Real-World Prescription Pattern and Healthcare Cost Among Patients with Ulcerative Colitis in Japan: A Retrospective Claims Data Analysis

Miyazaki, Celine; Sakashita, Takuya; Jung, Wonjoo; Kato, Shingo

doi:10.1007/s12325-020-01615-4

Cited by 5 publications

(2 citation statements)

References 27 publications

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“…The use of administrative data for such purposes is still in its early stages in Japan; however, several national databases, such as the Japan Medical Data Center and Medical Data Vision, are now available to researchers. Recently, two studies in Japan reported to have used the Japan Medical Data Center database to investigate rates of persistence with biologic UC therapies 13 and explore the prescription pattern and economic burden 22 in patients with UC identified using a combination of diagnostic codes and prescription data. A further study has investigated the use of ICD‐10 codes to identify patients with UC and CD in the Medical Data Vision database in order to determine the incidence of nonmelanoma skin cancers and non‐Hodgkin lymphoma, and their relationship with use of IBD treatments 14 .…”

Section: Discussionmentioning

confidence: 99%

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

Ogino

Morikubo

Fukaura³

et al. 2021

J of Gastro and Hepatol

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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.

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Section: Discussionmentioning

confidence: 99%

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

Ogino

Morikubo

Fukaura³

et al. 2021

J of Gastro and Hepatol

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“…Patients receiving tofacitinib as first-line (1L) were transferred to infliximab in second-line (2L) therapy if they experienced primary treatment failure; similarly, patients not on tofacitinib as 1L were transferred to tofacitinib at 2L (Table 5 ). The assumption to model two lines of treatment was based on claims data in Japan, which indicated patients with UC on biologics or any treatment prior to biologics to be either on a 1L biologic or 2L continuous biologic (53.65% on 1L, 16.04% on 2L) [ 51 ]. This assumption was further validated by clinical experts.…”

Section: Methodsmentioning

confidence: 99%

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

Hoshi¹,

Yuasa²,

Arai³

et al. 2023

PharmacoEconomics

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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 U...

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Change in systemic steroid use and surgery rate in patients with inflammatory bowel disease: a Japanese real-world database analysis

Hirayama,

Hyodo,

Morita

et al. 2024

J Gastroenterol

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Background Corticosteroids are recommended only for induction of remission in inflammatory bowel disease (IBD), including ulcerative colitis (UC) and Crohn’s disease (CD). This study aimed to evaluate the change in pharmacologic treatment use, particularly systemic corticosteroids, over approximately 30 years, and the impact of biologics on IBD treatment since their appearance in the 2000s. Methods This retrospective study conducted in Japan used data from the Phoenix cohort database (January 1990 to March 2021). Patients with disease onset at age ≥ 10 years who received treatment for UC or CD between January 1990 and March 2021 were included. Outcome measures were change in IBD treatments used, total cumulative corticosteroid doses, initial corticosteroid dose, duration of corticosteroid treatment, and surgery rate. Results A total of 1066 and 579 patients with UC and CD, respectively, were included. In UC, the rate of corticosteroid use as initial treatment was relatively stable regardless of the year of disease onset; however, in CD, its rate decreased in patients who had disease onset after 2006 (before 2006: 14.3–27.8% vs. after 2006: 6.6–10.5%). Compared with patients with disease onset before biologics became available, cumulative corticosteroid doses in both UC and CD, and the surgery rate in CD only, were lower in those with disease onset after biologics became available. Conclusions Since biologics became available, corticosteroid use appears to have decreased, with more appropriate use. Furthermore, use of biologics may reduce surgery rates, particularly in patients with CD. UMIN Clinical Trials Registry; UMIN000035384.

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Real-World Prescription Pattern and Healthcare Cost Among Patients with Ulcerative Colitis in Japan: A Retrospective Claims Data Analysis

Cited by 5 publications

References 27 publications

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

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

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

Change in systemic steroid use and surgery rate in patients with inflammatory bowel disease: a Japanese real-world database analysis

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