OBJECTIVES: The study aims at assessing the impact of innovative status on negotiation outcomes of drugs in Italy in terms of overall discount and duration of the Pricing and Reimbursement (P&R) process negotiation with the Italian Medicine Agency (AIFA).

METHODS: The analysis was conducted on drugs which negotiated their first indication in Italy between 2016 and 2023, using an IQVIA proprietary database on Italian negotiation dynamics. Descriptive analyses were conducted to explore the median overall discount and P&R process duration of drugs which were granted innovative status (either full or potential) and non-innovative drugs. Next, a negative binomial generalized linear model and a beta regression model were run to investigate the impact of innovativeness status on overall discount and P&R process duration, respectively. Finally, sensitivity analyses were performed considering a further stratification of the panel (full innovativeness / potential innovativeness / not granted / never requested).

RESULTS: A total of 293 drugs met the inclusion criteria, of which 57 were granted innovative status. Innovative drugs obtained an estimated median overall discount of 38.0% (IQR 25.4-48.9%) at first negotiation, similarly to non-innovative drugs (39.0%; IQR 30.0-50.1%). The median P&R process duration for innovative drugs was 405 days (IQR 348-535), compared to 424 (IQR 343-527) days for non-innovative drugs. Inferential analyses showed that innovativeness is not associated with a significant variation in the outcomes of interest. In the sensitivity analyses, only full innovativeness was significantly associated with a lower discount with respect to drugs which never requested innovativeness (-8.8 percentage points; p<0.01), while no impact on process duration was found.

CONCLUSIONS: The analysis showed that innovative status does not emerge as a driver of overall discount or P&R process duration. Nevertheless, drugs with a full innovative status are awarded a significantly lower discount, suggesting an alignment on value perception between the manufacturer and AIFA.