Maureen O'Sullivan (Dublin Central, Independent)
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182. To ask the Minister for Health the reason for the delay for the reimbursement of a drug (details supplied). [17974/19]

Simon Harris (Wicklow, Fine Gael)
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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 relation to such matters.

I am advised by the HSE that following detailed consideration of an application for the reimbursement of Osimertinib (Tagrisso) and engagement with the company, HSE Leadership decided that it was unable to reimburse Osimertinib (Tagrisso).  The HSE concluded that it could not support reimbursement on the basis that reimbursement was not likely to represent a cost efficient use of resources. 

The HSE wrote to the manufacturer involved and informed them of the proposal to refuse reimbursement at the current price offering. Under the requirements of the Health (Pricing and Supply of Medical Goods) Act 2013 the company had 28 days to respond or make representations to the HSE’s proposed decision.

I am advised by the HSE that the manufacturer has submitted representations, which will be considered by the HSE Drugs Group in due course, following which a recommendation will be made to the HSE Leadership Team for a final decision.