OBJECTIVES: The Italian Medicines Agency (AIFA), is responsible for setting the national reimbursement status and pricing of pharmaceuticals. In 2007, AIFA granted more favorable reimbursement conditions for therapies deemed “innovative”. In April 2017, a new innovation algorithm was established alongside innovation funds. Therapies can now be designated “conditionally (or potentially) innovative” and gain immediate formulary inclusion as well as “innovative,” where they also can benefit from innovation funds (worth a total of €1 billion/year) and exemptions from excess expenditure clawbacks. This research evaluates all therapies granted AIFA innovative designation under this new algorithm.

METHODLOGY: Therapies with innovation designation were identified from the AIFA website and key information extracted (to 14-Jan-2020).

RESULTS: 30 drug:indication pairings have innovative designations (8 [2017], 16 [2018], 6 [2019]- for context, the EMA provided 66 positive opinions in 2019). 16/30 have “innovative” designations (12/16 were designated “innovative” for 3 years, 1/16 for 2.6 years [a follower product), 2/16 for 18 months, and 1/16 for 12 months; 12/16 were AIFA class H (reimbursed for hospital use). 8/16 were for oncology indications and 11/16 were for EMA-designated orphan indications]. 4/30 had “potential” innovation designations (4/4 were for 3 years. 3/4 were AIFA class H. 3/4 were for oncology indications and 3/4 were for EMA-designated orphan indications). 10/30 had “conditional” innovation designations (10/10 were for 18 months. 9/10 were AIFA class H; 8/10 were for oncology indications and 5/10 were for EMA-designated orphan indications).

CONCLUSIONS: AIFA is only applying innovative status to a minority of new therapies, most of which are either for oncology indications and/or EMA-designated orphan indications. 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.