Vedolizumab (Entyvio) intravenous infusion coverage
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Defines medical necessity, site-of-care, quantity limits, and documentation requirements for vedolizumab (Entyvio) IV for adults with moderately to severely active Crohn's disease or ulcerative colitis for Blue Cross NC.
Added allowance for patients currently established on a biologic or systemic immunomodulator agent who have had positive clinical benefit from that agent.
For Crohn's disease and ulcerative colitis removed required trial and failure of conventional therapy and replaced criteria to require documented moderately to severely active disease with specific confirmatory evidence.
Updated Site of Care medical necessity criteria to add bypass conditions for severe adverse events and high-risk conditions for outpatient hospital administration.
Coverage Criteria for Vedolizumab (Entyvio) IV
Initial Therapy - Crohn's disease
Covered when ALL of the following are met:
CD Initial
- CD disease activity: One of: (1) BOTH: symptoms consistent with active CD (e.g., diarrhea, abdominal pain, weight loss, fatigue, fever, anemia, nutrient deficiencies, nausea/vomiting) AND evidence of active inflammation confirmed by ONE of: active inflammatory disease on cross-sectional imaging (MRE, CTE), intestinal ultrasound, or pelvic MRI for perianal disease (eg bowel wall thickening, ulceration, hyperenhancement, fistula, abscess); OR biomarker evidence indicative of inflammation (eg elevated fecal calprotectin, elevated CRP, elevated ESR, low serum albumin); OR (2) significant extent of disease or upper GI involvement on radiographic or endoscopic assessment (eg large/deep mucosal lesions, fistulas/perianal abscesses, strictures, extensive disease such as ileal involvement >40 cm or prior bowel resection); OR (3) corticosteroid-dependence or refractory to oral corticosteroids. [Medical record documentation required]
Initial Therapy - Ulcerative colitis
Covered when ALL of the following are met:
UC Initial
- UC disease activity: One of: (1) BOTH: symptoms consistent with active UC (e.g., increased stool frequency, rectal bleeding, urgency, nocturnal symptoms, abdominal pain/cramping, extraintestinal manifestations, weight loss) AND evidence of active inflammation or high-risk disease confirmed by ONE of: moderate-to-severe disease activity on lower GI endoscopy using a validated endoscopic score (MES, UCEIS, or equivalent); OR evidence of active inflammatory disease on intestinal ultrasound (eg increased bowel wall thickness, hyperemia); OR biomarker evidence indicative of inflammation (eg elevated fecal calprotectin, elevated CRP, elevated ESR, low serum albumin); OR presence of ≥1 poor prognostic factor (eg age <40 at diagnosis, extensive colitis, hospitalization); OR (2) corticosteroid-dependence or refractory to oral corticosteroids. [Medical record documentation required]
Established biologic/systemic immunomodulator benefit
Covered when ALL of the following are met for patients established on another biologic/systemic immunomodulator:
Dosing and Quantity Limits
Coverage includes only FDA-labeled dosing and specified exceptions:
Site of Care Criteria
Site of Care medical necessity for injection/infusion administration:
Vedolizumab (Entyvio) must not be used in combination with another biologic immunomodulator agent or with Zeposia. Requests for vedolizumab where the patient will receive concurrent therapy with any other biologic immunomodulator or with Zeposia will not meet coverage criteria and are excluded from approval.
Requests that would exceed the policy maximum units = 2400 for the approval period are not approved unless a quantity limit exception is granted. Quantity limit exceptions are limited (for example, documented titration during initiation for up to 90 days) and the prescriber must provide supporting documentation when requesting doses higher than the FDA‑labeled regimen. If the requested quantity exceeds the maximum FDA‑labeled or studied dose, the prescriber must submit medical record documentation justifying the higher dose and showing duration of use and prior therapies tried/failed.
Coding and Related Operational Details
| J3380 | vedolizumab injection, 1 mg (HCPCS code listed in FDA label reference) |
Prior Authorization, Documentation, and Provider Requirements
Prior Authorization Required
Prior authorization is required for vedolizumab IV (HCPCS J3380). Approvals are limited to the specified maximum units and duration shown below. Requests for inpatient or outpatient hospital administration must also meet Site of Care criteria when applicable.
- HCPCS: J3380
- Maximum units: 2400
- Duration of approval: 365 days (1 year)
Step Therapy Update
Policy no longer requires trial and failure of conventional therapy for Crohn's disease (CD) or ulcerative colitis (UC). Eligibility now focuses on documented moderately-to-severely active disease as defined in the medical necessity criteria.
- Effective 2026-07-01: removed requirement for trial/failure of conventional therapy for CD and UC
- Criteria now require documentation of moderately-to-severely active disease (see required documentation callout)
Required Documentation
Medical record documentation is required to demonstrate diagnosis, age, symptoms of active disease, and objective evidence of active inflammation or high-risk features. Include documentation of prior biologic/systemic immunomodulator use and clinical benefit when applicable.
- Documentation must confirm patient is ≥18 years old
- For CD/UC: documentation of symptoms consistent with active disease (examples listed in policy) [medical record documentation required]
- Objective evidence of active inflammation or high‑risk disease (one or more of: endoscopic findings, cross-sectional imaging or IUS consistent with active inflammation, elevated biomarkers such as fecal calprotectin or CRP, low albumin, or documented poor prognostic factors) [medical record documentation required]
- For patients established on a biologic or systemic immunomodulator: documentation of prior use and positive clinical benefit (e.g., symptom improvement, reduced disease severity) [medical record documentation required]
- If corticosteroid‑dependent or steroid‑refractory, include documentation supporting this status
Basis for Denial
Requests lacking required medical record documentation of diagnosis, age (≥18), and evidence of moderately to severely active disease (both symptomatic and objective findings where specified) will be denied.
- Missing documentation of symptoms consistent with active CD or UC
- Missing objective evidence of active inflammation or high‑risk features
- No documentation of age ≥18
- No evidence of therapeutic benefit for patients continuing on a current biologic/systemic immunomodulator when that allowance is applicable
Background
Vedolizumab (Entyvio) is an intravenous biologic approved for adults with moderately to severely active Crohn's disease or ulcerative colitis. The FDA‑labeled IV dosing is 300 mg at weeks 0, 2, and 6, then every 8 weeks thereafter, and the label recommends discontinuing therapy if there is no evidence of therapeutic benefit by week 14.
Definitions
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