The HSE has statutory responsibility for medicine pricing and reimbursement decisions, under the Health (Pricing and Supply of Medical Goods) Act 2013. The 2013 Health Act specifies criteria for decisions on the reimbursement of medicines.On 11 June 2019, the HSE Leadership Team approved access to the drug Spinraza for children with Spinal Muscular Atrophy (SMA) Type I, II or III on an exceptional and individualised basis.
The HSE has confirmed that a number of children are currently receiving treatment with Spinraza. Application for approval is based on clearly defined criteria and clinical guidelines are being followed in each case.
The actual delivery of this drug to approved patients in a safe and sustainable way requires a considerable amount of service planning and assessment of patients at an individual level. The HSE has confirmed that the provision of the appropriate auxiliary services and clinical arrangements to facilitate the administration of Spinraza to the remaining approved patients based on the clinical need is currently being worked on.
Furthermore, I have been advised by the HSE that Children's Health Ireland (CHI) is currently engaging on an individual basis with the families involved regarding each child's treatment plan. In addition, on 25 November 2019, CHI held a productive meeting with members of the SMA Ireland Advocacy Group and the HSE, and open lines of communication regarding the provision of this service have now been established.