Cost-Effectiveness of Adding Rh-Endostatin to First-Line Chemotherapy in Patients With Advanced Non-Small-Cell Lung Cancer in China

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1 Clinical Therapeutics/Volume 33, Number 10, 2011 Cost-Effectiveness of Adding Rh-Endostatin to First-Line Chemotherapy in Patients With Advanced Non-Small-Cell Lung Cancer in China Bin Wu, PhD 1, Huafeng Chen, MS 1, Jinfang Shen, BS 1, and Ming Ye, MD 2 1 Department of Pharmacy, Renji Hospital, School of Medicine, Shanghai, China; and 2 Department of Radiation Oncology and Clinical Cancer Center, Renji Hospital, School of Medicine, Shanghai, China ABSTRACT Background: Adding rh-endostatin to standard platinum-based chemotherapy may significantly improve progression-free and overall survival in patients with advanced non small cell lung cancer (NSCLC), but the cost-effectiveness of this practice is unclear. Objective: The purpose of this cost-effectiveness analysis was to estimate the effects of adding rh-endostatin to standard chemotherapy in patients with advanced NSCLC on health and economic outcomes in China. Methods: A semi-markov model was constructed to track 3-week patient transitions between 3 health states: progression-free survival, progressed survival, and death. Probabilities were derived mainly from the results of a pivotal Phase III trial assessing the addition of rh-endostatin to standard first-line chemotherapy with vinorelbine cisplatin in patients with advanced NSCLC. Costs were estimated from the perspective of the Chinese health care system, and the analysis was run over a 10-year time horizon. The primary outcome was the incremental cost-effectiveness ratio (ICER) of adding rh-endostatin at a willingness-to-pay (WTP) threshold of 3 the per-capita gross domestic product (GDP) per quality-adjusted life-year (QALY) gained. One-way and probabilistic sensitivity analyses were performed. Results: According to the model, treatment with rh-endostatin plus standard chemotherapy would increase overall survival by 0.63 years and 0.35 QALYs per patient compared with standard chemotherapy, at an additional cost of $ The ICER for adding rh-endostatin to chemotherapy was $24,454.25/QALY gained (at a 3% discounted rate). On 1-way sensitivity analysis, the utility value of progression-free survival was the most influential factor on the results, followed by the cost of rhendostatin. On probabilistic sensitivity analysis, the probabilities of cost-effectiveness varied by region due to discrepant per-capita GDPs in China. Modeling to extrapolate clinical survival beyond trial completion was the main limitation. Conclusion: The findings from the present analysis suggest that the addition of rh-endostatin to standard first-line chemotherapy is unlikely to be cost-effective. However, at a high WTP, rh-endostatin might be a cost-effective treatment option. (Clin Ther. 2011;33: ) 2011 Elsevier HS Journals, Inc. All rights reserved. Key words: chemotherapy, cost-effectiveness, non small cell lung cancer, rh-endostatin. INTRODUCTION Lung cancer is the most prevalent malignant cancer in adults, with 1.3 million deaths from the disease per year worldwide. 1 More than 87% of cases are non small cell lung cancer (NSCLC). Stage IIIB and IV NSCLC account for 46% of cases at presentation, and these stages are associated with a poor prognosis. 2 Standard therapy consists of first-line platinum-based chemotherapy. 3 However, the median survival is generally 1 year from the time of diagnosis, and even in the most favorable situations, most patients with NSCLC die within 2 years. The increasing prevalence of NSCLC worldwide presents an opportunity for new treatments to improve the clinical benefit of first-line treatment before disease progression. Since Folkman introduced antiangiogenesis therapy for cancer in 1971, 4 hundreds of angiogenesis inhibitors have been discovered and used for drug This article corresponds to Lyles, Editorial Comment, available at DOI /j.clinthera Accepted for publication September 12, doi: /j.clinthera /$ - see front matter 2011 Elsevier HS Journals, Inc. All rights reserved Volume 33 Number 10

2 B. Wu et al. Figure 1. Simplified model structure of the decision tree used in the Markov model of 2 strategies for the treatment of advanced non small cell lung cancer. *Vinorelbine 25 mg/m 2 on days 1 and 5 cisplatin 30 mg/m 2 on days 2 to 4, every 3 weeks for 4 cycles. NP strategy rh-endostatin 7.5 mg/m 2 on days 1 to 14 for each of 4 cycles. development. Among these, endostatin, an endogenous antiangiogenic protein activated by proteolytic processing, is the most prominent. A novel recombinant human (rh)-endostatin is a designed peptide expressed in Escherichia coli, purified, and fused to an additional 9 amino acid sequence, forming a polyhistidine-tag structure. Rh-endostatin has been reported to inhibit endothelial cell proliferation, migration, invasion, and tube formation. Although monotherapy with rh-endostatin was not associated with clinical efficacy in Phase II clinical trials, a Phase III trial in patients with advanced NSCLC reported that the combination of rh-endostatin and platinum-based chemotherapy was associated with significantly increased progression-free survival (PFS) (from 3.59 to 6.28 months) and overall survival (from 9.77 to months). 5,6 Rh-endostatin has been approved by the State Food and Drug Administration of China for the treatment of advanced NSCLC, 7 and a randomized clinical trial is planned in the United States and Europe. The financial implications of adding rh-endostatin to standard first-line treatment with platinum-based chemotherapy remain unclear. Decisions about health care resource allocation are increasingly based on findings from economic analyses Table I. Parameters of Weibull models fitted to Kaplan-Meier survival curves in this analysis of the cost-effectiveness of adding rh-endostatin to standard first-line chemotherapy for non small cell lung cancer. 5,6 Treatment Scale, Mean (SE) Shape, Mean Correlation (SE) Adjusted R 2 Coefficient Progression-free survival NP strategy* ( ) (0.016) Endostatin strategy ( ) (0.054) Overall survival NP strategy* ( ) (0.017) Endostatin strategy ( ) (0.026) *Vinorelbine 25 mg/m 2 on days 1 and 5 cisplatin 30 mg/m 2 on days 2 to 4, every 3 weeks for 4 cycles. NP strategy rh-endostatin 7.5 mg/m 2 on days 1 to 14 for each of 4 cycles. October

3 Clinical Therapeutics Table II. Base-case cost estimates, probability of serious adverse events, and utilities in this analysis of the cost-effectiveness of adding rh-endostatin to standard first-line chemotherapy for non small cell lung cancer. Data are 2010 US $. Parameter Median Range Description and Reference Cost Treatment Local charge a Rh-endostatin per 15 mg b Cisplatin, 1 vial at 20 mg c Vinorelbine, 1 ampule at 10 mg c Docetaxel, 1 ampule at 20 mg c Routine follow-up of patients per unit d c Local charge a Serious adverse events Calculation Neutropenia toxicity per unit e c Thrombocytopenia toxicity per unit e 3, , ,804.6 c Gastrointestinal toxicity per unit e c Probability of serious adverse events f Wang et al 5 and Sung et al 6 Neutropenia toxicity in NP strategy g h Thrombocytopenia toxicity in NP strategy h Gastrointestinal toxicity in NP strategy h Neutropenia toxicity in endostatin strategy i h Toxicity f Wang et al 5 and Sung et al 6 Thrombocytopenia h Gastrointestinal h Utility Carlson et al 12 Progression-free survival j Overall survival j a Cost was collected from local hospitals and/or the department of local government who control the price of medical services and medications. b The range was assumed for one-way sensitivity analysis; the price of rh-endostatin is fixed in the real world as it is a brand name drug. c The ranges were estimated from local data. d The cost included the physician visit (5%), the computed tomography scan (75%), and other examinations and drugs (20%). e The cost per serious adverse event included drugs and medical consumables (87%), ward treatment and nursing (7%), and accommodation and meals (6%). f Values are not percentages, unless indicated. g Vinorelbine 25 mg/m 2 on days 1 and 5 cisplatin 30 mg/m 2 on days 2 to 4, every 3 weeks for 4 cycles. h The ranges were estimated from rh-endostatin trial. i NP strategy rh-endostatin 7.5 mg/m 2 on days 1 to 14 for each of 4 cycles. j The ranges were derived from the published literature. that have identified the therapies that provide the greatest health benefits at acceptable costs. Clinical trials rarely collect enough financial data on treatments and consequences for economic assessment. Thus, mathematic modeling is required to support economic analyses of health care resource ulitization. 8,9 Used appropriately, modeling is a helpful technique, particularly for extrapolating beyond trial durations. The present analysis evaluated the long-term cost-effectiveness of adding rh-endostatin to standard first-line treatment with platinum-based chemotherapy for advanced NSCLC. The perspective of the Chinese health care system was used for determining the direct economic value of rh-endostatin in advanced NSCLC at 1448 Volume 33 Number 10

4 B. Wu et al. different willingness-to-pay (WTP) thresholds per quality-adjusted life-year (QALY) gained. The model excludes indirect societal costs, such as lost productivity and caregiver costs. MATERIALS AND METHODS Decision Model Structure A semi-markov model was used to evaluate the 10-year clinical and economic outcomes associated with advanced NSCLC and its treatment. The costeffectiveness model of advanced NSCLC consisted of 3 mutually exclusive health states: PFS, progressed survival, and death. The structure of the Markov model is shown in Figure 1. In the Markov model, the cycle duration was 3 weeks, and the entry state was PFS. During each of four 3-week cycles, patients either remained in their assigned health state or progressed to a new health state. R for Statistical Computing (R Foundation, Wien, Austria) was used for the development of the model and to evaluate the results. This economic study was based on a literature review and model techniques; approval of the protocol was not required by the institutional research ethics board of Renji Hospital. A hypothetical cohort clinically similar to patients with advanced NSCLC in the Phase III trial of rh-endostatin was entered into the model. 5,6 The hypothetical patients were aged 18 to 76 years and had histologically or cytologically confirmed, newly diagnosed Stage IIIB (malignant pleural effusion) or Stage IV cancer or recurrent NSCLC for which they had not received chemotherapy. They would receive 1 of 2 comparison strategies to manage advanced NSCLC (firstline therapy): vinorelbine cisplatin (NP strategy) or NP rh-endostatin (endostatin strategy). After the cancer progressed, patients were treated with secondline therapy, docetaxel. A cost-effectiveness analysis evaluated the outcomes of the different strategies. The outcomes were calculated using QALYs. The results are presented as an incremental cost-effectiveness ratio (ICER). In the model, both cost and health outcomes were discounted at 3% annually to allow for current values. Disease Progression Transition parameters and proportions were derived from randomized clinical trials (Table I). Kaplan- Meier survival curves for PFS and overall survival (OS) for each strategy were available from the Phase III trial. In that trial, 493 patients with histologically or cytologically confirmed Stage IIIB or IV NSCLC were randomly assigned to receive NP rh-endostatin (n 326) or NP placebo (n 167). The median PFS was significantly longer in the NP rh-endostatin arm than in the control arm (6.3 vs 3.6 months; P 0.001). The overall response rate was also higher in the NP rhendostatin arm than in the control arm (35.4% vs 19.5%; P ). The overall prevalences of adverse events were not statistically different between the 2 arms. Weibull curves were fitted to the data extracted from the Kaplan-Meier curves using R for Statistical Computing. The estimated scale and shape parameters, SEs, adjusted R 2 values, and correlation coefficients are presented in Table I. The shape parameter ( ) allowed the hazard function to increase or decrease with increasing time; if 1.0, the hazard ratio increased in a strictly nonlinear pattern with increasing time. The scale parameter ( ) was related to the measurement unit of time. Medical Costs and Utility The costs of each strategy (Table II) were estimated from the perspective of health care system in China, which is representative of a developing coun- Table III. The median survival time from the present model and from trial data in this analysis of the cost-effectiveness of adding rh-endostatin to standard first-line chemotherapy for non small cell lung cancer. Data are months.* Treatment Trial Model Difference Progression-free survival NP strategy Endostatin strategy Overall survival NP strategy Endostatin strategy *Median survival time (month) is evaluated from treatment initiation. Vinorelbine 25 mg/m 2 on days 1 and 5 cisplatin 30 mg/m 2 on days 2 to 4, every 3 weeks for 4 cycles. NP strategy rh-endostatin 7.5 mg/m 2 on days 1 to 14 for each of 4 cycles. October

5 Clinical Therapeutics try. The population in China is 1.3 billion, and health care resources are insufficient. 10 Indirect costs were not included in the present analysis. The direct medical costs considered in the model were the following: first- and second-line medical therapy (including prescription, preparation, and administration), concurrent medication during therapy, managing treatment-related severe adverse events (SAEs) (grade 3 or 4), routine follow-up, and laboratory testing. The costs and per-capita gross domestic product (GDP) were not inflation-adjusted because the prices of medical service and medications in China would not notably fluctuate together with the change in consumer price index. The estimated treatment costs were based on the following schedules: vinorelbine 25 mg/m 2 on days 1 and 5 and cisplatin 30 mg/m 2 on days 2 to 4, every 3 weeks for 4 cycles (NP strategy); and the NP strategy rh-endostatin 7.5 mg/m 2 on days 1 to 14 for each of 4 cycles (endostatin strategy). To calculate the dosage of chemotherapeutic agents, it was assumed that a typical patient weighed 65 kg and had a height of 1.64 m, resulting in a body surface area of 1.72 m 2.Itwas assumed that, after cancer progressed, all patients would receive active treatment with docetaxel 75 mg/m 2 on day 1 of each 3-week cycle for 6 cycles. 11 It was assumed that the unused drugs in the open vials were discarded. Resource utilization associated with treatmentrelated SAEs (grade 3 or 4) was based on expert opinion and published sources. Rates of treatmentrelated toxicities for each strategy were obtained from the clinical trials. Toxicities were graded according to the National Cancer Institute Common Toxicity Criteria version 2.0. Gastrointestinal and hematologic toxicities were the main SAEs and were included in the analysis. The unit costs of treating SAEs were estimated based on patient records in local hospitals. Toxicities were assumed to have occurred in the state of PFS. Utility values for PFS and progressive survival derived from the literature 12 are presented in Table III. The utility of PFS was 0.65 and was used for both strategies, as there were no differences in quality of life with the addition of rh-endostatin to chemotherapy because the prevalences of adverse drug events were not significantly different between the 2 strategies. For Table IV. Base-case results of alternative strategies on cost and health benefits in this analysis of the cost-effectiveness of adding rh-endostatin to standard first-line chemotherapy for non small cell lung cancer. Strategy Disease-free LYG Total LYG QALYs Gained Cost, $ Incremental cost per LYG, $ Incremental cost per QALY, $ 1y NP strategy* Endostatin strategy , , , y NP strategy* Endostatin strategy , , , y NP strategy* Endostatin strategy , , , y NP strategy* Endostatin strategy , , , LYG life-years gained; QALY quality-adjusted life-years. *Vinorelbine 25 mg/m 2 on days 1 and 5 cisplatin 30 mg/m 2 on days 2 to 4, every 3 weeks for 4 cycles. NP strategy rh-endostatin 7.5 mg/m 2 on days 1 to 14 for each of 4 cycles Volume 33 Number 10

6 B. Wu et al. the state of progressed survival, a utility value of 0.47 was assigned. Sensitivity Analysis Each rate, cost, and utility value was put into the model with a distribution. Logarithm-normal distributions were adopted for all input costs, with the exception of the price of rh-endostatin (which was fixed); bivariate normal distributions were adopted for all Weibull parameters; and distributions were adopted for probabilities and proportions A probabilistic sensitivity analysis based on a secondorder Monte Carlo simulation (1000 simulations) was conducted, and the cost-effectiveness plane acceptability curves were plotted. The threshold used was 3 the per-capita GDP of China ($11,034)/ QALY gained, based on recommendations from the World Health Organization. 16 Base-case analysis was run for 10 years, which is nearly a lifetime horizon. To evaluate the impact of parameter uncertainty on the robustness, 1-way sensitivity analyses of all variables were conducted over the ranges shown in Tables I to III. The results were expressed as tornado graphs. RESULTS Base-case Analysis The findings on model-derived survival satisfactorily matched those from the clinical trial (Table III). With the NP strategy, median PFS and OS were 3.52 and 9.12 months, respectively, compared with 3.59 and 9.77 months in the trial. The corresponding values with the endostatin strategy were 6.64 and months in the model and 6.28 and months in the trial. The model results suggest that adding rh-endostatin to standard chemotherapy with vinorelbine cisplatin would increase health benefits after 1, 2, 5, and 10 years. Disease-free life-years gained (LYGs) were increased with the NP strategy compared with the endostatin strategy at 1 and 2 years (by 0.25 and 0.34 years, respectively). Total LYGs were increased by 0.09, 0.37, 0.60, and 0.63 years after 1, 2, 5, and 10 years. QALYs gained were 0.08 after 1 year and 0.35 Utility of PFS Cost of endostatin per dose Utility of OS Median OS time in NP arm * Median OS time in endo arm Cost of decetaxel per dose Median PFS time in endo arm Discount Median PFS time in NP arm Bodysurface Cost of vinorelbine per dose Probablity of neutropenia in endo arm Probablity of neutropenia in NP arm Cost of follow up per unit Probablity of thrombocytopenia in endo arm Cost of gastrointestinal toxicity per unit Probablity of thrombocytopenia in NP arm Cost of cisplatin per dose Cost of thrombocytopenia per unit Probablity of gastrointestinal toxicity in endo arm Probablity of gastrointestinal toxicity in NP arm Cost of neutropenia per unit 0.79 $ mo 10.3 mo $ mo 0% 3.94 mo 1.5 m 2 $ % 32% $ % $ % $3.50 $ % 44% $ $ mo 8% 3.27 mo 1.9 m 2 $ % 24.5% $ % $ % $6.10 $ % 58.1% $ $ mo 8.45 mo ICER ($) Figure 2. Tornado graph of univariate analyses in cohorts with advanced non small cell lung cancer, showing results of the 1-way uncertainty analyses of the variables on the incremental cost-effectiveness ratio (ICER) between the NP and endostatin strategies. The width of the bars represents the range of the results when the variables were changed as shown in Tables I to III. The vertical dotted line represents the base-case results. OS overall survival; PFS progression-free survival. *Vinorelbine 25 mg/m 2 on days 1 and 5 cisplatin 30 mg/m 2 on days 2 to 4, every 3 weeks for 4 cycles. NP strategy rh-endostatin 7.5 mg/m 2 on days 1 to 14 for each of 4 cycles October

7 Clinical Therapeutics after 10 years (Table IV). The ICER for adding rhendostatin to standard vinorelbine cisplatin chemotherapy was $24, per QALY gained at 10 years. Uncertainty Analyses On 1-way sensitivity analysis, some model variables had a substantial impact on the results. The most influential variables with respect to cost-effectiveness and cost-utility are presented in the tornado graph in Figure 2. The utility of PFS had the greatest impact on the ICER but did not result in an ICER approaching the WTP threshold of $11,034 (3 the per-capita GDP of China). 17,18 The other most influential variables included the price per dose of endostatin, the utility of OS, the median OS with the NP strategy, the median OS with the endostatin strategy, the price per dose of docetaxel, the discounted rate, the median PFS with the endostatin strategy, and the median PFS with the NP strategy. However, none of the variables led to an ICER below the WTP threshold of $11,034 per QALY. Probabilistic sensitivity analysis showed a zero cost-effective probability at the WTP threshold of $11,034 (Figure 3). If the per-capita GDP was $8031, 50% of the advanced NSCLC cohort could achieve cost-effectiveness. Acceptability curves suggested that the probability of cost-effectiveness increased with increasing WTP thresholds, with sensitivity at $17,000 to $40,000 (Figure 4). At WTPs $40,000, 100% of patients could achieve cost-effectiveness; at WTPs $17,000, the probability of cost-effectiveness was 0%. DISCUSSION Despite reports of clinical benefit with the addition of rh-endostatin to standard platinum-based chemotherapy in a Phase III clinical trial, 5,6 the use of rh-endostatin has been associated with increased health care costs. Precise economic evaluations of rh-endostatin use in the clinical setting are needed. The main focus of the present study was to evaluate the cost-effectiveness of adding rh-endostatin to standard platinum-based chemotherapy for the treatment of NSCLC in China. The model estimated that, in a trial-like scenario, the addition of rh-endostatin to standard chemotherapy with cisplatin and vinorelbine in patients with advanced NSCLC would result in a gain of 0.34 QALYs. This health benefit was associated Figure 3. Probabilistic results of the incremental cost-effectiveness differences between the NP and endostatin treatment strategies in a cohort of 1000 patients with advanced non small cell lung cancer. The solid line represents the willingnessto-pay (WTP) threshold of China (3 per-capita gross domestic product of China [$11,034]); the dashed line represents the threshold when 50% of the cohort could achieve cost-effectiveness. Dots below the WTP reflect simulations in which the cost per quality-adjusted life-years (QALYs) gained with the endostatin strategy was less than the incremental cost-effectiveness ratio threshold of $24,094. For example, the endostatin strategy would be more cost-effective than the NP strategy if a patient treated with endostatin gained 1 incremental QALY and the incremental cost was $24,094. NP strategy vinorelbine 25 mg/m 2 on days 1 and 5 cisplatin 30 mg/m 2 on days 2 to 4, every 3 weeks for 4 cycles. Endostatin strategy NP strategy rh-endostatin 7.5 mg/m 2 on days 1 to 14 for each of 4 cycles. with a mean additional cost of $ , leading to a mean ICER of $24,454.50/QALY gained. This ratio is largely attributable to the higher cost associated with the acquisition of rh-endostatin, whereas the costs of other drugs and the management of treatment-emergent adverse events had less impact. In comparison, the pharmacoeconomic findings from a Swiss perspective were that the addition of cetuximab to standard che Volume 33 Number 10

8 B. Wu et al. Figure 4. Cost-effectiveness acceptability curves, showing the probabilities of net benefits achieved by each strategy at different willingness-to-pay (WTP) thresholds in patients with advanced non small cell lung cancer. The horizontal axis represents the WTP threshold to gain 1 quality-adjusted life-year. Vinorelbine 25 mg/m 2 on days 1 and 5 cisplatin 30 mg/m 2 on days 2 to 4, every 3 weeks for 4 cycles. NP strategy rh-endostatin 7.5 mg/m 2 on days 1 to 14 for each of 4 cycles. motherapy would result in a gain of 0.07 QALYs per patient with advanced NSCLC, at an additional cost of 26,088; thus, the ICER for adding cetuximab was 376,205 per QALY gained. 19 From a US perspective, the addition of cetuximab achieved an incremental cost of $80,000 over a period of 18 weeks, resulting in an expenditure of $800,000 per LYG in patients with advanced NSCLC. 20 Compared with the addition of cetuximab, the ICER of rh-endostatin is low. These results may be explained in 1 of 2 ways: rh-endostatin may deliver more health benefits than cetuximab, or the additional cost of rh-endostatin is much lower than that of cetuximab. The association of rh-endostatin with the inhibition of disease progression was a major determinant of clinical and economic outcomes. On 1-way sensitivity analysis, the most influential factor was the utility of PFS, suggesting that improving the quality of life in the state of PFS may increase the cost-effectiveness of rhendostatin therapy. However, in patients with advanced NSCLC with a low risk for progression, the addition of rh-endostatin might be less cost-effective. The second most influential factor was the price of rh-endostatin. If the price per dose of rh-endostatin was decreased by 20%, the ICER for the addition of rh-endostatin was decreased by 21.4%. Because on probabilistic sensitivity analysis the probability of cost-effectiveness with the addition of rh-endostatin was zero at the per-capita GDP of China, a reduction in the price of rh-endostatin might be the most advisable way of achieving a reasonable ICER. Although the addition of rh-endostatin has been reported to have a negative pharmacoeconomic profile in a preliminary analysis that used an overall GDP for all of China, the findings from the present analysis cannot be generalized to all regions or payers in China. The Chinese mainland has 32 provinces, among which the per-capita GDP differs significantly; for example, in 2009, the per-capita GDP ranged from $1355 in the Guizhou province to $11,354 in the city of Shanghai. At the present price of rh-endostatin, only the health care systems of Shanghai, Beijing, and Tianjin might afford the addition of rh-endostatin to standard chemotherapy. In those cities, the 3 per-capita GDP is $24,094; thus cost-effectiveness may be achieved in 50% of the advanced NSCLC cohort. October

9 Clinical Therapeutics Several limitations of the present analysis must be considered. First, modeling to extrapolate clinical survival beyond trial completion was an inevitable limitation. 21 Using the present model, PFS and OS benefits had important effects on the result. The short median follow-up of the pivotal rh-endostatin trial did not afford enough observed survival data to compare with the median survival estimated using the model. Thus, the greatest model uncertainty surrounds the longterm survival rates. Second, the model did not fully detail the natural history of the disease and therefore may not adequately reflect the efficacy and utility achievable in routine clinical practice. Furthermore, on sensitivity analyses, the uncertainty of the utility values had an important effect on the findings from the present evaluation. Third, because of a lack of head-tohead trial data, the present model did not include other biotherapeutic agents used as first-line chemotherapy, such as cetuximab and bevacizumab, as comparators for assessing the incremental cost-effectiveness of rhendostatin. Fourth, the impact of the addition of rhendostatin on society was not assessed. The incidence of lung cancer in China is 300,000 newly diagnosed cases per year, 22 and rh-endostatin might be prescribed to 20,000 patients each year according to expert opinions. Based on the findings from the present analysis, the addition of rh-endostatin to standard chemotherapy would increase expenditures by $166 million and would result in a gain of 6800 QALYs. Finally, because of a lack of data from China, utility estimates were obtained from non-chinese studies. However, because the findings from this analysis reflected the common clinical conditions of advanced NSCLC in China, the present may serve as an important reference for health policy decision makers in China. CONCLUSIONS From the perspective of the health care system in China, the addition of rh-endostatin to standard firstline chemotherapy for advanced NSCLC is unlikely to be considered cost-effective. However, in areas with a high per-capita GDP, rh-endostatin may be a cost-effective treatment option. ACKNOWLEDGMENTS This research was supported by grant no from the Shanghai government. The authors have indicated that they have no other conflicts of interest with regard to the content of the article. Dr. Ye was responsible for the conception and design of the study. Dr. Wu was responsible for the analysis and interpretation of the data. Prof. Chen was responsible for obtaining funding. Prof. Shen was responsible for the collection and assembly of data. REFERENCES 1. Jemal A, Bray F, Center MM, et al. Global cancer statistics. CA Cancer J Clin. 2011;61: William WN Jr, Lin HY, Lee JJ, et al. Revisiting stage IIIB and IV non-small cell lung cancer: analysis of the surveillance, epidemiology, and end results data. Chest. 2009;136: Gridelli C, Ardizzoni A, Douillard JY, et al. Recent issues in first-line treatment of advanced non-small-cell lung cancer: results of an International Expert Panel Meeting of the Italian Association of Thoracic Oncology. Lung Cancer. 2010;68: Folkman J. Tumor angiogenesis: therapeutic implications. N Engl J Med. 1971;285: Wang J, Sun Y, Liu Y, et al. Results of randomized, multicenter, double-blind phase III trial of rh-endostatin (YH-16) in treatment of advanced non-small cell lung cancer patients [in Chinese]. Zhongguo Fei Ai Za Zhi. 2005;8: Sun Y, Wang J, Liu Y, et al. Results of phase III trial of rh-endostatin (YH-16) in advanced non-small cell lung cancer (NSCLC) patients. JClinOncol. 2005;23(Suppl):Abstract Ling Y, Yang Y, Lu N, et al. Endostar, a novel recombinant human endostatin, exerts antiangiogenic effect via blocking VEGF-induced tyrosine phosphorylation of KDR/Flk-1 of endothelial cells. Biochem Biophys Res Commun. 2007;361: Brennan A, Akehurst R. Modelling in health economic evaluation. What is its place? What is its value? Pharmacoeconomics. 2000;17: Barton P, Bryan S, Robinson S. Modelling in the economic evaluation of health care: selecting the appropriate approach. J Health Serv Res Policy. 2004;9: Liu Q, Wang B, Kong Y, Cheng KK. China s primary health-care reform. Lancet. 2011;377: Kim ES, Hirsh V, Mok T, et al. Gefitinib versus docetaxel in previously treated non-small-cell lung cancer (INTEREST): a randomised phase III trial. Lancet. 2008;372: Carlson JJ, Garrison LP, Ramsey SD, Veenstra DL. The potential clinical and economic outcomes of pharmacogenomic approaches to EGFR-tyrosine kinase inhibitor therapy in non-small-cell lung cancer. Value Health. 2009;12: Volume 33 Number 10

10 B. Wu et al. 13. Thompson SG, Nixon RM. How sensitive are cost-effectiveness analyses to choice of parametric distributions? Medical Decision Making. 2005;25: Doubilet P, Begg CB, Weinstein MC, et al. Probabilistic sensitivity analysis using Monte Carlo simulation. Medical DecisionMaking. 1985;5: Briggs A. Probabilistic analysis of cost-effectiveness models: statistical representation of parameter uncertainty. Value Health. 2005;8: Eichler HG, Kong SX, Gerth WC, et al. Use of cost-effectiveness analysis in health-care resource allocation decision-making: how are cost-effectiveness thresholds expected to emerge? Value Health. 2004;7: Siebert U, SroczynskiG, AidelsburgerP, et al. Clinical effectiveness and cost effectiveness of tailoring chronic hepatitis C treatment with peginterferon alpha-2b plus ribavirin to HCV genotype and early viral response: a decision analysis based on German guidelines. Pharmacoeconomics. 2009;27: WHO-CHOICE. Threshold Values for Intervention Cost-Effectiveness by Region. costs/cer_levels/en/index. html. Accessed October 15, Joerger M, Matter-Walstra K, Fruh M, et al. Addition of cetuximab to first-line chemotherapy in patients with advanced non-small-cell lung cancer: a cost-utility analysis. Ann Oncol. 2011;22: Fojo T, Grady C. How much is life worth: cetuximab, non-small cell lung cancer, and the $440 billion question. J Natl Cancer Inst. 2009; 101: Sheldon TA. Problems of using modelling in the economic evaluation of health care. Health Econ. 1996;5: Shin HR, Masuyer E, Ferlay J, Curado MP. Cancer in Asia Incidence rates basedondataincancerincidenceinfive continents IX ( ). Asian Pac J CancerPrev. 2010;11(Suppl2): Address correspondence to: Prof. Ming Ye, Department of Radiation Oncology and Clinical Cancer Center, Renji Hospital, affiliated with the School of Medicine, Shanghai Jiaotong University, Dongfang Road 1600, Shanghai, China. tgrjwsjtu@yahoo.com.cn October

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