OBJECTIVES: In April 2017, a €1 billion Innovative Drug Fund was introduced by the Italian ministry of Health (€500 million each being allocated to oncology and non-oncology indications). Concurrently, a new algorithm was released under which the Italian Medicines Agency (AIFA) assesses the level of innovation provided by new pharmaceuticals. Therapies designated “innovative” benefit from funding through these Innovative Drug Funds and are exempt from expenditure paybacks. This research evaluates how many and what types of therapies have been granted AIFA innovative designation and included in the Innovative Drug Funds.

METHODOLOGY: Therapies with an AIFA innovative designation were identified from the AIFA website and key information extracted (up to 10/01/2020)

RESULTS: Since the new AIFA innovation algorithm was established in April 2017, 15 therapies have been included in the Innovative Drug Funds (0 in 2017, 9 in 2018 and 6 in 2019). For context, the EMA provided 66 positive opinions in 2019, with approval granted to 30 new active substances. 11/15 were for oncology indications, 11/15 were EMA-designated orphan products, and 2/15 were ATMPs (the CAR-T cell therapies, YESCARTA and KYMRIAH). 1/15 was a “follower” to another product with the same indication and MoA. 12/15 were designated Class H (reimbursed for hospital use), 2/15 Class A (essential drugs for reimbursement) and 1/15 class A/H. The duration of innovative designation is on average: 2.2 years (range: 0.7-3.0 years)

CONCLUSIONS: AIFA is only applying innovative status to a small minority of new therapies. This may reflect stringency in application of the new criteria. However, it may also reflect companies not applying for this designation. The limited scope of benefits (for example, the lack of pricing incentives) may contribute towards this.