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 which include the clinical and cost effectiveness of the product, the opportunity cost and the impact on resources that are available to the HSE.
As Minister for Health, I do not have any statutory power or function in relation to the reimbursement of medicines.
However, I can advise the Deputy that 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 Spinraza involved a full Health Technology Assessment followed by detailed consideration by the HSE expert groups on new drug therapies, including the Technology Review Group for Rare Diseases and the Drugs Committee. Evidence of the clinical effectiveness of this new drug therapy was also reviewed.
The recommendation is to approve access for children with genetically confirmed SMA Type I, II or III, in accordance with the controlled access criteria recommended by the Rare Diseases Technology Review Committee. The rare diseases committee 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.