OBJECTIVES: In last years the Italian Medicines Agency (AIFA) has increasingly adopted negotiating agreement to manage the raise of pharmaceutical expenditure, as AIFA discount, especially for high-cost drugs distributed through hospital channel. This analysis aimed to quantify the amount of price reductions negotiated with AIFA, identifying the deviation between ex-factory price and Real Purchasing Price (RPP).

METHODS: 102 drugs belonging to different therapeutic areas and approved by EMA in 2016-2018 period was investigated. Of 102 drugs approved, the 55 drugs reimbursed by AIFA for the first indication were analyzed. For each drug, EMA website and Italian Official Gazette were investigated to evaluate regulatory (i.e. orphan and innovative designations) and pricing features (i.e. ex-factory prices). The RPP by hospital pharmacies came from an IQVIA statistic elaboration based on a proprietary dataset, which gathers drug consumption and price from a panel of Italian hospital pharmacies. Finally, the difference between ex-factory net price and RPP represented the total discount negotiated with AIFA, including commercial discounts.

RESULTS: In 2016, AIFA reimbursed 19 drugs, presenting an average total discount of 30%, increased to 38% in 2017 (22 drugs) and 39% for 14 drugs in 2018. Focusing on innovative drugs, the discount increased from 36% in 2016, to 47% in 2018. Investigation of therapeutic areas highlighted that AIFA applied higher discounts to cancer drugs, from 38% in 2016, to 45% in 2018. Contrary, orphan drugs showed a 35% discount in 2017 and 2018.

CONCLUSIONS: Last years showed an overall increase of discount applied, maybe linked to several high-cost drugs introduction. Contrary to innovative drugs, orphan drugs benefit for their status, showing discounts below the average. The analysis highlighted the crucial step of the price negotiation for launches in the Italian market: further investigation is needed to evaluate the whole impact of negotiation agreements, which can additionally influence molecules’ effective price.