Cost-Effectiveness Analysis of Tofacitinib Compared with Biologics in Biologic-Naïve Patients with Moderate-to-Severe Ulcerative Colitis in Japan.

OBJECTIVE: Tofacitinib is an oral Janus kinase inhibitor approved for the treatment of ulcerative colitis (UC). The objective of this study was to evaluate the long-term cost-effectiveness of tofacitinib versus current biologics, considering combinations of first-line (1L) and second-line (2L) therapies, from a Japanese payer's perspective in patients with moderate-to-severe active UC following an inadequate response to conventional therapy and in those who were naïve to biologics. METHODS: A cost-effectiveness analysis was conducted during the time horizon specified in the Markov model, which considers a patient's lifetime as 60 years and an annual discount rate of 2% on costs and effects. The model compared tofacitinib with vedolizumab, infliximab, adalimumab, golimumab, and ustekinumab. The time of active treatment was divided into induction and maintenance phases. Patients not responding to their biologic treatment after induction or during the maintenance phase were switched to a subsequent line of therapy. Treatment response and remission probabilities (for induction and maintenance phases) were obtained through a systematic literature review and a network meta-analysis that employed a multinomial analysis with fixed effects. Patient characteristics were sourced from the OCTAVE Induction trials. Mean utilities associated with UC health states and adverse events (AEs) were obtained from published sources. Direct medical costs related to drug acquisition, administration, surgery, patient management, and AEs were derived from the JMDC database analysis, which corresponded with the medical procedure fees from 2021. The drug prices were adjusted to April 2021. Further validation through all processes by clinical experts in Japan was conducted to fit the costs to real-world practices. Scenario and sensitivity analyses were also performed to confirm the accuracy and robustness of the base-case results. RESULTS: In the base-case, the treatment pattern including 1L tofacitinib was more cost-effective than vedolizumab, infliximab, golimumab, and ustekinumab for 1L therapies in terms of cost per quality-adjusted life year (QALY) gained (based on the Japanese threshold of 5,000,000 yen/QALY [38,023 United States dollars {USD}/QALY]). The base-case results demonstrated that the incremental costs would be reduced for all biologics, and decreases in incremental QALYs were observed for all biologics other than adalimumab. The incremental cost-effectiveness ratio (ICER) was found to be dominant for adalimumab; for the other biologics, it was found to be less costly and less efficacious. The efficiency frontier on the cost-effectiveness plane indicated that tofacitinib-infliximab and infliximab-tofacitinib were more cost-effective than the other treatment patterns. When infliximab-tofacitinib was compared with tofacitinib-infliximab, the ICER was 282,609,856 yen/QALY (2,149,157 USD/QALY) and the net monetary benefit (NMB) was -12,741,342 yen (-96,894 USD) with a threshold of 5,000,000 yen (38,023 USD) in Japan. Therefore, infliximab-tofacitinib was not acceptable by this threshold, and tofacitinib-infliximab was the cost-effective treatment pattern. CONCLUSION: The current analysis suggests that the treatment pattern including 1L tofacitinib is a cost-effective alternative to the biologics for patients with moderate-to-severe UC from a Japanese payer's perspective.

Reducing Health Anxiety in Patients With Inflammatory Bowel Disease Using Video Testimonials: Pilot Assessment of a Video Intervention.

BACKGROUND: Health anxiety has many damaging effects on patients with chronic illness. Physicians are often unable to alleviate concerns related to living with a disease that has an impact on daily life, and unregulated websites can overrepresent extreme anxiety-inducing outcomes. Educational clinician video interventions have shown some success as an acute anxiolytic in health settings. However, little research has evaluated if peer-based video interventions would be a feasible alternative or improvement. OBJECTIVE: This pilot study assesses the efficacy of anxiety reduction for patients with Crohn disease (CD) and those with ulcerative colitis (UC) by showing patient testimonial videos during hospital visits. It investigates the degree to which patient testimonials can affect state anxiety, and whether patients are comfortable enough with the technology to share their stories. METHODS: Patients with CD (n=51) and those with UC (n=49) were shown testimonial videos of patients with CD during their physician consultations at Kitasato University Kitasato Institute Hospital in Japan. The video testimonials were collected from Dipex Japan, the Japan branch of an international organization specializing in understanding patient experiences. Patients completed a Visual Analogue Scale for Anxiety before and after viewing the videos, a Hospital Anxiety and Depression Scale (HADS) survey before the videos, and satisfaction surveys. Patients receiving infusion therapy participated in the study while receiving treatment to minimize hospital workflow disruption. RESULTS: Anxiety reduction, on the Visual Analog Scale for Anxiety, was significant in the entire cohort both when viewed as an ordinal variable (P=.003, t98=1086.5) and as a continuous variable (P=.01, t94=-2.54, 90% CI -3.47 to -0.72). Eighty percent (n=15) of patients with high HADS Anxiety (HADS-A) scores and 71% (n=24) of patients with high starting state anxiety experienced reduced anxiety after watching testimonials. Patients with high state anxiety but low HADS-A scores experienced anxiety reduction (69%, n=16). Forty-two percent (n=100) of patients responded that they would share their stories for future users. When patients with UC received testimonials from patients with CD, 71% (n=49) of patients reported that they were relevant despite differences in condition. CONCLUSIONS: Our pilot results suggest that patient testimonial videos can reduce illness-related state anxiety for patients with CD and those with UC, especially in those with higher baseline state anxiety. The success of this study in reducing anxiety and achieving patient involvement suggests that video interventions for reducing anxiety might be a low-cost intervention that could scale to any number of hospitals, suggesting that technology can help scale up efforts to record and share patient testimonials. Future work can establish whether patient testimonials can be helpful in other contexts, such as before major surgeries or when a family member receives a difficult diagnosis.

Validation of a claims-based algorithm to identify cases of ulcerative colitis in Japan.

BACKGROUND AND AIM: The prevalence of ulcerative colitis (UC) is increasing in Japan. Validated claims-based definitions are required to investigate the epidemiology of UC and its treatment and disease course in clinical practice. This study aimed to develop a claims-based algorithm for UC in Japan. METHODS: A committee of epidemiologists, gastroenterologists, and internal medicine physicians developed a claims-based definition for UC, based on diagnostic codes and claims for UC treatments, procedures (cytapheresis), or surgery (postoperative claims). Claims data and medical records for a random sample of 200 cases per site at two large tertiary care academic centers in Japan were used to calculate the positive predictive value (PPV) of the algorithm for three gold standards of diagnosis, defined as physician diagnosis in the medical records, adjudicated cases, or registration in the Japanese Intractable Disease Registry (IDR). RESULTS: Overall, 1139 claims-defined UC cases were identified. Among 393 randomly sampled cases (mean age 44; 48% female), 94% had received ≥ 1 systemic treatment (immunosuppressants, tumor necrosis factor inhibitors, corticosteroids, or antidiarrheals), 7% had cytapheresis, and 7% had postoperative claims. When physician diagnosis was used as a gold standard, PPV was 90.6% (95% confidence interval [CI]: 87.7-93.5). PPV with expert adjudication was also 90.6% (95% CI: 87.7-93.5). PPVs with enrollment in the IDR as gold standard were lower at 41.5% (95% CI: 36.6-46.3) due to incomplete case registration. CONCLUSIONS: The claims-based algorithm developed for use in Japan is likely to identify UC cases with high PPV for clinical studies using administrative claims databases.