John Brassil (Kerry, Fianna Fail)
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971. To ask the Minister for Health if clinical expert opinion will be included in the decision-making process for the reimbursement of Vimizim; if consultation with local expert opinion will also be taken into account by the HSE drugs group; and if he will make a statement on the matter. [1093/18]

Simon Harris (Wicklow, Fine Gael)
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The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drug schemes, in accordance with the provisions of the Health (Pricing and Supply of Medical Goods) Act 2013; therefore, the matter has been referred to the HSE for reply to the Deputy.

John Brassil (Kerry, Fianna Fail)
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972. To ask the Minister for Health his views on whether the current QALY-based system for reimbursing orphan drugs is inappropriate; his plans to engage with key stakeholders to reform the system to take into account evidence from other jurisdictions; and if he will make a statement on the matter. [1094/18]

Simon Harris (Wicklow, Fine Gael)
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The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drug schemes, in accordance with the provisions of the Health (Pricing and Supply of Medical Goods) Act 2013; therefore, the matter has been referred to the HSE for reply to the Deputy.