Tuesday, 19 February 2019
Department of Health
Medicinal Products Availability
328. To ask the Minister for Health the status of the approval of the drug Spinraza for availability under the general medical services system; and if he will make a statement on the matter. [7727/19]
434. To ask the Minister for Health the status of the application for reimbursement for Nusinersen for the treatment of spinal muscular atrophy; if he has engaged with the HSE in an effort to advance this process; and if he will make a statement on the matter. [8324/19]
I propose to take Questions Nos. 328, 383, 388, 395, 415 and 434 together.
The Health Service Executive has statutory responsibility for decisions on pricing and reimbursement of medicines, 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.
I am advised by the HSE that the application for the reimbursement of Nusinersen (Spinraza) was considered by HSE Leadership at a meeting on 12 February 2019 and that the HSE is in the process of communicating its decision to the relevant company.