Charlie McConalogue (Donegal, Fianna Fail)
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547. To ask the Minister for Health his plans to issue the reimbursement of a drug (details supplied); and if he will make a statement on the matter. [44841/18]

Simon Harris (Wicklow, Fine Gael)
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The Health Service Executive has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drug schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. The 2013 Act does not give the Minister for Health any powers in this regard.

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.

The HSE has received a new application for the reimbursement of ataluren (Translarna) from PTC Therapeutics.

The application is being assessed at present in accordance with the criteria set out in the Health (Pricing and Supply of Medical Goods) Act 2013. Discussions between the HSE and the company are actively underway.