Dataset Information

Budget Impact of Adding Vedolizumab to a Health Plan Formulary as Another First-Line Biologic Option for Ulcerative Colitis and Crohn's Disease.

ABSTRACT:

Background

Vedolizumab 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.

Objective

To 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.

Methods

We 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.

Results

Including 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.

Conclusion

Based 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.

SUBMITTER: Wilson M

PROVIDER: S-EPMC6207303 | biostudies-literature | 2018 Jul

REPOSITORIES: biostudies-literature

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Publications

Budget Impact of Adding Vedolizumab to a Health Plan Formulary as Another First-Line Biologic Option for Ulcerative Colitis and Crohn's Disease.

Wilson Michele M Lucas Aaron A Cameron Ann A Luo Michelle M

American health & drug benefits 20180701 5

<h4>Background</h4>Vedolizumab 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 ...[more]

PMID: 30464793

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Project description:Background/aimsVedolizumab is indicated for moderately-to-severely active ulcerative colitis (UC) and Crohn's disease (CD). Because multiple factors may result in different pharmacokinetics and clinical efficacies, understanding determinants of vedolizumab clearance may enhance dose and treatment strategies. The aim was to characterize vedolizumab pharmacokinetics in Asian and non-Asian UC and CD patients.MethodsPopulation pharmacokinetic analysis for repeated measures, using data from 5 studies, was conducted using nonlinear mixed-effects modeling. A Bayesian estimation approach in NONMEM 7.3 was utilized to leverage the predominantly sparse data available for this analysis with results from a prior population pharmacokinetic analysis of vedolizumab.ResultsVedolizumab pharmacokinetics were described by a 2-compartment model with parallel linear and nonlinear elimination. Using reference covariate values, linear elimination half life of vedolizumab was 24.7 days for anti-vedolizumab antibody (AVA)-negative patients and 18.1 days for AVA-positive patients; linear clearance (CLL) was 0.165 L/day for AVA-negative patients and 0.246 L/day for AVA-positive patients; central (Vc) and peripheral compartment volumes of distribution were 3.16 L and 1.84 L, respectively. Interindividual variabilities (percent coefficient of variation) were 30.8% for CLL and 19% for Vc; interoccasion variability on CLL was 20.3%; residual variance was 17.8%. For albumin, body weight and AVA, only extreme values were identified as potentially clinically important predictors of CLL. The effect of race (Asian/non-Asian) and diagnosis (UC/CD) on CLL was negligible and likely not of clinical importance.ConclusionsPharmacokinetic parameters were similar in Asian and non-Asian patients with moderately-to-severely active UC and CD. This analysis supports use of vedolizumab flat-fixed dosing in these patients. (Clinicaltrials.gov Identifiers: NCT00783718 (GEMINI 1); NCT00783692 (GEMINI 2). CCT 101; NCT02039505 and CCT-001; NCT02038920).

Project description:BackgroundCrohn's disease (CD) is a chronic inflammatory bowel disease characterized by relapsing and remitting inflammation that leads to progressive bowel damage. Despite advances in medical treatment for CD, many patients require surgical intervention. Most studies of surgery rates are from patients treated with anti-tumor necrosis factor alpha (anti-TNFα) treatments, with comparatively little data on the surgery rates of patients treated with vedolizumab and ustekinumab. SOJOURN aimed to estimate the hazard rate and incidence of the first CD-related surgery following initiation of treatment with vedolizumab or ustekinumab in biologic-naïve patients with CD.MethodsSOJOURN was a retrospective, observational cohort study examining administrative claims data from the Optum® Research Database between July 1, 2017 and March 31, 2020. Included participants were adults with a diagnosis of CD and a claim for vedolizumab or ustekinumab (defined as the index treatment) between January 1, 2018 and December 31, 2019, with no claims for a biologic in the 6 months before initiation of this treatment. The variable follow-up started on the day after the index date and continued until whichever came first of discontinuation of the index treatment, surgery event, switching of the index treatment, initiation of combination biologic treatment, disenrollment, or March 31, 2020. The time to the first CD-related surgery on biologic treatment was estimated by Kaplan-Meier analysis. The hazard ratio and incidence rate ratio of CD-related surgery for each treatment cohort was compared using a Cox proportional hazards model and a Poisson regression model, respectively.ResultsOf the 1,122 included patients, 578 received vedolizumab and 544 received ustekinumab. After 1 year of the variable follow-up, 7.7% of patients receiving vedolizumab and 11.6% of patients receiving ustekinumab had undergone a CD-related surgery. Vedolizumab was associated with a 34.2% lower hazard rate of surgery (hazard ratio 0.658, 95% confidence interval [CI] 0.436-0.994, p = 0.047) and a 34.5% lower incidence of surgery (rate ratio 0.655, 95% CI 0.434-0.988, p = 0.044) than ustekinumab.ConclusionsThis real-world analysis of biologic-naïve patients with CD suggests that vedolizumab is associated with greater effectiveness in reducing the rate of CD-related surgery than ustekinumab.

Dataset Information

Budget Impact of Adding Vedolizumab to a Health Plan Formulary as Another First-Line Biologic Option for Ulcerative Colitis and Crohn's Disease.

Background

Objective

Methods

Results

Conclusion

Publications

Budget Impact of Adding Vedolizumab to a Health Plan Formulary as Another First-Line Biologic Option for Ulcerative Colitis and Crohn's Disease.

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