From the Guidelines
Vedolizumab typically costs between $5,000 to $7,000 per infusion in the United States without insurance coverage, with total annual costs ranging from $30,000 to $84,000 depending on the dosing schedule. The cost of vedolizumab is significant due to its complex manufacturing process as a biologic medication and the substantial research investment required for its development 1.
Key Points to Consider
- The total annual cost of vedolizumab can vary widely, from $30,000 to $84,000, based on the specific dosing schedule, which usually involves infusions every 4-8 weeks after initial loading doses.
- Insurance coverage significantly impacts patient out-of-pocket costs, with copays potentially ranging from $0 to several hundred dollars per infusion, depending on the coverage plan.
- Patient assistance programs are available through the manufacturer (Takeda) for eligible individuals who cannot afford the medication, helping to mitigate the financial burden.
- As a biologic medication under patent protection, generic versions of vedolizumab are not yet available, contributing to its premium pricing 1.
Clinical Context and Cost Consideration
In the context of treating ulcerative colitis and Crohn's disease, the cost of vedolizumab must be weighed against its efficacy and the potential for improved patient outcomes, as demonstrated in studies such as the GEMINI-2 trial 1.
Conclusion on Cost and Treatment
Given the high cost of vedolizumab and the variability in insurance coverage, it is essential for healthcare providers to discuss the financial implications with patients and explore available assistance programs to ensure that those who can benefit from this medication have access to it.
From the Research
Vedolizumab Price and Cost-Effectiveness
- The cost-effectiveness of vedolizumab for the treatment of ulcerative colitis and Crohn's disease has been evaluated in several studies 2, 3, 4, 5, 6.
- A study published in 2018 found that including vedolizumab in a health plan formulary as a preferred first-line biologic therapy for UC and CD can result in substantial cost-savings compared with including vedolizumab as a preferred second-line treatment only 2.
- Another study published in 2025 found that sequencing vedolizumab as a first-line biologic prior to anti-TNFα in UC and CD provided additional clinical benefit to patients, and in UC, vedolizumab as a first-line biologic also saved healthcare system costs compared with anti-TNFα 3.
- A study published in 2020 found that the most cost-effective strategy in UC depends on the proportion of patients using adalimumab as the initial anti-TNF, and if adalimumab was ≥14%, vedolizumab was preferred as the first biologic 4.
- A review of the current literature on the cost-effectiveness of vedolizumab for inflammatory bowel disease found that cost-conscious, high-value care has an important role in the practice of medicine, and vedolizumab is a novel biologic agent approved for the treatment of Crohn's disease and ulcerative colitis 5.
- A cost-effectiveness analysis of vedolizumab compared with other biologics in anti-TNF-naïve patients with moderate-to-severe ulcerative colitis in Japan found that vedolizumab was dominant or cost-effective compared with other branded biologics 6.
Cost-Savings and Cost-Effectiveness Ratios
- The total cost-savings of including vedolizumab in a health plan formulary as a preferred first-line biologic therapy for UC and CD were from $0.13 million to $1.63 million in year 1, and from $0.38 million to $4.68 million in year 3 2.
- The per-member per-month cost-savings were from $0.01 to $0.14 in year 1 and from $0.03 to $0.39 in year 3 2.
- The incremental cost-effectiveness ratio of vedolizumab as a first-line biologic in UC was dominant, and in CD, it was $1,265,775 per QALY 3.
- The cost-effectiveness of vedolizumab compared with other biologics in anti-TNF-naïve patients with moderate-to-severe ulcerative colitis in Japan was found to be dominant or cost-effective, with incremental cost-effectiveness ratios of ¥4,821,940 and ¥4,687,692, respectively 6.