Written answers

Wednesday, 15 April 2015

Department of Health

Medicinal Products Availability

Photo of Joanna TuffyJoanna Tuffy (Dublin Mid West, Labour)
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485. To ask the Minister for Health if he will make available the drug, Regorafenib, to treat patients (details supplied); and if he will make a statement on the matter. [14093/15]

Photo of Bernard DurkanBernard Durkan (Kildare North, Fine Gael)
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493. To ask the Minister for Health his plans to have the drug, Regorafenib, made available through the Health Service Executive, a drug which is often used in the treatment of bowel cancer; and if he will make a statement on the matter. [14128/15]

Photo of Mick WallaceMick Wallace (Wexford, Independent)
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504. To ask the Minister for Health the reason Regorafenib Stivarga is not currently available to a person (details supplied) in Dublin 22, whose oncologist has recommended this as a potentially life-saving option in that person's cancer treatment; and if he will make a statement on the matter. [14212/15]

Photo of Kathleen LynchKathleen Lynch (Cork North Central, Labour)
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I propose to take Questions Nos. 485, 493 and 504 together.

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 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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