PurposePrevious Japanese studies have not compared health-related quality of life (HRQoL), work productivity and activity impairment, health care resource utilization (HRU), and costs in inflammatory bowel disease (IBD) patients with non-IBD controls, leading to insufficient evidence regarding IBD’s true burden. The aim of this study was to examine the impact of IBD on patient-reported outcomes and costs among Japanese adults (≥18 years).Patients and methodsThis retrospective cross-sectional study used data from the 2012–2014 Japan National Health and Wellness Survey (N=83,505). HRQoL (SF-36v2), work productivity and activity impairment (work productivity and activity impairment-General Health Questionnaire), HRU, and annual costs were compared between respondents with IBD (n=441) and non-IBD controls (n=82,944), and within IBD subtypes (Crohn’s disease [CD] and ulcerative colitis [UC]) using chi-square and ANOVA tests.ResultsMental Component Summary (MCS), Physical Component Summary (PCS), and health state utility (Short-Form-6 Dimensions [SF-6D]) scores were significantly lower in IBD respondents than in controls (differences of 2.2 points, 2.6 points, and 0.041 points, respectively; all P<0.001). However, only differences in SF-6D scores reached the minimally important difference threshold. Furthermore, IBD-diagnosed respondents reported greater absenteeism, presenteeism, overall work productivity loss and activity impairment, and HRU than controls (all P<0.001). Consequently, direct and indirect costs were 3-fold and 1.5-fold higher in IBD-diagnosed respondents than in controls (both, P<0.001). Additionally, CD-diagnosed respondents had lower MCS, PCS, and SF-6D scores (all P<0.01) and higher direct costs (P<0.001) than UC-diagnosed respondents.ConclusionIBD and its subtype CD were associated with lower HRQoL, greater impairment to work and non-work activities, HRU, and costs among Japanese adults. This reinforces the general consensus that IBD patients, specifically those diagnosed with CD, require support from their family and society to combat the disease.

PurposeDepression is associated with substantial health and economic burden. This study examined the impact of diagnosed and undiagnosed depression on health-related outcomes and costs among Japanese adults.MethodsA retrospective, observational study was conducted using 2012–2014 Japan National Health and Wellness Survey (N=83,504) data. Differences between respondents diagnosed with depression (n=2,843) and undiagnosed with depression (weighted n=2,717) and controls without depression (weighted n=2,801) in health-related quality of life, impairment to work productivity and daily activities (Work Productivity and Activity Impairment Questionnaire), health care resource utilization, and annual costs were evaluated. Propensity score weighting and weighted generalized linear models were used to compare groups on the outcome variables, after adjusting for covariates.ResultsOverall, respondents with undiagnosed depression had significantly better outcomes than those diagnosed with depression, but significantly worse outcomes than controls (for all, P<0.001). The mean Mental Component Summary scores were lower in the diagnosed group when compared with undiagnosed respondents and controls (33.2 vs 34.5 vs 48.6). Similar findings were obtained for mean Physical Component Summary (49.2 vs 49.5 vs 52.8) and health state utility scores (0.61 vs 0.62 vs 0.76). Additionally, the diagnosed group reported greater absenteeism (13.1 vs 6.6 vs 2.5%), presenteeism (41.4 vs 38.1 vs 18.8%), overall work productivity impairment (47.2 vs 41.1 vs 20.2%), and activity impairment (48.4 vs 43.3 vs 21.1%) than the undiagnosed and control groups, respectively. Consistently, patients with diagnosed depression had higher annual per patient direct (1.6-fold) and indirect costs (1.1-fold) than those in the undiagnosed depression group.ConclusionDiagnosed depression was associated with lower health-related quality of life and greater impairment in work productivity and daily activities, higher health care resource utilization, and higher costs, compared with undiagnosed respondents and controls. These study findings suggest a need for greater awareness of depression symptoms among Japanese adults, which is needed to facilitate proper diagnosis and treatment.

Universal vaccination with RV5 in Japan is projected to have a substantial public health impact and may be cost-effective from both the payer and societal perspectives if parental disutilities are included in the cost-effectiveness ratios.

Background Vedolizumab (VDZ) was approved by the Japanese Ministry of Health, Labor and Welfare in 2018 for the treatment of patients with moderate-to-severe active ulcerative colitis (UC). The comparative cost-effectiveness of VDZ compared with other biologics is unknown in Japan. This information could be useful for decision makers at the time of repricing biologics for the treatment of patients with moderate-to-severe UC. Objective The aim was to assess the cost-effectiveness of VDZ versus other branded biologics for the treatment of patients with moderate-to-severe UC who were anti-tumor necrosis factor (TNF)-naïve, from the Japanese public healthcare payer perspective. Methods A hybrid decision tree/Markov model was developed to predict the number of patients who achieved response and remission at the end of the induction phase and sustained it during the maintenance phase, translating this into qualityadjusted life-years (QALYs) and costs. Treatment-related adverse events, discontinuation and surgery, and their impact on QALYs and costs were also modeled. A systematic literature review and network meta-analysis were conducted to estimate the comparative efficacy of each treatment versus placebo. Rates of adverse events, surgery, surgery complications, and utilities were from the literature. Costs (2018 Japanese yen) were obtained from the Japanese National Health Insurance drug price list and medical fee table and local claims databases. Clinical and economic outcomes were projected over a lifetime and discounted at 2% annually. Results Over a lifetime, VDZ yielded greater QALYs and cost savings compared with golimumab and was cost-effective compared with adalimumab and infliximab (incremental cost-effectiveness ratios ¥4,821,940 and ¥4,687,692, respectively). Deterministic and probabilistic analyses supported the robustness of the findings in the base-case analysis, indicating that VDZ was either dominant or cost-effective in most scenarios and replications. The main limitations of this analysis include excluding tofacitinib and infliximab biosimilar as comparators, health-state utility estimates were obtained from population studies in the United Kingdom, and the impact of subsequent (i.e., second-line) biologic treatment was not evaluated. Conclusion Our analysis suggests that VDZ is dominant or cost-effective compared with other branded biologics for the treatment of anti-TNF-naïve patients with moderate-to-severe UC in Japan.

PD was associated with poorer HRQoL, greater work productivity loss, and higher direct and indirect costs. The findings suggest that an unmet need exists among patients with PD in Japan. Improving PD treatment and management could benefit both patients and society.

PurposeMultiple sclerosis (MS) imposes a huge burden on patients. This study examined the relationship between MS and health-related and economic burden in Japan; secondarily, health status was compared across patients with MS in Japan, US, and five European Union (5EU) countries (France, Germany, Italy, Spain, and UK).MethodsA retrospective cross-sectional study was conducted using self-reported data from 2009 to 2014 Japan National Health and Wellness Survey (n=145,759). Health status, work productivity loss, activity impairment, health care resource utilization, and annual costs associated with MS (n=85) were compared with controls without MS (n=145,674). Propensity score matching and multivariable linear regressions determined the effect of MS after controlling for confounders. Health status in Japan was also compared with that of 5EU (n=62) and US (n=67) patients with MS.ResultsPatients with MS in Japan reported significantly worse health status via mental component summary score (MCS; 40.1 vs 45.8) and physical component summary score (PCS; 41.4 vs 51.2) and health state utility scores (0.63 vs 0.74; all P<0.001). They also reported more absenteeism (12.0% vs 3.7%), presenteeism (33.8% vs 19.8%), overall work impairment (40.9% vs 21.6%), and activity impairment (43.6% vs 24.0%), with higher indirect costs (¥2,040,672/US $20,102 vs ¥1,076,306/US$10,603) than controls (all P<0.001). Patients with MS reported higher resource use, including provider visits (8.0 vs 4.7), emergency room visits (0.03 vs 0.1), and hospitalizations (2.7 vs 0.69) in the past 6 months, with higher direct costs (¥3,670,906/US$36,162 vs ¥986,099/US$9,714) than controls (all P<0.001). Finally, Japanese patients with MS reported lower MCSs and higher PCSs than their US and 5EU counterparts.ConclusionMS in Japan is associated with poor health status and high work productivity loss, resource use, and costs, underscoring the need for improved treatment, especially vis-à-vis mental health, when comparing Japanese patients with their 5EU and US counterparts.

Objectives: The gastrointestinal symptom score (GIS) is used in a standardised form to ascertain dyspeptic symptoms in patients with functional dyspepsia. Each symptom is included with equal importance in the overall evaluation. The objective was to derive utility weights for the ten gastrointestinal symptoms by using a best-worst scaling (BWS). The common assumption that each symptom has the same meaning for affected patients should be tested and analyzed with a stated preference approach. MethOds: In the course of a patient preference study a BWS object scaling was applied. Therefore the symptoms of the GIS were included in a questionnaire using a balanced-incomplete-block-design (BIBD). The BIBD generated a total of 15 choice sets, which each included four attributes. Results: N= 1096 affected patients were asked for their preferences regarding a treatment of functional dyspepsia and motility disorder. The results demonstrated that respondents were capable of trading between the 10 symptoms. Respondents were most sensitive to (in declining importance) the symptoms abdominal cramps (w:-1,27), vomiting (w:-1,07) and epigastric pain (w:-0,76) These symptoms were most important and thus have the greatest influence on the well-being of patients with functional dyspepsia and motility disorders. Whereas the symptoms causing the least impact are the feeling of fullness (w:0,80), early satiety (w:1,54) and loss of appetite (w:1,95). cOnclusiOns: By using a BWS the patients' preferences for prioritizing and weighting different gastrointestinal symptoms could be measured. The evaluation of the symptoms has shown, however, that the restrictive assumption of GIS reflects the reality of dyspeptic patients to a limited degree. The calculated utility weights of the patient-relevant symptoms provide an insight on the importance of individual symptoms as part of a treatment decision. The findings provide first signs of a potential modification of the established GIS. One area of potential future work is focusing on exploration of the sensitivity of the GIS. PGI30 a sysTemaTIc revIeW of The sf-36® healTh sUrvey for measUrInG healTh-relaTeD QUalITy of lIfe In PaTIenTs WITh UlceraTIve colITIsObjectives: Ulcerative colitis (UC), an inflammatory bowel disease, substantially impacts patients' health-related quality of life (HRQL). The SF-36® Health Survey (SF-36), a generic health status measure, quantifies the impact of UC on HRQL, though to-date there is no summary of evidence of its psychometric properties for this purpose. A systematic review of the literature evaluated the SF-36 as a valid and responsive measure of HRQL in UC. MethOds: We searched PubMed, EMBASE, Cochrane CENTRAL, and BIOSIS Weekly databases. Search terms included 'ulcerative colitis', 'inflammatory bowel disease', SF-36, and HRQL. English-language articles reporting SF-36 findings from UC-only samples were selected. When possible, SF-36 mean scale scores were extracted and converted to norm-based T-scores and summarized across studies. Results: Fifty-nine artic...

In this study, the direct medical cost of UC treatment in Japan was estimated. As the UC is a lifelong disease that appears mainly in young adults, the economic impact including productivity loss is expected to be even greater.