The HSE has statutory responsibility for decisions on medicine pricing and reimbursement in the community drugs schemes, 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.
I am advised by the HSE that following detailed consideration of an application for the reimbursement of Tagrisso and lengthy engagement with the company, HSE Leadership decided that it was unable to reimburse Tagrisso. The HSE concluded that the evidence for clinical meaningful benefit was insufficiently robust and could not support reimbursement on the basis that reimbursement was not likely to represent a cost efficient use of resources.
On the 22 February, the HSE wrote to the company involved and informed it of the proposal to refuse to reimburse Tagrisso. Under the terms of the Health (Pricing and Supply of Medical Goods) Act 2013, the company has 28 days from the 22 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 this medicine during this 28 day timeframe.