Regorafenib Stivarga will be made available to a person (details supplied) in Dublin 24; and if he will make a statement on the matter. [13027/15]

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. 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. No further comment is possible at this time.

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