Eoin Ó Broin (Dublin Mid West, Sinn Fein)
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878. To ask the Minister for Health if the HSE drugs group met to consider the revised pricing proposal from the manufacturer of Spinraza; if so, the recommendation of the HSE leadership team; and when the leadership team will make a final decision on the reimbursement of the drug. [19385/19]

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 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.

On the 21 February 2019, 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 submitted additional information which was considered by the HSE Drugs Group at their meeting on 16th April 2019. This information is scheduled for consideration at a HSE Leadership Team meeting on 14th May 2019.