Validation of modeled PFS and OS data using updated GEMSTONE-301 and external data.

Validation of modeled PFS and OS data using updated GEMSTONE-301 and external data.</p

Cost-effectiveness acceptability curves of sugemalimab vs. placebo with and without PAP.

Cost-effectiveness acceptability curves of sugemalimab vs. placebo with and without PAP.</p

The exploration and fitting of PFS and OS curves for sCRT population in comparison with external data.

Model simulation visual PFS curve (A), OS curve (B) of sugemalimab arm and PFS curve (C), OS curve (D) of placebo arm.</p

AIC and BIC of parametric distributions for cCRT and sCRT curves.

*, best fitted model; cCRT, concurrent chemoradiotherapy; sCRT, sequential chemoradiotherapy; Suge: Sugemalimab; PC; AIC, Akaike information criterion; BIC, Bayesian information criterion; PFS, progression-free survival; OS, overall survival; Suge, sugemalimab. (DOCX)</p

Table_3_Cost-effectiveness analysis of sugemalimab vs. placebo, in combination with chemotherapy, for treatment of first-line metastatic NSCLC in China.DOCX

ObjectiveThe purpose of this study was to estimate the cost-effectiveness of sugemalimab plus chemotherapy (SC) vs. placebo plus chemotherapy (PC), as the first-line treatment for patients with non-small cell lung cancer (NSCLC) in China.Material and methodsA three-state Markov model with a cycle of 3 weeks was built to assess the incremental cost-effectiveness ratio (ICER) of SC vs. PC as first-line treatment for patients with NSCLC over a 10-year horizon from Chinese health care perspective. Time-dependency transition probability and safety data were derived from a multicenter, randomized, double-blind, phase 3 clinical trial performed in China (GEMSTONE-302). Primary model outcomes included the costs in US dollars and health outcomes in quality-adjusted life-years (QALYs) and the ICER under a willingness-to-pay (WTP) threshold of $37,663/QALYs. Deterministic, scenario and probabilistic sensitivity analysis were employed to investigate the robustness of model outcomes.ResultsIn base-case analysis, compared with PC, first-line SC for intention-to-treat (ITT) population gained an additional 0.57 QALYs with an incremental cost of$62,404.15, resulting in an ICER of $109,480.97/QALYs gained. When a patient assistance program (PAP) was available, the ICER decreased to$52,327.02/QALYs. In subgroup analysis, the ICER values were above the WTP threshold with or without PAP. Sensitivity analysis results suggested that the model outcomes were reliable.ConclusionFrom the perspective of Chinese healthcare system, the SC was not cost-effective in comparison to PC as first-line treatment for NSCLC, regardless of PD-L1 tumor expression level and pathological subtype.</p

Results of scenario analyses for cCRT population.

ObjectiveThe effectiveness of sugemalimab vs. placebo in post-chemoradiotherapy patients with locally advanced, unresectable stage III NSCLC has been demonstrated and approved by China National Medical Products Administration. The purpose of this study was to assess the cost-effectiveness of sugemalimab vs. placebo for consolidation treatment of stage III NSCLC from the perspective of the Chinese healthcare system.MethodsA 3-state Markov model with a 3-week cycle length was performed to appraise the incremental cost-utility ratio (ICUR) of sugemalimab consolidation therapy based on the GEMSTONE-301 clinical trial over a 10-year time horizon. Only direct medical costs, including costs of drug (maintenance and subsequent treatment), routine follow-up, best supportive care, and terminal care in end of life were considered in this model. Costs and health utilities were obtained from local databases and published articles. Sensitivity and scenario analyses were adopted to evaluate the model uncertainty. Internal and external data sources were used to justify the plausibility of the extrapolated portion of the survival model chosen.ResultsIn comparison with the placebo, sugemalimab consolidation therapy was not cost-effective as it yielded an ICUR value of $90,277 and$49,692 for the concurrent chemoradiotherapy (cCRT) and the sequential chemoradiotherapy (sCRT) population at the willingness-to-pay (WTP) threshold of $37,663/QALYs, respectively. When taking the sugemalimab patient assistance program (PAP) into consideration, sugemalimab consolidation therapy was cost-effective with an ICUR dramatic decreases below the WTP. Sensitivity analyses demonstrated that the ICUR was most sensitive to the discount rate and subsequent treatment. However, none of the sensitive parameters could affect the cost-effective conclusions without or with PAP. Scenario analyses revealed that the model was particularly affected by assumptions regarding discount in sugemalimab, time horizon, mean duration of sugemalimab maintenance treatment.ConclusionsFrom the perspective of Chinese healthcare system, sugemalimab consolidation therapy was not a cost-effective strategy in cCRT and sCRT patients with unresectable stage III NSCLC. Given that the sugemalimab PAP was available, sugemalimab consolidation therapy became a cost-effective option.</div

Best fit and the values of the parameters.

ObjectiveThe effectiveness of sugemalimab vs. placebo in post-chemoradiotherapy patients with locally advanced, unresectable stage III NSCLC has been demonstrated and approved by China National Medical Products Administration. The purpose of this study was to assess the cost-effectiveness of sugemalimab vs. placebo for consolidation treatment of stage III NSCLC from the perspective of the Chinese healthcare system.MethodsA 3-state Markov model with a 3-week cycle length was performed to appraise the incremental cost-utility ratio (ICUR) of sugemalimab consolidation therapy based on the GEMSTONE-301 clinical trial over a 10-year time horizon. Only direct medical costs, including costs of drug (maintenance and subsequent treatment), routine follow-up, best supportive care, and terminal care in end of life were considered in this model. Costs and health utilities were obtained from local databases and published articles. Sensitivity and scenario analyses were adopted to evaluate the model uncertainty. Internal and external data sources were used to justify the plausibility of the extrapolated portion of the survival model chosen.ResultsIn comparison with the placebo, sugemalimab consolidation therapy was not cost-effective as it yielded an ICUR value of $90,277 and$49,692 for the concurrent chemoradiotherapy (cCRT) and the sequential chemoradiotherapy (sCRT) population at the willingness-to-pay (WTP) threshold of $37,663/QALYs, respectively. When taking the sugemalimab patient assistance program (PAP) into consideration, sugemalimab consolidation therapy was cost-effective with an ICUR dramatic decreases below the WTP. Sensitivity analyses demonstrated that the ICUR was most sensitive to the discount rate and subsequent treatment. However, none of the sensitive parameters could affect the cost-effective conclusions without or with PAP. Scenario analyses revealed that the model was particularly affected by assumptions regarding discount in sugemalimab, time horizon, mean duration of sugemalimab maintenance treatment.ConclusionsFrom the perspective of Chinese healthcare system, sugemalimab consolidation therapy was not a cost-effective strategy in cCRT and sCRT patients with unresectable stage III NSCLC. Given that the sugemalimab PAP was available, sugemalimab consolidation therapy became a cost-effective option.</div

Tornado diagram of one-way deterministic sensitivity analysis (DSA) of sugemalimab vs. placebo.

DSA for sCRT population without PAP. sCRT, sequential chemoradiotherapy; PAP: Patient assistance program.</p

Tornado diagram of one-way deterministic sensitivity analysis (DSA) of sugemalimab vs. placebo.

DSA for cCRT population without PAP. cCRT, concurrent chemoradiotherapy; PAP: Patient assistance program.</p

Table_1_Cost-effectiveness analysis of sugemalimab vs. placebo, in combination with chemotherapy, for treatment of first-line metastatic NSCLC in China.DOCX

ObjectiveThe purpose of this study was to estimate the cost-effectiveness of sugemalimab plus chemotherapy (SC) vs. placebo plus chemotherapy (PC), as the first-line treatment for patients with non-small cell lung cancer (NSCLC) in China.Material and methodsA three-state Markov model with a cycle of 3 weeks was built to assess the incremental cost-effectiveness ratio (ICER) of SC vs. PC as first-line treatment for patients with NSCLC over a 10-year horizon from Chinese health care perspective. Time-dependency transition probability and safety data were derived from a multicenter, randomized, double-blind, phase 3 clinical trial performed in China (GEMSTONE-302). Primary model outcomes included the costs in US dollars and health outcomes in quality-adjusted life-years (QALYs) and the ICER under a willingness-to-pay (WTP) threshold of $37,663/QALYs. Deterministic, scenario and probabilistic sensitivity analysis were employed to investigate the robustness of model outcomes.ResultsIn base-case analysis, compared with PC, first-line SC for intention-to-treat (ITT) population gained an additional 0.57 QALYs with an incremental cost of$62,404.15, resulting in an ICER of $109,480.97/QALYs gained. When a patient assistance program (PAP) was available, the ICER decreased to$52,327.02/QALYs. In subgroup analysis, the ICER values were above the WTP threshold with or without PAP. Sensitivity analysis results suggested that the model outcomes were reliable.ConclusionFrom the perspective of Chinese healthcare system, the SC was not cost-effective in comparison to PC as first-line treatment for NSCLC, regardless of PD-L1 tumor expression level and pathological subtype.</p