The 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 respect of 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 21 February, the HSE wrote to the company involved and informed it of the proposal to refuse to reimburse Spinraza at the current price offering. Under the terms of the Health (Pricing and Supply of Medical Goods) Act 2013, the company has 28 days from 21 February to respond or make representations to the HSE’s proposed decision.
The HSE remains open to considering any new evidence or information which emerges regarding the clinical effectiveness or price of this medicine during this 28 day timeframe. The Government hopes that the company will use this opportunity to come back to the HSE and that this can result in an acceptable outcome for both parties. Responsibility for progressing this issue is now firmly with the company.