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・Integration of data from Electronic Medical Record and Receipts from Eight Medical Institutions, Led by 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 costs incurred during the treatment period are obtained from medical receipt data, to create a uniquely linked data set on a patient basis.
・Cost-effectiveness of immune checkpoint inhibitors, atezolizumab and durvalumab, for the elderly population, aged 71 years and above, in terms of efficacy and economics
・No difference was observed in overall survival (OS) between the regimens; however, atezolizumab was more economical.
・The results of this study were presented as a poster session at the ESMO Congress 2024 in September 2024.
A research team of eight medical institutions, including Healthcare Consulting, Inc. (HCC, Chiyoda, Tokyo, Japan; CEO: Kinya Kokubo), a group company of CareNet, Inc. that works to resolve issues related to health and medical care by analyzing medical big data, and the Kobe Minimally Invasive Cancer Center Clinical Trials and Clinical Research Support Center (KMCC, Kobe, Hyogo, Japan; Director: Akito Hata), are promoting cost-effectiveness analysis by constructing a dataset that uniquely links electronic medical record and receipt data of patients with small cell lung cancer on a patient basis.
The results of the study, which analyzed the cost-effectiveness of regimens, including immune checkpoint inhibitors (ICIs), in the elderly population aged 71 years or older, were presented in a poster at the ESMO*1 Congress 2024, to be held from September 13 to September 17, 2024 (Barcelona, Spain and online).
Cost-effectiveness study of atezolizumab (ATZ) vs. durvalumab (DUR) in elderly patients (pts) with extensive disease small-cell lung cancer (ED-SCLC)): real-world data (RWD) on first-line chemotherapy, combined with immune-checkpoint inhibitors (Chemo-ICIs)
Ken Yamamoto; Katsuya Hirano; Akito Hata; Yuta Yamanaka; Toshiyuki Sumi; Motohiro Tamiya; Yuki Sato; Yuko Oya; Kosuke Hamai; Nobuyuki Katakami; Katsuhiko Iwasaki; Tatsuhiro Uenishi; Kinya Kokubo; Ataru Igarashi
Background
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 costs.
The 2022 edition of the Lung Cancer Clinical Practice Guidelines recommends the combination treatment of platinum agents + etoposide + PD-L1 inhibitors for advanced small cell lung cancer (PS0-1*2).2) As of April 2023, the regimens listed by insurance for advanced small cell lung cancer are, Atezolizumab combination therapy (CBDCA + ETP + atezolizumab)*3, *4 and durvalumab combination therapy (CDDP/CBDCA + ETP + durvalumab)*5. They have all demonstrated significant overall survival (OS) gains compared to conventional chemotherapy alone3), 4), 5), 6). At the time this study commenced, no trials were being conducted to directly compare the therapeutic efficacy of the atezolizumab and durvalumab combination therapies. However, given that both are chemotherapy plus ICI, it can be inferred that the therapeutic efficacy of the two is generally equivalent. The NHI price for atezolizumab is 563,917 yen per 1200 mg dose, and that for durvalumab is 827,079 yen per 1500 mg dose as of September 2024, although the difference between the two drugs has decreased with the 2024 NHI price revision7). Considering other conditions, such as dosing intervals, it can be inferred that there is a difference in economic efficiency between the two drugs. Against this background, it is important to generate evidence of cost-effectiveness, including efficacy and economy, for the treatment of advanced small alveolar carcinoma, considering the expected further escalation of medical costs in Japan.
When examining cost-effectiveness, it is necessary to consider treatment outcomes, such as efficacy, safety, as well as medical costs. The former can be extracted from medical records, such as electronic medical records, whereas the latter can be extracted from billing records, such as receipt data; both records are usually managed separately. The data stored in medical and billing records are limited, and most cost-effectiveness analyses to date have been conducted by independently determining outcomes and economics from different sources. If this information, obtained from different data sources, can be linked on a patient-by-patient basis and segregated, it will be possible to analyze cost-effectiveness, while ensuring consistency in the relationship between the use of medical resources and resulting treatment outcomes.
Overview:
PURPOSE:
An aging society is a global challenge, and cost-effectiveness, including the balance of toxicities, is important for cancer treatment in the elderly. Combination regimens of chemotherapy and immune checkpoint inhibitors (atezolizumab and durvalumab) are the standard of care for the first-line treatment of advanced small cell lung cancer (ED-SCLC). This study aimed to compare the costs, efficacies, and toxicities of these treatments in elderly patients with ED-SCLC.
Prior to this study, the investigators published an analysis of the overall population (including non-elderly patients) that showed no difference in overall survival (OS) between the regimens; however, atezolizumab was more economical in terms of healthcare costs. This was a subgroup analysis focusing on the elderly population.
METHODS:
This study was a retrospective analysis of real-world data from eight medical institutions: the Kobe Minimally Invasive Cancer Center and other participating institutions (Osaka International Cancer Center, Hakodate Goryokaku Hospital, Takarazuka City Hospital, Kobe City Medical Center Central Municipal Hospital, Kansai Medical University Hospital, JA Onomichi Hospital, and Fujita Medical University Hospital).
Among the patients diagnosed with small cell lung cancer, those aged 71 years or older, who had commenced PD-L1 inhibitor combination chemotherapy (CDBCA + ETP + atezolizumab or CDDP/CBDCA + ETP + durvalumab) by the end of December 2022, were included in the analysis.
Efficacy measures included overall survival (OS) and progression-free survival (PFS). Additionally, as a measure of economic efficiency, we evaluated the monthly medical costs during the ICI treatment period.
Data on the patient background and treatment outcomes, such as efficacy and safety, were obtained from the electronic medical records of each medical institution while information on medical costs were obtained from the receipt data. These datasets were uniquely linked on a per-patient basis and used in the analysis.
Patients were divided into two groups: atezolizumab combination therapy group (ATZ-G) and durvalumab combination therapy group (DUR-G), and propensity score matching was performed based on pretreatment information.
RESULTS:
From August 2018 to December 2022, 274 cases (ATZ-G/DUR-G = 176 / 98) were identified from eight medical institutions. Of these, 158 patients aged over 71 years were selected. About 76 patients (ATZ-G/DUR-G = 38 / 38) with comparable backgrounds were selected by propensity score matching.
Total monthly medical costs (mean ± standard deviation) during ICI treatment amounted to 1,012,397 ± 322,163 yen for ATZ-G and 1,536,132 ± 283,228 yen for DUR-G (Wilcoxon rank sum test: P<0.001).
Median OS for ATZ-G vs. DUR-G was 11.9 months (95% confidence interval [CI]: 7.0-18.5) vs. 13.6 months (95% CI: 11.1-17.7), respectively, with no significant difference (P=0.937). ATZ vs. DUR for OS (hazard ratio, 1.02; p=0.953).
The median PFS for ATZ-G vs. DUR-G was significantly different at 3.9 months (95% CI: 3.4-5.1) vs. 5.3 months (95% CI: 4.8-6.4), respectively (p=0.025).
ATZ had a lower incidence of grade 2 or higher immune-related adverse events (irAE) than DUR (2.6% vs. 21.1%, p=0.028), and a trend toward a lower incidence of interstitial lung disease (ILD) than DUR (5.3% vs. 21.1%, p=0.086).
CONCLUSIONS:
Real-world data from elderly patients with ED-SCLC showed similar OS for ATZ and DUR, with higher medical costs for DUR, suggesting superior cost-effectiveness of ATZ. DUR resulted in a longer PFS than ATZ, whereas the irAE and ILD rates were lower with ATZ.
Future Developments
The HCC and KMCC plan to present the results of this study at the ESMO Congress in 2024 and publish them in a paper. Additionally, the results of this study are based on a subpopulation analysis focusing on patients aged 71 years or older. In the future, we plan to conduct and publish subpopulation analyses focusing on specific patient backgrounds, such as the presence or absence of metastases. Through these research activities, we will contribute to the selection of appropriate treatments for patients with small cell lung cancer.
HCC plans to use this study as a model case to examine the cost-effectiveness of treatment for not only other types of cancer, including non-small cell lung cancer, but also for other diseases, and collaborate with a variety of medical institutions. We will contribute to the extension of healthy life expectancy and the realization of a sustainable society by utilizing our experiences, analyzing a wide variety of data, and generating evidence.
About Healthcare Consulting, Inc.
Sumitomo Fudosan Chiyoda Fujimi Building, 8-19, Fujimi 1-chome, Chiyoda-ku, Tokyo
Start of operations: November 2021
Representative Director: Kinya Kokubo
Business Overview: Healthcare consulting, data science of healthcare-related information, evidence-based marketing, ROI verification, etc.
Official Website: https://www.hc-c.co.jp/
*1 ESMO: European Society for Medical Oncology
*2 PS: Performance status.
*3 CDDP: Cisplatin
*4 ETP: Etoposide
*5 CBDCA: Carboplatin
References
1) Annual Report of Vital Statistics, Ministry of Health, Labour and Welfare, Table 8, Rankings of causes of death
2) Guidelines for Lung Cancer Treatment – Including Malignant Pleural Mesothelioma and Thymic Tumors – 2022 Edition (7th ed.) Japan Lung Cancer Society ed. Kanehara Shuppan, December 2022
3) Horn L,Manfield AS, Szczęsna A, et al. First-line atezolizumab plus chemotherapy in extensive-stage small-cell lung cancer. N Engl J Med. 2018;379( 23):2220-9.
4) Liu SV, Reck M, Mansfield AS, et al. Updated overall survival and PD-L1 subgroup analysis of patients with extensive-stage small-cell lung cancer J Clin Oncol. 2021;2021;2021-3) Liu SV, Reck M, Mansfield AS, et al. Updated overall survival and PD-L1 subgroup analysis of patients with extensive-stage small-cell lung cancer. J Clin Oncol. 2021;39(6):619-30.
5) Paz-Ares L, Dvorkin M, Chen Y, et al. Durvalumab plus platinum-etoposide versus platinum-etoposide in first-line treatment of extensive-stage small-cell lung cancer (CASPIAN): a randomised, controlled, open-label, phase 3 trial. lancet. 2019:394(10212):1929-39.
6) Goldman JW, Dvorkin M, Chen Y, et al. Durvalumab with or without tremeli- mumab plus platinum-etoposide versus platinum-etoposide alone in first Lancet Oncol. 2021;22(22):229-233. Oncol. 2021;22(1):51-65
7) Ministry of Health, Labour and Welfare website, NHI Drug Price Standard List and Information on Generic Drugs (effective May 22, 2024) (https://www.mhlw.go.jp/topics/2024/04/tp20240401-01.html)
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