Michael Healy-Rae (Kerry, Independent)
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205. To ask the Minister for Health the reason pegvaliase, a game-changing medicine for a handful of phenylketonuria patients, has taken more than four years to go through the various stages of the HSE's appraisal process (details supplied); where this currently is in the system; the other steps required; when they will be completed; and if he will make a statement on the matter. [26584/24]

Stephen Donnelly (Wicklow, Fianna Fail)
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Under the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for decisions on the pricing and reimbursement of medicines; therefore, the matter has been referred to the HSE for attention and direct reply to the Deputy.