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. 2016 Apr 21;11(4):e0153943.
doi: 10.1371/journal.pone.0153943. eCollection 2016.

Cost-Effectiveness of Cetuximab for Advanced Esophageal Squamous Cell Carcinoma

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Cost-Effectiveness of Cetuximab for Advanced Esophageal Squamous Cell Carcinoma

Vincent T Janmaat et al. PLoS One. .

Abstract

Background: Costly biologicals in palliative oncology are emerging at a rapid pace. For example, in patients with advanced esophageal squamous cell carcinoma addition of cetuximab to a palliative chemotherapy regimen appears to improve survival. However, it simultaneously results in higher costs. We aimed to determine the incremental cost-effectiveness ratio of adding cetuximab to first-line chemotherapeutic treatment of patients with advanced esophageal squamous cell carcinoma, based on data from a randomized controlled phase II trial.

Methods: A cost effectiveness analysis model was applied based on individual patient data. It included only direct medical costs from the health-care perspective. Quality-adjusted life-years and incremental cost-effectiveness ratios were calculated. Sensitivity analysis was performed by a Monte Carlo analysis.

Results: Adding cetuximab to a cisplatin-5-fluorouracil first-line regimen for advanced esophageal squamous cell carcinoma resulted in an the incremental cost-effectiveness ratio of €252,203 per quality-adjusted life-year. Sensitivity analysis shows that there is a chance of less than 0.001 that the incremental cost-effectiveness ratio will be less than a maximum willingness to pay threshold of €40,000 per quality-adjusted life-year, which is representative for the threshold used in The Netherlands and other developed countries.

Conclusions: Addition of cetuximab to a cisplatin-5-fluorouracil first-line regimen for advanced esophageal squamous cell carcinoma is not cost-effective when appraised according to currently accepted criteria. Cost-effectiveness analyses using outcome data from early clinical trials (i.c. a phase II trial) enable pharmaceutical companies and policy makers to gain early insight into whether a new drug meets the current eligibility standards for reimbursement and thereby potential admittance for use in regular clinical practice.

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Conflict of interest statement

Competing Interests: One of the authors F. Lordick received research support, travel support and lecture honoraria from Merck Serono. This did not alter the authors' adherence to PLOS ONE policies on sharing data and materials.

Figures

Fig 1
Fig 1. Schematic representation of the health states and utility scores used in the linear model.
At diagnosis a utility score of 0.675 was assumed. This utility score remains stable during progression free survival. During progressive disease, it was assumed that the utility score declines linearly from 0.675 to 0 at the time of death.
Fig 2
Fig 2. Tornado plot of a one-way sensitivity analysis.
Input variables were tested in a one-way sensitivity analysis. These variables were either decreased by 10% of the value used in the base case model, or increased 10% from their original value. The bars represent the range of the ICER if the variable lies between -10% and +10% of its assumed value in the base case model. The ICER form the base case model was indicated by the vertical dotted line.
Fig 3
Fig 3. Scatter plot of Monte Carlo sensitivity analysis.
One thousand repeated random samplings from the model described are depicted in the figure. Each sampling is depicted by one dot and represents the average QALY gained and the incremental cost of that sampling from the model. The vertical line separates the plane (to the left), for which the intervention is not effective. With the plane to the right for which the intervention is effective. The inclining line depicts the maximum willingness to pay threshold at an ICER of €40,000 per QALY gained. This line separates the plane above it, for which the intervention is effective but not cost effective, with the plane below, for which the intervention is effective and cost effective.

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