Louise O'Reilly (Dublin Fingal, Sinn Fein)
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408. To ask the Minister for Health when a decision will be made regarding the availability of Spinraza in view of the fact a new application has been submitted by a company (details supplied). [17756/19]

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.  The Minister for Health has no role or powers in relation to such matters. 

Following detailed consideration of an application for the reimbursement of Spinraza and lengthy engagement with the company, the HSE recently decided that it was unable to reimburse 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.