ABSTRACT

Nivolumab is approved and reimbursed by Italian Drug Agency (AIFA) in several tumors, including non-small cell lung cancer, head & neck cancer and renal cell cancer. In May 2018, the original schedule (3 mg/kg every 2 weeks) – used in pivotal clinical trials demonstrating treatment efficacy – was replaced by a flat dose (240 mg every 2 weeks). Aim of this study was to identify the most cost-effective dosing strategy of nivolumab in a real-world setting. The primary endpoint of this analysis was the difference of nivolumab costs between the real scenario based on data from our hospital, and the hypothetical expenditure according to different simulated strategies of nivolumab dosing. The secondary endpoint was to report the economic savings associated with “drug day” and dose rounding strategies in the same scenario.
We collected data from patients treated with nivolumab at Mauriziano Umberto I Hospital in Turin, from January 2019 to August 2020. We analysed different dosing strategies (flat dose, weightbased-dose and hybrid), computed the cost of each one and compared them to the real expense. In addition, we performed sensitivity analysis modifying nivolumab price and mean patients’ body weight. Among different dosing strategies, hybrid strategy was the most cost-effective approach, with a 11.7% saving compared to the real expense. Dose rounding and vial sharing minimized the drug waste. Applying our data to a hypothetical population of 1000 patients, savings associated with hybrid strategy could have covered 1423 additional treatment cycles. Hybrid strategy was confirmed the mostcost effective in all sensitivity analyses. Hybrid strategy was the most cost-effective strategy compared to the other dosing strategies and compared to the real scenario, mainly based on fixed dose). Furthermore, this analysis demonstrated the importance of waste minimization policies, ecreasing oncologic therapies costs.

IMPACT STATEMENT

This analysis compared the economic impact of different dosing strategies of nivolumab, based on the results obtained in a single Italian center, and showing hybrid dose strategy as the most cost-effective one.