Real-world safety and efficacy of biologics in elderly patients with psoriasis: A multicenter observational study.

Clinical trials of biologics have frequently excluded elderly patients, resulting in inadequate data on their safety and efficacy. Additionally, evidence of their safety and efficacy remains limited, despite some real-world studies. To assess the safety and efficacy of biologics in elderly patients with psoriasis, we compared these outcomes in younger patients using data from the West Japan Psoriasis Registry (WJPR). The WJPR consists of approximately 30 facilities in Western Japan, including various healthcare settings. This study enrolled 1395 patients who participated in the 2022 follow-up survey of the WJPR and were either using or had used biologics during the survey. These included 456 patients in the elderly group (≥65 years) and 939 patients in the younger group (<65 years). Treatment-ending adverse events (TEAEs) occurred in 15.8% and 11.3% of elderly and younger patients, respectively. The incidence rate per 1000 patient-years (PY) for TEAEs was significantly higher in elderly patients than in younger patients (32.9 vs 23.2, p = 0.0234). Infectious diseases were more prevalent in the elderly group than the younger group; however, no significant difference in the frequency of infectious diseases was found between the two groups (p = 0.0807). Malignant neoplasms occurred significantly more frequently in the elderly group than in the younger group (p = 0.0169). Our results indicate a few concerns about infection when prescribing biologics to elderly patients. Biologics were effective for both elderly and younger patients. We found no significant differences in the proportion of patients with a body surface area score ≤3%, Physician's Global Assessment score 0/1, or Patient's Global Assessment score 0/1, as well as in the mean Dermatology Life Quality Index and the Itch Numerical Rating Scale between the younger and the elderly groups. Overall, our results confirm the appropriateness of using biologics in elderly patients with regard to safety and efficacy.

Cost-effectiveness of behavioural counselling intervention compared with non-intervention for adult patients with metabolic syndrome to prevent cardiovascular diseases and type 2 diabetes in Japan: a microsimulation modelling study.

OBJECTIVES: Nationwide lifestyle intervention-specific health guidance (SHG) in Japan-employs counselling and education to change unhealthy behaviours that contribute to metabolic syndrome, especially obesity or abdominal obesity. We aimed to perform a model-based economic evaluation of SHG in a low participation rate setting. DESIGN: A hypothetical population, comprised 50 000 Japanese aged 40 years who met the criteria of the SHG, used a microsimulation using the Markov model to evaluate SHG's cost-effectiveness compared with non-SHG. This hypothetical population was simulated over a 35-year time horizon. SETTING: SHG is conducted annually by all Japanese insurers. OUTCOME MEASURES: Model parameters, such as costs and health outcomes (including quality-adjusted life-years, QALYs), were based on existing literature. Incremental cost-effectiveness ratios were estimated from the healthcare payer's perspective. Deterministic and probabilistic sensitivity analyses (PSA) were conducted to evaluate the uncertainty around the model input parameters. RESULTS: The simulation revealed that the total costs per person in the SHG group decreased by JPY53 014 (US$480) compared with that in the non-SHG group, and the QALYs increased by 0.044, wherein SHG was considered the dominant strategy despite the low participation rates. PSA indicated that the credibility intervals (2.5th-97.5th percentile) of the incremental costs and the incremental QALYs with the SHG group compared with the non-SHG group were -JPY687 376 to JPY85 197 (-US$6226 to US$772) and -0.009 to 0.350 QALYs, respectively. Each scenario analysis indicated that programmes for improving both blood pressure and blood glucose levels among other risk factors for metabolic syndrome are essential for improving cost-effectiveness. CONCLUSIONS: This study suggests that even small effects of counselling and education on behavioural modification may lead to the prevention of acute life-threatening events and chronic diseases, in addition to the reduction of medication resulting from metabolic syndrome, which results in cost savings.

Cost-effectiveness analysis of minimally invasive surgical treatments for benign prostatic hyperplasia: implications for Japan's public healthcare system.

AIMS: Benign prostatic hyperplasia (BPH) represents a significant public health issue in Japan. This study evaluated the lifetime cost-effectiveness of water vapor energy therapy (WAVE) versus prostatic urethral lift (PUL) for men with moderate-to-severe BPH from a public healthcare payer's perspective in Japan. MATERIALS AND METHODS: A decision analytic model compared WAVE to PUL among males in Japan. Clinical effectiveness and adverse event (AE) inputs were obtained from a systematic literature review. Resource utilization and cost inputs were derived from the Medical Data Vision database and medical service fee national data in Japan. Experts reviewed and validated model input parameters. One-way and probabilistic sensitivity analyses were conducted to determine how changes in the values of uncertain parameters affect the model results. RESULTS: Throughout patients' lifetimes, WAVE was associated with higher quality-adjusted life years (0.920 vs. 0.911 year 1; 15.564 vs. 15.388 lifetime) and lower total costs (¥734,134 vs. ¥888,110 year 1; ¥961,595 vs. ¥1,429,458 lifetime) compared to PUL, indicating that WAVE is a more effective and less costly (i.e. dominant) treatment strategy across all time horizons. Lifetime cost-savings for the Japanese healthcare system per patient treated with WAVE instead of PUL were ¥467,863. The 32.7% cost difference between WAVE and PUL was predominantly driven by lower WAVE surgical retreatment rates (4.9% vs. 19.2% for WAVE vs PUL, respectively, at 5 years) and AE rates (hematuria 11.8% vs. 25.7%, dysuria 16.9% vs. 34.3%, pelvic pain 2.9% vs. 17.9%, and urinary incontinence 0.4% vs. 1.3% for WAVE vs PUL, respectively, at 3 months). Model findings were robust to changes in parameter input values. LIMITATIONS: The model represents a simplification of complex factors involved in resource allocation decision-making. CONCLUSIONS: Driven by lower retreatment and AE rates, WAVE was a cost-effective and cost-saving treatment for moderate-to-severe BPH in Japan compared to PUL, providing better outcomes at lower costs to the healthcare system.

Benign prostatic hyperplasia (BPH) is an important public health issue in Japan, given its high prevalence and potential morbidity in a rapidly aging population. This study compared the clinical and economic outcomes of two minimally invasive surgical treatments for BPH (water vapor energy therapy [WAVE] vs. prostatic urethral lift [PUL]) for patients in Japan. Clinical effectiveness and adverse event (AE) information from published medical literature, and real-world health services and cost data from Japan, were used to estimate the impact of the two treatments. Compared to PUL, WAVE was found to provide better clinical outcomes and quality-of-life for patients whilst costing less to the Japanese healthcare system. Patients treated with WAVE had higher lifetime quality-adjusted life years vs. patients treated with PUL (15.564 vs. 15.388). Lifetime cost-savings for the Japanese healthcare system per patient treated with WAVE instead of PUL were estimated to be ¥467,863. The 32.7% cost difference between WAVE and PUL was predominantly driven by lower retreatment rates for WAVE (surgical retreatment rate was 4.9% vs. 19.2% for WAVE vs. PUL, respectively, at 5 years) and AE rates (AE rates at 3 months for WAVE vs. PUL, respectively, were: hematuria 11.8% vs. 25.7%, dysuria 16.9% vs. 34.3%, pelvic pain 2.9% vs. 17.9%, and urinary incontinence 0.4% vs. 1.3%). These findings provide evidence-based insights for clinicians, payers, and health policymakers to further define the role of WAVE for BPH in Japan.

Clinical characteristics of patients with psoriasis with family history: A multicenter observational study.

Previous studies on family history of psoriasis showed that patients with a family history have an earlier onset of the disease, but such studies in Japan are still limited. To elucidate the characteristics of patients with familial psoriasis, we studied the family history of patients with psoriasis using the West Japan Psoriasis Registry, a multi-institutional registry operated by 26 facilities in the western part of Japan, including university hospitals, community hospitals, and clinics. This study enrolled 1847 patients registered between September 2019 and December 2021, with 199 (10.8%) having a family history of psoriasis. Patients with a family history of psoriasis had significantly earlier onset of the disease than those without a family history. Furthermore, patients with a family history of psoriasis had significantly longer disease duration. Psoriatic arthritis (PsA) was significantly more common in patients with a family history (69/199, 34.7%) than in those without a family history (439/1648, 26.6%) (adjusted P = 0.023). A subanalysis of patients with PsA revealed a significant difference in the patient global assessment (PaGA) score in Fisher's exact test and adjusted test. The numbers of patients with PaGA 0/1 were 29 (43.3%) and 172 (39.9%) in patients with PsA with and without family history of psoriasis, respectively, whereas the numbers of patients with PaGA 3/4 were 13 (19.4%) and 145 (33.6%) in patients with PsA with and without family history of psoriasis, respectively. Other disease severity variables did not show a difference between the two groups. Our findings suggest that genetics play a larger role in the development of PsA than in the development of psoriasis vulgaris. Most cases of PsA occur in patients who already have psoriasis, therefore dermatologists should pay attention to joint symptoms, especially in patients with psoriasis who have a family history of psoriasis.

Long-term effectiveness of a disease management program to prevent diabetic nephropathy: a propensity score matching analysis using administrative data in Japan.

BACKGROUND: Existing reviews indicated that disease management for patients with diabetes may be effective in achieving better health outcomes with less resource utilization in the short term. However, the long-term results were inconsistent because of the heterogeneous nature of the study designs. In the present study, we evaluated the 5-year follow-up results of a local disease management program focused on diabetic nephropathy prevention under the universal public health insurance scheme in Japan. METHODS: Patients diagnosed with type 2 diabetes who had stage 3 or 4 diabetic kidney disease and were aged between 20 and 75 years were invited to join a disease management program to support self-management and receive a recommended treatment protocol between 2011 and 2013. Follow-up data were collected from an electronic claims database for the public insurance scheme. Considering the non-random selection process, we prepared two control groups matched by estimated propensity scores to compare the incidence of diabetes-related complications, death, and resource utilization. RESULTS: The treatment group was more likely to receive clinical management in accordance with the guideline-recommended medication. After propensity score matching, the treatment group had lower incidence of diabetic nephropathy and emergency care use than the control group selected from a beneficiary pool mainly under primary care. Comparisons between the treatment group and the control group with more selected clinical conditions did not show differences in the incidence rate and resource utilization. CONCLUSIONS: The present results demonstrated limited effectiveness of the program for reducing complication incidence and resource utilization during the 5-year follow-up. Further research on the long-term effectiveness of co-management by primary care physicians, subspecialists in endocrinology and nephrology, and nurse educators is required for effective management of diabetes-related nephropathy.

Differences in Cumulative Long-Term Care Costs by Community Activities and Employment: A Prospective Follow-Up Study of Older Japanese Adults.

We evaluated differences in the cumulative benefit costs of public long-term care (LTC) insurance services by employment status and frequency of community activities. A baseline survey was conducted on functionally independent older people from 12 municipalities as a nationwide survey from 2010 to 2011. Employment status was dichotomized, and community activity was assessed based on the frequency of participation in hobbies, sports clubs, or volunteering. We followed the respondents' LTC service costs over a period of 6 years using public LTC claim records (n = 46,616). We adopted a classical linear regression analysis and an inverse probability weighting estimation with multiple imputation for missing values. Compared with non-participation in each community activity, the cumulative LTC costs among individuals who participated in hobbies or sports group activities at least twice a week were 1.23 (95% confidence interval: 0.73-1.72) to 1.18 (0.68-1.67) thousand USD lower per person over the 6-year period (28.7% to 30.1% lower, respectively). Similarly, the costs for employed persons were 0.55 (0.20-0.90) to 0.64 (0.29-0.99) thousand USD per person lower than among retirees (14.5% to 16.9% lower). Promoting employment opportunities and frequent participation in community activities among older adults may help reduce future LTC costs by around 20% as a result of extending healthy longevity.

Time cost of child rearing and its effect on women's uptake of free health checkups in Japan.

Women of child-rearing age have the lowest uptake rates for health checkups in several developed countries. The time cost incurred by conflicting child-rearing roles may contribute to this gap in access to health checkups. We estimated the time cost of child rearing empirically, and analyzed its potential impact on uptake of free health checkups based on a sample of 1606 women with a spouse/partner from the dataset of a population-based survey conducted in the greater Tokyo metropolitan area in 2010. We used a selection model to estimate the counterfactual wage of non-working mothers, and estimated the number of children using a simultaneous equation model to account for the endogeneity between job participation and child rearing. The time cost of child rearing was obtained based on the estimated effects of women's wages and number of children on job participation. We estimated the time cost to mothers of rearing a child aged 0-3 years as 16.9 USD per hour, and the cost for a child aged 4-5 years as 15.0 USD per hour. Based on this estimation, the predicted uptake rate of women who did not have a child was 61.7%, while the predicted uptake rates for women with a child aged 0-3 and 4-5 were 54.2% and 58.6%, respectively. These results suggest that, although Japanese central/local governments provide free health checkup services, this policy does not fully compensate for the time cost of child rearing. It is strongly recommended that policies should be developed to address the time cost of child rearing, with the aim of closing the gender gap and securing universal access to preventive healthcare services in Japan.

Process value of care safety: women's willingness to pay for perinatal services.

OBJECTIVE: To evaluate the process value of care safety from the patient's view in perinatal services. DESIGN: Cross-sectional survey. SETTINGS: Fifty two sites of mandated public neonatal health checkup in 6 urban cities in West Japan. PARTICIPANTS: Mothers who attended neonatal health checkups for their babies in 2011 (n = 1316, response rate = 27.4%). MAIN OUTCOME MEASURE: Willingness to pay (WTP) for physician-attended care compared with midwife care as the process-related value of care safety. WTP was estimated using conjoint analysis based on the participants' choice over possible alternatives that were randomly assigned from among eight scenarios considering attributes such as professional attendance, amenities, painless delivery, caesarean section rate, travel time and price. RESULTS: The WTP for physician-attended care over midwife care was estimated 1283 USD. Women who had experienced complications in prior deliveries had a 1.5 times larger WTP. CONCLUSIONS: We empirically evaluated the process value for safety practice in perinatal care that was larger than a previously reported accounting-based value. Our results indicate that measurement of process value from the patient's view is informative for the evaluation of safety care, and that it is sensitive to individual risk perception for the care process.