John McGuinness (Carlow-Kilkenny, Fianna Fail)
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180. To ask the Minister for Health the progress on the approval process for the drug nusinersen, that is, Spinraza; if the case of a person (details supplied) will be examined; the type of care and medication that his Department and or the HSE will fund in this case; if he will meet the parents of the person; and if he will make a statement on the matter. [17963/19]

Simon Harris (Wicklow, Fine Gael)
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The HSE has statutory responsibility for medicine pricing and reimbursement, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. The Act specifies the criteria for decisions on the reimbursement of medicines.  As Minister for Health I have no role or powers in this regard.

I am advised by the HSE that, following detailed consideration of an application for the reimbursement of Nusinersen (Spinraza) and lengthy engagement with the company, the HSE recently decided that it was unable to reimburse Nusinersen (Spinraza). The HSE concluded that the evidence for clinical effectiveness was still quite limited and that the price proposed by the manufacturer was not a cost-effective use of resources.

The HSE wrote to the manufacturer involved and informed them of the proposal to refuse reimbursement at the current price offering. Under the requirements of the Health (Pricing and Supply of Medical Goods) Act 2013 the company had 28 days to respond or make representations to the HSE’s proposed decision.

I am advised by the HSE that the manufacturer has submitted a revised submission, which will now be considered at the next HSE Drugs Group meeting, following which a recommendation will be made to the HSE Leadership Team for a final decision.   As the statutory process is ongoing, it would be inappropriate for me to meet with family members at this time.