Thomas Byrne (Meath East, Fianna Fail)
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205. To ask the Minister for Health the status of the approval of the drug VIMIZIM for the illness Morquio, including if he will approve it for the public health service; and if he will make a statement on the matter. [9132/16]

Leo Varadkar (Dublin West, Fine Gael)
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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. Prior to reimbursing any medicine, the HSE considers a range of statutory criteria, including clinical need, cost-effectiveness and the resources available to the HSE.

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). They are not political or ministerial decisions. The NCPE conducts the health technology assessment of pharmaceutical products for the HSE, and can make recommendations on reimbursement to assist the HSE in its decision-making process.

The HSE has received an application for the inclusion of Elosulfase alfa (brand name Vimizim) in the GMS and community drugs schemes; the application is currently being considered under the national medicines pricing and reimbursement assessment process. As the assessment process is ongoing, it would not be appropriate for me to comment further on this process, which is an independent function of the HSE.