Cost-Effectiveness of Nivolumab in Recurrent Metastatic Head and Neck Squamous Cell Carcinoma


Abstract

Background: Treatment options for patients with platinum-refractory, recurrent, metastatic head and neck squamous cell carcinoma (r/m HNSCC) are limited and prognosis is poor. The recent CheckMate 141 clinical trial demonstrated that nivolumab, an anti-programmed cell death protein 1 monoclonal antibody, was efficacious in extending the median overall survival (OS) in this patient population compared with standard therapies. We conducted a cost-effectiveness analysis to determine whether nivolumab is a cost-effective treatment in this patient population and examined various subgroups to determine for which, if any, the treatment is more cost-effective.

Materials and methods: We implemented a state transition model for HNSCC with a patient cohort who had tumor progression 6 months after the last dose of platinum-containing chemotherapy and compared the cost-effectiveness of nivolumab with docetaxel. Treatment effect estimates and adverse event rates were obtained from CheckMate 141. Costs, utilities, and other model inputs were gathered from published sources. We used a Canadian perspective, a 5-year time horizon, and a 1.5% discount rate for the analysis.

Results: Nivolumab extended mean OS by 4 months compared with docetaxel and resulted in fewer treatment-related adverse events, producing an incremental effectiveness of 0.13 quality-adjusted life years (QALY). The incremental cost of treatment with nivolumab was $18,823. At a willingness-to-pay threshold of $100,000/QALY, nivolumab was not a cost-effective treatment option for r/m HNSCC, with an incremental cost-effectiveness ratio of $144,744/QALY. Nivolumab would be cost-effective if its price was reduced by 20%. Our subgroup analysis seemed to indicate that nivolumab might be cost-effective for tumors with expression of programmed death-ligand 1 >5%.

Conclusion: We conclude that although nivolumab offers clinical benefit for the treatment of r/m HNSCC over current regimens, it is not cost-effective based on its list price. We have also established a value-based price estimate for nivolumab to be cost-effective in this patient population. Further study is required to draw a definitive conclusion on biomarkers for cost-effectiveness.

Implications for practice: In health care settings in which cost considerations are a constraint on choice of therapy, patient selection should be carefully considered to maintain efficiency in the system. Until a biomarker for response to therapy is identified for nivolumab, this medication is unlikely to be cost-effective for most patients with recurrent, metastatic head and neck squamous cell carcinoma.

Keywords: Carcinoma, metastatic; Carcinoma, squamous cell; Cost‐effectiveness analysis; Docetaxel; Drug therapy; Nivolumab; Programmed cell death 1 ligand 2 protein.

Conflict of interest statement

Disclosures of potential conflicts of interest may be found at the end of this article.

Figures

Figure 1.
Figure 1.
Health states and progression of recurrent metastatic head and neck squamous cell carcinoma. This figure represents the natural health states of platinum‐refractory, recurrent metastatic head and neck squamous cell carcinoma. The patient is assumed to be in progression‐free disease at the start of the treatment. Treatment is initiated in this stage. At some point the patient transitions to progressive disease and finally death. Patients may also transition to death while in progression‐free disease because of other complications. The PFS curve and OS curve determine the transition probabilities over time. Abbreviations: OS, overall survival; PFS, progression‐free survival.
Figure 2.
Figure 2.
Projected versus actual OS and PFS curves using the Weibull distribution. (A): Actual and projected OS curves for nivolumab and docetaxel. Actual data are digitized from the original clinical trial. The projection is based on the method described by Guyot et al. [16] of retrieving IPD data from the Kaplan‐Meier curve and the associated at risk data. Weibull distribution was used to project the data. (B): Actual and projected PFS curves for nivolumab and docetaxel. Actual data are digitized from the original clinical trial and projected in a similar manner to OS curves. The projected data do not capture the extended PFS benefit of nivolumab in a small subgroup of patients; however, our analysis shows that even if PFS remained flat beyond 16 months, it would have no impact on the ICER of treatment. Abbreviations: Act, actual; Doct, docetaxel; ICER, incremental cost‐effectiveness ratio; IPD, individual patient data; Nivo, nivolumab; OS, overall survival; PFS, progression‐free survival; Proj, projected.
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