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

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.

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S454-S455
Author(s):  
I Diakite ◽  
B Schultz ◽  
J Carter ◽  
S Snedecor ◽  
R Turpin

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.


2019 ◽  
Vol 6 (1) ◽  
pp. e000302 ◽  
Author(s):  
Christoph Lohan ◽  
Alex Diamantopoulos ◽  
Corinne LeReun ◽  
Emily Wright ◽  
Natalie Bohm ◽  
...  

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.


Author(s):  
Fitria Ningsih ◽  
Rani Sauriasari ◽  
Agusdini Banun Saptaningsih

Objectives: This retrospective cohort study aimed to compare the cost-effectiveness of using D10-CaGluconate and D5 1/4NS preparations in normalweightneonatal patients with Respiratory Distress Syndrome (RDS) in Kambang General Hospital, Jambi, Indonesia.Methods: The research was conducted from September 2014 to June 2015. The study participants were divided into two groups; D10-CaGluconatewas administered to 40 patients and D5 1/4NS to 43 patients. Effectiveness was assessed based on the changes in the physical examination results,average weight gain (28.48 and 23.49 g/day), blood glucose levels (26.73 and 26.42 mg/dL), respiratory rate (−12.35 breaths/minute and −7.77breaths/minute), pulse frequency (−10.98 and −8.07 ±), and body temperature (0.013°C and 0.012°C) of the patients in the D10-CaGluconate andD5 1/4NS groups, respectively.Results: The average direct medical costs of using D10-CaGluconate and D5 1/4NS were 458,290 IDR and 408,347 IDR, respectively. The average costeffectivenessratio value of total direct medical costs for D10-CaGluconate preparation was 35,207,467 IDR while that for D5 1/4NS was 33,958,602IDR. The direct medical cost of the incremental cost-effectiveness ratio mean value of the D5 1/4NS preparation that compared to the D10-CaGluconatepreparation was 10,017,210 IDR.Conclusions: The parenteral nutrition preparation of D10-CaGluconate is more cost-effective than that of D5 1/4NS.


2013 ◽  
Vol 16 (3) ◽  
pp. A213-A214 ◽  
Author(s):  
K. Goszczyńska ◽  
W. Wrona ◽  
M. Niewada ◽  
C.M. Black ◽  
T. Fan ◽  
...  

Stroke ◽  
2020 ◽  
Vol 51 (Suppl_1) ◽  
Author(s):  
Ana Claudia de Souza ◽  
Sheila Martins ◽  
Carisi Polanczyk ◽  
Denizar Vianna ◽  
Leonardo Carbonera ◽  
...  

Background and purpose: RESILIENT Trial was the first study in a developing country to demonstrate the benefit of mechanical thrombectomy (MT) in acute stroke patients. This economic evaluation aimed to access the cost-utility of MT under the perspective of the Brazilian Public Healthcare System. Methods: Analysis was based on a subset sample of the original study (151 of 221 patients) from 4 hospitals. We compared costs and utilities between MT plus standard care (n=78) vs. standard care alone (n=73). Direct medical costs were considered, and utilities were inputted according to each patient’s Utility-Weighted modified Rankin Score (UW-mRS). First-year survival was obtained from trial follow-up and modelled for a life-time horizon adjusted by National Mortality Data. Direct medical costs were converted to I$ using Purchasing Power Parity (PPP). A discount rate of 5% was used. Incremental cost-effectiveness ratio (ICER) is expressed in cost (I$) per Quality-Adjusted Life Year (QALY). Results: RESILIENT trial was stopped on its first interim analysis because of early efficacy. The incremental costs and QALYs gained with MT were estimated at I$ 8,369 and 0.75, respectively, compared with standard medical care, yielding an incremental cost-effectiveness ratio (ICER) of I$ 7,256 per QALY. Conclusion: The initially higher costs of MT were offset by the clear benefit of the intervention. RESILIENT trial demonstrated that such therapy is likely to be cost-effective despite the economical constraints in the Brazilian healthcare system.


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