Finian McGrath (Dublin Bay North, Independent) | Oireachtas source

I thank Deputies Chambers, Ó Caoláin and Curran for raising this important issue. As far as I am concerned, I am taking this matter on behalf of the Minister, Deputy Harris, who sends his apologies. I will not fob anybody off.

I fully recognise that spinal muscular atrophy places considerable strain on SMA sufferers and that families are anxious to see their children who suffer from this debilitating and painful condition begin treated with this medicine. In June 2019, following a thorough review process and engagement with the manufacturer, the HSE leadership team approved access to the drug Spinraza for children with SMA types I, Il and Ill on an exceptional and individualised basis.

The actual patient assessment and approval process is the means for determining access on an individual case by case basis to this complex and expensive treatment. Since July, 11 children have been approved for Spinraza treatment in Temple Street Hospital. Application for approval is based on clearly defined criteria and clinical guidelines being followed in each case.

Spinraza is injected during a procedure known as lumbar puncture. The actual delivery of this drug to approved patients in a safe and sustainable way requires very specific and quite complex service arrangements to be put in place. There are two categories of patients with regard to the administration of Spinraza. For category l, where the administration of Spinraza is deemed not too technically difficult, a consultant paediatric neurologist and lead clinician need access to the day ward as administration is performed under local anaesthetic. Each of these patients will also require a physiotherapy assessment pre-administration and recovery time in the day ward.

Category II are more complex patients who have already undergone spinal fusion surgery and insertion of spinal rods, which makes the administering of Spinraza potentially more complex. For these patients, the delivery of Spinraza will require specialist care to include input by an anaesthetist and an interventional radiologist with associated nursing and the availability of capacity in the paediatric intensive care unit.

It will be appreciated, therefore, that a considerable amount of service planning and assessment of patients at an individual level is required in order for treatment with Spinraza to be undertaken. The HSE has confirmed that the provision of auxiliary services to facilitate the administration of Spinraza to these patients is currently being worked on.

The Minister, Deputy Harris, has been advised by the HSE that four children are now receiving Spinraza, three of whom were successfully started on Spinraza treatment in Temple Street on 7 November. The HSE has also confirmed that Children's Health Ireland, CHI, is in discussions with colleagues across the three children's hospitals in Crumlin, Temple Street and Tallaght with regard to arranging a schedule so that administration of Spinraza can be performed for approved patients. As part of this process, CHI is engaging on an individual basis with the families involved regarding each child's treatment plan.

Furthermore, the HSE has indicated that a meeting has now been scheduled between CHI and the SMA Ireland advocacy group at the end of November to discuss arrangements for the delivery of Spinraza. The Minister, Deputy Harris, has asked to be kept updated on any further developments. I will bring any of the concerns raised to date back to the Minister immediately.

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