Lead Investigator: Yi-Wen Tsai, National Yang Ming Chiao Tung University
Title of Proposal Research: Cost effectiveness analysis of atezolizumab plus chemotherapy for untreated extensive stage small cell lung cancer in Asia
Vivli Data Request: 7830
Funding Source: None
Potential Conflicts of Interest: This is an independent study without any grants. Lead researcher is a university professor, who has no conflict of interest to claim.
Summary of the Proposed Research:
Extensive stage small cell lung cancer (ES-SCLC) is an aggressive form of lung cancer that grows rapidly and spreads extensively, which means the cancer has spread widely throughout the lung, to the other lung or to other organs. Although the standard chemotherapy (CTX) shows 60%–80% overall response rate for ES-SCLC, the majority of patients relapse within 6 months and the 5-year survival rate is only about 2%.
Currently, atezolizumab has been investigated for treatment naive ES-SCLC with significant survival benefit. However, combination regimen with atezolizumab plus standard CTX was found not cost-effective compared with CTX alone in research of the US setting. Adding atezolizumab to CTX results in additional 0.10 quality adjusted life years [The quality-adjusted life year (QALY) is a standard to measure the disease burden. QUALY also can be applied to present how well a medical intervention lengthen or improve patients’ lives] and corresponding incremental costs $52,881, leading to an incremental cost effective ratio (ICER) of $528,810 per QALY. ICER provides a ratio of extra cost per unit of health effect. ICER is calculated by dividing the difference in cost between two interventions by the difference in their treatment effect.
In terms of Asian population, genetic and physical differences can alter the efficacy and incidence of treatment-related adverse events. Therefore, subgroup effect on cost and effectiveness between Asian and non Asian is important to emphasize. Hence, our study intends to evaluate the cost effectiveness of atezolizumab plus CTX for newly diagnosed ES-SCLC compared to the current standard CTX with etoposide and platinum (EP) and explore the subgroup effect under Asian settings. We will derive the efficacy, safety and utility data from the IMpower133 trial and consider the costs of atezolizumab, CTX, symptom relief therapy, palliative care and management for grade≥3 adverse events from the local charges. Grade ≥3 AEs include severe or life-threatening AEs and death related to AEs. In our study, we will present the medical utilization and cost for treating the Grade ≥3 AEs from the local charges by Taiwan dollar.
We will analyze the model by TreeAge Pro 2017 (TreeAge Software, Williamstown, MA) to estimate the economic outcomes, such as lifetime costs life years and QALYs. QALY gained and estimate of overall costs will be used to evaluate the ICER. Adding atezolizumab to CTX will be regarded as cost-effective as the ICER is less than three times of the national annual gross domestic product (GDP) per capita. Furthermore, we will perform one-way and probabilistic sensitivity analyses to observe the uncertainty. Results of our study will be applied to identify patients who benefit from this intervention the most and provide evidence for decision making in insurance coverage.
Requested Studies:
A Phase I/III, Randomized, Double-Blind, Placebo-Controlled Study of Carboplatin Plus Etoposide With or Without Atezolizumab (Anti-PD-L1 Antibody) in Patients With Untreated Extensive-Stage Small Cell Lung Cancer
Data Contributor: Roche
Study ID: NCT02763579
Sponsor ID: GO30081