Manufacturer paybacks of E1 billion in relation to 2021
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Italy: Manufacturer paybacks of €1 billion in relation to 2021


According to analysis by IQVIA reported in the local press, the direct purchase expenditure ceiling (ie covering spending on hospital medicines and drugs dispensed directly to non-hospitalised patients) will be exceeded by €2-2.1 billion in 2021. Consequently, paybacks from pharmaceutical manufacturers of around €1 billion will be due from pharmaceutical manufacturers (who cover 50% of any overspend, with the regions covering the other 50%).  

The local press reports that legislation signed in 2020 and 2021 to tackle the COVID-19 pandemic increased overall healthcare funding, and increased the ceiling on direct purchases to 7.85%, (including 0.2% for the direct purchase of medical gases). However, despite the increase spending on direct purchases continues to grow.   

Drugs covered by the two innovative drugs funds, the fund for innovative oncology drugs and the fund for innovative non-oncology drugs (both with a budget of €500 million per year), are excluded from the calculations in relation to the expenditure ceilings. According to IQVIA estimates, spending on innovative oncology drugs may have exceeded the fund’s budget by “a few tens of millions of euros”; manufacturers will have to repay half of the overspend. On the other hand, spending on innovative non-oncology drugs reportedly totalled around €270 million, well within the fund’s budget. Notably, from 2022 the two funds are unified into a single innovative medicines fund of €1 billion a year. 

According to the local press, Sergio Liberatore, CEO of IQVIA Italia commented, “Despite the increase in the ceiling for direct purchases in 2021 and the unification of the two funds for innovative drugs into a single one billion fund starting from 1 January 2022, the pharmaceutical spending remains underfunded. It is improper to set such a low pharmaceutical spending ceiling when it is known that it will be breached by over two billion euros and it is therefore important that this issue returns to being a political priority “. 

Source:, “Spesa farmaceutica. Iqvia: “Per 2021 stima superamento tetto di spesa ospedaliera sarà di 2-2,1 mld””, 18th March 2022 

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