OBJECTIVES

Anti-tumor necrosis factor (anti-TNF) biologic agents, adalimumab, golimumab, and infliximab, are standard of care in Japan for patients with moderate-to-severely active ulcerative colitis (UC). Vedolizumab, an antibody to gut-selective α₄β₇ integrin, was recently approved by Japan’s Ministry of Health, Labor, and Welfare, based on favorable results from a phase III study in Japanese patients; however, vedolizumab’s long-term clinical and economic outcomes versus other biologics in patients with UC are unknown in Japan. We assessed the cost-effectiveness of vedolizumab versus other biologics for the treatment of anti-TNF-naïve patients with moderate-to-severely active UC from the Japanese Public Payer perspective.

METHODS

A hybrid decision tree and Markov model was developed to predict the number of patients who achieve response and remission at the end of the treatment induction phase and sustain it during the treatment maintenance phase. Treatment-related adverse events, discontinuation, and surgery were also modeled. A systematic literature review and network meta-analysis were conducted to estimate the comparative efficacy of each treatment. Rates of surgery and utilities were obtained from scientific literature. Costs (in 2018 Japanese Yen) of treatment, surgery, and disease management were derived from the National Health Insurance drug price list and medical fee table and a commercial database (JMDC Inc., Tokyo). Clinical and economic outcomes were projected over lifetime and discounted at 2% annually.

RESULTS

Vedolizumab yielded greater clinical benefits and quality-adjusted life-years (QALYs), and cost savings compared with golimumab. Compared with adalimumab and infliximab, vedolizumab yielded greater clinical benefits and QALYs at a higher cost; the incremental cost-effectiveness ratios were ¥4,711,806 and ¥3,865,266 per QALY gained, respectively. Deterministic and probabilistic sensitivity analyses confirmed the results were robust.

CONCLUSIONS

With a willingness-to-pay threshold of ¥5,000,000 per QALY gained in Japan, vedolizumab is cost-effective versus other biologics for the treatment of anti-TNF-naïve patients with moderate-to-severely active UC in Japan.