Nivolumab in the treatment of metastatic renal cell carcinoma: A cost-utility analysis.

Abstract

e18331 Background: Nivolumab was recently shown to improve overall survival (OS) and health-related quality of life compared to Everolimus in metastatic renal cell carcinoma (mRCC) patients previously treated with antiangiogenic therapies (CheckMate-025 trial). The aim of this study is to assess the cost-utility of Nivolumab versus Everolimus from the perspective of the Canadian publicly funded healthcare system. Methods: To evaluate the cost-utility of Nivolumab versus Everolimus, a Markov cohort model that incorporated data from the phase 3 CheckMate-025 trial and other sources was developed. The outcomes of interest were healthcare costs, life-months and quality-adjusted life-months (QALMs) gained with Nivolumab as well as the incremental cost-effectiveness ratio (ICER), and the incremental net monetary benefit. A lifetime time horizon was used in the base case with costs and outcomes discounted 5% annually. The probabilities of progression and death from cancer and utility values were captured from the CheckMate-025 trial. Expected costs were based on Ontario fees and other sources. Scenario and sensitivity analyses (SAs) were conducted to assess uncertainty. Results: Compared to Everolimus, treatment with Nivolumab provided an additional 3.9 QALMs at an incremental cost of 33,386 Canadian dollars (CAD). The resulting ICER was 8,608CAD per QALM gained. With a willingness-to-pay (WTP) of 50,000CAD per Quality-adjusted life-year (QALY) ( = 4,167CAD per QALM), Nivolumab was not cost-effective in the base case. In one-way SAs, Nivolumab cost, median OS and treatment duration on Nivolumab were sensitive to changes with plausible threshold values. Assuming a WTP of 100,000CAD per QALY ( = 8,334CAD per QALM) and a scenario of Nivolumab cost with no drug wastage, Nivolumab became a cost-effective strategy with an ICER of 7,881CAD per QALM. Conclusions: With its current price , Nivolumab is unlikely to be cost-effective compared with Everolimus for previously treated mRCC patients from a Canadian healthcare payer perspective. While mRCC patients derive a meaningful clinical benefit from Nivolumab, considerations should be given to reduce drug wastage and increase the WTP threshold to render this strategy more affordable.

Economic Burden of Renal Cell Carcinoma—Part I: An Updated Review

“…[28] As more new drugs were approved for second-line therapy of mRCC, BSC became less common in second-line settings and cost-effectiveness analyses were able to model clinical parameters from head-to-head trials, such as the AXIS (AXItinib vs. Sorafenib in advanced renal cell carcinoma) trial for axitinib vs. sorafenib [32] and the CheckMate 025 trial for nivolumab vs. everolimus. [33] Eight studies included both nivolumab and everolimus in the comparators [29][30][31][34][35][36][37][38] and these two drugs were directly compared in six. [29,31,[34][35][36]38].…”

“…[33] Eight studies included both nivolumab and everolimus in the comparators [29][30][31][34][35][36][37][38] and these two drugs were directly compared in six. [29,31,[34][35][36]38]. Only two out of the six studies found nivolumab to be cost effective compared to everolimus.…”

“…[35] The other four studies concluded that nivolumab was unlikely to be more cost effective than everolimus when benchmarking against the societal willingness to pay (WTP) of $100,000/ QALY. [31,34,36,38] It is worth noting that the study by Giuliani et al may reflect a partial assessment because their analyses only considered drug cost. [29] Comparisons between cabozantinib and everolimus were identified in three studies; all three reported ICER higher than $150,000 per QALY or LY when cabozantinib was compared to everolimus.…”

Pembrolizumab plus axitinib and nivolumab plus ipilimumab as first-line treatments of advanced intermediate- or poor-risk renal-cell carcinoma: a number needed to treat analysis from the Brazilian private perspective

“…Previous analysis have assessed the relationship between clinical and economic benefits of pembrolizumab, axitinib, nivolumab and ipilimumab, isolated or in combination for mRCC management, using traditional strategies such as costeffectiveness and cost-utility analyses 15,16,39,40 . In Brazil, the National Sanitary Agency (Agência Nacional de Vigilância Sanit aria -ANVISA) is responsible for registering new drugs, an exclusive task of the State that intervenes in the production-consumption relationship by establishing legal rules for granting this registration.…”