Duncan Smith (Dublin Fingal, Labour)
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657. To ask the Minister for Health the level of expenditure on new medicines in 2022; and if he will make a statement on the matter. [6780/23]

Stephen Donnelly (Wicklow, Fianna Fail)
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Under the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for pricing and reimbursement of new medicines.

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.

In 2021, 29 new medicines and 21 new uses of existing medicines and 2 expansions of reimbursement were approved at a year one cost of €34.39 million, with an additional cost of €477m over the first 5 years of those decisions.

In 2022, 30 new medicines and 30 new uses of existing medicines were approved at a year one cost of €15.5 million, with an additional cost of €178m over the first 5 years of those decisions.