Seán Fleming (Laois-Offaly, Fianna Fail)
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514. To ask the Minister for Health the position regarding the availability of Spinraza to adults here; his plans to facilitate the provision of same; and if he will make a statement on the matter. [2619/20]

Simon Harris (Wicklow, Fine Gael)
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The HSE has statutory responsibility for medicine pricing and reimbursement decisions, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.  The Act specifies the criteria to be applied in the making of reimbursement decisions.

As Minister for Health, I do not have any statutory power or function in relation to the reimbursement of medicines.

On 11 June 2019, the HSE Leadership Team approved access to the drug nusinersen (Spinraza) for children with Spinal Muscular Atrophy (SMA) Type I, II or III on an exceptional and individualised basis.

The HSE decision process in relation to nusinersen involved a full Health Technology Assessment and report issued by the National Centre for Pharmacoeconomics. This was followed by detailed consideration by the HSE expert groups on new drug therapies, including the HSE Drugs Group and the Rare Diseases Technology Review Committee (RDTRC). Evidence of the clinical effectiveness of this new drug therapy was also reviewed.

After a thorough review of all the data it was decided to approve access for children with genetically confirmed SMA Type I, II or III, in accordance with the controlled access criteria recommended by the RDTRC.

The RDTRC recommendation was clearly targeted at the youngest and most severely affected SMA patients, and this group is the clear priority for the HSE.  The actual patient assessment and approval process will be the means for determining access on an individual case-by-case basis.