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Background: Inaccurate estimates of diabetes-related healthcare costs can undermine the efficiency of resource allocation for diabetes care. The quantification of these costs using claims data may be affected by the method for defining diagnoses., Objectives: The aims were to use panel data analysis to estimate diabetes-related healthcare costs and to comparatively evaluate the effects of diagnostic definitions on cost estimates., Research Design: Monthly panel data analysis of Japanese claims data., Subjects: The study included a maximum of 141,673 patients with type 2 diabetes who received treatment between 2005 and 2013., Measures: Additional healthcare costs associated with diabetes and diabetes-related complications were estimated for various diagnostic definition methods using fixed-effects panel data regression models., Results: The average follow-up period per patient ranged from 49.4 to 52.3 months. The number of patients identified as having type 2 diabetes varied widely among the diagnostic definition methods, ranging from 14,743 patients to 141,673 patients. The fixed-effects models showed that the additional costs per patient per month associated with diabetes ranged from US$180 [95 % confidence interval (CI) 178-181] to US$223 (95 % CI 221-224). When the diagnostic definition excluded rule-out diagnoses, the diabetes-related complications associated with higher additional healthcare costs were ischemic heart disease with surgery (US$13,595; 95 % CI 13,568-13,622), neuropathy/extremity disease with surgery (US$4594; 95 % CI 3979-5208), and diabetic nephropathy with dialysis (US$3689; 95 % CI 3667-3711)., Conclusions: Diabetes-related healthcare costs are sensitive to diagnostic definition methods. Determining appropriate diagnostic definitions can further advance healthcare cost research for diabetes and its applications in healthcare policies.

Background: The valuation study of the five-level version of the EuroQol five-dimensional questionnaire (EQ-5D-5L) involved composite time trade-off (cTTO) and a discrete choice experiment (DCE). The DCE scores must be anchored to the quality-of-life scale from 0 (death) to 1 (full health). Nevertheless, the characteristics of the statistical methods used for converting the EQ-5D-5L DCE results by using TTO information are not yet clearly known., Objectives: To present the Japanese DCE value set of the EQ-5D-5L and compare three methods for converting latent DCE values., Methods: The survey sampled the general population at five locations in Japan. 1098 respondents were stratified by age and sex. To obtain and compare the value sets of the EQ-5D-5L, the cTTO and DCE data were analyzed by a linear mixed model and conditional logit, respectively. The DCE scores were converted to the quality-of-life scale by anchoring to the worst state using cTTO, mapping DCE onto cTTO, and a hybrid model., Results: The data from 1026 respondents were analyzed. All the coefficients in the cTTO and DCE value sets were consistent throughout all the analyses. Compared with the cTTO algorithm, the mapping and hybrid methods yielded very similar scoring coefficients. The hybrid model results, however, produced a lower root mean square error and fewer health states with errors exceeding 0.05 than did the other models. The DCE anchored to the worst state overestimated the cTTO scores of almost all the health states., Conclusions: Japanese value sets based on DCE were demonstrated. On comparing the observed cTTO scores, we found that the hybrid model was slightly superior to the simpler methods, including the TTO model., (Copyright © 2016 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.)

Background and Objectives: Although quality-adjusted life-years (QALYs) may not completely reflect the value of a healthcare technology, it remains unclear how to adjust the cost per QALY threshold. First, the present study compares two survey methods of measuring people's preferences for a specific healthcare technology when each choice has the same efficiency. The second objective was to consider how this information regarding preferences could be used in decision making., Methods: We conducted single-attribute (budget allocation) and multi-attribute (discrete-choice) experiments to survey public medical care preferences. Approximately 1000 respondents were sampled for each experiment. Six questions were prepared to address the attributes included in the study: (a) age; (b) objective of care; (c) disease severity; (d) prior medical care; (e) cause of disease; and (f) disease frequency. For the discrete-choice experiment (a) age, (b) objective of care, (c) disease severity, and (d) prior medical care were orthogonally combined. All assumed medical care had the same costs and incremental cost-effectiveness ratio (ICER; cost per life-year or QALY). We also calculated the preference-adjusted threshold (PAT) to reflect people's preferences in a threshold range., Results: The results of both experiments revealed similar preferences: intervention for younger patients was strongly preferred, followed by interventions for treatment and severe disease states being preferred, despite the same cost per life-year or QALY. The single-attribute experiment revealed that many people prefer an option in which resources are equally allocated between two interventions. Marginal PATs were calculated for age, objective of care, disease severity, and prior medical care., Conclusion: The single- and multi-attribute experiments revealed similar preferences. PAT can reflect people's preferences within the decision-maker's threshold range in a numerical manner.

Purpose: The purpose of this study was to measure the population norms for the Japanese versions of preference-based measures (EQ-5D-3L, EQ-5D-5L, and SF-6D). We also considered the relations between QOL score in the general population and socio-demographic factors., Methods: A total of 1143 adult respondents (aged ≥ 20 years) were randomly sampled from across Japan using data from the Basic Resident Register. The health status of each respondent was measured using the EQ-5D-3L, EQ-5D-5L, and SF-6D, and responses regarding socio-demographic data as well as subjective diseases and symptoms were obtained. The responses were converted to a QOL score using Japanese value sets., Results: The percentages of respondents with full health scores were 68 % (EQ-5D-3L), 55 % (EQ-5D-5L), and 4 % (SF-6D). The QOL score measured using the SF-6D was significantly lower than those measured using either EQ-5D score. The QOL score was significantly lower among respondents over the age of 60 years, those who had a lower income, and those who had a shorter period of education. Intraclass correlation coefficient showed a poor agreement between the EQ-5D and SF-6D scores. The differences in QOL scores between respondents with and those without any disease were 0.064 for the EQ-5D-3L, 0.061 for the EQ-5D-5L, and 0.073 for the SF-6D; these differences are regarded as between-group minimal important differences in the general population., Conclusion: The Japanese population norms of three preference-based QOL measures were examined for the first time. Such information is useful for economic evaluations and research examining QOL score.

Objectives: The combination use of gefitinib and epidermal growth factor receptor (EGFR) testing is a standard first-line therapy for patients with non-small cell lung cancer (NSCLC). Here, we examined the cost-effectiveness of this approach in Japan., Materials and Methods: Our analysis compared the 'EGFR testing strategy', in which EGFR mutation testing was performed before treatment and patients with EGFR mutations received gefitinib while those without mutations received standard chemotherapy, to the 'no-testing strategy,' in which genetic testing was not conducted and all patients were treated with standard chemotherapy. A three-state Markov model was constructed to predict expected costs and outcomes for each strategy. We included only direct medical costs from the healthcare payer's perspective. Outcomes in the model were based on those reported in the Iressa Pan-Asia Study (IPASS). The incremental cost-effectiveness ratio (ICER) was calculated using quality-adjusted life-years (QALYs) gained. Sensitivity and scenario analyses were conducted., Results: The incremental cost and effectiveness per patient of the 'EGFR testing strategy' compared to the 'no-testing strategy' was estimated to be approximately JP¥122,000 (US$1180; US$1=JP¥104 as of February 2014) and 0.036 QALYs. The ICER was then calculated to be around JP¥3.38 million (US$32,500) per QALY gained. These results suggest that the 'EGFR testing strategy' is cost-effective compared with the 'no-testing strategy' when JP¥5.0 million to 6.0 million per QALY gained is considered an acceptable threshold. These results were supported by the sensitivity and scenario analyses., Conclusion: The combination use of gefitinib and EGFR testing can be considered a cost-effective first-line therapy compared to chemotherapy such as carboplatin-paclitaxel for the treatment for NSCLC in Japan., (Copyright © 2015 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.)

Background: Sensory loss or paresthesia due to division of the intercostobrachial nerve (ICBN) is a complication of axillary lymph node dissection (ALND). Preservation of the ICBN may be of value, but few prospective studies have shown an impact of preservation on sensory changes or health-related quality of life (HRQOL) after breast cancer surgery., Methods: This prospective study was performed to evaluate the association between ICBN preservation and sensory change and HRQOL at 1 (baseline), 6, 12, and 24 months after breast cancer surgery in 140 patients. The sensory examination included dysesthesia, paresthesia, and abnormal touch and pain sensation in the upper arm., Results: Division of the ICBN did not influence the frequency or severity of subjective dysesthesia and paresthesia. There was no marked difference in touch or pain sensation at baseline between patients with a preserved (group P) and divided (group D) ICBN. In group P, the percentage of patients aware of a sensory deficit or loss decreased with time, and that of patients aware of a hypersensitive sensation increased. These changes did not occur in group D, leading to a significant difference between the groups at 24 months. The main difference between the groups was the area with reduced touch or pain sensation. This area decreased with time in group P, but not in group D. ICBN preservation or division did not influence HRQOL., Conclusion: ICBN preservation in ALND has a benefit of a reduced area with long-term axillary hypoesthesia, but has no influence on improvement of pain and HRQOL.

Background: In economic evaluation, cost per quality-adjusted life year (QALY) is generally used as an indicator for cost-effectiveness. Although JPY 5 million to 6 million (USD 60, 000 to 75,000) per QALY is frequently referred to as a threshold in Japan, do all QALYs have the same monetary value?, Methods: To examine the relationship between severity of health status and monetary value of a QALY, we obtained willingness to pay (WTP) values for one additional QALY in eight patterns of health states. We randomly sampled approximately 2,400 respondents from an online panel. To avoid misunderstanding, we randomly allocated respondents to one of 16 questionnaires, with 250 responses expected for each pattern. After respondents were asked whether they wanted to purchase the treatment, double-bounded dichotomous choice method was used to obtain WTP values., Results: The results clearly show that the WTP per QALY is higher for worse health states than for better health states. The slope was about JPY -1 million per 0.1 utility score increase. The mean and median WTP values per QALY for 16 health states were JPY 5 million, consistent with our previous survey. For respondents who wanted to purchase the treatment, WTP values were significantly correlated with household income., Conclusion: This survey shows that QALY based on the EQ-5D does not necessarily have the same monetary value. The WTP per QALY should range from JPY 2 million (USD 20,000) to JPY 8 million (USD 80,000), corresponding to the severity of health states.

Objectives: When quality-adjusted life-years are used for economic evaluation, the controversial issue of "double counting" of productivity loss emerges, particularly given the lack of empirical data., Methods: In this study, we performed a Web-based, large-sample survey to address the issue of double counting. To determine the influence of income reduction on utility scores, we obtained utility scores of eight health states with three instruction types: a) no instruction, b) instructed to consider income reduction, and c) instructed not to consider income reduction (compensated). Respondents were randomly sampled from the online panel and asked to evaluate 1 of 24 patterns by both standard gamble and time trade-off methods., Results: A total of 6551 respondents completed the questionnaire. First, despite the lack of instruction on income reduction, many respondents spontaneously assumed lost income. The proportion tended to be higher when considering more severe health states. Second, the degree of assumed income reduction was related to utility scores. For a 10% income reduction, respondents assumed a 0.02- to 0.04-decrease in utility score (both standard gamble and time trade-off methods). Third, utility scores did not change significantly when instruction was given not to consider income reduction (compensated) compared with when no instruction was given., Conclusions: An assumed income reduction clearly influenced utility scores; however, compensation for lost income failed to sufficiently improve utility scores. In our view, the effect of income on utility scores does not only reflect wage loss. Our results suggest that the impact of double counting is negligible., (Copyright © 2013 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.)

Objective: To evaluate the cost-effectiveness of adjuvant FOLFOX therapy versus 5-fluorouracil/leucovorin (FU/LV) for patients with stage III colorectal cancer., Methods: We performed the cost-effectiveness of FOLFOX compared with standard FU/LV treatment by the retrospective analysis of patient-level data from the randomized controlled Multicenter International Study of Oxaliplatin, 5-Fluorouracil, and Leucovorin in the Adjuvant Treatment of Colon Cancer (MOSAIC) trial. Predicted mean time spent in each disease state was calculated by our statistical model, which takes into account the cure rate and treats death from causes other than colon cancer as a competing risk. We performed this analysis from the perspective of the health-care payer. Using a time horizon of 30 years, both cost and effectiveness were discounted by 3% per year., Results: Estimated cure rates for colon cancer were 0.715 (FOLFOX) and 0.622 (FU/LV). Estimated medical costs of FOLFOX were JPY 3.1 million (USD 34,000) compared with JPY 1.9 million (USD 22,000) of FU/LV. The mean estimated quality-adjusted life-year was 9.83 with FOLFOX and 9.07 with that of FU/LV. The incremental cost-effectiveness ratio of FOLFOX was JPY 1.5 million (USD 17,000) per quality-adjusted life-year compared with FU/LV, which was supported by sensitivity analysis. Even if we assume that Japanese outcomes were better than those reported by the MOSAIC trial, which would reduce the difference between cure rates for each treatment to 5%, the incremental cost-effectiveness ratio remained below 5.0 million (USD 56,000) per quality-adjusted life-year., Conclusions: Adjuvant FOLFOX is a cost-effective treatment for stage III colon cancer in Japan compared with FU/LV therapy. Even when parameters were changed to reflect smaller improvements with FOLFOX, the conclusion is the same., (Copyright © 2012 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.)

Provision of social support and rehabilitation for patients with physical, mental, and functional problems after cancer treatment is important for long-term health-related quality of life (HRQOL). Effective use of human and financial healthcare resources requires identification of patients requiring rehabilitation. The objectives of the current study were to clarify the patterns of physical and psychosocial recovery over time, to evaluate the associations among baseline variables, treatment-related factors and HRQOL at 6 months, 1, and 2 years after breast cancer surgery, and to identify the significant factors predicting HRQOL at each point. A multicenter longitudinal study was performed to evaluate physical conditions, anxiety, depression, and HRQOL at 1 month (baseline), 6 months, 1, and 2 years after surgery in 196 patients (mean age: 53.3 years old) with early breast cancer and no postoperative recurrence. Physical conditions were evaluated using a patient-reported symptom checklist. HRQOL was rated using the functional assessment of cancer treatment scale-general (FACT-G) and the breast cancer subscale (FACT-B). Anxiety and depression were rated using the hospital anxiety and depression scale (HADS). More than 50% of patients had local problems of "tightness", "arm weakness." and "arm lymphedema", and systemic problems of "reduced energy, fatigue, and general weakness" postoperatively. The HRQOL score significantly improved 1 year after surgery, and scores for physical, emotional and functional well-being also increased with time, whereas the score for social well-being was the highest at baseline and decreased with time. Depression and anxiety significantly improved with time. Concomitant disease, marital status, and the presence of a partner, anxiety and depression at baseline, pathological lymph node involvement, and adjuvant intravenous chemotherapy were significant factors predicting FACT-G scores at 6 months, 1, and 2 years after surgery. Depression at baseline was a strong predictor of HRQOL up to 2 years after surgery. These results suggest that physical rehabilitation is required for tightness and lymphedema to improve long-term postoperative physical function. A further study of psychosocial interventions is required to improve depression and social well-being after breast cancer surgery.

Objective: To examine health-related quality of life, we investigated the effect of adjuvant chemotherapy regimens on utility scores assessed by the EuroQoL-5D (EQ-5D) instrument in a randomized, controlled trial for breast cancer patients after surgery. We also investigated the relationship between Functional Assessment of Cancer Therapy (FACT) scale scores and EQ-5D utilities., Methods: Patients were randomly assigned to the following four chemotherapy regimens: four cycles of anthracycline followed by paclitaxel (ACP), four cycles of anthracycline-containing regimens followed by docetaxel (ACD), eight cycles of paclitaxel (PTX), and eight cycles of docetaxel (DTX). Of 1060 registered, the first 300 consecutive patients were included in the current utility study. Utility scores were assessed using the EQ-5D instrument at baseline; cycles 3, 5, and 7; 7 months; and 1 year. We also evaluated the correlation between these scores and FACT-G, -B, and -Taxane scores at each time point., Results: Utility scores were significantly lower in the DTX group than in the ACP and ACD groups. Mean utility scores in the DTX group were lowest at 7 months and tended to remain low for a long time. The combined anthracycline followed by taxane group had significantly higher utility scores that the taxane-alone group, with no significant difference depending on the type of taxane. Only the FACT-G social/family well-being subscale had no relationship with EQ-5D responses and utility scores., Conclusions: Although the regimens in this study were similar in that they included taxane, the mean utility scores and longitudinal patterns of utility scores were different among regimens., (Copyright © 2011 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.)

Background: Cetuximab, a monoclonal antibody directed against the epidermal growth factor receptor, improves progression-free survival and overall survival in patients with metastatic colorectal cancer (mCRC). However, patients with a KRAS gene mutation do not benefit from cetuximab therapy., Methods: We performed a cost-effectiveness analysis of KRAS testing and cetuximab treatment as last-line therapy for patients with mCRC in Japan. In our analysis, we considered three treatment strategies. In the 'KRAS-testing strategy' (strategy A), KRAS testing was performed to guide treatment: patients with wild-type KRAS received cetuximab, and those with mutant KRAS received best supportive care (BSC). In the 'no-KRAS-testing strategy' (strategy B), genetic testing was not conducted and all patients received cetuximab. In the 'no-cetuximab strategy' (strategy C), genetic testing was not conducted and all patients received BSC. To evaluate the cost effectiveness of KRAS testing, the KRAS-testing strategy was compared with the no-KRAS-testing strategy; to evaluate the cost effectiveness of KRAS testing and cetuximab, the KRAS-testing strategy was compared with the no-cetuximab strategy; and to evaluate the cost effectiveness of cetuximab treatment without KRAS testing, the no-KRAS-testing strategy was compared with the no-cetuximab strategy. A three-state Markov model was used to predict expected costs and outcomes for each group. Outcomes in the model were based on those reported in a retrospective analysis of data from the National Cancer Institute of Canada Clinical Trials Group CO.17 study. We included only direct medical costs from the perspective of the Japanese healthcare payer. A 3% discount rate was used for both costs and outcome. Two outcomes, life-years (LYs) gained and quality-adjusted life-years (QALYs) gained, were used to calculate the incremental cost-effectiveness ratio (ICER)., Results: Our cost-effectiveness analysis revealed that the KRAS-testing strategy was dominant compared with the no-KRAS-testing strategy, with an expected cost reduction of ¥0.5 million per patient and an estimated budget impact of ¥3-5 billion ($US42-59 million; July 2010 values) per year. The ICER of the KRAS-testing strategy compared with the no-cetuximab strategy was ¥11 million ($US120 000) per LY gained and ¥16 million ($US160 000) per QALY gained, whereas the ICER of the KRAS-testing strategy compared with the no-KRAS-testing strategy was ¥14 million ($US180 000) per LY gained and ¥21 million ($US230 000) per QALY gained. These results were supported by the sensitivity analysis., Conclusions: KRAS testing is recommended before administering cetuximab as last-line therapy for patients with mCRC. However, our analysis suggests that the ICER of cetuximab treatment (with or without KRAS testing) is too high, even if treatment is limited to patients with wild-type KRAS.

Various molecular target drugs are developed in recent era in Japan, especially for treatment of cancer, rheumatoid arthritis and other diseases. Although they are much more effective compared to previous drugs, their costs are much more expensive. Thus, pharmacoeconomic analysis in which we evaluate their efficiency, would be highly needed. When we take pharmacoeconomic analyses, we need to assess both costs and health outcomes. In addition, we must compare cost-effectiveness of new interventions and control. To estimate costs of each intervention, not only direct medical costs, but direct non-medical costs (e.g. transportation costs, caregiving costs, house--modification costs) and indirect costs, or productivity losses should be separately calculated and presented. To evaluate efficiencies of anti-rheumatoid biologic agent in Japan, we started to collaborate with large-scale cohort of patient with rheumatoid arthritis in Japan, IORRA cohort in Tokyo Women's Medical University. With this data, we are taking various pharmacoeconomic analysis.

Objective: The purpose of our study was to estimate the out-of-pocket payment and cost-effectiveness of capecitabine plus oxaliplatin (XELOX) or XELOX plus bevacizumab from the perspective of patients with metastatic colorectal cancer (MCRC)., Methods: Based on the NO16966 and NO16967 trials, the mean out-of-pocket payment was calculated from patient-level data. Out-of-pocket payments for 16 cycles (11 months) of first-line chemotherapy and 8 cycles (5 months) of second-line chemotherapy were included. In addition, incremental cost-effectiveness ratios (ICERs) for first-line bevacizumab were calculated by dividing the difference of the out-of-pocket payment by the difference of the mean number of progression-free survival (PFS) years or quality-adjusted PFS (QAPFS) years., Results: The mean out-of-pocket payments for middle-income patients under 70 years of age were JPY 328,000 for 16 cycles of first-line XELOX and JPY 376,000 for XELOX plus bevacizumab. The mean out-of-pocket payment for 8 cycles of second-line XELOX was calculated to be JPY 175,000. Middle-income patients over 70 years of age were required to pay JPY 61,000 and JPY 72,000 for first-line XELOX and XELOX plus bevacizumab, respectively. The ICERs of middle-income patients <70 years of age were JPY 430,000/PFS-year and JPY 720,000/QAPFS-year, and those of middle-income patients >70 years of age were JPY 100,000/PFS-year and JPY 170,000/QAPFS-year., Conclusions: We clarified the out-of-pocket payment and cost-effectiveness of chemotherapy of MCRC patients in Japan. Our previous survey shows it is highly possible that many patients prefer to pay that incremental out-of-pocket payment to gain one additional QAPFS year. However, our cost-effectiveness analysis was not conducted from the perspective of society or healthcare payers.

Although the threshold of cost effectiveness of medical interventions is thought to be 20 000- 30 000 UK pounds in the UK, and $50 000-$100 000 in the US, it is well known that these values are unjustified, due to lack of explicit scientific evidence. We measured willingness-to-pay (WTP) for one additional quality-adjusted life-year gained to determine the threshold of the incremental cost-effectiveness ratio. Our study used the Internet to compare WTP for the additional year of survival in a perfect status of health in Japan, the Republic of Korea (ROK), Taiwan, Australia, the UK, and the US. The research utilized a double-bound dichotomous choice, and analysis by the nonparametric Turnbull method. WTP values were JPY 5 million (Japan), KWN 68 million (ROK), NT$ 2.1 million (Taiwan), 23 000 UK pounds (UK), AU$ 64 000 (Australia), and US$ 62 000 (US). The discount rates of outcome were estimated at 6.8% (Japan), 3.7% (ROK), 1.6% (Taiwan), 2.8% (UK), 1.9% (Australia), and 3.2% (US). Based on the current study, we suggest new classification of cost-effectiveness plane and methodology for decision making., (Copyright (c) 2009 John Wiley & Sons, Ltd.)

Purpose: We measured health utility scores of colorectal cancer (CRC) patients from a societal perspective in Japan., Methods: Twenty-five states of health were described: four metastatic states without severe adverse events (AEs), 16 metastatic states with Grade 3/4 AEs, four adjuvant states, and one terminal state. A total of 1,500 respondents stratified by age and gender were recruited randomly from the largest Web-panel in Japan. Respondents were allocated randomly to three of the 25 health states and answered questionnaires by standard gamble (SG) and time trade-off (TTO) methods., Results: Although utility scores of metastatic CRC receiving XELOX (capecitabine plus oxaliplatin) chemotherapy were 0.48(SG and TTO) (with stoma) and 0.57(SG) or 0.59(TTO) (without stoma), utility scores of those receiving FOLFOX4 (5-fluorouracil/folinic acid and oxaliplatin) chemotherapy were 0.42(SG) or 0.43(TTO) (with stoma) and 0.52(SG) or 0.53(TTO) (without stoma). These differences between XELOX and FOLFOX4 were statistically significant (P = 0.0198 in SG and P = 0.0059 in TTO). Stage 3/4 AEs decreased utility scores to 0.35-0.4 and 0.4-0.45 in the presence and absence of stoma, respectively., Conclusions: XELOX was generally considered a significantly preferable chemotherapy regimen compared to FOLFOX4 for CRC in Japan. Almost all Grade 3/4 AEs and stoma significantly decreased utility scores. These differences are dependent on the accuracy of the health state description and to confirm these results. In future research, it would be preferable that preference-based HRQoL measures are used directly in patients if utility scores are practically measurable by such method.

Objective: A cost-effectiveness analysis of oral capecitabine versus intravenous bolus 5-fluorouracil/l-leucovorin (FU/LV) as adjuvant therapy in patients with stage 3 colon cancer was performed from a Japanese healthcare payer perspective., Methods: Adjuvant therapy comprised 24 weeks of treatment with either oral capecitabine 1250 mg/m(2) twice daily on days 1-14 of a 21-day cycle or intravenous bolus FU 500 mg/m(2) and LV 250 mg/m(2) weekly for 6 weeks of an 8-week cycle (Roswell Park regimen). The analysis comprised short-term (1 year after initiation of adjuvant therapy) and long-term (up to 15 years) components. The long-term analysis involved a three-state (disease-free, recurrence and death) Markov model. Estimates for transition probabilities, costs and utilities were derived from the X-ACT trial, a Japanese phase II trial, and other published sources. Cost estimates were considered from the perspective of a healthcare payer. Costs were expressed in Japanese Yen (yen), year 2007 values. A discount rate of 3% was applied to costs and outcomes. Cost effectiveness was expressed as a cost per QALY. The effects of uncertainty were explored through one-way and probabilistic sensitivity analyses., Results: In the 1-year analysis, direct costs were yen440,000 ($US4000) less per patient with capecitabine than with FU/LV. In the long-term analysis, differences between treatments in direct medical costs ranged from yen470,000 ($US4300) to yen580,000 ($US5300) depending on the time horizon used. Capecitabine was also projected to increase the number of QALYs compared with FU/LV. The sensitivity analysis suggested that the model outcome was robust. The probabilistic sensitivity analysis estimate of capecitabine being the dominant regimen was 96.6% at a zero willingness to pay. Direct costs remained lower with capecitabine if the price of generic LV was >OR=50% of the branded product., Conclusion: This analysis suggests that capecitabine improves health outcomes and lowers direct costs compared with bolus FU/LV (i.e. dominant treatment strategy) when used as adjuvant therapy in patients with stage 3 colon cancer in Japan.

Background: Several randomized controlled trials have confirmed the usefulness of trastuzumab as an adjuvant therapy for HER2-overexpressed breast cancer patients; however, the costs for 1-year treatment are high. Therefore, we performed an economic analysis regarding the efficient distribution of medical resources., Methods: To analyze the cost-effectiveness for a 1-year adjuvant trastuzumab treatment group compared with the observation group, we constructed a Markov model adopting a 3% per year discount rate for costs and outcomes. The time horizon was 50 years. The perspective was that of health-care payers, as only direct medical costs were calculated. The outcome was measured as life-year gained (LYG) from 2-year follow-up HERA trial data., Results: The ICER of the standard setting (5 years efficacy and 50-60 kg patient weight) was JPY 2,600,000 (17,000) per LYG. The calculation results of other weight class ICER were JPY 2,200,000 (15,000) and JPY 3,300,000 (22,000) per LYG for the patients, respectively, who weighed less than 50 kg, and 60-75 kg. In the sensitivity analysis, the period of trastuzumab efficacy was the most influential parameter for the result of cost-effectiveness. However, even if the trastuzumab efficacy were to continue for only 2 years, at least, which is a conservative setting judging from the joint analysis (NSABP B-31 and NCCTG N9831 trials), the ICER remains acceptable for any weight class., Conclusion: These results suggest that the 1-year adjuvant trastuzumab treatment is cost-effective. Both clinical and economic benefits were superior for the 1-year adjuvant trastuzumab treatment group compared with the observation group.

Background: Rapid progress has been made in the treatment of metastatic colorectal cancer (mCRC). New treatment regimens for mCRC include not only cytotoxic chemotherapy but also targeted monoclonal antibodies, including bevacizumab. However, bevacizumab is an expensive medication, which costs from 300,000 yen to 400,000 yen (US $2500-$3300) per month., Objective: The purpose of this cost-effectiveness analysis was to examine the economic efficiency of treating mCRC with bevacizumab plus chemotherapy versus chemotherapy alone in Japan., Methods: We searched an electronic database (MEDLINE, UpToDate, and American Society of Clinical Oncology [ASCO] Virtual Meeting; key terms: bevacizumab limited to randomized controlled trial; years: 2000 to present [June 29, 2007]) to detect randomized controlled trials (RCTs) that compared chemotherapy alone with chemotherapy plus bevacizumab. To analyze the cost-effectiveness of bevacizumab, we used the Weibull regression model and determined an expected treatment duration at each state using reported survival curves of RCTs. We included only the direct medical costs (2006) of these medications to estimate the expected values of incremental costs; thus, the analysis was conducted from the perspective of the health care payer. The incremental cost-effectiveness ratios (ICERs) were calculated from these expected values of incremental life-years and incremental costs., Results: We identified 5 articles using MEDLINE and 1 trial found on UpToDate and ASCO Virtual Meeting; these data composed the final analysis group. First-line chemotherapy regimens included in this analysis were bevacizumab + 5-fluorouracil/leucovorin (FU/LV), irinotecan/FU/LV (IFL), infusional FU/LV/ oxaliplatin (FOLFOX6), bolus FU/LV/oxaliplatin (bFOL), and capecitabine/oxaliplatin (CAPOX). The only second-line chemotherapy regimen included was FOLFOX4. The ICERs of additional bevacizumab when combined with FU/LV,IFL,FOLFOX6, bFOL, and CAPOX were 17.4 million yen (US $145,000), 11.9 million yen ($99,000), 13.5 million yen ($113,000), 16.9 million yen ($141,000), and 8.5 million yen ($71,000), respectively, per life-year gained; the ICER was 14.1 million yen ($118,000) with second-line FOLFOX4., Conclusions: In this cost-effectiveness analysis in Japan, the ICERs of bevacizumab + FU/LV combination treatment, IFL, and second-line FOLFOX4 were high compared with other chemotherapies for mCRC. It remains difficult to assess first-line therapies comprising bevacizumab with oxaliplatin-based regimens, especially CAPOX. Further information is needed to assess cost-effectiveness.