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Cost-effectiveness and Budgetary Consequence Analysis of Durvalumab Consolidation Therapy vs No Consolidation Therapy After Chemoradiotherapy in Stage III Non-Small Cell Lung Cancer in the Context of the US Health Care System.

ABSTRACT: Importance:In early 2018, durvalumab became the first immunotherapy to be approved for adjuvant treatment of patients with unresectable stage III non-small cell lung cancer (NSCLC) whose cancer has not progressed after definitive chemoradiotherapy. However, the cost-effectiveness and potential economic implications of using this high-priced therapy in this indication are unknown to date. Objective:To explore the cost-effectiveness and potential budgetary consequences of durvalumab consolidation therapy vs no consolidation therapy after chemoradiotherapy in stage III NSCLC in the context of the US health care system. Design, Setting, and Participants:A decision analytic microsimulation model was developed in an academic medical setting to compare the following 2 postchemoradiotherapy strategies: all patients receive no consolidation therapy until progression vs all patients receive durvalumab consolidation therapy until progression or for a maximum of 1 year. The potential budgetary consequence was calculated by applying the proportion of patients with NSCLC who were diagnosed in stage III and received chemoradiotherapy to the projected number of annual new cases for 2018 to 2022 to find total eligible patients and then multiplied by the mean difference in annual cost between the strategies over this 5-year period. Simulated conditions were matched to those of the PACIFIC phase 3 randomized clinical trial and reasonable treatment strategies for metastatic NSCLC. All simulated patients begin disease free after having received radical treatment with chemoradiotherapy and are followed up as they progress to metastatic disease first-line treatment, metastatic disease second-line treatment, end-stage progressive disease, and death. Main Outcomes and Measures:The main outcome of this study was the incremental cost-effectiveness ratio of durvalumab consolidation therapy vs no consolidation therapy, given as aggregate cost of treatment per quality-adjusted life-year gained. Results:Among 2 million simulated patients, durvalumab consolidation therapy was cost-effective compared with no consolidation therapy at a $100?000 per quality-adjusted life-year willingness-to-pay threshold, with an estimated incremental cost-effectiveness ratio of $67?421 per quality-adjusted life-year, and would contribute an additional $768 million to national cancer spending in year 1. The annual budgetary consequence would then decrease to $241 million in year 5. Conclusions and Relevance:Durvalumab consolidation therapy represents an indication where expensive immunotherapies can be cost-effective. Treating with immunotherapy earlier in the course of cancer progression can provide significant value, despite having a substantial budgetary consequence.

SUBMITTER: Criss SD

PROVIDER: S-EPMC6439842 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

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Cost-effectiveness and Budgetary Consequence Analysis of Durvalumab Consolidation Therapy vs No Consolidation Therapy After Chemoradiotherapy in Stage III Non-Small Cell Lung Cancer in the Context of the US Health Care System.

Criss Steven D SD Mooradian Meghan J MJ Sheehan Deirdre F DF Zubiri Leyre L Lumish Melissa A MA Gainor Justin F JF Reynolds Kerry L KL Kong Chung Yin CY

JAMA oncology 20190301 3

<h4>Importance</h4>In early 2018, durvalumab became the first immunotherapy to be approved for adjuvant treatment of patients with unresectable stage III non-small cell lung cancer (NSCLC) whose cancer has not progressed after definitive chemoradiotherapy. However, the cost-effectiveness and potential economic implications of using this high-priced therapy in this indication are unknown to date.<h4>Objective</h4>To explore the cost-effectiveness and potential budgetary consequences of durvalumab ...[more]

PMID: 30543349

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Project description: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.

Project description:BackgroundDurvalumab is an anti-PD-L1 immune checkpoint inhibitor approved for consolidation therapy for patients with stage III non-small cell lung cancer (NSCLC) after chemoradiation. The purpose of our study was to evaluate the association between the degree of tumor PD-L1 expression and outcomes of stage III NSCLC patients treated with durvalumab.MethodsWe conducted a retrospective analysis of all the patients who received durvalumab between July 2017 and July 2019 at our facilities and were diagnosed with or progressed to stage III NSCLC before durvalumab consolidation. Patients were divided into groups based on the degree of PD-L1 expression: <1%, 1-49%, and 50-100%. Overall survival and progression-free survival were estimated by the Kaplan-Meier method and the Multivariate Cox proportional hazard model was used to assess the effect of PD-L1 expression level on OS and PFS, adjusting for age and gender.ResultsWe identified 121 patients with stage III NSCLC that underwent durvalumab consolidation. Of them, 29.8% had PD-L1 expression of 50-100%, 24.8% had PD-L1 expression of 1-49%, and 27.3% had PD-L1 expression of <1%, while 18.2% were not tested for PD-L1 expression. The rate of cancer progression in the group with 50-100% PD-L1 expression was 16.7% compared to 60% in the 1-49% expression group and 54.6% in the <1% expression group, and the 1-year survival rates were higher in the 50-100% group (97%) compared to the 1-49% group and the <1% group (73% and 78%, respectively; P=0.028). Survival analysis via Kaplan-Meier revealed a significant difference in both PFS (P<0.0001) and OS (P<0.028) based on the extent of PD-L1 expression. Multivariate analysis revealed that a PD-L1 expression >50% was the only factor that was significantly associated with improved PFS (HR =0.205, P=0.0004) and OS (HR =0.339, P=0.04).ConclusionsOur study demonstrated that patients whose tumors had >50% PD-L1 expression had significantly longer progression-free survival and overall survival than those with lower PD-L1 expression. This suggests that the degree of tumor PD-L1 expression may play a role in predicting benefit from durvalumab for these patients.

Dataset Information

Cost-effectiveness and Budgetary Consequence Analysis of Durvalumab Consolidation Therapy vs No Consolidation Therapy After Chemoradiotherapy in Stage III Non-Small Cell Lung Cancer in the Context of the US Health Care System.

Publications

Cost-effectiveness and Budgetary Consequence Analysis of Durvalumab Consolidation Therapy vs No Consolidation Therapy After Chemoradiotherapy in Stage III Non-Small Cell Lung Cancer in the Context of the US Health Care System.

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