Search

Abstract Background The approval of lecanemab, an anti-amyloid therapy for Alzheimer’s disease (AD), necessitates addressing healthcare preparedness for disease-modifying treatment (DMT) to ensure appropriate, safe, and sustainable drug administration. Understanding public perceptions on this matter is crucial. We aimed to assess discrepancies and similarities in the perceptions of Japanese trial-ready cohort study (‘J-TRC webstudy’) participants and clinical specialists in the fields of dementia treatment and radiology, concerning affairs related to challenges in DMT preparedness. Methods This was a cross-sectional prospective observational study conducted in November–December 2023. The J-TRC webstudy participants were invited to participate in an online survey using Google Forms, and clinical specialists were invited to complete a mail-based survey. Main questionnaire items had been designed to be common in both surveys, and their responses were analyzed for participant attributes, interests, attitudes, expectations, and concerns about DMTs without specifying lecanemab. Results Responses were obtained from n = 2,050 J-TRC webstudy participants and n = 1,518 clinical specialists. Compared to specialists, more J-TRC respondents perceived the eligible proportion for DMT as smaller (59.1% versus 30.7%), perceived the eligible severity for DMT as more limited (58.0% versus 24.5%), and perceived the efficacy of DMT as slightly more encouraging (29.3% versus 34.8%). In terms of treatment prioritization, both J-TRC respondents and specialist respondents exhibited similar levels of acceptance for prioritizing patients to treat: e.g., approximately two-thirds endorsed patient prioritization under hypothetical resource constraints or other reasons. A medical rationale emerged as the most compelling reason for acceptance of patient prioritization across the surveys. In contrast, the need to address vulnerable populations was the reason that led to the least acceptance of prioritization, followed by economic considerations. Conclusions Our findings offer valuable insights into the discrepancies in knowledge and perception between patients and healthcare providers. This could enhance the delivery of patient information in clinical settings and inform the discussion surrounding patient prioritization strategies.

ABSTRACTBackground Respiratory syncytial virus (RSV), a common respiratory pathogen, can lead to severe symptoms, especially in older adults (OA). A recently developed RSV prefusion F protein (RSVPreF3 OA) vaccine confers high protection against RSV lower respiratory tract disease (LRTD) over two full RSV seasons. The aim of this study was to assess the potential public health impact of RSVPreF3 OA vaccination in the Japanese OA population.Research design and methods A static Markov model was used to estimate the number of symptomatic RSV cases, hospitalizations and deaths in the Japanese population aged ≥ 60 years over a 3-year time horizon. Japan-specific RSV epidemiology and healthcare resource use parameters were used; vaccine efficacy was derived from a phase 3 randomized study (AReSVi-006, NCT04886596). Vaccination coverage was set to 50%.Results Without vaccination, >5 million RSV acute respiratory illness (ARI) would occur (2.5 million LRTD and 2.8 million upper respiratory tract infections) leading to ~ 3.5 million outpatient visits, >534,000 hospitalizations and ~ 25,500 RSV-related deaths over 3 years. Vaccination could prevent > 1 million RSV-ARI cases, 728,000 outpatient visits, 143,000 hospitalizations and 6,840 RSV-related deaths.Conclusions RSVPreF3 OA vaccination is projected to have a substantial public health impact by reducing RSV-related morbidity and mortality in the OA population.

ABSTRACTBackground This study aimed to evaluate VE of primary, first, and second booster ancestral-strain monovalent mRNA COVID-19 vaccination against symptomatic infections and severe diseases in Japan.Methods We conducted a test-negative case-control study. We included medically attended episodes and hospitalizations involving individuals aged [Formula: see text]16 with signs and symptoms from July to November 2022, when Omicron BA.5 was dominant nationwide. To evaluate VE, we calculated adjusted ORs of vaccination among test-positive versus test-negative individuals using a mixed-effects logistic regression.Results For VE against symptomatic infections among individuals aged 16 to 59, VE of primary vaccination at > 180 days was 26.1% (95% CI: 10.6–38.8%); VE of the first booster was 58.5% (48.4–66.7%) at [Formula: see text]90 days, decreasing to 41.1% (29.5–50.8%) at 91 to 180 days. For individuals aged [Formula: see text]60, VE of the first booster was 42.8% (1.7–66.7%) at [Formula: see text]90 days, dropping to 15.4% (−25.9–43.2%) at 91 to 180 days, and then increasing to 44.0% (16.4–62.5%) after the second booster. For VE against severe diseases, VE of the first and second booster was 77.3% (61.2–86.7%) at [Formula: see text]90 days and 55.9% (23.4–74.6%) afterward.Conclusion mRNA booster vaccination provided moderate protection against symptomatic infections and high-level protection against severe diseases during the BA.5 epidemic in Japan.

Objectives The use of digital technology in surgery is increasing rapidly, with a wide array of new applications from presurgical planning to postsurgical performance assessment. Understanding the clinical and economic value of these technologies is vital for making appropriate health policy and purchasing decisions. We explore the potential value of digital technologies in surgery and produce expert consensus on how to assess this value.Design A modified Delphi and consensus conference approach was adopted. Delphi rounds were used to generate priority topics and consensus statements for discussion.Setting and participants An international panel of 14 experts was assembled, representing relevant stakeholder groups: clinicians, health economists, health technology assessment experts, policy-makers and industry.Primary and secondary outcome measures A scoping questionnaire was used to generate research questions to be answered. A second questionnaire was used to rate the importance of these research questions. A final questionnaire was used to generate statements for discussion during three consensus conferences. After discussion, the panel voted on their level of agreement from 1 to 9; where 1=strongly disagree and 9=strongly agree. Consensus was defined as a mean level of agreement of >7.Results Four priority topics were identified: (1) how data are used in digital surgery, (2) the existing evidence base for digital surgical technologies, (3) how digital technologies may assist surgical training and education and (4) methods for the assessment of these technologies. Seven consensus statements were generated and refined, with the final level of consensus ranging from 7.1 to 8.6.Conclusion Potential benefits of digital technologies in surgery include reducing unwarranted variation in surgical practice, increasing access to surgery and reducing health inequalities. Assessments to consider the value of the entire surgical ecosystem holistically are critical, especially as many digital technologies are likely to interact simultaneously in the operating theatre.

Background: NVX-CoV2373 is one of the vaccines marketed for COVID-19 prevention in Japan. Information on its cost-effectiveness is important for making well-informed decisions on the future of Japan’s COVID-19 vaccination programme from the public healthcare payer’s perspective. The aim of this study was to evaluate the cost-effectiveness of NVX-CoV2373 vaccination in the elderly Japanese population. Methods: Two analysis populations that included elderly Japanese individuals (aged ≥ 65 years) were defined in this study: those who had not received a COVID-19 vaccine or had not completed a primary vaccination series (i.e., first two vaccinations) with an approved COVID-19 vaccine (analysis population 1), and those who had received two primary vaccinations with an approved COVID-19 vaccine (analysis population 2). A literature-informed Markov model for each analysis population was developed to evaluate the cost-effectiveness of vaccination with NVX-CoV2373 against no vaccination with NVX-CoV2373 from the public healthcare payer’s perspective as a base-case analysis and from the societal perspective as a scenario analysis. Vaccine efficacy was estimated from a phase 3 study of NVX-CoV2373 (EudraCT number: 2020–004123-16). Cost-effectiveness was assessed using a willingness-to-pay threshold of Japanese yen (JPY) 5 million per quality-adjusted life-year (QALY). Deterministic and probabilistic sensitivity analyses were also performed. Results: For analysis population 1, NVX-CoV2373 primary and booster vaccinations would reduce costs by JPY 37,647 and prolong QALYs by 0.01601. Therefore, NVX-CoV2373 primary and booster vaccinations were considered to be dominant over no vaccination. For analysis population 2, an NVX-CoV2373 booster vaccination would increase costs by JPY 5010 and prolong QALYs by 0.00550, with the incremental cost-effectiveness ratio of JPY 910,566 per QALY gained. Conclusions: Our analyses suggest that a vaccination strategy with NVX-CoV2373 is cost-effective in the elderly population (aged ≥ 65 years) of Japan.

Abstract Background This study evaluates cost reduction in participants of a health awareness program (the Center of Healthy Aging Program, CHAP) in a Japanese rural area, characterized by an annual check-up and personalized interview on health issues and related risks immediately after the check-up. Methods This is a cross-sectional study using medical and caregiving costs and Japan-specific health check-up results in Hirosaki residents stored by the local government, which were individually-based linked to the CHAP information collected by Hirosaki University. This is the first study that used anonymized data with individually-based linkages to both a research institute and a local government in Japan under a strict limitation regarding linking to third-party data. We included residents who had been continuously enrolled for > 6 months as of 1 July 2015. We compared 5-year all-cause costs between three groups (with CHAP, with Japan-specific health check-up, and no check-up) using a multivariate negative binomial regression model considering risk factors including lifestyle habits and an inverse probability weight to adjust for baseline characteristics: age, sex, Charlson comorbidity index, baseline care level, and risk score of coronary heart diseases. Results A total of 384, 9805, and 32,630 residents aged 40–74 years were included for the CHAP, Japan-specific health check-up, and no check-up groups, respectively. The Japan-specific health check-up group showed older and higher Charlson comorbidity index than the others. After inverse probability weight adjusting, the amount of all-cause medical costs was significantly lower only in the CHAP group. Faster walking speed and exercise habits were independently associated with lower all-cause medical and caregiving costs. Conclusions We demonstrated a 5-year all-cause cost reduction in residents who participated in the CHAP and also suggested the effect of exercise habits in Hirosaki, which indicated the significance of individually-based data linkages to external third-party data for all local governments to improve the health condition of residents.

BackgroundDemographic changes and a low birth rate have led to a workforce shortage in Japan. To address this issue, the government has promoted engagement of female employment. However, increased female employment can impact women's health. Using Internet of Things (IoT) and apps to manage women's health has gained attention, but few studies have focused on working women. ObjectiveThis study aimed to clarify the current situation of working women and their use of IoT or apps to manage their health. MethodsA large-scale, nationwide internet survey was conducted among 10,000 female participants aged from 20 years to 64 years in Japan. Participants were recruited from a marketing research company’s active survey panel of 5.24 million members. The survey included questions about health status, sociodemographic factors, psychological characteristics, and the use of IoT or apps for health management. We compared perceived health status and reasons for current IoT use using t tests and assessed participant characteristics that predicted IoT use using the C5.0 decision tree algorithm. Ethical approval was granted by St. Luke's International University. ResultsAmong participants, 14.6% (1455/10,000) currently used IoT or apps, 7% (695/10,000) used them previously, and 78.5% (7850/10,000) had never used them. Current users (42.7 years old) were older than past users (39.7 years old). Discrepancies were observed between participants’ perceived health problems and the purpose for using IoT or apps, with 21.3% (2130/10,000) of all women reporting they experienced menstrual symptoms or disorders but only 3.5% (347/10,000) used IoT or apps to manage the same symptom. On the other hand, current users were more likely to use IoT or apps to manage nutrition-related problems such as underweight or obesity (405/1455, 27.8%). Device use was highest among current users, with 87.3% (1270/1455) using smartphones, 19.7% (287/1455) using smartwatches, and 13.3% (194/1455) using PCs. Decision tree analysis identified 6 clusters, the largest consisting of 81.6% (5323/6523) of non-IoT users who did not exercise regularly, while pregnant women were more likely to use IoT or apps. ConclusionsOur findings highlight the idea that woman with particular health problems (ie, menstrual symptoms or disorders and premenstrual syndrome) have lower use of IoT or apps, suggesting an unmet need for IoT and apps in specific areas.

Summary: Aim: Constipation is a common complication in patients receiving enteral nutrition, and fecal incontinence caused by laxative use can lead to a decrease in patients' quality of life and an increase in the burden on healthcare providers. This study aimed to investigate the effects of a high-fiber liquid diet on constipation and defecation care. Methods: An anonymous online survey of 184 healthcare providers was conducted on the use of ISOCAL® Fibecare (IF). Results: Many patients who used IF experienced underlying neurological disease (56.5%), and the number of days of use (mean ± standard deviation [SD]) was 41.6 ± 41.5 days. The intake of dietary fiber before and after IF use increased significantly from 11.2 ± 7.6 to 23.8 ± 5.6 g/day (P < 0.001), the number of normal bowel movements per week increased from 1.4 ± 1.8 to 1.9 ± 2.4 times/week (P < 0.01), and the number of people not receiving constipation treatment increased significantly from 19 (10.3%) to 47 (25.5%) (P < 0.001). With treatment, the use of osmotic laxatives, diphenylmethane derivatives, and enemas significantly decreased. Changes after the use of IF included decreased burden of defecation care for 31.0% of respondents, decreased frequency of bed sheet changes due to fecal soil in 22.2%, and decreased frequency of diaper exchange in 15.2%. Conclusions: Our findings suggest that the use of IF reduces the burden of healthcare providers at the time of defecation care due to the increased number of normal stools and decreased use of laxatives and enemas. Trial Registry: https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055173.

Background Evaluating COVID-19 vaccine effectiveness (VE) domestically is crucial for assessing and determining national vaccination policy. This study aimed to evaluate VE of mRNA COVID-19 vaccines in Japan. Methods We conducted a multicenter test-negative case-control study. The study comprised individuals aged ≥16 visiting medical facilities with COVID-19-related signs or symptoms from 1 January to 26 June 2022, when Omicron BA.1 and BA.2 were dominant nationwide. We evaluated VE of primary and booster vaccination against symptomatic SARS-CoV-2 infections and relative VE of booster compared with primary. Results We enrolled 7,931 episodes, including 3,055 test positive. The median age was 39, 48.0% were male, and 20.5% had underlying medical conditions. In individuals aged 16 to 64, VE of primary vaccination within 90 days was 35.6% (95% CI, 19.0–48.8%). After booster, VE increased to 68.7% (60.6–75.1%). In individuals aged ≥65, VE of primary and booster was 31.2% (−44.0–67.1%) and 76.5% (46.7–89.7%), respectively. Relative VE of booster compared with primary vaccination was 52.9% (41.0–62.5%) in individuals aged 16 to 64 and 65.9% (35.7–81.9%) in individuals aged ≥65. Conclusions During BA.1 and BA.2 epidemic in Japan, mRNA COVID-19 primary vaccination provided modest protection. Booster vaccination was necessary to protect against symptomatic infections.

Abstract Introduction Alzheimer’s disease (AD), a neurodegenerative disorder that progresses from mild cognitive impairment (MCI) to dementia, is responsible for significant burden on caregivers and healthcare systems. In this study, data from the large phase III CLARITY AD trial were used to estimate the societal value of lecanemab plus standard of care (SoC) versus SoC alone against a range of willingness-to-pay (WTP) thresholds from a healthcare and societal perspective in Japan. Methods A disease simulation model was used to evaluate the impact of lecanemab on disease progression in early AD based on data from the phase III CLARITY AD trial and published literature. The model used a series of predictive risk equations based on clinical and biomarker data from the Alzheimer’s Disease Neuroimaging Initiative and Assessment of Health Economics in Alzheimer’s Disease II study. The model predicted key patient outcomes, including life years (LYs), quality-adjusted life years (QALYs), and total healthcare and informal costs of patients and caregivers. Results Over a lifetime horizon, patients treated with lecanemab plus SoC gained an additional 0.73 LYs compared with SoC alone (8.50 years vs. 7.77 years). Lecanemab, with an average treatment duration of 3.68 years, was found to be associated with a 0.91 increase in patient QALYs and a total increase of 0.96 when accounting for caregiver utility. The estimated value of lecanemab varied according to the WTP thresholds (JPY 5–15 million per QALY gained) and the perspective employed. From the narrow healthcare payer’s perspective, it ranged from JPY 1,331,305 to JPY 3,939,399. From the broader healthcare payer’s perspective, it ranged from JPY 1,636,827 to JPY 4,249,702, while from the societal perspective, it ranged from JPY 1,938,740 to JPY 4,675,818. Conclusion The use of lecanemab plus SoC would improve health and humanistic outcomes with reduced economic burden for patients and caregivers with early AD in Japan.

BackgroundWestern guidelines often recommend biguanides as the first-line treatment for diabetes. However, dipeptidyl peptidase-4 (DPP-4) inhibitors, alongside biguanides, are increasingly used as the first-line therapy for type 2 diabetes (T2DM) in Japan. However, there have been few studies comparing the effectiveness of biguanides and DPP-4 inhibitors with respect to diabetes-related complications and cardio-cerebrovascular events over the long term, as well as the costs associated.ObjectiveWe aimed to compare the outcomes of patients with T2DM who initiate treatment with a biguanide versus a DPP-4 inhibitor and the long-term costs associated.MethodsWe performed a cohort study between 2012 and 2021 using a new-user design and the Shizuoka Kokuho database. Patients were included if they were diagnosed with T2DM. The primary outcome was the incidence of cardio-cerebrovascular events or mortality from the initial month of treatment; and the secondary outcomes were the incidences of related complications (nephropathy, renal failure, retinopathy, and peripheral neuropathy) and the daily cost of the drugs used. Individuals who had experienced prior events during the preceding year were excluded, and events within 6 months of the start of the study period were censored. Propensity score matching was performed to compare between two groups.ResultsThe matched 1:5 cohort comprised 529 and 2,116 patients who were initially treated with a biguanide or a DPP-4 inhibitor, respectively. Although there were no significant differences in the incidence of cardio-cerebrovascular events or mortality and T2DM-related complications between the two groups (p = 0.139 and p = 0.595), daily biguanide administration was significantly cheaper (mean daily cost for biguanides, 61.1 JPY; for DPP-4 inhibitors, 122.7 JPY; pConclusionIn patients with T2DM who initiate pharmacotherapy, there were no differences in the long-term incidences of cardio-cerebrovascular events or complications associated with biguanide or DPP-4 use, but the former was less costly.

ABSTRACTPurpose: Remarkable progress in healthcare technology has recently been made alongside changes in concepts related to drugs and medical devices. It is speculated that this progress benefits not only patients but also healthcare professionals, such as medical doctors. We performed a systematic review of the characteristics of current data assessment tools to measure medical doctors’ work-related quality of life (QOL).Methods: A literature search was conducted through PubMed and Ichushi-Web in 2020. The related search terms used were ‘medical doctor,’ ‘quality of work life,’ and ‘questionnaire/interview.’ Two reviewers independently screened the studies, and the characteristics of the QOL assessment tools used in the identified studies were qualitatively reviewed and summarized.Results: In total, 5,443 and 760 articles were retrieved from PubMed and Ichushi-Web, respectively, of which 82 studies were included in this review. Sixty-five (79%) studies used structured questionnaires, and 17 (21%) studies used semistructured questionnaires. In terms of the study purpose, the identified studies mainly included four: mental health, the work or labor situation, satisfaction, and QOL. Components used to measure work-related QOL included satisfaction, burnout, QOL, the work environment, stress, mental health, work-life balance, and others. None of the studies used an originally developed QOL questionnaire to assess the work-related benefits of medical doctors.Conclusion: This systematic review found that there is a lack of studies directly assessing the work-related QOL of medical doctors and a lack of effective data collection tools to assess all work-related QOL components.

ABSTRACTBackground Perianal fistula (PF), a complication of Crohn’s disease (CD), affects health-related quality of life (QOL).Objective To elucidate QOL of health states corresponding to different stages of PF associated with CD in Japan.Method This cross-sectional, observational, web-based questionnaire survey assessed eight different health states in patients with CD and PF and individuals without CD (non-patients) from the Medilead Healthcare Panel (MHP) and determined the utility values (QOL scores) in each health state by the time trade-off method. In patients, we determined also the utility value of the current health state associated with CD and the PF. The analysis excluded respondents with logical inconsistencies.Results The analysis included 82 patients and 576 non-patients with the same sex and age distribution as the Japanese population. In both groups, mean utility values were higher in remission (patients, 0.78; non-patients, 0.51) than in non-remission states, with lowest values for poor prognosis after proctectomy (patients, 0.13; non-patients, −0.10) and highest values for the state with mild symptoms (patients, 0.60; non-patients, 0.30). In patients, the mean utility value of the current health state was 0.71.Conclusion QOL decreases with increasing severity of PF and is lower for good prognosis after proctostomy than for remission.

This analysis estimates the economic and clinical impact of a Moderna updated COVID-19 mRNA Fall 2023 vaccine for adults ≥18 years in Japan. A previously developed Susceptible-Exposed-Infected-Recovered (SEIR) model with a one-year analytic time horizon (September 2023–August 2024) and consequences decision tree were used to estimate symptomatic infections, COVID-19 related hospitalizations, deaths, quality-adjusted life years (QALYs), costs, and incremental cost-effectiveness ratio (ICER) for a Moderna updated Fall 2023 vaccine versus no additional vaccination, and versus a Pfizer–BioNTech updated mRNA Fall 2023 vaccine. The Moderna vaccine is predicted to prevent 7.2 million symptomatic infections, 272,100 hospitalizations and 25,600 COVID-19 related deaths versus no vaccine. In the base case (healthcare perspective), the ICER was ¥1,300,000/QALY gained ($9400 USD/QALY gained). Sensitivity analyses suggest results are most affected by COVID-19 incidence, initial vaccine effectiveness (VE), and VE waning against infection. Assuming the relative VE between both bivalent vaccines apply to updated Fall 2023 vaccines, the base case suggests the Moderna version will prevent an additional 1,100,000 symptomatic infections, 27,100 hospitalizations, and 2600 deaths compared to the Pfizer–BioNTech vaccine. The updated Moderna vaccine is expected to be highly cost-effective at a ¥5 million willingness-to-pay threshold across a wide range of scenarios.

Abstract 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.

Background: Regular visits with healthcare professionals are important for preventing serious complications in patients with diabetes. The purpose of this retrospective cohort study was to clarify whether there was any suppression of physician visits among patients with diabetes during the spread of the novel coronavirus 2019 (COVID-19) in Japan and to assess whether telemedicine contributed to continued visits. Methods: We used the JMDC Claims database, which contains the monthly claims reported from July 2018 to May 2020 and included 4,595 (type 1) and 123,686 (type 2) patients with diabetes. Using a difference-in-differences analysis, we estimated the changes in the monthly numbers of physician visits or telemedicine per 100 patients in April and May 2020 compared with the same months in 2019. Results: For patients with type 1 diabetes, the estimates for total overall physician visits were −2.53 (95% confidence interval [CI], −4.63 to 0.44) in April and −8.80 (95% CI, −10.85 to −6.74) in May; those for telemedicine visits were 0.71 (95% CI, 0.47–0.96) in April and 0.54 (95% CI, 0.32–0.76) in May. For patients with type 2 diabetes, the estimates for overall physician visits were −2.50 (95% CI, −2.95 to −2.04) in April and −3.74 (95% CI, −4.16 to −3.32) in May; those for telemedicine visits were 1.13 (95% CI, 1.07–1.20) in April and 0.73 (95% CI, 0.68–0.78) in May. Conclusion: The COVID-19 pandemic was associated with suppression of physician visits and a slight increase in the utilization of telemedicine among patients with diabetes during April and May 2020.

Objective To describe the prevalence of multimorbidity and its associations with clinical outcomes across age groups.Design Retrospective cohort study using nationwide medical claims data.Setting Carried out in Japan between April 2014 and March 2019.Participants N=246 671 Japanese individuals aged 20–74 enrolled in the health insurance were included into the baseline data set for fiscal year (FY) 2014. Of those, N=181 959 individuals were included into the cohort data set spanning FY2014–FY2018.Exposures Multimorbidity was defined as having ≥2 of 15 chronic conditions according to the International Classification of Diseases 10th Revision codes of the Charlson Comorbidity Index.Primary and secondary outcomes Primary outcome: the standardised prevalence of multimorbidity across age groups was evaluated using data from FY2014 and extrapolated to the Japanese total population. Secondary outcome: hospitalisation or death events were traced by month using medical claims data and insurer enrolment data. Associations between multimorbidity and 5-year hospitalisation and/or death events across age groups were analysed using a Cox regression model.Results The standardised prevalence rate of multimorbidity in the nationwide Japanese total population was estimated to 26.1%. The prevalence rate with age was increased, approximately 5% (ages 20–29), 10% (30–39), 20% (40–49), 30% (50–59), 50% (60–69) and 60% (70–74). Compared with individuals aged 20–39 without multimorbidity, those with multimorbidity had a higher incidence of clinical events in any age group (HR=2.43 (95% CI 2.30 to 2.56) in ages 20–39, HR=2.55 (95% CI 2.47 to 2.63) in ages 40–59 and HR=3.41 (95% CI 3.23 to 3.53) in ages ≥60). The difference in the incidence of clinical events between multimorbidity and no multimorbidity was larger than that between age groups.Conclusions Multimorbidity is already prevalent in the middle-aged generation and is associated with poor clinical outcomes. These findings underscore the significance of multimorbidity and highlight the urgent need for preventive intervention at the public healthcare level.

AIM: To evaluate the cost-utility of iStent inject® with cataract surgery vs cataract surgery alone in patients with mild-to-moderate primary open angle glaucoma (POAG) in the Japanese setting from a public payer's perspective. METHODS: A Markov model was adapted to estimate the cost-utility of iStent inject® plus cataract surgery vs cataract surgery alone in one eye in patients with mild-to-moderate POAG over lifetime horizon from the perspective of Japanese public payer. Japanese sources were used for patients' characteristics, clinical data, utility, and costs whenever available. Non-Japanese data were validated by Japanese clinical experts. RESULTS: In the probabilistic base case analysis, iStent inject® with cataract surgery was found to be cost-effective compared with cataract surgery alone over a lifetime horizon when using the ¥5 000 000/quality-adjusted life year (QALY) willingness-to-pay threshold. The incremental cost-utility ratio (ICUR) was estimated to be ¥1 430 647/QALY gained and the incremental cost-utility ratio (ICER) was estimated to be ¥12 845 154/blind eye avoided. iStent inject® with cataract surgery vs cataract surgery alone was found to increase costs (¥1 025 785 vs ¥933 759, respectively) but was more effective in increasing QALYs (12.80 vs 12.74) and avoiding blinded eyes (0.133 vs 0.141). The differences in costs were mainly driven by costs of primary surgery (¥279 903 vs ¥121 349). In the scenario analysis from a societal perspective, which included caregiver burden, iStent inject® with cataract surgery was found to dominate cataract surgery alone. CONCLUSION: The iStent inject® with cataract surgery is a cost-effective strategy over cataract surgery alone from the public payer's perspective and cost-saving from the societal perspective in patients with mild-to-moderate POAG in Japan.

Abstract Background Improvements in the use of polypharmacy or potentially inappropriate medication (PIM) may reduce medication costs in Japan. We aimed to evaluate the impact of improvement in prescription on both overall health outcomes and medication costs in Japanese facilities for older people. Methods Residents in Japanese facilities for older people between March 2019 and March 2020 were included in this study. The following five indices were used to evaluate overall health outcomes: EuroQoL-5D-5L, Barthel Index, Mini Mental State Examination, Dementia Behaviour Disturbance Scale, and Vitality Index. The team, which consisted of one physician and several pharmacists, suggested improved prescriptions for the attending physicians of the participants. The impact of improvement in prescriptions on the health outcomes score, medication costs, and the number of medications were evaluated through two comparison groups: those whose number of medications decreased (decrement group, DG) and those whose medications did not (not decrement group, NDG); those prescribed PIMs in March 2019 and those not prescribed PIMs in March 2020 (improvement group, IG) and those prescribed PIMs both in March 2019 and March 2020 (not improvement group, NIG). In both comparison groups, propensity score matching was performed to balance demographics, and all health outcome scores, medication costs, and the number of medications in March 2020 were assessed using a t-test. Statistical significance was set at a p-value of

Introduction: Pneumococcal diseases (PDs) are among the leading causes of mortality and morbidity worldwide. However, the evidence on epidemiology, health economic, and patient-reported outcomes has not been systematically reviewed and published in Japan. This study aimed to assess the burden, treatment adherence and compliance, and serotype distribution associated with PDs in Japan. Method: One hundred and eight studies were identified between January 2005 and June 2020. The identified studies were mostly regional and with a limited scale, clinical settings, and populations. Results: In 2013–2017, invasive PD incidence rates were 4.98–9.47/100,000 in

Background Although medical costs need to be controlled, there are no easily applicable cost prediction models of transfer to palliative care (PC) for terminal cancer patients.Objective Construct a cost-saving prediction model based on terminal cancer patients’ data at hospital admission.Study design Retrospective cohort study.Setting A Japanese general hospital.Patients A total of 139 stage IV cancer patients transferred to PC, who died during hospitalization from April 2014 to March 2019.Main outcome measure Patients were divided into higher (59) and lower (80) total medical costs per day after transfer to PC. We compared demographics, cancer type, medical history, and laboratory results between the groups. Stepwise logistic regression analysis was used for model development and area under the curve (AUC) calculation.Results A cost-saving prediction model (AUC = 0.78, 95% CI: 0.70, 0.85) with a total score of 13 points was constructed as follows: 2 points each for age ≤ 74 years, creatinine ≥ 0.68 mg/dL, and lactate dehydrogenase ≤ 188 IU/L; 3 points for hemoglobin ≤ 8.8 g/dL; and 4 points for potassium ≤ 3.3 mEq/L.Conclusion Our model contains five predictors easily available in clinical settings and exhibited good predictive ability.

PURPOSEIn 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.METHODSWe 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.RESULTSThe 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).CONCLUSIONWe 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.

To promote health awareness and improve life expectancy in Hirosaki, a Japanese rural area, the Center of Healthy Aging Program (CHAP) was founded in 2013. The most important characteristic of CHAP is a personalized interview just after the checkup to discuss individual results. We evaluated the clinical and economic effects of CHAP by analyzing the cohort data of voluntary participants from annual health checkups since 2005 in the Iwaki district of Hirosaki. We calculated 10-year incidence risk scores for coronary heart diseases (CHDs) and stroke, and compared the risk-score trend before and after the start of CHAP by adjusting other risk factors using multivariate generalized linear regression analyses. We also predicted the 10-year incidences of CHDs and stroke based on the risk scores, for future scenarios of the two conditions, with and without CHAP, and compared them to their treatment costs between scenarios. The number of participants ranged between 808 and 1,167, from 2008 to 2016. The mean age (55 years) and proportion of women (60%) did not significantly change throughout the period. After adjusting for sex, age, outside temperature on the checkup date, the preparation effect of CHAP in 2012, and risk scores in the previous year, the annual increases in risk scores of CHDs and stroke were significant even after CHAP (+0.413, p

Background. In the 2010s, medications with new mechanisms were introduced in Japan for the treatment of chronic idiopathic constipation (CIC). A few systematic reviews have compared medications’ relative efficacy, but the reviews included studies on patients from various races, even though the mechanism of CIC is considered to differ between races. The aim of this study was to use a systematic review and network meta-analysis to compare the relative efficacy of these medications in Japanese patients. Methods. We conducted a meta-analysis and report it here according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). We identified studies by searching MEDLINE (via the PubMed interface) and the Cochrane Library and ICHUSHI databases and included randomized clinical trials that compared medications for CIC with placebo in Japanese adults. Two reviewers independently screened and assessed articles, abstracted data, and assessed the risk of bias. We pooled data by random-effects meta-analyses and also performed a Bayesian network meta-analysis to indirectly compare data. Results. The present systematic review and meta-analyses included 1460 patients in 6 randomized clinical trials: 2 on linaclotide, 3 on elobixibat, 2 on lubiprostone, and 1 on lactulose. The results of direct comparisons showed that linaclotide, elobixibat, and lubiprostone were superior to placebo in the change of spontaneous bowel movements (SBMs) within 1 week: linaclotide, 1.95 (95% CI, 1.51-2.39); elobixibat, 5.69 (95% CI, 3.31-8.07); and lubiprostone, 2.41 (95% CI, 0.82-4.01). The Bayesian network meta-analysis showed consistent results. Elobixibat 10 mg was ranked first for the increase in SBMs and complete SBMs within 1 week and the time to first SBM. Lubiprostone 48 μg was ranked first for the proportion of patients with SBM within 24 hours. Conclusion. Our direct and indirect meta-analyses revealed that the new CIC medications available in Japan have equal efficacy but that elobixibat and lubiprostone are highly likely to be more efficacious.

Background: Dementia has become a growing health-care problem in the rapidly ageing Japanese population. This study assesses the impact of dementia on quality of life, economic burden, and productivity loss. Objective: The objective of this study was to assess the impact of dementia on the Quality of Life (QoL), economic burden, and productivity loss among families living with dementia. Methods: An online survey was conducted among families who lived with relatives with dementia. Demographic data and information about health condition and costs of long-term care and treatment were collected. Participants were asked to answer the EuroQol (EQ-5D-5L) questionnaire, Zarit Burden Interview (ZARIT-8), and Work Productivity and Activity Impairment Questionnaire (WPAI). Multivariate analyses were conducted to assess factors associated with burden by families living with dementia. Results: Six hundred and thirty-five participants completed the survey. Of these participants, 50.5% were primary caregivers. Overall, 78.7% of dementia patients suffered from Alzheimer, and 43.9% needed long-term care. Compared to non-primary caregivers, primary caregivers had lower health utility scores (0.896 vs 0.873; p = 0.02), higher burden of caregiving (ZARIT-8: 21.1 vs 24.5; p

ObjectiveTo investigate the cost differences between magnetic resonance-guided focussed ultrasound (MRgFUS) and unilateral deep brain stimulation (DBS) for the treatment of medication-refractory essential tremor (ET) in Japan using a cost-minimisation model.MethodsA cost-minimisation model estimated total costs for MRgFUS and unilateral DBS by summing the pre-procedure, procedure, and post-procedure costs over a 12-month time horizon, using data from published sources and expert clinical opinion. The model base case considered medical costs from fee-for-service tariffs. Scenario analyses investigated the use of Diagnosis Procedure Combination tariffs, a diagnosis-related group-based fixed-payment system, and the addition of healthcare professional labour costs healthcare professionals using tariffs from the Japanese Health Insurance Federation for Surgery. One-way sensitivity analyses altered costs associated with tremor recurrence after MRgFUS, the extraction rate following unilateral DBS, the length of hospitalisation for unilateral DBS and the procedure duration for MRgFUS. The impact of uncertainty in model parameters on the model results was further explored using probabilistic sensitivity analysis.ResultsCompared to unilateral DBS, MRgFUS was cost saving in the base case and Diagnosis Procedure Combination cost scenario, with total savings of JPY400,380 and JPY414,691, respectively. The majority of savings were accrued at the procedural stage. Including labour costs further increased the cost differences between MRgFUS and unilateral DBS. Cost savings were maintained in each sensitivity analysis and the probabilistic sensitivity analysis, demonstrating that the model results are highly robust.ConclusionsIn the Japanese healthcare setting, MRgFUS could be a cost saving option versus unilateral DBS for treating medication-refractory ET. The model results may even be conservative, as the cost of multiple follow-ups for unilateral DBS and treatment costs for adverse events associated with each procedure were not included. This model is also consistent with the results of other economic analyses of MRgFUS versus DBS in various settings worldwide.

Purpose: Due to the use of multiple drugs and prevalence of diminished cognitive function, community-dwelling elderly individuals are more likely to have drug-related issues. We examined changes in quality of life (QOL) and activities of daily living (ADL) 3 months and 6 months after reducing drug use of dementia patients who had newly begun community-dwelling care. Methods: Prescription drug use was reduced in the intervention group, whereas the non-intervention group continued their regimen or began using additional drugs. QOL and ADL were assessed with the Japanese version of the EQ-5D and the Barthel Index, respectively. Results: Subjects were 32 individuals aged ≥65 years who had begun community-dwelling between March and July 2014 and had received approval for long-term care insurance. On average, the intervention group (n = 19) stopped using 2.6 prescription drugs. After 6 months, the differences in the QOL and ADL scores in the intervention group were -0.03 ± 0.29 and 6.32 ± 18.6, respectively, while the differences in the QOL and ADL scores in the non-intervention group (n = 13) were -0.13 ± 0.29 and -2.69 ± 23.7, respectively. In the intervention group, ADL scores were significantly increased by 14.0 ± 11.1 6 months after reduced benzodiazepine use. Conclusions: QOL was maintained with reduced drug use, while ADL score was slightly increased. In addition, the reduction of benzodiazepine use significantly increased ADL. In order to reduce polypharmacy among community-dwelling elderly patients, it is necessary to create an opportunity for pharmacists to re-examine their prescriptions This article is open to POST-PUBLICATION REVIEW. Registered readers (see “For Readers”) may comment by clicking on ABSTRACT on the issue’s contents page.

Health literacy (HL) refers to the ability to obtain, process, and understand basic health information and services, and is thus needed to make appropriate health decisions. The Newest Vital Sign (NVS) is comprised of 6 questions about an ice cream nutrition label and assesses HL numeracy skills. We developed a Japanese version of the NVS (NVS-J) and evaluated the validity and reliability of the NVS-J in patients with chronic pain. The translation of the original NVS into Japanese was achieved as per the published guidelines. An observational study was subsequently performed to evaluate the validity and reliability of the NVS-J in 43 Japanese patients suffering from chronic pain. Factor analysis with promax rotation, using the Kaiser criterion (eigenvalues ≥1.0), and a scree plot revealed that the main component of the NVS-J consists of three determinative factors, and each factor consists of two NVS-J items. The criterion-related validity of the total NVS-J score was significantly correlated with the total score of Ishikawa et al.'s self-rated HL Questionnaire, the clinical global assessment of comprehensive HL level, cognitive function, and the Brinkman index. In addition, Cronbach's coefficient for the total score of the NVS-J was adequate (alpha = 0.72). This study demonstrated that the NVS-J has good validity and reliability. Further, the NVS-J consists of three determinative factors: "basic numeracy ability," "complex numeracy ability," and "serious-minded ability." These three HL abilities comprise a 3-step hierarchical structure. Adequate HL should be promoted in chronic pain patients to enable coping, improve functioning, and increase activities of daily living (ADLs) and quality of life (QOL).

Objective: We compared the incidence rates of hospitalized infections (HIs) between tocilizumab (TCZ) and other biological/targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs) in adults aged ≥75 years with rheumatoid arthritis (RA). Methods: We used a Japanese claims database from Medical Data Vision Co., Ltd (Tokyo, Japan) to perform a retrospective longitudinal population-based study in patients with RA who were prescribed b/tsDMARDs between 2014 and 2019. We calculated adjusted risk ratios (aRRs) for HIs in three age groups (<65, ≥65 and <75, and ≥75 years). Results: Of 5506 patients, 2265 (41.1%) were <65 years, 1709 (31.0%) were 65–74 years, and 1532 (27.8%) were ≥75 years. Crude incidence rates (/100 person-years) of HIs were 3.99, 7.27, and 10.77, respectively. In the oldest group, aRRs (95% confidence interval) for HIs (b/tsDMARDs versus TCZ) were as follows: etanercept, 2.40 (1.24–4.61); adalimumab, 1.90 (0.75–4.83); golimumab, 1.21 (0.66–2.23); and abatacept, 0.89 (0.49–1.62). In the other age groups, the noticeable difference was a lower aRR of etanercept versus TCZ in the youngest group (0.30, 0.11–0.85). Conclusion: In patients with RA aged ≥75 years, b/tsDMARDs have a similar risk of HIs to tocilizumab except for etanercept. [ABSTRACT FROM AUTHOR]

Objective: To assess the cost-effectiveness of biologic and targeted synthetic disease-modifying anti-rheumatic drugs (b/tsDMARDs) in rheumatoid arthritis. Methods: We conducted three analyses: a lifetime analysis with a cohort model (Study A) and two short-term analyses (Studies B and C). Study A evaluated the incremental cost-effectiveness ratio (ICER) per quality-adjusted life-year (QALY) gained from costs of standard treatments. Study B evaluated yearly costs per person achieving American College of Rheumatology (ACR) response (ACR20, ACR50, and ACR70), and Study C evaluated costs per person achieving previously defined claims-based effectiveness (equivalent to 28-joint Disease Activity Score ≤ 3.2). The proportion of ACR responders to the drugs of interest were determined by mixed treatment comparisons. Studies B and C estimated costs using a claims database. Results: In Study A, ICERs of all b/tsDMARDs were lower than 5.0 million Japanese yen (JPY) per QALY. In Study B, yearly costs per person with ACR50 response were lower for subcutaneous tocilizumab (TCZ-SC; 1.9 million JPY) and SC abatacept (2.3 million JPY). In Study C, costs per person were lower for TCZ-SC (1.3 million JPY) and intravenous TCZ (1.6 million JPY) and effectiveness rates were higher for intravenous TCZ (45.3%) and infliximab (43.0%). Conclusion: The b/tsDMARDs with lower prices showed higher cost-effectiveness. [ABSTRACT FROM AUTHOR]

Aims: The Japanese government reimburses patients for drugs at prices specified in the Drug Price Standard (DPS) published by the National Health Insurance (NHI) scheme. It revises reimbursements for most drugs on the basis of their market prices. This study thereby identifies factors related to drugs or disease that impact market prices for drugs using the DPS list. Materials and methods: This study first examined the 2018 DPS list to identify all listed drugs, their prices, and their stipulated reimbursements. We then excluded from this study all the drugs for which prices are set per alternate rules. We calculated the percentage divergence between market prices and DPS prices and designated it our dependent variable. We performed descriptive and a univariate analysis on each variable and constructed multivariate regression models featuring independent variables for drug characteristics that might affect market prices. Results: We identified 1,775 drugs with prices revised only by the market. We observed higher percentage divergences between DPS and market prices for drugs with generic alternatives (p<0.001), drugs listed in the Japanese Pharmacopoeia (p<0.001), and drugs for which at least two new drugs entered the same therapeutic category (p<0.001). Injectable drugs exhibited a more significant and negative correlation with percentage divergences (p=0.009) than ingestible drugs. Drugs that treat specific organs (p<0.001), affect metabolism (p=0.001), and those prescribed for non-therapeutic purposes (p<0.001) display significantly higher percentage divergence than drugs affecting the nervous system and sensory organs. Divergences are less for narcotics (p<0.001) and drugs that counter pathologic microorganisms and parasites (p=0.004). Conclusions: Factors that elevate competition among pharmaceutical companies likely lower market prices for drugs, and the direction of prices under NHI in Japan is affected by the category of diseases a drug treats. [ABSTRACT FROM AUTHOR]

Objectives: To evaluate the efficacy and safety of tacrolimus in adult patients with rheumatoid arthritis (RA) by using the GRADE approach. Methods: We searched PubMed, Japana Centra Revuo Medicina Web (Ichu-shi web), and the Cochrane Database of Systematic Reviews. Articles fulfilling the predefined inclusion criteria were appraised and used for meta-analysis. The primary outcomes were American College of Rheumatology 20 (ACR20) and serum creatinine elevation. Other outcomes included ACR50, ACR70, changes in C-reactive protein, modified Health Assessment Questionnaire Disability Index, gastrointestinal disorders, metabolic and nutritional disorders, and infections and infestations. Results: We identified five randomized controlled studies, four of which compared tacrolimus to placebo and were included in the meta-analysis. The risk ratio of ACR20 achievement was 1.71 (95% confidence interval [CI] 1.20 -2.42) for 1 -2mg/day and 2.30 (95% CI 1.79 -2.96) for 3 mg/day. The risk ratio of creatinine elevation was 1.95 (95% CI 1.18 -3.23) for 1 -2mg/day and 3.81 (95% CI 2.43 -5.99) for 3 mg/day. Conclusion: Tacrolimus is effective with acceptable safety in the management of RA. [ABSTRACT FROM AUTHOR]

Objectives: To elucidate the epidemiological characteristics of patients with rheumatoid arthritis (RA) in Japan using data from the Comprehensive Survey of Living Conditions, a nationwide questionnaire survey conducted in 2016.Methods: In total, 222,365 men and 245,251 women aged ≥16 years were included in the study. RA patients were defined as those who reported 'currently receiving treatment for RA at hospitals, clinics, or a facility for Japanese traditional massage, acupuncture, moxibustion, or judo-orthopedics.' The number of RA patients was estimated from the age-specific prevalence and total Japanese population in 2016. Further, the prevalence of individuals experiencing difficulties in activities of daily living due to health problems and those with mental distress as evaluated by K6 Scale was examined.Results: The estimated number and prevalence of RA in Japan with 95% confidence interval was 822 (768-880) thousand and 0.75% (0.70-0.80%). The population peaked in the late 60s, and the prevalence continued increasing until the early 80s, regardless of sex. Compared with non-RA participants, RA patients were more likely to experience difficulties in activities and to be distressed.Conclusion: High prevalence of RA in older age and mental and physical burden among RA patients were confirmed. [ABSTRACT FROM AUTHOR]