Kevin O'Keeffe (Cork East, Fianna Fail)
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155. To ask the Minister for Health the position regarding the approval of the drug Spinraza in respect of persons suffering from spinal muscular atrophy. [8578/19]

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 the reimbursement of Nusinersen (Spinraza) was considered by HSE Leadership at a meeting on 12 February 2019 and that the HSE is in the process of communicating its decision to the relevant company.