OBJECTIVES: The Italian Medicines Agency (AIFA) negotiates agreements to manage the pharmaceutical expenditure, especially for high-cost drugs. The analysis aimed to assess the most relevant variables impacting medicine prices (Average Price - AP) which account for both discounts negotiated with AIFA and further discounts applied in tenders.

METHODS: Analysis was based on i-PRIME, an IQVIA proprietary database that integrates clinical and regulatory features on drugs and drugs average prices (AP). APs were estimated based on an IQVIA statistic elaboration on consumptions and expenditure data gathered from a panel of Italian hospital pharmacies. Drugs approved by EMA between 2015 and 2021, reimbursed by AIFA for their first indication, commercialized in Italy and without performance or financial based Managed Entry Agreements (except for capping) were considered.

RESULTS: The ~100 drugs included in the analysis had an average discount of 35%, with a growing trend observed in the analysis period. Discount varied across therapeutic areas, with oncology drugs negotiating the highest discount. Around 10% of drugs negotiated a capping and in 2021 the presence of an expenditure cap led to negotiate a discount below the overall average (discount <30%; N=6). The obtainment of the innovative designation highlighted no positive impact on discounts, which resulted above average. Conversely, the orphan designation led to a discount slightly lower than the average, phenomenon more evident for ultra-orphan drugs.

CONCLUSIONS: The average discount of drugs seems mostly driven by the presence of the unmet need in the therapeutic area and by the combination with cost-containment mechanism as capping. Nevertheless, further investigations in the following years are needed to evaluate variables’ impact on drugs average discount overtime.