scholarly journals Tofacitinib for the treatment of moderately to severely active ulcerative colitis: a systematic review, network meta-analysis and economic evaluation

2019 ◽  
Vol 6 (1) ◽  
pp. e000302 ◽  
Author(s):  
Christoph Lohan ◽  
Alex Diamantopoulos ◽  
Corinne LeReun ◽  
Emily Wright ◽  
Natalie Bohm ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Cost Effectiveness ◽  
Conventional Therapy ◽  
Controlled Trial ◽  
Meta Analysis ◽  
Inadequate Response ◽  
Active Ulcerative Colitis ◽  
Biological Therapies ◽  
Infection Rates ◽  
Serious Infection

Background and aimsIn the UK, treatments for patients with moderately to severely active ulcerative colitis who have an inadequate response to conventional therapies comprise four biological therapies—the tumour necrosis factor inhibitor (TNFi) agents adalimumab, golimumab and infliximab and the anti-integrin vedolizumab—and an orally administered small molecule therapy, tofacitinib. However, there have been few head-to-head studies of these therapies. This study aimed to compare the clinical and cost-effectiveness of tofacitinib with biological therapies.MethodsA systematic literature review was conducted to identify all relevant randomised controlled trial (RCT) evidence. Clinical response, clinical remission and serious infection rates were synthesised using network meta-analysis (NMA). The results were used to compare the cost-effectiveness of tofacitinib and biologics with conventional therapy, using a Markov model, which incorporated lifetime costs and consequences of treatment from a UK National Health Service perspective. Analyses were conducted separately for TNFi-naïve and TNFi-exposed populations.ResultsSeventeen RCTs were used in the NMAs. There were no statistically significant differences among biological therapies and tofacitinib for either TNFi-naïve or TNFi-exposed patients. In TNFi-naïve patients, all therapies were more efficacious than placebo. In TNFi-exposed patients, only tofacitinib was significantly more efficacious than placebo as induction therapy, and only tofacitinib and vedolizumab were significantly more efficacious than placebo as maintenance therapies. There were no significant differences in serious infection rates among therapies. The incremental cost-effectiveness ratios for tofacitinib versus conventional therapy were £21 338 and £22 816 per quality-adjusted life year (QALY) in the TNFi-naïve and TNFi-exposed populations, respectively. TNFi therapies were dominated or extendedly dominated in both populations. Compared with vedolizumab, tofacitinib was associated with a similar number of QALYs, at a lower cost.ConclusionTofacitinib is an efficacious treatment for moderately to severely active ulcerative colitis and is likely to be a cost-effective use of NHS resources.

scholarly journals P530 Cost-effectiveness of vedolizumab SC vs. adalimumab for moderately to severely active ulcerative colitis

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S454-S455
Author(s):  
I Diakite ◽  
B Schultz ◽  
J Carter ◽  
S Snedecor ◽  
R Turpin
Keyword(s):  
Ulcerative Colitis ◽  
Cost Effectiveness ◽  
Maintenance Treatment ◽  
Relative Effectiveness ◽  
Drug Acquisition ◽  
Medical Costs ◽  
Resource Utilisation ◽  
Inadequate Response ◽  
Active Ulcerative Colitis ◽  
Direct Medical Costs

Abstract Background Intravenous vedolizumab (VDZ IV) is approved for the treatment of moderately to severely active ulcerative colitis (UC). Subcutaneous VDZ (VDZ SC) was studied in the VISIBLE 1 trial (NCT02611830) and is under review by the US Food and Drug Administration for maintenance treatment. VARSITY (NCT02497469) is the first head-to-head trial to compare 2 biologics (VDZ IV vs. adalimumab SC [ADA]) in UC. We evaluated the cost-effectiveness of VDZ SC vs. ADA from a US payor perspective using efficacy data from these trials. Methods We used a cohort decision tree model with a time horizon up to 2 years. Simulated cohorts included patients with and without prior biologic therapy who initiated treatment with VDZ IV (300 mg in weeks 0, 2, and 6) or ADA (day 1: 160 mg; day 15: 80 mg) for a 6 week induction period. Initial responders went on to maintenance treatment with VDZ SC (108 mg every 2 weeks) or ADA (40 mg every 2 weeks); maintenance remitters continued treatment for 2 years. Patients with inadequate response to induction, or serious adverse drug reaction (ADR) switched to treatment with biologics (tofacitinib, infliximab, or golimumab). Patients who were intolerant to biologics received corticosteroids with or without curative surgery. The relative effectiveness of VDZ IV vs. ADA was derived from network meta-analyses of published randomised controlled trials. Model outcomes included total direct medical costs associated with drug acquisition, administration, routine monitoring, toxicity management, ADRs, and cost per remission achieved. Costs (eg, drug, monitoring, healthcare resource utilisation, administration) are expressed in 2019 US$. Results Based on our model, VDZ SC was associated with greater clinical response (52.92% vs. 45.07%) and remission at year 2 (22.49% vs. 14.36%) compared with ADA. Total direct medical costs per patient over 2 years were $98,034 for VDZ SC and $137,007 for ADA. After 2 years of treatment, more patients were in remission with VDZ SC than ADA for lower overall costs. Conclusion The clinical foundation for this model is built primarily on evidence from clinical trials of adults with moderately to severely active UC. This allowed us to extrapolate clinical outcomes out to 2 years and estimate direct medical costs over that time. These modelled outcomes indicated that treatment with VDZ IV followed by VDZ SC is more effective and less costly for remission compared with initiation with ADA.

scholarly journals P607 Cost-effectiveness of vedolizumab IV vs. adalimumab SC for moderately to severely active ulcerative colitis

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S508-S508
Author(s):  
R Schultz ◽  
I Diakite ◽  
J Carter ◽  
S Snedecor ◽  
R Turpin
Keyword(s):  
Ulcerative Colitis ◽  
Cost Effectiveness ◽  
Clinical Outcomes ◽  
Time Horizon ◽  
Relative Effectiveness ◽  
Drug Acquisition ◽  
Medical Costs ◽  
Inadequate Response ◽  
Active Ulcerative Colitis ◽  
Direct Medical Costs

Abstract Background VARSITY (NCT02497469) is the first head-to-head trial comparing two biologic therapies, intravenous vedolizumab (VDZ IV) and subcutaneous adalimumab (ADA), in adults with moderately to severely active ulcerative colitis (UC). We evaluated the cost-effectiveness of VDZ IV vs. ADA from a US payor perspective using efficacy data from VARSITY. Methods We used a cohort decision tree model with a time horizon up to 2 years. Simulated cohorts included patients with or without prior biologic therapy who initiated treatment with VDZ IV (300 mg in weeks 0, 2, and 6) or ADA (day 1: 160 mg; day 15: 80 mg) for a 6-week induction period. Initial responders proceeded to maintenance treatment with VDZ IV (300 mg every 8 weeks) or ADA (40 mg every 2 weeks); maintenance phase remitters continued treatment for 2 years. Patients with inadequate response to induction or a serious adverse drug reaction (ADR) switched to treatment with biologics (tofacitinib, infliximab, or golimumab). Patients who were intolerant to biologics received corticosteroids with or without curative surgery. The relative effectiveness of VDZ IV vs. ADA was derived from network meta-analyses of published randomised controlled trials. Model outcomes included total direct medical costs associated with drug acquisition, administration, routine monitoring, toxicity management, ADRs, and cost per remission achieved. Costs (eg, drug, monitoring, healthcare resource utilisation, administration) were expressed in 2019 US$. Results Based on our model, VDZ IV was associated with greater induction response (52.92% vs. 45.07%) and remission 2 (21.95% vs. 14.36%) rates at year 2 compared with ADA. Total direct medical costs were $90,673 for VDZ IV and $137,007 for ADA. After 2 years of treatment, more patients in the VDZ IV cohort were in remission and for lower costs compared with ADA. Conclusion The clinical foundation of this model is predicated primarily on head-to-head evidence from the Phase 3 VARSITY trial. This allowed us to extrapolate clinical outcomes out to 2 years and estimate direct medical costs over that timeframe. These modelled outcomes indicate that over a 2-year time horizon adults with moderately to severely active UC are expected to achieve better clinical outcomes and incur lower direct medical costs vs. ADA.

scholarly journals Infliximab, adalimumab, golimumab, vedolizumab and tofacitinib in moderate to severe ulcerative colitis: comparative cost-effectiveness study in Poland

2020 ◽  
Vol 13 ◽  
pp. 175628482094117
Author(s):  
Pawel Petryszyn ◽  
Pawel Ekk-Cierniakowski ◽  
Grzegorz Zurakowski
Keyword(s):  
Ulcerative Colitis ◽  
Cost Effectiveness ◽  
Meta Analysis ◽  
Maintenance Phase ◽  
Cost Effective ◽  
Inadequate Response ◽  
Lifetime Horizon ◽  
Exposed Population ◽  
Life Years ◽  
The Cost

Background: Current management of ulcerative colitis (UC) is aimed to treat active disease and to maintain remission. For patients in whom conventional treatment is no longer effective, biological or small molecule therapy may be an option. The aim was to assess the cost-effectiveness of induction and maintenance treatment up to 1 year of UC with infliximab (IFX), adalimumab (ADA), golimumab, vedolizumab (VDZ) and tofacitinib (TFB) compared with standard of care (SoC) in Poland. Methods: A hybrid decision tree/Markov model was used to estimate the expected costs and effects of four biologics, TFB and placebo in patients with the diagnosis of moderate to severe UC who had an inadequate response, lost response, or were intolerant to a conventional therapy. Prior exposure to anti-TNF was considered. At the beginning of the maintenance phase, the decision to continue biological therapy was determined by the achievement of response at the end of induction. Efficacy data were obtained from a network meta-analysis using placebo as the common comparator. Costs were presented in 2018 Polish zloty (PLN) and outcomes included quality-adjusted life-years (QALYs). The analysis was performed from the Polish public payer’s perspective and lifetime horizon was set. Results: In anti-TNF naïve, IFX and VDZ were characterized by the most favourable incremental cost-effectiveness ratios (ICURs) compared with SoC, PLN211,250.78 and PLN361,694.61/QALY (€49,589.38 and €84,904.84/QALY), respectively. In anti-TNF-exposed population the most effective treatment was TFB. Both ADA and VDZ were more effective than SoC; however, ICUR values were much above the cost-effectiveness threshold. The incorporation of biosimilars reversed the ranking of treatments in relation to the growing ICUR. Conclusion: Although ICUR values for all biological therapies exceeded the acceptability threshold in Poland, for anti-TNF-naïve UC patients IFX and for anti-TNF-exposed UC patients VDZ are currently the most cost-effective alternatives.

scholarly journals Infliximab is superior to other biological agents for treatment of active ulcerative colitis: A meta-analysis

2015 ◽  
Vol 21 (19) ◽  
pp. 6044-6051 ◽  
Author(s):  
Wei-Qun Mei ◽  
Hui-Zhen Hu ◽  
Ying Liu ◽  
Zhi-Chen Li ◽  
Wei-Guo Wang
Keyword(s):  
Ulcerative Colitis ◽  
Meta Analysis ◽  
Biological Agents ◽  
Active Ulcerative Colitis

scholarly journals First- and Second-Line Pharmacotherapies for Patients With Moderate to Severely Active Ulcerative Colitis: An Updated Network Meta-Analysis

2020 ◽  
Vol 18 (10) ◽  
pp. 2179-2191.e6 ◽  
Author(s):  
Siddharth Singh ◽  
Mohammad Hassan Murad ◽  
Mathurin Fumery ◽  
Parambir S. Dulai ◽  
William J. Sandborn
Keyword(s):  
Ulcerative Colitis ◽  
Meta Analysis ◽  
Active Ulcerative Colitis ◽  
Second Line
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