Cost-Effectiveness Comparison of Carbon-Ion Radiation Therapy and Transarterial Chemoembolization for Hepatocellular Carcinoma.

Purpose: Carbon-ion radiation therapy (CIRT) is a treatment option for patients with hepatocellular carcinoma (HCC) that results in better outcomes with fewer side effects despite its high cost. This study aimed to evaluate the cost-effectiveness of CIRT for HCC from medical and economic perspectives by comparing CIRT and transarterial chemoembolization (TACE) in patients with localized HCC who were ineligible for surgery or radiofrequency ablation. Methods and Materials: This study included 34 patients with HCC who underwent either CIRT or TACE at Gunma University between 2007 and 2016. Patient characteristics were employed to select each treatment group using the propensity score matching method. Life years were used as the outcome indicator. The CIRT technical fee was ¥3,140,000; however, a second CIRT treatment on the same organ within 2 years was performed for free. Results: Our study showed that CIRT was dominant over TACE, as the CIRT group had a higher life year (point estimate, 2.75 vs 2.41) and lower total cost (mean, ¥4,974,278 vs ¥5,284,524). We conducted a sensitivity analysis to validate the results because of the higher variance in medical costs in the TACE group, which demonstrated that CIRT maintained its cost effectiveness with a high acceptability rate. Conclusions: CIRT is a cost-effective treatment option for localized HCC cases unsuitable for surgical resection.

Trends in the cost-effectiveness level of percutaneous coronary intervention: Macro socioeconomic analysis and health technology assessment.

Percutaneous coronary intervention (PCI), one of the most prevalent techniques of revascularization, is a procedure that remarkably improves treatment outcomes. However, it consumes large amounts of medical resources and has resulted in an increased socioeconomic burden due to the increasing number of target patients. In recent years, there have been sporadic discussions, both in Japan and other countries, regarding the optimization of interventions and the perspective of medical economics. Based on this, previous studies on PCI-related cost-effectiveness were reviewed in order to consider the current level of medical economics regarding PCI. Using the databases MEDLINE and EMBASE, a survey involving data from original articles and systematic reviews was conducted from January 2010 to August 2022. Conditions were not imposed on the evidence level due to the paucity of studies, although field studies were prioritized over simulation studies. The macro medical economics of acute myocardial infarction treatment, which is the primary target of PCI, were generally at an average level when compared to those in other countries; however, there is room for further improvement in Japan's performance. Revascularization in a population with multivessel coronary artery disease showed that coronary artery bypass graft surgery tended to be more cost-effective than PCI in the long-term setting. However, it was suggested that PCI may be more cost-effective in patients with SYNTAX Score ≤22 or left main artery disease. A cost-effectiveness report for stable angina patients was not in favor of PCI over medical therapy. Moreover, there were some reports showing the medical economic superiority of early myocardial ischemia evaluation, and it was foreseen that active selection of patients will contribute to the improvement of the overall cost-effectiveness of PCI. In order to further improve the socioeconomic significance of PCI in the future, it is necessary to aim for harmony between clinical practice and health economics.

Health state utilities of patients with hepatitis B and C and hepatitis-related conditions in Japan.

Health state utilities are global measurements of quality of life and have been used to evaluate health outcomes for the cost-utility analysis. This study aimed to estimate the health state utilities of patients with hepatitis B (HB), hepatitis C (HC), and hepatitis-related diseases in Japan. We distributed a self-administered questionnaire, including the EuroQol 5-Dimension 5-Level (EQ-5D-5L), to 9,952 outpatients with several clinical conditions caused by HB or HC virus infection (such as asymptomatic chronic hepatitis, chronic hepatitis, compensated cirrhosis, and decompensated cirrhosis) and estimated the condition-specific utilities of patients with HB or HC. In patients with more severe conditions (patients with acute hepatitis, fulminant hepatitis, and hepatocellular carcinoma and patients undergoing post-liver transplantation), the utilities of these severe conditions were estimated by three hepatitis experts using the EQ-5D-5L. The means of the utilities for acute hepatitis, fulminant hepatitis, asymptomatic chronic hepatitis, chronic hepatitis, compensated cirrhosis, compensated cirrhosis, hepatocellular carcinoma stage I/II, hepatocellular carcinoma stage III/IV, and post-liver transplantation were 0.529, - 0.111, 0.904, 0.868, 0.845, 0.722, 0,675, 0,428, and 0.651 and 0.876, 0.821, 0.737, 0.671, 0.675, 0.428, and 0.651 in HB and HC, respectively. To the best of our knowledge, this is the first study that comprehensively assessed the health state utilities of patients with HB, HC and hepatitis-related conditions from a nationwide survey in Japan using the EQ-5D-5L.

Proxy responses regarding quality of life of patients with terminal lung cancer: preliminary results from a prospective observational study.

OBJECTIVE: This prospective study used the EQ-5D utility and Visual Analogue Scale (VAS) scores to analyse the potential usefulness of proxy responses in quality of life assessments of Japanese patients with terminal lung cancer sufficiently healthy to communicate and reply by themselves. We did not investigate the potential usefulness of using proxy responses for patients who could not respond by themselves. DESIGN: A prospective observational study. SETTING: Single centre. PARTICIPANTS: The EQ-5D and VAS responses were gathered from 30 in-hospital patients with lung cancer for a total of three observation points. At nearly the same time, two nurses responded by providing proxy responses. PRIMARY AND SECONDARY OUTCOME MEASURES: EQ-5D and VAS responses. RESULTS: There were no significant differences between the patients' and nurses' responses for EQ-5D utility and VAS scores. For the five dimensions of the EQ-5D, significant differences were found between the patients' and nurses' responses for usual activities (patients' response 1.64±0.07, nurses' response 1.41±0.05, p=0.03) and anxiety/depression (patients' response: 1.40±0.05, nurses' response: 1.19±0.03, p=0.02). There was a significant weak positive correlation between patients' and nurses' responses regarding changes in responses from the first to the third observation point (Spearman's rank correlation coefficient ρ=0.228; p<0.01). CONCLUSION: The results suggest that proxy responses are useful because there were no significant differences between the patients' and nurses' responses for EQ-5D utility and VAS scores at the three observation points. These findings should, however, be verified in future large-scale trials.

Cost-Effectiveness Analysis of the Treatment Strategies with or without Opioid Medications in Surgery-Eligible Patients with Osteoarthritis in Japan.

AIM: The aim of this study was to evaluate the cost effectiveness of treatment strategies without opioid medications (non-opioid treatment strategy) versus strategies with opioid medications (opioid treatment strategy) among surgery-eligible patients with osteoarthritis (OA) of the knee or hip in Japan. MATERIALS AND METHODS: We built a Markov cohort model to evaluate outcomes for the treatment strategies in surgery-eligible patients aged ≥ 65 years with OA of the knee or hip in Japan. The opioid treatment strategy as an intervention includes a health state with opioid medication in the treatment pathway. On the other hand, for the non-opioid treatment strategy, there is no health state with opioid medication. A targeted literature review and database analysis were conducted to identify and define the values of the variables included in the model. The time horizon was set to 30 years, and a 2% discount was applied for cost and quality-adjusted life-years (QALYs). Sensitivity analysis and scenario analysis were performed in the model. The outcomes were QALYs and the incremental cost-effectiveness ratio (ICER). RESULTS: In the base-case analysis, the non-opioid treatment strategy was dominant over the opioid treatment strategy and associated with an incremental cost and QALYs of - 53,878 JPY (- 499 USD) and 0.03 QALYs, respectively, in patients with knee OA, and - 54,129 JPY (- 502 USD) and 0.02 QALYs, respectively, in patients with hip OA. One-way sensitivity analysis showed the ICER was most sensitive to the QALY for opioid monotherapy. Probabilistic sensitivity analyses showed a high degree of uncertainty associated with the results. LIMITATIONS: Study limitations included assumptions related to transition probabilities of the health states, and a lack of Japanese-specific data for transition probabilities, incidence of adverse events and utility values. CONCLUSIONS: This study suggests that the non-opioid treatment strategy is cost effective compared with the opioid treatment strategy in the management of surgery-eligible patients with OA of the knee or hip. However, this final conclusion may not be accurate as the methodology is heavily reliant on assumptions.

Cost-effectiveness of carbon-ion radiotherapy versus stereotactic body radiotherapy for non-small-cell lung cancer.

Carbon-ion radiotherapy (CIRT) for clinical stage I non-small-cell lung cancer (NSCLC) is used as an advanced medical treatment regimen in Japan. Carbon-ion radiotherapy reportedly aids in achieving excellent treatment outcomes, despite its high medical cost. We aimed to compare CIRT with stereotactic body radiotherapy (SBRT) in terms of cost-effectiveness for treating clinical stage I NSCLC. Data of patients with clinical stage I NSCLC treated with CIRT or SBRT at Gunma University between 2010 and 2015 were analyzed. The CIRT and SBRT groups included 62 and 27 patients, respectively. After propensity-score matching, both groups comprised 15 patients. Life year (LY) was used as an indicator of outcome. The CIRT technical fee was 3 140 000 JPY. There was no technical fee for the second CIRT carried out on the same organ within 2 years. The incremental cost-effectiveness ratio (ICER) was calculated by dividing the incremental cost by the incremental LY for 5 years after treatment. Sensitivity analysis was applied to evaluate the impact of LY or costs of each group on ICER. The ICERs were 7 491 017 JPY/LY and 3 708 330 JPY/LY for all patients and matched patients, respectively. Hospitalization and examination costs were significantly higher in the CIRT group, and the impact of the CIRT technical costs was smaller than other costs and LY. Carbon-ion radiotherapy is a cost-effective treatment approach. However, our findings suggest that reducing excessive costs by considering the validity and necessity of examinations and hospitalizations would make CIRT a more cost-effective approach.

Comparison of the Effectiveness of Pharmacological Treatments for Patients with Chronic Low Back Pain: A Nationwide, Multicenter Study in Japan.

INTRODUCTION: Chronic low back pain (CLBP) is a leading cause of disability, yet there is limited high-quality evidence to identify the most suitable pharmacological therapy. The purpose of this Japanese nationwide, multicenter, prospective study was to compare the effectiveness of four representative drug therapies-acetaminophen, celecoxib, loxoprofen, and a tramadol and acetaminophen (T+A) combination drug-to establish evidence for a drug of choice for CLBP. METHODS: Patients with CLBP (N=471) received one of the four treatments and were evaluated, prospectively and comprehensively, once every month for six months using a visual analog scale (VAS) for LBP, the Japanese Orthopedic Association (JOA) score, the JOA Back Pain Evaluation Questionnaire (JOABPEQ), the Roland-Morris Disability Questionnaire (RDQ), the EuroQol five-dimensions three-levels (EQ-5D-3L), and the Short Form-8 item health survey (SF-8). We conducted multivariable linear regression analyses of the four drugs at 1 and 6 months after drug allocation. Differences with P<0.05 were considered statistically significant. RESULTS: Patients who received acetaminophen showed a significant improvement from baseline in the mental health subscale of the JOABPEQ at one month (P=0.02) and the JOA score at six months (P<0.01). None of the other outcome measures among the four drugs differed significantly. Across groups, all outcome measures, except the mental component summary (MCS) score of the SF-8, improved equivalently, although most measurements showed no obvious cumulative effect over six months. The MCS score of the SF-8 decreased gradually over six months in all groups. CONCLUSIONS: Most of the outcome measures among the treated groups were not significantly different, indicating similar treatment effects of the four drugs for CLBP. Our study indicated the limit of each outcome measure for evaluating the patient status, suggesting that a single outcome measure is insufficient to reflect treatment effectiveness.

Impact of background factors on outcomes of pharmacological therapy for chronic low back pain: A nationwide multicenter prospective study.

BACKGROUND: Chronic low back pain (CLBP) is a major cause of chronic pain with nociceptive, neuropathic or both pain components, and a leading cause of disability. The objectives of this study were to determine the impact of background factors including previous use of drugs on outcomes of pharmacological therapy for CLBP in a nationwide multicenter prospective study. METHODS: The subjects were 474 patients (male: 41.9%, median age: 73.0) with CLBP. Background factors that could influence outcomes after pharmacological treatment for 6 months were examined: age, gender, body mass index (BMI), duration of CLBP, osteoporosis, history of spinal surgery, history of malignant tumor, smoking habit, employment status (yes or no), exercise habit (frequency), number of live-in family members, having something to do for pleasure, Center for Epidemiologic Studies depression scale (CES-D) score, and medication at baseline. Japanese Orthopaedic Association (JOA) score, visual analogue scale (VAS) for LBP, JOA Back Pain Evaluation Questionnaire (JOABPEQ), Roland-Morris Disability Questionnaire (RDQ), Short-form 8-item health survey (SF-8), and EQ-5D were used for evaluation at baseline and after 6 months. Multivariate linear regression models were used in statistical analysis. RESULTS: Drugs for neuropathic pain at baseline (p < 0.001), Tramacet® at baseline (p < 0.05), weak opioids at baseline (p < 0.05), older age (p < 0.001), long disease duration (p < 0.005), history of spinal surgery (p < 0.001), and smoking habit (p < 0.001) had significant negative effects on outcomes. Employment (p < 0.05), exercise habit (p < 0.05), and CED-D at baseline (p < 0.001) had positive effects on outcomes. CONCLUSIONS: This is the first study to identify significant prognostic factors for outcomes of pharmacological treatment of CLBP. The neuropathic pain component of CLBP at baseline is a major significant negative factor for most outcomes involving improved pain, activities of daily life, and quality of life. Treatment strategies developed with consideration of these factors may be advantageous for recovery from CLBP.

Impact of Consultation Length on Satisfaction in Patients with Chronic Low Back Pain: A Nationwide Multicenter Study in Japan.

INTRODUCTION: Chronic low back pain (CLBP) is a major health burden worldwide and requires patient satisfaction with treatment. Consultation length can be an important factor in patient satisfaction, but few studies have investigated the impact of consultation length on satisfaction in patients with CLBP. This study tried to elucidate the impact of consultation length on clinical outcomes in patients with CLBP. METHODS: This study is part of an analysis using the database of the nationwide, multicenter cohort for CLBP performed by the Project Committee of the Japanese Society for Spine Surgery and Related Research. A total of 427 patients aged 20-85 years (median age, 73.0 years; female, 58.6%) with CLBP were prospectively followed-up monthly for 6 months. Multivariable nonlinear regression analyses were performed to assess the effect of consultation length on outcome measures including subjective satisfaction score, EuroQol 5-dimension, Japanese Orthopaedic Association (JOA) score, Roland-Morris Disability Questionnaire, JOA Back Pain Evaluation Questionnaire, visual analog scale (VAS) and Medical Outcome Survey short-form 8-item health survey that evaluated at the next phase. Furthermore, we assessed whether the effect of consultation length on patient satisfaction was modified by the baseline Brief Scale for Psychiatric Problems in Orthopaedic Patients (BS-POP) score for patient and physician versions. RESULTS: VAS for CLBP was the only score that correlated significantly with consultation length (P = 0.018). Satisfaction score showed a significant positive correlation with consultation length in patients with the highest baseline BS-POP scores (P < 0.2). Moreover, consultation lengths more than 7.6 min and 15.1 min offered increase of satisfaction if patients show the highest BS-POP scores on patient and physician versions, respectively. CONCLUSIONS: These findings suggest that a sufficiently long consultation is an important factor for subjective satisfaction in the patients with CLBP, particularly in patients with psychological problems.

Cost-effectiveness analysis of the pharmacological management of chronic low back pain with four leading drugs.

BACKGROUND: Chronic low back pain is a major health problem that has a substantial effect on people's quality of life and places a significant economic burden on healthcare systems. However, there has been little cost-effectiveness analysis of the treatments for it. Therefore, the purpose of this prospective observational study was to evaluate the cost-effectiveness of the pharmacological management of chronic low back pain. METHODS: A total of 474 patients received pharmacological management for chronic low back pain using four leading drugs for 6 months at 28 institutions in Japan. Outcome measures, including EQ-5D, the Japanese Orthopaedic Association (JOA) score, the JOA back pain evaluation questionnaire (BPEQ), the Roland-Morris Disability Questionnaire, the Medical Outcomes Study SF-8, and the visual analog scale, were investigated at baseline and every one month thereafter. The incremental cost-utility ratio (ICUR) was calculated as drug cost over the quality-adjusted life years. An economic estimation was performed from the perspective of a public healthcare payer in Japan. Stratified analysis based on patient characteristics was also performed to explore the characteristics that affect cost-effectiveness. RESULTS: The ICUR of pharmacological management for chronic low back pain was JPY 453,756. Stratified analysis based on patient characteristics suggested that the pharmacological treatments for patients with a history of spine surgery or cancer, low frequency of exercise, long disease period, low scores in lumbar spine dysfunction and gait disturbance of the JOA BPEQ, and low JOA score at baseline were not cost-effective. CONCLUSIONS: Pharmacological management for chronic low back pain is cost-effective from the reference willingness to pay. Further optimization based on patient characteristics is expected to contribute to the sustainable development of a universal insurance system in Japan.

Cost-Effectiveness of PCSK9 Inhibitor Plus Statin in Patients With Triple-Vessel Coronary Artery Disease in Japan.

BACKGROUND: The addition of a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor to statin therapy reduces the rate of cardiovascular events. This study examined the cost-effectiveness of PCSK9 inhibitor+statin compared with standard therapy (statin monotherapy) in the treatment of triple-vessel coronary artery disease (CAD) in Japan. Methods and Results: A Markov model was applied to assess the costs and benefits associated with PCSK9 inhibitor+statin over a projected 30-year period from the perspective of a public healthcare payer in Japan. The incremental cost-effectiveness ratio (ICER), expressed as the quality-adjusted life-years (QALYs), was estimated. The effects on survival and numbers of events were based on the FOURIER trial and the CREDO Kyoto registry. The ICER of PCSK9 inhibitor+statin over standard therapy was 13.5 million (95% confidence interval 7.6-23.5 million) Japanese Yen (JPY) per QALY gained for triple-vessel CAD. The probability of the cost-effectiveness of PCSK9 inhibitor+statin vs. standard therapy was 0.0008% at a cost-effectiveness threshold of 5 million JPY. In patients with poorly controlled familial hypercholesterolemia (FH) with triple-vessel CAD, the ICER was 3.4 million JPY per QALY gained. CONCLUSIONS: PCSK9 inhibitor plus statin did not show good cost-effectiveness for triple-vessel CAD; however, it showed good cost-effectiveness for patients with triple-vessel CAD and poorly controlled FH in Japan.

An Evaluation of Clinical Economics and Cases of Cost-effectiveness.

In order to maintain and develop a universal health insurance system, it is crucial to utilize limited medical resources effectively. In this context, considerations are underway to introduce health technology assessments (HTAs), such as cost-effectiveness analyses (CEAs), into the medical treatment fee system. CEAs, which is the general term for these methods, are classified into four categories, such as cost-effectiveness analyses based on performance indicators, and in the comparison of health technologies, the incremental cost-effectiveness ratio (ICER) is also applied. When I comprehensively consider several Japanese studies based on these concepts, I find that, in the results of the analysis of the economic performance of healthcare systems, Japan shows the most promising trend in the world. In addition, there is research indicating the superior cost-effectiveness of Rituximab against refractory nephrotic syndrome, and it is expected that health economics will be actively applied to the valuation of technical innovations such as drug discovery.

Cost-Effectiveness Analysis of Percutaneous Vertebroplasty for Osteoporotic Compression Fractures.

STUDY DESIGN: Single-center, single-arm, prospective time-series study. OBJECTIVE: To assess the cost-effectiveness and improvement in quality of life (QOL) of percutaneous vertebroplasty (PVP). SUMMARY OF BACKGROUND DATA: PVP is known to relieve back pain and increase QOL for osteoporotic compression fractures. However, the economic value of PVP has never been evaluated in Japan where universal health care system is adopted. METHODS: We prospectively followed up 163 patients with acute vertebral osteoporotic compression fractures, 44 males aged 76.4±6.0 years and 119 females aged 76.8±7.1 years, who underwent PVP. To measure health-related QOL and pain during 52 weeks observation, we used the European Quality of Life-5 Dimensions (EQ-5D), the Rolland-Morris Disability Questionnaire (RMD), the 8-item Short-Form health survey (SF-8), and visual analogue scale (VAS). Quality-adjusted life years (QALY) were calculated using the change of health utility of EQ-5D. The direct medical cost was calculated by accounting system of the hospital and Japanese health insurance system. Cost-effectiveness was analyzed using incremental cost-effectiveness ratio (ICER): Δ medical cost/Δ QALY. RESULTS: After PVP, improvement in EQ-5D, RMD, SF-8, and VAS scores were observed. The gain of QALY until 52 weeks was 0.162. The estimated lifetime gain of QALY reached 1.421. The direct medical cost for PVP was ¥286,740 (about 3061 US dollars). Cost-effectiveness analysis using ICER showed that lifetime medical cost for a gain of 1 QALY was ¥201,748 (about 2154 US dollars). Correlations between changes in EQ-5D scores and other parameters such as RMD, SF-8, and VAS were observed during most of the study period, which might support the reliability and applicability to measure health utilities by EQ-5D for osteoporotic compression fractures in Japan as well. CONCLUSIONS: PVP may improve QOL and ameliorate pain for acute osteoporotic compression fractures and be cost-effective in Japan.

The future of medical reimbursement for orthopedic surgery in Japan from the viewpoint of the health economy.

BACKGROUND: The financial burden of medical insurance on the government of Japan has recently become severe, which has led to the control of outpatient orthopedic reimbursements for common procedures. On the other hand, the overall disease burden for total hip or knee arthroplasty, decompression for cervical myelopathy or lumbar spinal canal stenosis, and new surgical technologies to treat other painful conditions and the post-surgical care related to these procedures has been reduced. METHODS: Medical insurance systems in Japan are generally influenced by budget-balancing action. Consequently, the further development of interventional evaluation methods should be promoted. From the viewpoint of health economics, the value (meaning) of medical intervention can partly be explained by its cost-effectiveness. In order for appropriate medical reimbursement levels to be set for orthopedic surgery, the financial status of medical institutions needs to be concurrently reviewed. In particular, the relationship between the expense structure and medical reimbursement must be discussed to evaluate its role in community medicine system. RESULTS: Over the past 10 years, medical expenditures have increased by 9.6% in all fields, whereas the monthly medical reimbursements per patient have dropped by an average of 17.5%. Remarkably, surgery-related costs have increased by 36.5%, while other medical costs have decreased by 19.8%. There are a few reports of cost-utility analyses which investigate interventions such as total hip arthroplasty for hip osteoarthritis patients (US$ 4,600-70,500/QALY) and laminectomy for patients with spinal canal stenosis. Interventions may be an inevitable part of relative expense control under the current trend; however, there has been a slight increase in other parameters in response to changes in medical reimbursement evaluations - specifically, in the total income of medical institutions. CONCLUSIONS: If medical professionals such as orthopedic surgeons contribute to the economic value of orthopedic surgery, it is crucial to clearly establish interventions among the different performances of medical reimbursement to motivate the increased allocation of management resources. To further develop this concept, discussions between stakeholders should involve the value of medicine based on cost and benefit.

Perspectives of Japanese oncologists on the health economics of innovative cancer treatments.

BACKGROUND: Few reports have thus far discussed the influence of economic factors on treatment decision-making by patients. The objective of the present study was to clarify the awareness among oncologists of health economics in cancer treatment. METHODS: The present study was based on the questionnaire regarding health economics in cancer treatment carried out by the Japan Society of Clinical Oncology (JSCO) in July 2013. The subjects were trustees registered with JSCO. The survey investigated the influence of medical expenses on patient access to and selection of medical treatment in order to clarify the primary attributes of the respondents and their awareness of economics. The study also investigated the maximum allowable public medical expenses to prolong the life expectancy of a cancer patient by 1 year and the factors that can influence treatment selection. RESULTS: The 172 respondents had completed a mean of 30.3 ± 6.2 postgraduate years, and the mean number of patients they treated annually was 1323 ± 1963. The degree of treatment accessibility among patients was perceived positively by 112 (71.3 %) and negatively by 49 (28.7 %) of the respondents, irrespective of medical expenses. Of the 172 respondents, 66 (41.0 %) believed that the maximum allowable medical expenses for cancer treatment should be ≤4 million yen/LY, with 62 (39.8 %) reporting a value of 4.01-8 million yen/LY. CONCLUSION: The findings of this study suggest that a certain range of medical expenses has come to be regarded as the standard range of medical expenses for cancer treatment among oncologists, with answers based on the premise that patients should have access to effective medical treatment.

Preliminary report on the cost effectiveness of ventricular assist devices.

The aim of the present study was to perform a cost-effectiveness analysis (CEA) of ventricular assist devices (VAD) implantation surgery in the Japanese medical reimbursement system. The study group consisted of thirty-seven patients who had undergone VAD implantation surgery for dilated cardiomyopathy (n = 25; 67.6 %) or hypertrophic cardiomyopathy (n = 4; 10.8 %), and others (n = 8; 21.6 %). Quality-adjusted life years (QALYs) were calculated using the utility score and years of life. Medical reimbursement bills were chosen as cost indices. The observation period was the 12-month period after surgery. Then, the incremental cost-effectiveness ratio was calculated according to the VAD type. In addition, the prognosis after 36 months was estimated on the basis of the results obtained using the Markov chain model. The mean preoperative INTERMACS profile score was 2.35 ± 0.77. Our results showed that the utility score, which indicates the effectiveness of VAD implantation surgery, improved by 0.279 ± 0.188 (ΔQALY, p < 0.05). The cost of VAD implantation surgery was 313,282 ± 25,275 (ΔUS$/year) on the basis of medical reimbursement bills associated with therapeutic interventions. The calculated result of CEA was 364,501 ± 190,599 (ΔUS$/QALY). The improvement in the utility score was greater for implantable versus extracorporeal VADs (0.233 ± 0.534 vs. 0.371 ± 0.238) and ICER was 303,104 (ΔUS$/ΔQALY). Furthermore, when we estimated CEA for 36 months, the expected baseline value was 102,712 (US$/QALY). Therefore, VAD implantation surgery was cost effective considering the disease specificities.

Assessment of vision-related quality of life among patients with cataracts and the outcomes of cataract surgery using a newly developed visual function questionnaire: the VFQ-J11.

OBJECTIVE: To investigate vision-related quality of life (VRQoL) and associated factors in patients with cataracts and the outcomes of cataract surgery using the newly developed VRQoL instrument: the visual function questionnaire, 11-item Japanese version (the VFQ-J11). METHODS: A total of 457 patients scheduled for cataract surgery at 12 clinical sites from November 2008 through February 2010 were included in the study. The patients completed the VFQ-J11 before and 3 months after surgery. The VFQ-J11 was used to investigate factors associated with VRQoL of the cataract patients, the outcome of cataract surgery, and the predictors of improved VRQoL due to cataract surgery. RESULTS: In a multiple regression model, the VFQ-J11 score was significantly associated with corrected distance visual acuity in the better-seeing eye (better eye VA), and improvement in the VFQ-J11 score after cataract surgery was associated not only with improvement in the better eye VA, but also with improvement in the worse eye VA. Compared to one-eye cataract surgery, both-eyes surgery had a greater impact on VFQ-J11 score improvement. CONCLUSIONS: The VFQ-J11 is a good measure of VRQoL in cataract patients. The present study indicates that by including the domains measured in the VFQ, the VFQ-J11 can provide valid data on VRQoL and be less of a burden for patients.

Cost-utility analysis of cataract surgery in Japan: a probabilistic Markov modeling study.

OBJECTIVE: To evaluate with the best available clinical data in Japan the cost-effectiveness of cataract surgery through the estimation of the incremental costs per quality-adjusted life years (QALYs) gained. METHODS: A Markov model with a probabilistic cohort analysis was constructed to calculate the incremental costs per QALY gained by cataract surgery in Japan. A 1-year cycle length and a 20-year horizon were applied. Best available evidence in Japan supplied the model with data on the course of cataract surgery. Uncertainty was explored using univariate and probabilistic sensitivity analysis. RESULTS: In base case analysis, cataract surgery was associated with incremental costs of Japanese yen (¥) 551,513 (US$ 6,920) and incremental effectiveness of 3.38 QALYs per one cataract patient. The incremental cost effectiveness ratio (ICER) was ¥ 163,331 (US$ 2,049) per QALY. In Monte Carlo simulation, the average patient with cataract surgery accrued 4.65 [95 % confidence interval (CI): 2.75-5.69] more QALYs than patients without surgery, giving an ICER of ¥ 118,460 (95 % CI: 73,516-207,926) (US$ 1,486) per QALY. CONCLUSIONS: Cataract surgery in Japan is highly cost-effective even when allowing for the uncertainty of the known variability that exists in estimates of the costs, utilities, and postoperative complication rate.

[Evaluation of utility index of quality of life (QOL) in prostate cancer patients: comparison of QOL utility index EuroQol-5D (EQ-5D) and visual analogue scale (VAS) with health-related QOL questionnaires SF-36 and EPIC].

PURPOSE: For the management of patients with localized prostate cancer, a number of therapeutic options are available. To compare the therapeutic modalities, it is important and necessary to evaluate economical aspects based on cost-effectiveness analysis. In addition, the survival time adjusted by quality of life (QOL), quality adjusted life year (QALY), is more reliable than the crude survival time. Thus, the usefulness of the commonly used QOL utility indexes, EuroQol-5D (EQ-5D) and visual analogue scale (VAS, 0-100 points), was investigated in prostate cancer patients. PATIENTS AND METHODS: A total of 81 patients with prostate cancer were included. The patients were asked to answer the four sets of questionnaires (EQ-5D, VAS, SF-36 and EPIC). The QOL utility indexes (EQ-5D and VAS) were evaluated in relation to the general and prostate cancer-specific QOL questionnaires (SF-36 and EPIC, respectively). RESULTS: The results of EQ-5D and VAS were significantly correlated to all domains of the general QOL questionnaire (SF-36). On the contrary, no remarkable relationship of EQ-5D and VAS was observed with any domain (urinary, bowel, sexual or hormonal) of the prostate cancer-specific QOL questionnaire (EPIC). There was significant and close correlation between the actual values of VAS and the estimates of VAS calculated from SF-36 data (R = 0.53, p < 0.0001). CONCLUSIONS: The QOL utility indexes (EQ-5D and VAS) are pertinent to evaluation of QOL utility index in prostate cancer patients and can be utilized for cost-utility analysis. It is suggested that the accumulated data of SF-36 could be used by conversion to QOL utility index.

[Study on medical economic evaluation methods for metastatic brain tumors therapy].

INTRODUCTION: Treatment design for metastatic brain tumors is required to firstly care about the life and function for which the patient hopes because it is terminal care. Therefore, to discuss the value of the therapy, a viewpoint of the QOL and the socioeconomic factors other than the survival rate is important. However, examination that applies these factors to the therapy needs to be carried out more thoroughly. With this in mind, we discuss cost effectiveness of therapy for metastatic brain tumor, through a pilot study on gamma knife therapy. MATERIALS AND METHOD: We studied 18 patients (mean age 61.6 years old) undergoing therapy for metastatic brain tumors. The health rate QOL was assessed by the profile-type measure SF-36 (Short-Form 36-Item Ver1.2) and the preference-based measure EQ-5D (EuroQoL-5D), before and six months after gamma knife therapy. Cost-utility-analysis (yen/Qaly) was carried out from quality adjusted life years (Qalys) and medical fee claims. In addition, we made a correlation analysis of the irradiation procedure and the gains attained. RESULTS: The observation by SF-36 for six months was useful for metastatic brain tumor. As a result, the QOL indicators showed increased mental health (MH: p=0.040) and role emotional (RE: p=0.029) with significant difference. In the measurement of EQ-5D, it was added only for one month based on the significant difference (p=0.022) from the pre-therapy QOL. The utilities that were analyzed became 0.052+/-0.175SD (score), and Qalys were 0.135. Because the cost was 721.4+/-5.2SD (thousand yen), the performance of cost-utility-analysis was estimated as 5, 330, 000 (yen/Qaly). In addition, positive correlation (r=0.845/p=0.034) was found between the EQ-5D utility score and the tumor irradiation energy (mJ), etc. CONCLUSION: We established a new value over and above mere survival rate concerning metastatic brain tumor therapy. The socioeconomics and efficacy of therapy are more difficult to discuss in this disease than in other diseases. We did this by clarifying the measurement and analysis of QOL as compared with the cost factor. We found that quantitatively, the mental health rate involved in the QOL, had improved. We established that it is appropriate to cover this disease by public insurance, because cost-utility-analysis showed that it was under the threshold line. Our study also suggested that, when guessing the QOL of the prognosis, there should be grades of sensitivity according to the irradiation element involved in the therapy.