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Abstract Introduction Japan will be transitioning from the free-of-charge COVID-19 vaccination program to annual periodic vaccination under a national immunization program for old adults and high-risk patients from 2024 fall/winter season. The policy transition including out-of-pocket payment requirement may discourage vaccination, leading to a lower vaccination rate. This study aimed to estimate the impact of varying vaccination rates with BNT162b2 COVID-19 mRNA vaccine on economics and public health in an illustrative prefecture which administers and promotes the periodic vaccination program, using budget impact analysis. Methods A combined cohort Markov decision tree model estimated the public health outcomes of COVID-19-related symptomatic cases, hospitalizations and deaths; and the economic outcomes including vaccine-related cost, non-vaccine-related medical cost, and productivity loss from the societal perspective. The base case examined the impact on the outcomes when vaccination coverage changed from the reference value of 50% to upper and lower values, respectively. Scenario analyses were performed based on multiple scenarios. Results Increase in the vaccination rate demonstrated improvement in all public health outcomes. At 50% vaccination, the vaccine-related cost for 3 years in a prefecture was estimated at JPY 7.58 billion (USD 57.67 million), the non-vaccine-related medical cost at JPY 79.22 billion (USD 602.48 million), the productivity loss at JPY 253.11 billion (USD 1.92 billion), and the total cost at JPY 339.92 billion (USD 2.59 billion). When the vaccination rate increased to 90%, the total cost decreased by JPY 4.88 billion (USD 37.11 million) (1.4%). When the vaccination rate decreased to 10%, the total cost increased by JPY 5.73 billion (USD 43.58 million) (1.7%). Results were consistent across almost all scenario analyses. Conclusions Maintaining a high vaccination rate with BNT162b2 is important from both public health and economic perspectives in Japan. The findings highlight to local governments the importance of continued effort to promote vaccination.

Abstract Introduction Real-world data on the comparative effectiveness of endothelin receptor antagonists (ERAs; macitentan, bosentan, ambrisentan) for pulmonary arterial hypertension (PAH), particularly in Asian countries, are scarce. We evaluated the persistence of these ERAs before and after macitentan approval in Japan (2015). Methods We used real-world data from the Japanese Medical Data Vision administrative claims database between April 2008 and November 2020. Patients with PAH were identified from the dataset. Persistence to ERA treatment before and after approval of macitentan in Japan was defined as the time between start of the index ERA and treatment discontinuation or death. Propensity score adjustment was applied to minimize confounding effects among treatment groups. Results In the pre-macitentan approval cohort, 153 and 51 patients received bosentan and ambrisentan, respectively. In the post-macitentan approval cohort, 331, 284, and 91 patients received macitentan, bosentan, and ambrisentan, respectively. Unadjusted median persistence for ambrisentan- and bosentan-treated patients was 19 and 10 months, respectively (adjusted HR 0.87 [95% CI 0.61–1.24]; P = 0.434 [bosentan as reference]). In the post-macitentan approval cohort, unadjusted median persistence was 18 months for macitentan-treated patients versus 6 and 8 months for ambrisentan- and bosentan-treated patients, respectively. Adjusted HRs for ambrisentan and bosentan were 1.48 (95% CI 1.12–1.95; P = 0.006) and 1.63 (95% CI 1.30–2.04; P

Background: Intra-articular injection of hyaluronic acid (HA) for knee osteoarthritis (OA) effectively reduces pain and delays total knee replacement (TKR) surgery; however, little is known about relative differences in clinical and cost outcomes among different HA products. Objective: To compare disease-specific costs and risk of TKR among patients receiving different HA treatments in a commercially insured cohort of patients with knee OA in the USA. Method: Retrospective analyses using IMS Health’s PharMetrics Plus Health Plan Claims Database were conducted by identifying knee OA patients with claims indicating initiation of HA treatment at an ‘index date’ during the selection period (2007–2010). Patients were required to be continuously enrolled in the database for 12 months preindex to 36 months postindex. A generalized linear model (GLM) with a gamma distribution and log-link function was used to model aggregate patient-based changes in disease-specific costs. A Cox proportional hazards model (PHM) was used to model the risk of TKR. Both multivariate models included covariates such as age, gender, comorbidities, and preindex healthcare costs. Results: 50,389 patients with HA treatment for knee OA were identified. 18,217 (36.2%) patients were treated with HA products indicated for five injections per treatment course (Supartz and Hyalgan). The remainder were treated with HA products indicated for fewer than five injections per treatment course, with 20,518 patients (40.7%) receiving Synvisc; 6,263 (12.4%), Euflexxa; and 5,391 (10.7%), Orthovisc. Synvisc- and Orthovisc-injected patients had greater disease-specific costs compared to Supartz/Hyalgan (9.0%, p

BACKGROUND:The growing prevalence of osteoarthritis (OA) and the medical costs associated with total knee replacement (TKR) surgery for end-stage OA motivate a search for agents that can delay OA progression. We test a hypothesis that hyaluronic acid (HA) injection is associated with delay of TKR in a dose-dependent manner. METHODS AND FINDINGS:We retrospectively evaluated records in an administrative claims database of ~79 million patients, to identify all patients with knee OA who received TKR during a 6-year period. Only patients with continuous plan enrollment from diagnosis until TKR were included, so that complete medical records were available. OA diagnosis was the index event and we evaluated time-to-TKR as a function of the number of HA injections. The database included 182,022 patients with knee OA who had TKR; 50,349 (27.7%) of these patients were classified as HA Users, receiving ≥1 courses of HA prior to TKR, while 131,673 patients (72.3%) were HA Non-users prior to TKR, receiving no HA. Cox proportional hazards modelling shows that TKR risk decreases as a function of the number of HA injection courses, if patient age, gender, and disease comorbidity are used as background covariates. Multiple HA injections are therefore associated with delay of TKR (all, P < 0.0001). Half of HA Non-users had a TKR by 114 days post-diagnosis of knee OA, whereas half of HA Users had a TKR by 484 days post-diagnosis (χ2 = 19,769; p < 0.0001). Patients who received no HA had a mean time-to-TKR of 0.7 years; with one course of HA, the mean time to TKR was 1.4 years (χ2 = 13,725; p < 0.0001); patients who received ≥5 courses delayed TKR by 3.6 years (χ2 = 19,935; p < 0.0001). CONCLUSIONS:HA injection in patients with knee OA is associated with a dose-dependent increase in time-to-TKR.

Objectives: Real-world evidence regarding prevalence, patient characteristics, and treatment patterns for pulmonary arterial hypertension (PAH) related to systemic lupus erythematosus (SLE) in Japan is limited. Methods: We conducted a retrospective study analysing Japan's Medical Data Vision database from April 2008 to September 2020. Prevalence, incidence, patient characteristics, treatment patterns, and use of vasodilators by treatment line were evaluated. Results: The prevalence of PAH was 0.392% in SLE patients (n = 114/29,077). Cumulative incidence was 0.53% (3 years) and 0.77% (5 years). Of 114 SLE–PAH patients, 49% developed PAH <1 year from SLE diagnosis. SLE–PAH patients were predominantly females (88% vs. 72%), had a lower mean age at SLE diagnosis (53 vs. 56 years), and had more severe SLE (61% vs. 25%) than non-PAH–SLE patients. Glucocorticoids (58%) and vasodilators (27%) were preferred first-line monotherapy for SLE–PAH. A combination of glucocorticoids and immunosuppressants (19%) was the predominant first-line combination therapy. Endothelin receptor antagonists (40% and 44%) and nitric oxide analogues (31% and 40%) were dominant first- and second-line vasodilators. Conclusions: SLE–PAH patients were predominantly females, were younger at diagnosis, and had more severe SLE than non-PAH–SLE patients. Most were diagnosed <1 year of SLE diagnosis. In Japan's real-world practice, the initial treatment goal is SLE management, while vasodilators are preferred in advanced diseases, as per the Medical Data Vision database. [ABSTRACT FROM AUTHOR]

Background: Gel-200 is a cross-linked hyaluronate single-injection device for treatment of osteoarthritis pain in the knee. This report summarizes new analyses of the safety of retreatment with Gel-200 from the 13-week, pivotal, multicenter, randomized controlled trial (RCT) followed by an open-label extension trial (OLE).Methods: 379 patients were enrolled in the RCT [Gel-200; phosphate-buffered saline (PBS)]. Safety of retreatment with Gel-200 was assessed by comparing adverse events (AEs) and device-related AEs reported through Week 4 following retreatment with Gel-200 to those reported in patients receiving their first injection in the OLE.Results: 350 patients completed the initial RCT (231 Gel-200; 119 PBS); 258 patients enrolled in the OLE (162 Gel-200; 96 PBS). In total, 202 patients (125 Gel-200; 77 PBS) qualified for retreatment, while 56 (37 Gel-200; 19 PBS) did not. There were no significant demographic or disease characteristic differences between Gel-200 patients who were and were not retreated; those who were not eligible for retreatment experienced greater pain relief from Gel-200 in the RCT by all effectiveness endpoints (all p < 0.001), without differences in their safety profile. In the OLE, the safety of Gel-200, including percentages of patients who experienced any AEs (p = 0.547) and device-related AEs (p = 0.521), did not significantly differ between those receiving a second versus a first injection of Gel-200 following PBS in the RCT.Conclusion: In the OLE, the safety of a second injection of Gel-200 was comparable to that of a first injection and effectiveness was similar, as previously reported.Trial Registration: ClinicalTrials.gov identification numbers NTC 00449696 and NTC 00450112. [ABSTRACT FROM AUTHOR]

To determine whether an elevated serum total cholesterol level in a first‐available sample obtained at a systemic lupus erythematosus (SLE) clinic is associated with worse renal outcome in patients with SLE.Survival analysis methods were used on prospectively gathered data on 1,060 patients with SLE who were registered in the University of Toronto Lupus Databank. The effect of total cholesterol and 15 additional variables on the outcomes of renal deterioration, end‐stage renal disease (ESRD), and death was assessed using Cox proportional hazards methods.In 474 (45%) of the 1,060 patients, the total cholesterol level exceeded 5.2 mmoles/liter. In the entire study group, the median total cholesterol level was 5.1 mmoles/liter (range 1.6–17.1). During a mean followup period of 8.8 years, 93 patients (9%) experienced renal deterioration, 42 patients (4%) had ESRD, and 161 deaths occurred, 48 (30%) of which were associated with renal dysfunction (renal death), and 113 (70%) of which were not associated with renal dysfunction (nonrenal death). Kaplan‐Meier survival estimates for each outcome were statistically significantly different between patients with normal versus those with elevated total cholesterol levels (cutoff 5.2 mmoles/liter), with a worse outcome observed among those with an elevated total cholesterol concentration. In multivariate analyses, total cholesterol level (hazard ratio [HR] 1.17, 95 confidence interval [95% CI] 1.01–1.36), serum creatinine level (HR 1.06, 95% CI 1.04–1.07), proteinuria (HR 2.44, 95% CI 1.25–4.76), the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (HR 1.44, 95% CI 1.16–1.80), and corticosteroid dose (HR 1.01, 95% CI 1.00–1.02) were associated with renal deterioration. Significant predictors of ESRD were baseline proteinuria (HR 6.24, 95% CI 1.96–19.88) and serum creatinine level (HR 1.15, 95% CI 1.08–1.22). The total cholesterol level was correlated with death (HR 1.20, 95% CI 1.11–1.29), retaining statistical significance for renal death (HR 1.33, 95% CI 1.20–1.47) but not for nonrenal death (HR 1.12, 95% CI 0.99–1.25).Those results indicate that an elevated serum total cholesterol level in a first‐available sample obtained at an SLE clinic is associated with adverse renal outcomes and mortality. [ABSTRACT FROM AUTHOR]