Objective: To examine the clinical and economic impact of vedolizumab (VDZ) compared with conventional therapy (CT) and biologics (infliximab [IFX], adalimumab [ADA], golimumab [GOL]) in the treatment of moderately to severely active ulcerative colitis (UC) from a US payer perspective.
Methods: A Markov decision analytic model in Microsoft Excel was used to compare VDZ with IFX, ADA, GOL, and CT (aminosalicylates, corticosteroids, immunomodulators) in anti-tumor necrosis factor (anti-TNF) naïve patients and to compare VDZ with ADA in patients who previously failed anti-TNF therapy. Inputs were obtained from published literature, clinical trial data, and claims databases. For biologics, the efficacy outcomes estimates were obtained from a recently completed mixed treatment comparison analysis. Costs are presented in 2014 US dollars. Outcomes included quality-adjusted life-years (QALY), number of surgeries, and time spent in clinical response and time spent in clinical remission for 5 year and lifetime horizons. Incremental cost-effectiveness ratios were presented for VDZ compared with each of the other treatments. Costs and outcomes were discounted at 3% per year. Univariate and multivariate probabilistic sensitivity analyses were conducted to assess model robustness.
Results: Over a 5-year time horizon, the model predicted that anti-TNF naïve patients on VDZ accrued 2.843 QALY, compared with 2.602, 2.627, 2.606, and 2.252 QALY for patients on IFX, ADA, GOL, and CT, respectively. Over a lifetime horizon, VDZ-treated patients accrued 12.718 QALY, compared with 12.270, 12.410, 12.308, and 11.778 QALY for patients on IFX, ADA, GOL, and CT, respectively. Results were similar for other outcomes: patients on VDZ spent more time in clinical response and remission and experienced fewer surgeries than patients on any other treatment (Table 1). The incremental cost per QALY gained over lifetime horizon for VDZ suggests that VDZ is a cost-effective treatment compared with IFX ($2,714/QALY), ADA ($12,998/QALY), and CT ($28,545/QALY), and dominant compared with GOL (Table 2). In anti-TNF failure UC patients, VDZ is cost effective compared with ADA both at 5 years ($2,702/QALY) and over a lifetime horizon ($12,311/QALY). Sensitivity analyses suggest that results are most sensitive to treatment efficacy in the maintenance phase. However, VDZ remains cost effective irrespective of variations in the parameter.
Conclusions: Our model predicted that treatment with VDZ improves QALY, time in remission and response, reduces surgeries, and is a cost-effective treatment option for both anti-TNF naïve and anti-TNF failure patients with moderately to severely active UC compared with conventional and biological therapy options over both 5-year and lifetime horizons.
