Italy: Italian Medicines Agency Resolution on regional pharmaceutical expenditure

In brief

By resolution no. 68 of 10 December 2024, the Italian Medicines Agency approved the updated national and regional pharmaceutical expenditure monitoring document for the year 2023.


Contents

Key takeaways 

The monitoring document attests that:

  1. with reference to pharmaceutical spending on direct purchases, the deficit is equal to 3,278.8 million compared to the programmed spending ceiling of 7.95% of the national health care requirement for the year 2023 (net of medical gases); and that
  2. the total repayment value of the pharmaceutical expenditure ceiling breach for direct purchases, again net of medical gases and referring to 2023, is equal to EUR 1,640,532,614.

The document also defines the individual shelf allowances allocated to each marketing authorization holder pharmaceutical company (SIS code).

The documentation regarding the regional allocation of the pharmaceutical expenditure repayment quotas for direct purchases for the year 2023 allocated to each pharmaceutical company holding Marketing Authorizations along with the final determination will be published once the implementation process set forth in Law Decree No. 155/2024 (converted with amendments by Law No. 189/2024) has been finalized.


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