Charlie McConalogue (Donegal, Fianna Fail)
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263. To ask the Minister for Health further to Parliamentary Question No. 547 of 6 November 2018, the status of the reimbursement of Translarna from a company (details supplied); and if he will make a statement on the matter. [10291/19]

Simon Harris (Wicklow, Fine Gael)
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The Health Service Executive has statutory responsibility for decisions on pricing and reimbursement of medicines, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.

The Act specifies the criteria to be applied in the making of reimbursement decisions which include the clinical and cost effectiveness of the product, the opportunity cost and the impact on resources that are available to the HSE.

I am advised by the HSE that the application for Translarna (Ataluren) was approved at the January HSE Leadership Team meeting. The company is being contacted to finalise the implementation arrangements for reimbursement.