Duncan Smith (Dublin Fingal, Labour)
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1579. To ask the Minister for Health the level of spending on new medicines and extension indications by the HSE in 2022; if the €30 million allocation was spent in full; if any unspent allocations were returned to the Exchequer by the HSE or diverted to other expenditure areas; and if he will make a statement on the matter. [1775/23]

Stephen Donnelly (Wicklow, Fianna Fail)
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The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drugs schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.

The HSE in its decision making considers the 5 year budget impact of each new medicine notwithstanding that the budget of the HSE is set on an annual basis. The year 1 costs of most medicines represent a fraction of the overall costs of those medicines when fully introduced.

The HSE has increased the approval of new medicines in 2021 and 2022 (in comparison to the 2 previous years (2019 and 2020)).

The HSE has confirmed that: 

- In 2022, 30 new medicines and 30 new uses of existing medicines were approved at an additional cost of €178m over the first 5 years. 

- In 2021, 29 new medicines and 21 new uses of existing medicines and 2 expansions of reimbursement were approved at an additional cost of €477m over the first 5 years of those decisions.