Managed Entry Agreements and Appropriateness Tools Over the Last Three Years in Italy

OBJECTIVES: The objective of the analysis is to describe the application of Managed Entry Agreements (MEAs) and tools for prescriptive appropriateness (PA) applied by Italian Medicines Agency (AIFA) to reimburse medicinal products (MP) in the last 3 years (Nov 2019-Apr 2023).

METHODS: Negotiation procedures for MPs reimbursed by the Italian National Health System was extracted and analysed from the webpage of the Italian Official Gazette for the period 11/2019-04/2023. For each MP, the status of innovation, orphan designation, MEA and/or appropriateness tool, class and therapeutic area was traced.

RESULTS: In the analysed timeframe, 567 procedures involving 486 MPs was traced, 2% of which have been negotiated with the application of a MEA, 49% an PA tool and 5% a combination of MEA and PA. The most frequently applied MEA was the sales cap (88%), mostly on class A/PHT (52%). The most frequent PA tool was the AIFA Registry (40%), especially for class H (88%), followed by the Therapeutic Plan (TP) (39%). The diseases areas most frequently associated with a MEA are neurology/psychiatry (35%), metabolism and endocrinology (26%), infectious diseases (22%), respiratory (17%). The MPs that have been granted an PA belong most to the area of oncology (26%), such as the application of an AIFA Registry.

CONCLUSIONS: As we already observed in our previous research, the use of outcome-based (OB) MEAs in Italy decreased significantly year by year until its almost complete disappearance in 2017-2018. Our last data (included in this research) enhance how AIFA is now preferring the application of appropriateness tools and financial-based MEAs. This may be related to different aspects such as: the complexity to define the responders and non, the administrative burden of data collection; the feasibility to implement innovative payment model (ATMP cases) etc.