James Browne (Wexford, Fianna Fail)
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359. To ask the Minister for Health when the relevant stakeholders regarding a drug (details supplied) will be informed regarding the recent HSE leadership team meeting; and if he will make a statement on the matter. [7864/19]

Michael Fitzmaurice (Roscommon-Galway, Independent)
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411. To ask the Minister for Health when a decision will be made in respect of the application submitted in July 2018 by a company (details supplied) for the Translarna drug for the treatment of Duchenne muscular dystrophy; and if he will make a statement on the matter. [8199/19]

Michael Fitzmaurice (Roscommon-Galway, Independent)
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412. To ask the Minister for Health when the drugs committee will assess the new submission made by a company (details supplied) for the Translarna drug for the treatment of Duchenne muscular dystrophy; and if he will make a statement on the matter. [8200/19]

Simon Harris (Wicklow, Fine Gael)
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I propose to take Questions Nos. 359, 411 and 412 together.

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 discussed at the January HSE Leadership Team meeting and that the HSE is in the process of communicating its decision to the relevant company.