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- Integrates electronic medical record data and medical receipt data from eight medical institutions, including Kobe Minimally Invasive Cancer Medical Center.
- Data on treatment outcomes, such as overall survival (OS), and other efficacy and safety data are obtained from electronic medical records, and medical expenses incurred during the treatment period are obtained from medical receipt data, to create a uniquely linked data set on a patient basis.
- Examining the cost-effectiveness of immune checkpoint inhibitors (ICIs) atezolizumab and durvalumab from the perspectives of efficacy and economics.
- Although there was no difference in efficacy between the regimens in terms of OS, atezolizumab was found to be more cost-effective in terms of medical costs.
- The results of this study were presented as a poster session at the 2024 ASCO Annual Meeting in June 2024.
A research team comprising eight facilities, centered on Healthcare Consulting Co., Ltd. (Head office: Chiyoda-ku, Tokyo; President and CEO: Kinya Okubo; hereinafter referred to as HCC), a group company of CareNet Co., Ltd. that works to solve health and medical issues through the analysis of medical big data, and Kobe Minimally Invasive Cancer Center Clinical Trials and Clinical Research Support Center (Location: Kobe City, Hyogo Prefecture; Director: Akito Hata; hereinafter referred to as KMCC), has built a dataset that uniquely links electronic medical record data and medical receipt data for small cell lung cancer patients on a patient-by-patient basis and is promoting cost-effectiveness analysis.
The results of this study, analyzing the cost-effectiveness of regimens including ICIs, were presented in a poster format at the 2024 ASCO*1 Annual Meeting to be held from May 31 to June 4, 2024.
Research Background and Significance
Japan is facing challenges of a declining birthrate and an aging society, and medical expenses are rising year by year, which is considered a major social issue. Malignant neoplasms are listed as the leading cause of death among people in their 40s to 80s1), and the efficiency between the effectiveness of treatment and the costs required to achieve that effectiveness (i.e., cost-effectiveness) is considered an important social issue vis-à-vis rising medical expenses.
The 2022 edition of the Lung Cancer Treatment Guidelines recommends the combination of platinum agents + etoposide + PD-L1 inhibitors for the treatment of extensive-stage small cell lung cancer (PS0-1※2) 2）. As of April 2023, the regimens covered by insurance for extensive-stage small cell lung cancer include atezolizumab combination therapy (CBDCA+ETP+atezolizumab) ※3, ※4 and durvalumab combination therapy (CDDP/CBDCA+ETP+durvalumab) ※5, both of which have been shown to significantly extend OS compared to conventional chemotherapy alone 3-6）.
As of the commencement of this study, there were no studies directly comparing the therapeutic effects of atezolizumab combination therapy and durvalumab combination therapy; however, considering that both therapies involve chemotherapy plus ICIs, it is assumed that the therapeutic effects of the two are roughly equivalent. Nevertheless, the prices of the two drugs are still significantly different, although the difference has become smaller compared to before due to the drug price revision in fiscal year 20247）, with atezolizumab costing 563,917 yen per 1,200 mg dose and durvalumab costing 930,462 yen per 1,500 mg dose. Even when other conditions such as administration intervals are considered, it is believed that there will be differences in economic efficiency between the two. Given this background, it is important to generate evidence regarding the cost-effectiveness of extensive-stage small cell carcinoma treatment, encompassing efficacy and economic efficiency, to consider medical expenses in Japan, which are expected to increase further in the future.
When verifying cost-effectiveness, it is necessary to consider both the treatment outcomes (e.g., efficacy and safety) and medical costs. The former can be extracted from medical records, such as electronic medical records, while the latter can be extracted from claim records, such as prescription data, which are usually managed separately from electronic medical records. Data stored in linked medical and claim records are limited, and most cost-effectiveness analyses to date have been conducted by independently determining treatment outcomes and economic efficiency using different information sources. If these separate data sources could be linked on a patient-by-patient basis to create a single source, it would be possible to perform cost-effectiveness analysis while ensuring consistency in the relationship between the use of medical resources and the resulting treatment outcomes.
Research Overview
Purpose:
This study aimed to verify the efficacy of treatment with regimens including ICIs for extensive-stage small cell lung cancer and the cost-effectiveness required to achieve that efficacy.
Method:
This retrospective study analyzes real-world data from actual clinical trials obtained from eight facilities, including Kobe Minimally Invasive Cancer Medical Center and participating institutions (Osaka International Cancer Institute, Hakodate Goryokaku Hospital, Takarazuka City Hospital, Kobe City Medical Center General Hospital, Kansai Medical University Hospital, JA Onomichi Hospital, and Fujita Health University Hospital).
The analysis included patients diagnosed with small cell lung cancer who had started PD-L1 inhibitor combination chemotherapy (CDBCA+ETP+atezolizumab or CDDP/CBDCA+ETP+durvalumab) by the end of December 2022.
Notably, OS and other measures were evaluated as indicators of efficacy. In addition, medical costs per month during the ICI treatment period were evaluated as an indicator of economic efficiency. Data on patient background and treatment outcomes, such as efficacy and safety, were obtained from the electronic medical records of each facility. Data on medical expenses were obtained from the medical receipts at each facility. A data set uniquely linked to each patient was created and used for analysis.
Patients were divided into two groups: atezolizumab combination therapy group (ATZ-G) and durvalumab combination therapy group (DUR-G). Propensity score matching was performed based on information obtained before the start of treatment, and populations with similar backgrounds were re-extracted for comparison between the two groups.
Result:
Between August 2018 and December 2022, 274 cases (ATZ-G/DUR-G = 176/98) were extracted from 8 facilities.
In total, 128 cases (ATZ-G/DUR-G = 64/64) were extracted as a patient population with similar backgrounds via propensity score matching.
The total medical costs (mean ± SD) per month during ICI treatment were 1,003,922 ± 310,192 yen for ATZ-G and 1,596,511 ± 371,405 yen for DUR-G (Wilcoxon rank-sum test: P<0.001).
The median OS for ATZ-G vs DUR-G was 13.9 months (95% confidence interval [CI]: 11.7-17.5) vs 13.6 months (95%CI: 11.0-20.0), respectively (P=0.919). The COX proportional hazards model identified poor PS (hazard ratio [HR]: 5.5, P<0.001) and bone metastases (HR: 1.8, P=0.029) as significant factors for shorter OS but did not identify differences in ICI between ATZ and DUR.
ATZ-G was associated with a lower incidence of grade ≥2 immune-related adverse events (irAEs) (10.9% vs. 31.3%, exact test: P=0.009) and interstitial lung disease (ILD) (3.1% vs. 20.3%, exact test: P=0.004) compared to DUR-G. The number of hospitalizations for ATZ-G (median = 1, range = 0-6) was lower than that for DUR-G (median = 2, range = 0-7) (Wilcoxon rank sum test: P = 0.005).
Conclusion:
This study demonstrated that ATZ was more cost-effective than DUR. The efficacies of both ICIs were generally similar; however, the safety profile, including irAEs and ILD, was better with atezolizumab.
The Next Deployment
Notably, HCC and KMCC plan to present the results of this study at the 2024 ASCO Annual Meeting and then publish them in a medical journal. In addition, while the results of this study are those of a primary analysis of the entire population, they plan to conduct and publish analyses of the elderly population and subgroup analyses focusing on specific patient backgrounds, such as the presence or absence of metastasis. Through these research activities, they will contribute to the selection of appropriate treatments for each patient with small cell lung cancer.
In this study, electronic medical record data and medical receipt data were uniquely linked for each patient to verify the cost-effectiveness of small cell lung cancer treatment from both the perspectives of efficacy and economics. It is noteworthy that HCC aims to use the method of this study as a model case to verify other types of cancer, including non-small cell lung cancer, and even diseases other than cancer, and to collaborate with various medical institutions. We will utilize our experience in analyzing a wide variety of data and generating evidence to contribute to extending healthy lifespan and realizing a sustainable society.
About Healthcare Consulting, Inc.
Main office: Sumitomo Real Estate, Chiyoda Fujimi Building, 1-8-19 Fujimi, Chiyoda-ku, Tokyo
Start of business: November 2021
CEO: Kinya Okubo
Business overview: Consulting in the healthcare field, data science for medical-related information, evidence-based marketing, ROI verification, and so on.
Official website: https://www.hc-c.co.jp/
Glossary
※1 ASCO: American Society of Clinical Oncology
※2 PS: Performance status
※3 CDDP: Cisplatin
※4 ETP: Etoposide
※5 CBDCA: Carboplatin
References
- Ministry of Health, Labor and Welfare, Annual Report on Vital Statistics, Main Statistical Tables, Table 8, Ranking of Causes of Death
- Lung Cancer Treatment Guidelines – Including Malignant Pleural Mesothelioma and Thymic Tumors – 2022 Edition (7th Edition) Edited by the Japan Lung Cancer Society. Kanehara Publishing, December 2022
- Horn L,Manfield AS, Szczęsna A, et al. First-line atezolizumab plus chemotherapy in extensive-stag e small-cell lung cancer. N Engl J Med. 2018;379(23):2220-9.
- Liu SV, Reck M, Mansfield AS, et al. Updated overall survival and PD-L1 subgroup analysis of patie nts with extensive-stage small-cell lung cancer treated with atezolizumab, carboplatin, and etoposid e (IMpower133). J Clin Oncol.2021;39(6):619-30.
- Paz-Ares L, Dvorkin M, Chen Y, et al. Durvalumab plus platinum-etoposide versus platinum-etopos ide in first-line treatment of extensive-stage small-cell lung cancer(CASPIAN): a randomised,controlle d,open-label,phase3 trial. Lancet. 2019:394(10212):1929-39.
- Goldman JW, Dvorkin M, Chen Y, et al. Durvalumab with or without tremeli- mumab plus platinum etoposide versus platinum-etoposide alone in first-line treatment of extensive-stage small-cell lung cancer (CASPIAN): updated results from a randomized, controlled open-labeled phase 3 trial. Lancet Oncol.2021;22(1):51-65
- Ministry of Health, Labor and Welfare website: List of products included in the drug price standard and information on generic drugs (effective May 22, 2024) (https://www.mhlw.go.jp/topics/2024/04/tp20240401-01.html)
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