An economic evaluation of nivolumab as second-line treatment for advanced renal cell carcinoma (aRCC) concluded that “for the United States, nivolumab is unlikely to be a high-value treatment mRCC [metastatic RCC] at the current price, and a price reduction is justified.” The analysis was published online in Cancer.1
Reductions in price by 85% and 60% of the cost would make nivolumab (full price in 2014: $25.62/mg) cost-effective, according to the researchers.
For their analysis, the researchers used 3 health states to represent progression of mRCC: progression-free survival (PFS), progressive disease, and death. Direct medical costs included cost of drug, administration, and costs to manage adverse events. Drug cost was calculated based on the U.S. Food and Drug Administration (FDA) modified dosing regimen of 240 mg given intravenously every 2 weeks. The model also accounted for systemic therapy that patients received following disease progression. Drug costs from all sources were adjusted to 2014 US dollars.
The model was applied to results from CheckMate 025 (ClinicalTrials.gov Identifier: NCT01668784), which was the pivotal study used for the FDA approval.2 In this study, patients with mRCC who progressed on 1 or more regimens with antiangiogenic agents were randomized to receive either nivolumab or everolimus.
The primary information that such an analysis provides is total cost, life-years (LY), quality-adjusted life-years (QALYs; 1 QALY = 1 year in perfect health), and incremental cost-effectiveness ratios (ICERs: difference in cost/difference in treatment effect).
In the base-case scenario, over a 20-year time horizon, life expectancy of patients receiving nivolumab was projected to be 2.435 LYs, 0.301 LYs longer than the life expectancy for patients on everolimus.
Accounting for quality of life information, patients on nivolumab gained 1.786 QALYs, 0.29 QALY more than patients on everolimus. The researchers estimated that the use of nivolumab cost an additional $44,002, resulting in ICERs of $145,940/LY or $151,676 QALY compared with everolimus.
The model was sensitive to costs of nivolumab. A reduction to 80% of base case provided ICERs of $63,861/LY or $66,371/QALY; for an increase to 120%, corresponding ICERs were $227,928/LY or $236,949/QALY.
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When the cost of nivolumab was set at $22.50/mg, the ICER was close to the willingness-to-pay (WTP) threshold of $100,000/QALY.