Tuesday, 28 May 2019

Questions (251, 308)

James Lawless

Question:

251. Deputy James Lawless asked the Minister for Health his plans to make Spinraza treatment available for patients suffering with spinal muscular atrophy; and if he will make a statement on the matter. [22520/19]

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Éamon Ó Cuív

Question:

308. Deputy Éamon Ó Cuív asked the Minister for Health when a decision will be made on providing Spinraza for patients suffering from spinal muscular atrophy, SMA; the reason for the delay with the decision; and if he will make a statement on the matter. [22852/19]

View answer

Written answers (Question to Health)

I propose to take Questions Nos. 251 and 308 together.

As the Deputy is 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.

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 it 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.