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Best practices on immunomodulators and biologic agents for ulcerative colitis and Crohn's disease in Asia.

ABSTRACT: The Asia-Pacific Working Group on inflammatory bowel disease (IBD) was established in Cebu, Philippines, under the auspices of the Asian Pacific Association of Gastroenterology with the goal of improving IBD care in Asia. This consensus is carried out in collaboration with Asian Organization for Crohn's and Colitis. With biologic agents and biosimilars becoming more established, it is necessary to conduct a review on existing literature and establish a consensus on when and how to introduce biologic agents and biosimilars in the conjunction with conventional treatments for ulcerative colitis (UC) and Crohn's disease (CD) in Asia. These statements also address how pharmacogenetics influence the treatments of UC and CD and provide guidance on response monitoring and strategies to restore loss of response. Finally, the review includes statements on how to manage treatment alongside possible hepatitis B and tuberculosis infections, both common in Asia. These statements have been prepared and voted upon by members of IBD workgroup employing the modified Delphi process. These statements do not intend to be all-encompassing and future revisions are likely as new data continue to emerge.

SUBMITTER: Ooi CJ

PROVIDER: S-EPMC6667368 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

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Best practices on immunomodulators and biologic agents for ulcerative colitis and Crohn's disease in Asia.

Ooi Choon Jin CJ Hilmi Ida I Banerjee Rupa R Chuah Sai Wei SW Ng Siew Chien SC Wei Shu Chen SC Makharia Govind K GK Pisespongsa Pises P Chen Min Hu MH Ran Zhi Hua ZH Ye Byong Duk BD Park Dong Il DI Ling Khoon Lin KL Ong David D Ahuja Vineet V Goh Khean Lee KL Sollano Jose J Lim Wee Chian WC Leung Wai Keung WK Ali Raja Affendi Raja RAR Wu Deng Chyang DC Ong Evan E Mustaffa Nazri N Limsrivilai Julajak J Hisamatsu Tadakazu T Yang Suk Kyun SK Ouyang Qin Q Geary Richard R De Silva Janaka H JH Rerknimitr Rungsun R Simadibrata Marcellus M Abdullah Murdani M Leong Rupert Wl RW

Intestinal research 20190531 3

The Asia-Pacific Working Group on inflammatory bowel disease (IBD) was established in Cebu, Philippines, under the auspices of the Asian Pacific Association of Gastroenterology with the goal of improving IBD care in Asia. This consensus is carried out in collaboration with Asian Organization for Crohn's and Colitis. With biologic agents and biosimilars becoming more established, it is necessary to conduct a review on existing literature and establish a consensus on when and how to introduce biol ...[more]

PMID: 31146509

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Project description:BackgroundThis retrospective cohort study aimed to describe and quantify healthcare resource utilization and costs for patients with ulcerative colitis (UC) and Crohn's disease (CD) following initiation of biologic therapy.MethodsResource utilization and costs were analyzed at baseline and 1- and 2-years after initiating a biologic. Data were extracted from a US administrative health insurance claims database for adults ≥18 years. Eligible patients were continuously enrolled in a health plan with medical and pharmacy benefits for ≥12 months prior to, and 12 months (primary analysis) or 24 months (secondary analysis) after index date (biologic initiation).ResultsIn total, 4864 and 2692 patients with UC, and 8910 and 5227 patients with CD were identified in the 1- and 2-year follow-up cohorts, respectively. Of 1-year follow-up cohort patients, 45% received the same biologic initiated at index for ≥1 year. Infliximab and adalimumab were the most commonly initiated biologics in patients with UC or CD. The highest proportion of patients who continued with the same biologic after 1- and 2-years had initiated therapy with infliximab for both indications (although at the 1-year follow-up for CD, the highest proportion continued to use natalizumab, but this was a small sample [n=15]).Generally, the proportion of patients having inpatient admissions and emergency department (ED) visits decreased after receiving the same biologic for 1 year compared with baseline, although the proportion having outpatient visits did not change. Mean per patient all-cause costs for inpatient hospitalizations, ED visits and outpatient visits decreased for patients with UC or CD who received the same biologic for 1 year, while mean pharmacy costs per patient increased.ConclusionsThis descriptive analysis shows that although biologics effectively reduced inpatient and ED resource utilization and corresponding costs in patients with UC and CD, total management costs increased, driven by increased pharmacy costs.

Project description:BackgroundVedolizumab is a biologic drug approved by the US Food and Drug Administration (FDA) for the treatment of adults with moderately to severely active Crohn's disease (CD) or ulcerative colitis (UC) who have had inadequate response to, lost response to, or were intolerant of immunomodulators or tumor necrosis factor (TNF) blocker therapy, or who had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroid therapy. The biologics approved by the FDA for CD and/or UC include adalimumab, infliximab, golimumab, certolizumab, and ustekinumab.ObjectiveTo assess the budget impact of including vedolizumab in a health plan formulary among current options as a preferred first-line biologic therapy for UC and CD rather than only for patients who failed anti-TNF therapy.MethodsWe developed a 3-year budget impact model for a 1-million-member health plan. Comparators included all currently approved brand-name biologic and biosimilar agents for the treatment of UC (ie, adalimumab, infliximab, and golimumab) and CD (ie, adalimumab, certolizumab, infliximab, and ustekinumab). Clinical inputs included therapy response probabilities, disease remission, and surgery risk. Given the lack of head-to-head clinical trials, we estimated indirect comparisons of treatment efficacy based on clinical trial data using the Bucher method. The drug and medical costs were obtained from published literature. The model compared hypothetical health plan costs for 2 scenarios-(1) a market mix with vedolizumab included on the formulary with currently existing first- and second-line preferred treatments, and (2) vedolizumab included only with existing preferred second-line treatments on the hypothetical formulary. These scenarios were compared in the context of 3 hypothetical health plan formulary cases.ResultsIncluding vedolizumab in a hypothetical formulary with currently preferred first-line biologic treatment options (Scenario 1) resulted in cost-savings compared with vedolizumab as a preferred second-line biologic option (Scenario 2). The total cost-savings were from $0.13 million to $1.63 million in year 1, and from $0.38 million to $4.68 million in year 3. The per-member per-month cost-savings were from $0.01 to $0.14 in year 1 and from $0.03 to $0.39 in year 3.ConclusionBased on our model's results, including vedolizumab among the current health plan formulary biologic options as a preferred first-line treatment for UC and CD can result in substantial cost-savings compared with including vedolizumab as a preferred second-line treatment only.

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Best practices on immunomodulators and biologic agents for ulcerative colitis and Crohn's disease in Asia.

Publications

Best practices on immunomodulators and biologic agents for ulcerative colitis and Crohn's disease in Asia.

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