Dáil Éireann Debate, Tuesday - 2 April 2019
297. Deputy Stephen Donnelly asked the Minister for Health the status of the decision not to make Spinraza available to patients here now that a 28-day period has## passed which allowed the drug company time to respond to the initial State decision or provide further information; and if he will make a statement on the matter. [14961/19]
Amharc ar fhreagraThe HSE has statutory responsibility for medicine pricing and reimbursement, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. The Act specifies the criteria for decisions on the reimbursement of medicines. The Minister for Health has no role or powers in relation to such matters.
Following detailed consideration of an application for the reimbursement of Spinraza and lengthy engagement with the company, the HSE recently decided that it was unable to reimburse Spinraza. The HSE concluded that the evidence for clinical effectiveness was still quite limited and that the price proposed by the manufacturer was not a cost-effective use of resources.
On the 21 February the HSE wrote to the company informing them of the HSE’s proposal to refuse reimbursement of Spinraza at the current price offering. Under the terms of the Health (Pricing and Supply of Medical Goods) Act 2013 the company had 28 days to come back to the HSE with a new proposal.
I am advised by the HSE that the manufacturer, Biogen has been in contact with the HSE and has notified them that it intends to submit full and final representations, which will be carefully considered by the HSE.
To facilitate Biogen’s request, the period for representations was temporarily extended to enable the company to submit their representations. This is in line with the Health (Pricing and Supply of Medical Goods) Act 2013.
