Financial Toxicity in Japanese Patients with Metastatic Renal Cell Carcinoma: A Cross-Sectional Study.

Information on the financial toxicity experienced by Japanese patients with metastatic renal cell carcinoma (mRCC) is lacking, even though Japan has its own unique public health insurance system. Thus, a web-based survey was conducted to evaluate the financial toxicity experienced by Japanese mRCC patients using the COmprehensive Score for financial Toxicity (COST) tool. This study enrolled Japanese patients who underwent, or were undergoing, systemic therapy for mRCC. The outcomes evaluated were the distribution of COST scores, the correlation between COST and quality of life (QOL) assessed by the Functional Assessment of Cancer Therapy-General (FACT-G) scale, and demographic factors associated with financial toxicity. The median (range) COST score was 19.0 (3.0-36.0). The Pearson correlation coefficient for COST and FACT-G total scores was 0.40. Univariate analysis revealed that not having private health insurance and lower household income per year were significantly associated with lower COST scores. Multivariate analyses showed that age < 65 years and not having private health insurance were significantly associated with lower COST scores. This study revealed that Japanese mRCC patients experience adverse financial impacts even under the universal health insurance coverage system available in Japan, and financial toxicity negatively affects their QOL.

Health technology assessment for cancer medicines across the G7 countries and Oceania: an international, cross-sectional study.

BACKGROUND: Criticisms have emerged that cancer medicines offer modest benefits at increasingly high prices. Reimbursement decisions made by health technology assessment (HTA) agencies have become a complex endeavour for cancer medicines. Most high-income countries (HICs) use HTA criteria to identify high-value medicines for reimbursement under public drug coverage plans. We compared HTA criteria specific for cancer medicines in economically similar HICs, to understand how these criteria contribute to reimbursement decisions. METHODS: We did an international, cross-sectional analysis in collaboration with author investigators across eight HICs, from the Group of Seven (known as G7; Canada, England, France, Germany, Italy, and Japan) and Oceania (Australia and New Zealand). Publicly available data from HTA agency reports and official documentation were extracted and analysed between Aug 15, 2021, and July 31, 2022. We collected data pertaining to the decision-making criteria used by the national HTA agency; HTA reimbursement status for 34 medicine-indication pairs corresponding to 15 unique US top-selling cancer medicines; and HTA reimbursement status for 18 cancer medicine-indication pairs (13 unique medicines) with minimal clinical benefit (score of 1 on the European Society of Medical Oncology Magnitude of Clinical Benefit Scale). Descriptive statistics were used to compare HTA decision criteria and drug reimbursement recommendations (or for Germany and Japan, final reimbursement status) across the eight countries. FINDINGS: Therapeutic impact related to clinical outcomes of the new medicine was a uniform criterion across the eight countries, whereas quality of evidence (under the remit of therapeutic impact assessment) and equity were infrequently cited criteria. Only the German HTA agency mandated that surrogate endpoints be validated in therapeutic impact assessment. All countries except Germany included formal cost-effectiveness analyses within HTA reports. England and Japan were the only countries that specified a cost-effectiveness threshold. Of the 34 medicine-indication pairs corresponding to US top-selling cancer medicines, Germany reimbursed the maximum (34 [100%]), followed by Italy (32 [94%] recommended for reimbursement), Japan (28 [82%] reimbursed), Australia, Canada, England, and France (27 [79%] recommended for reimbursement), and New Zealand (12 [35%] recommended for reimbursement). Of the 18 cancer medicine-indication pairs with marginal clinical benefit, Germany reimbursed 15 (83%) and Japan reimbursed 12 (67%). France recommended nine (50%) for reimbursement, followed by Italy (seven [39%]), Canada (five [28%]), and Australia and England (three [17%] each). New Zealand did not recommend any medicine-indications with marginal clinical benefit for reimbursement. Considering the overall cumulative proportion across the eight countries, 58 (21%) of 272 indications for the US top-selling medicines and 90 (63%) of 144 marginally beneficial medicine-indications were not recommended for reimbursement or reimbursed. INTERPRETATION: Our findings indicate discordance in public reimbursement decisions across economically similar countries, despite overlapping HTA decision criteria. This suggests a need for improved transparency around the nuances of the criteria to ensure improved access to high-value cancer medicines, and deprioritisation of low-value cancer medicines. Health systems have opportunities to improve their HTA decision-making processes by learning from the systems in other countries. FUNDING: None.

Association between financial toxicity and health-related quality of life of patients with gynecologic cancer.

OBJECTIVES: Patients often struggle with their financial situation during cancer treatment due to treatment-related costs or loss of income. This resulting negative effect is called financial toxicity, which is a known as a side effect of cancer care. This study aimed to evaluate the association between financial toxicity and health-related quality of life among patients with gynecologic cancer using validated questionnaires. METHODS: In this multicenter study, patients with gynecologic cancer receiving anti-cancer drug treatment for > 2 months were recruited. Patients answered the COmprehensive Score for Financial Toxicity (COST) tool, EORTC-QLQ-C30, disease-specific tools (EORTC-QLQ-OV28/CX24/EN24), and EQ-5D-5L. Spearman's rank correlation coefficient was used to determine associations. RESULTS: Between April 2019 and July 2021, 109 cancer patients completed the COST questionnaire. The mean COST score was 19.82. Strong associations were observed between financial difficulty (r = - 0.616) in the EORTC-QLQ-C30 and body image (r = 0.738) in the EORTC-QLQ-CX24, while weak associations were noted between the global health status/quality of life (r = 0.207), EQ-5D-5L index score (r = 0.252), and several function and symptom scale scores with the COST score. CONCLUSIONS: Greater financial toxicity was associated with worse health-related quality of life scores, such as financial difficulty in gynecologic cancer patients and body image in cervical cancer patients as strong associations, and weakly associated with general health-related quality of life scores and several function/symptom scales.

Use of Anticancer Therapies and Economic Burden Near the End of Life in Japan: Results From Claims Database.

PURPOSE: In patients with cancer, aggressive treatment near the end of life (EOL) may decrease quality of life and increase medical costs. In this study, we examined the use of anticancer therapies near the EOL in Japan. METHODS: We used a commercial database of health insurance claims in Japan, to examine patient data on cancer and death until August 2020. We assessed the proportion of patients using anticancer therapies within 14 days of death, associated factors, and medical costs from the payer's perspective. RESULTS: The database documented 5,759 patients with cancer who died between December 2013 and August 2020. Among them, 4.8% of patients and 3.9% of age-adjusted patients received anticancer therapy within 14 days of death. Patients age < 60 years were associated with a high probability of receiving anticancer therapy near the EOL. The estimated annual anticancer therapy and related costs were Japanese yen 1,296 million (US dollars 12.6 million). CONCLUSION: We found the percentage of patients receiving anticancer therapies within 14 days of death in Japan, its associated factors, and economic burden. Our findings can serve as a benchmark for optimizing EOL care.

Validity of the COmprehensive Score for financial Toxicity (COST) in patients with gynecologic cancer.

OBJECTIVE: Financial toxicity is a financial burden of cancer care itself, which leads to worse quality of life and higher mortality and is considered an adverse effect. The COmprehensive Score for financial Toxicity (COST) tool is a patient-reported outcome measurement used to evaluate financial toxicity. We aimed to validate the internal consistency and reproducibility of the COST tool in patients with gynecologic cancer. METHODS: In this multicenter study covering the period April 2019 to July 2021, using the COST tool in Japan, patients diagnosed with ovarian, cervical, or endometrial cancer receiving systemic anti-cancer drug therapy for more than 2 months were eligible. Patients with no out-of-pocket costs for direct medical costs were excluded. The patients answered the initial test and a retest, which was completed from 2 to 14 days after the initial test. Internal consistency and reproducibility were assessed using Cronbach's alpha and intraclass correlation coefficient (ICC), respectively. Cronbach's alpha ≥0.8 indicates good internal consistency, and ICC ≥0.8 is highly reliable. RESULTS: A total of 112 patients (ovarian: 50, cervical: 26, endometrial: 36) responded to the initial test, and 89 patients answered the retest from 2 to 14 days after the initial test. The median patient age was 58 (range, 28-78) years. The median COST score was 19. Cronbach's alpha showed good internal consistency at 0.83 (95% CI 0.78 to 0.87). The ICC at 0.850 (95% CI 0.777 to 0.900) showed high reliability. CONCLUSIONS: The COST tool has good internal consistency and reliable reproducibility in patients with gynecologic cancer in Japan. The COST tool quantifies financial toxicity in the insurance system, where patients have limited out-of-pocket direct medical costs. The results support the use of the COST tool in patients with gynecologic cancer.

Prospective Survey of Financial Toxicity Measured by the Comprehensive Score for Financial Toxicity in Japanese Patients With Cancer.

PURPOSE: We previously reported on the pilot study assessing the feasibility of using the Japanese translation of the Comprehensive Score for Financial Toxicity (COST) tool to measure financial toxicity (FT) among Japanese patients with cancer. In this study, we report the results of the prospective survey assessing FT in Japanese patients with cancer using the same tool. PATIENTS AND METHODS: Eligible patients were receiving chemotherapy for a solid tumor for at least 2 months. In addition to the COST survey, socioeconomic characteristics were collected by using a questionnaire and medical records. RESULTS: Of the 191 patients approached, 156 (82%) responded to the questionnaire. Primary tumor sites were colorectal (n = 77; 49%), gastric (n = 39; 25%), esophageal (n = 16; 10%), thyroid (n = 9; 6%), head and neck (n = 4; 3%), and other (n = 11; 7%). Median COST score was 21 (range, 0 to 41; mean ± standard deviation, 12.1 ± 8.45), with lower COST scores indicating more severe FT. On multivariable analyses using linear regression, older age (ß, 0.15 per year; 95% CI, 0.02 to 0.28; P = .02) and higher household savings (ß, 8.24 per ¥15 million; 95% CI, 4.06 to 12.42; P < .001) were positively associated with COST score; nonregular employment (ß, -5.37; 95% CI, -10.16 to -0.57; P = .03), retirement because of cancer (ß, -5.42; 95% CI, -8.62 to -1.37; P = .009), and use of strategies to cope with the cost of cancer care (ß, -5.09; 95% CI, -7.87 to -2.30; P < .001) were negatively associated with COST score. CONCLUSION: Using the Japanese version of the COST tool, we identified various factors associated with FT in Japanese patients with cancer. These findings will have important implications for cancer policy planning in Japan.

A prospective survey of comprehensive score for financial toxicity in Japanese cancer patients: report on a pilot study.

BACKGROUND: Financial toxicity (FT) has a negative impact on the quality of life and survival of patients with cancer. The comprehensive score for FT (COST) questionnaire is a tool to measure FT which has already been validated in patients with cancer in the United States. However, the feasibility and validity of assessing FT using the COST questionnaire have not been established in non-US healthcare settings, including that in Japan. METHODS: This is a prospective pilot survey to ascertain the feasibility of using the COST questionnaire to evaluate FT in Japanese patients with advanced solid cancer who had been receiving chemotherapy for at least 2 months. The COST questionnaire was translated into Japanese using Functional Assessment of Chronic Illness Therapy methodology. RESULTS: Of the 12 patients approached, 11 (92%) responded to the questionnaire. The median COST score was 22 (range, 6-29; mean ± SD, 20.18 ± 8.17). Five (45%) and two (18%) patients suffered grade 1 (COST score 14-25) and grade 2 (COST score 1-13) FT, respectively. The COST measure demonstrated good internal consistency with a Cronbach α of 0.87. CONCLUSIONS: The COST measure demonstrated good feasibility in measuring FT in the Japanese healthcare setting. Despite the existing universal health insurance system and ceiling amount for high-cost medical expenses, some Japanese patients experienced meaningful FT during chemotherapy. A prospective study is already underway to confirm the preliminary results (UMIN: 000025043).

[Measuring Financial Toxicity in Japanese Cancer Patients].

Financial toxicity (FT) has a negative impact on quality of life (QOL) and survival of patients with cancer. However, FT has not been well defined and unlike the Common Terminology Criteria for Adverse Events (CTCAE) for physical toxicities, valid methods to quantify FT have not been well established. Hence, further studies into the methods to properly measure and quantify the risks of FT are important. The COmprehensive Score for financial Toxicity (COST) score has been validated as a useful tool for measuring FT among patients with cancer in the US. However, the health insurance system in the US is unique and thus, COST score's feasibility and validity in other countries with public universal health care in place is unknown. Thus, we aimed to evaluate the feasibility of COST questionnaire as a tool to evaluate FT among patients with cancer in a different health care system of Japan where universal public health insurance system exists. We performed a prospective survey to ascertain the feasibility of using COST questionnaire (Japanese version) to evaluate FT in Japanese patients with advanced solid cancer who were receiving chemotherapy. The survey showed some Japanese patients experienced meaningful FT during chemotherapy.

Assessment of left ventricular diastolic function during trastuzumab treatment in patients with HER2-positive breast cancer.

BACKGROUND: The ratio of mitral peak velocity of early filling (E) to early diastolic mitral annular velocity (e', E/e' ratio) as estimated by tissue Doppler imaging is a noninvasive surrogate for the left ventricular diastolic function. Because diastolic dysfunction usually precedes systolic dysfunction in cardiovascular diseases, we investigated whether monitoring the E/e' ratio can help to predict the risk of trastuzumab-induced cardiotoxicity. METHODS: E/e' ratio on tissue Doppler imaging was retrospectively reviewed to assess its value for early detection of the left ventricular ejection fraction (LVEF) decline in women with human epidermal growth factor receptor 2 (HER2)-positive breast cancer who received trastuzumab with or without cytotoxic chemotherapy. Echocardiography was performed at baseline and every 3 months after treatment began. RESULTS: Among 129 patients, LVEF declined in 25 (19 %) during trastuzumab treatment; the decline was grade 2 in 23 patients and grade 3 in 2. Elevation of the E/e' ratio to more than 15 was detected in 17 patients (13 %), 7 of whom (5.4 % of total) concurrently had LVEF decline. A weak negative correlation was observed between E/e' elevation and the worst LVEF decline (P = 0.0077), which was confirmed by multiple regression analysis (P = 0.023). E/e' ratio at baseline or 3 months after beginning trastuzumab treatment was not significantly associated with the subsequent LVEF decline. CONCLUSION: Monitoring of the left ventricular diastolic function on the basis of the E/e' ratio at baseline or 3 months after is unlikely to predict LVEF decline in patients who receive trastuzumab. However, there is a potential chronological relation between E/e' elevation and LVEF decline, implying that the degree of E/e' elevation could have a role as a surrogate marker for predicting the LVEF decline characteristic of trastuzumab-induced cardiotoxicity.

Should low-income countries invest in breast cancer screening?

With the increase in incidence and mortality of breast cancer in low-income countries (LICs), the question of whether LICs should promote breast cancer screening for early detection has gained tremendous importance. Because LICs have limited financial resources, the value of screening must be carefully considered before integrating screening programs into national healthcare system. Mammography-the most commonly used screening tool in developed countries-reduces breast cancer-specific mortality among women of age group 50-69, but the evidence is not so clear for younger women. Further, it does not reduce the overall mortality. Because the women in LICs tend to get breast cancer at younger age and are faced with various competing causes of mortality, LICs need to seriously evaluate whether mammographic screening presents a good value for the investment. Instead, we suggest a special module of clinical breast examination that could provide similar benefits at a very low cost. Nevertheless, we believe that LICs would obtain a much greater value for their investment if they promote primary prevention by tobacco cessation, healthier food and healthier lifestyle campaigns instead.