Billy Kelleher (Cork North Central, Fianna Fail)
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455. To ask the Minister for Health the timeframe for a final decision on the reimbursement of translarna in view of the fact that it was originally submitted for health technology assessment in October 2015 and is now available in most European countries; if its reimbursement will require approval from his Department or the Cabinet; and if he will make a statement on the matter. [11193/17]

Billy Kelleher (Cork North Central, Fianna Fail)
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456. To ask the Minister for Health the status of the drug translarna for the treatment of Duchenne muscular dystrophy, which is currently available to 80% of eligible persons across the EU, including in Northern Ireland, Scotland, England, Wales and the Isle of Man; the details of the engagement between the HSE and the manufacturer to date; and if he will make a statement on the matter. [11194/17]

Billy Kelleher (Cork North Central, Fianna Fail)
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457. To ask the Minister for Health the way in which a decision on the reimbursement of translarna will be communicated to families (details supplied). [11195/17]

Jack Chambers (Dublin West, Fianna Fail)
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507. To ask the Minister for Health his plans to reimburse persons for a treatment (details supplied); the reason for the delay in making a determination in regard to this treatment to date; when a decision will be made in this regard; and if he will make a statement on the matter. [11373/17]

Simon Harris (Wicklow, Fine Gael)
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I propose to take Questions Nos. 455 to 457, inclusive, and 507 together.

The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines in the community drugs schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.

I am informed that HSE Leadership has taken a proposed decision not to reimburse Translarna and informed the company of this decision by letter in January of this year. Under the HSE statutory assessment process, the HSE is legally required to provide at least a 28 day period (from the formal written notice of proposal), to enable the pharmaceutical company to consider any such proposal not to reimburse and to make representations to the HSE if it wishes to do so. The HSE is required to consider any such representations in advance of a formal decision.

As HSE Leadership has taken a proposed decision not to reimburse Translarna, there is no requirement for the reimbursement of the drug to be considered by the Department of Health or Cabinet.

I have asked the HSE to respond to the Deputies on the matters raised regarding communication to the families, engagement between the HSE and the company to date and timeframes around the decision-making process.