Niamh Smyth (Cavan-Monaghan, Fianna Fail)
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418. To ask the Minister for Health if there is a timeframe as to when a drug (details supplied) will have gone through the National Centre for Pharmacoeconomics, NCPE, process; when it is likely to be on the Irish market; and if he will make a statement on the matter. [31622/16]

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 drugs schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. Prior to deciding whether to reimburse a medicine, the HSE considers a range of statutory criteria, including clinical need, cost-effectiveness and the resources available.

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 (NCPE). The NCPE conducts health technology assessments (HTAs) of pharmaceutical products for the HSE, and can make recommendations on reimbursement to assist the HSE in its decision-making process.

At the request of the HSE, the NCPE is currently conducting an assessment of Vimizim for the treatment of mucopolysaccharidosis, type IVa (also known as Morquio A syndrome) in patients of all ages. The NCPE completes all phamacoeconomic evaluations within the 180 day timeline set out in the Health (Pricing and Supply of Medical Goods) Act 2013. The Act allows for stop clocks where companies are required to provide additional data. Once this assessment is completed, a summary report will be published on the NCPE website. The HSE will then consider the NCPE assessment as part of its decision-making process when considering the drug for reimbursement.

As the NCPE's assessment of Vimizim is ongoing, it is not possible to provide further details at this time.