Clare Daly (Dublin Fingal, Independent)
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217. To ask the Minister for Health when spinraza treatment will be rolled out to persons with spinal muscular atrophy in view of the suffering and deterioration in their health and quality of life in the absence of same; and if he will make a statement on the matter. [22353/19]

Brendan Griffin (Kerry, Fine Gael)
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225. To ask the Minister for Health his views in relation to spinraza (details supplied); and if he will make a statement on the matter. [22402/19]

Simon Harris (Wicklow, Fine Gael)
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I propose to take Questions Nos. 217 and 225 together.

As the Deputies are aware, the Oireachtas put in place a strong legal framework, in the Health (Pricing and Supply of Medical Goods) Act 2013, to give full statutory powers to the HSE to assess and make decisions on reimbursement of medicines, taking account of a range of objective factors and expert opinion as appropriate.

I fully recognise that this debilitating and progressive condition places enormous strain on SMA sufferers and their families and carers, and I can understand their wish to have access to potentially beneficial drug treatments.

However, because of the significant monies involved, the HSE must ensure that the best price is achieved for all medicines, as these commitments are often multi-million euro investments on an on-going basis. This can lead to a protracted deliberation process, where suppliers commence the negotiation process with a pricing proposal that does not reflect affordability or the evaluation of clinical effectiveness.

In the case of nusinersen (Spinraza), following detailed consideration of an application for reimbursement and lengthy engagement with the company, the HSE decided that it was unable to reimburse nusinersen. 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 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 and that the matter remains under consideration by the HSE.