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      Cost Effectiveness of Tofacitinib for the Treatment of Moderate to Severe Active Ulcerative Colitis in Colombia

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          Abstract

          Objective

          The aim of this study was to evaluate the cost effectiveness of tofacitinib versus other treatment options currently available in Colombia in naïve to biologics (first-line) and exposed to biologics (second-line) patients with moderate to severe active ulcerative colitis (UC).

          Methods

          A Markov model was constructed with 8-week cycles, simulating a cohort of patients in a 5-year time horizon. The health states included remission, treatment response, active UC, and colectomy. The transition probabilities for the induction and maintenance phase were obtained from a network meta-analysis, and effectiveness was measured using quality-adjusted life-years (QALYs). Unit costs were derived from official national sources.

          Results

          For first line, the incremental cost-effectiveness ratio (ICER) per QALY was $883 for tofacitinib and $3619 for infliximab, compared with adalimumab. Sensitivity analysis showed that tofacitinib is cost effective in 45% of the iterations, adalimumab in 5%, and infliximab in 50%. Meanwhile, the ICER of adalimumab was $14,927 compared with tofacitinib in second-line treatment. In the sensitivity analysis, tofacitinib was cost effective in 64% of the iterations, followed by adalimumab in 36%. Infliximab and golimumab were not included due to data limitations in the network meta-analysis of second-line treatment.

          Conclusion

          The analysis suggests that in Colombia, treatment with tofacitinib for patients with moderate-to-severe UC is a cost-effective option in both lines compared with other treatment options.

          Supplementary Information

          The online version contains supplementary material available at 10.1007/s41669-022-00360-4.

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          Most cited references39

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          Infliximab for induction and maintenance therapy for ulcerative colitis.

          Paul Rutgeerts, William J Sandborn, Brian Feagan … (2005)
          Infliximab, a chimeric monoclonal antibody directed against tumor necrosis factor alpha, is an established treatment for Crohn's disease but not ulcerative colitis. Two randomized, double-blind, placebo-controlled studies--the Active Ulcerative Colitis Trials 1 and 2 (ACT 1 and ACT 2, respectively)--evaluated the efficacy of infliximab for induction and maintenance therapy in adults with ulcerative colitis. In each study, 364 patients with moderate-to-severe active ulcerative colitis despite treatment with concurrent medications received placebo or infliximab (5 mg or 10 mg per kilogram of body weight) intravenously at weeks 0, 2, and 6 and then every eight weeks through week 46 (in ACT 1) or week 22 (in ACT 2). Patients were followed for 54 weeks in ACT 1 and 30 weeks in ACT 2. In ACT 1, 69 percent of patients who received 5 mg of infliximab and 61 percent of those who received 10 mg had a clinical response at week 8, as compared with 37 percent of those who received placebo (P<0.001 for both comparisons with placebo). A response was defined as a decrease in the Mayo score of at least 3 points and at least 30 percent, with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or an absolute rectal-bleeding subscore of 0 or 1. In ACT 2, 64 percent of patients who received 5 mg of infliximab and 69 percent of those who received 10 mg had a clinical response at week 8, as compared with 29 percent of those who received placebo (P<0.001 for both comparisons with placebo). In both studies, patients who received infliximab were more likely to have a clinical response at week 30 (P< or =0.002 for all comparisons). In ACT 1, more patients who received 5 mg or 10 mg of infliximab had a clinical response at week 54 (45 percent and 44 percent, respectively) than did those who received placebo (20 percent, P<0.001 for both comparisons). Patients with moderate-to-severe active ulcerative colitis treated with infliximab at weeks 0, 2, and 6 and every eight weeks thereafter were more likely to have a clinical response at weeks 8, 30, and 54 than were those receiving placebo. (ClinicalTrials.gov numbers, NCT00036439 and NCT00096655.) Copyright 2005 Massachusetts Medical Society.
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            Vedolizumab as induction and maintenance therapy for ulcerative colitis.

            Brian Feagan, Paul Rutgeerts, Bruce Sands … (2013)
            Gut-selective blockade of lymphocyte trafficking by vedolizumab may constitute effective treatment for ulcerative colitis. We conducted two integrated randomized, double-blind, placebo-controlled trials of vedolizumab in patients with active disease. In the trial of induction therapy, 374 patients (cohort 1) received vedolizumab (at a dose of 300 mg) or placebo intravenously at weeks 0 and 2, and 521 patients (cohort 2) received open-label vedolizumab at weeks 0 and 2, with disease evaluation at week 6. In the trial of maintenance therapy, patients in either cohort who had a response to vedolizumab at week 6 were randomly assigned to continue receiving vedolizumab every 8 or 4 weeks or to switch to placebo for up to 52 weeks. A response was defined as a reduction in the Mayo Clinic score (range, 0 to 12, with higher scores indicating more active disease) of at least 3 points and a decrease of at least 30% from baseline, with an accompanying decrease in the rectal bleeding subscore of at least 1 point or an absolute rectal bleeding subscore of 0 or 1. Response rates at week 6 were 47.1% and 25.5% among patients in the vedolizumab group and placebo group, respectively (difference with adjustment for stratification factors, 21.7 percentage points; 95% confidence interval [CI], 11.6 to 31.7; P 1), as compared with 15.9% of patients who switched to placebo (adjusted difference, 26.1 percentage points for vedolizumab every 8 weeks vs. placebo [95% CI, 14.9 to 37.2; P<0.001] and 29.1 percentage points for vedolizumab every 4 weeks vs. placebo [95% CI, 17.9 to 40.4; P<0.001]). The frequency of adverse events was similar in the vedolizumab and placebo groups. Vedolizumab was more effective than placebo as induction and maintenance therapy for ulcerative colitis. (Funded by Millennium Pharmaceuticals; GEMINI 1 ClinicalTrials.gov number, NCT00783718.).
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              Ustekinumab as Induction and Maintenance Therapy for Ulcerative Colitis

              Bruce Sands, William J Sandborn, Remo Panaccione … (2019)
              The efficacy of ustekinumab, an antagonist of the p40 subunit of interleukin-12 and interleukin-23, as induction and maintenance therapy in patients with ulcerative colitis is unknown.
              Article 0 comments Cited 369 times – based on 0 reviews     Review now
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                Author and article information

                Contributors
                Juan Manuel Reyes:
                ORCID: http://orcid.org/0000-0003-0806-7173
                JuanManuel.Reyes@pfizer.com
                Journal
                Journal ID (nlm-ta): Pharmacoecon Open
                Journal ID (iso-abbrev): Pharmacoecon Open
                Title: PharmacoEconomics Open
                Publisher: Springer International Publishing (Cham )
                ISSN (Print): 2509-4262
                ISSN (Electronic): 2509-4254
                Publication date (Electronic): 9 August 2022
                Publication date PMC-release: 9 August 2022
                Publication date Collection: November 2022
                Volume: 6
                Issue: 6
                Pages: 837-846
                Affiliations
                [1 ]Clinica Colombia, Bogotá, Colombia
                [2 ]GRID grid.413124.1, ISNI 0000 0004 1784 5448, Hospital Pablo Tobon Uribe, ; Medellin, Colombia
                [3 ]Pfizer SAS, Av. Suba #95-66, 112111 Bogotá, Colombia
                Author information
                http://orcid.org/0000-0002-4008-6123
                http://orcid.org/0000-0002-8610-9925
                http://orcid.org/0000-0001-7383-6800
                http://orcid.org/0000-0003-0806-7173
                Article
                Publisher ID: 360
                DOI: 10.1007/s41669-022-00360-4
                PMC ID: 9596638
                PubMed ID: 35943702
                SO-VID: b59eaefd-c85d-4588-b0bd-2d7c53323936
                Copyright © © The Author(s) 2022
                License:

                Open AccessThis article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/.

                History
                Date accepted : 18 July 2022
                Funding
                Funded by: Pfizer S.A.S
                Categories
                Subject: Original Research Article
                Custom metadata
                issue-copyright-statement © The Author(s) 2022

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