CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Vedolizumab (Entyvio) — Coverage Criteria for Ulcerative Colitis, Crohn's Disease, and Immune Checkpoint Inhibitor–Related Colitis

Policy governs prior authorization, coverage criteria, dosing, quantity limits, and continuation rules for vedolizumab (Entyvio) IV and SC for adult members treated for moderately to severely active ulcerative colitis, Crohn's disease, and immune checkpoint inhibitor–related diarrhea/colitis.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyVedolizumab (Entyvio) — Coverage Criteria for UC, CD, and ICI-related colitis

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit patient chart/medical record documenting baseline disease severity and medical necessity to support prior authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18+Minimum patient age for coverage

4 monthsInitial auth length (UC/CD)

6 monthsContinuation auth length

300 mgStandard IV dose

108 mgSC maintenance dose

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Coverage Criteria for Vedolizumab (Entyvio)

Ulcerative Colitis — Initial Therapy

Authorization of 4 months may be granted when ALL of the following are met:

Operational note: Entyvio will not be used concomitantly with another injectable biologic response modifier or certain listed biologics; provide documentation if applicable.

Provider must document prior and concomitant medications.

Crohn's Disease — Initial Therapy

Authorization of 4 months may be granted when ALL of the following are met:

Operational note: Provide details of prior biologic therapies tried and reasons for discontinuation (failure, intolerance, contraindication).

Prior therapy documentation required.

Immune Checkpoint Inhibitor–Related Diarrhea/Colitis — Initial Therapy

Authorization of 3 IV doses may be granted when ALL of the following are met:

Operational note: Limit initial authorization to 3 IV doses; provide documentation of response for continuation requests.

Documentation of prior interventions and response required.

Product Strengths, Supply, and Coding Notes

Product strengths / supplymixed

300 mg vial	Entyvio IV vial size (300 mg)
108 mg/0.68 mL	Entyvio SC pen strength

Prior biologic trial durations — infliximab and ustekinumab

Infliximab trial durationMinimum 3-month trial of infliximab IV at maximum tolerated doses is required (documented failure, contraindication, or ineffective response)

Ustekinumab trial durationMinimum 6-month trial of ustekinumab at maximum tolerated doses is required for biologic‑experienced patients when specified

ApplicabilityPrior biologic trial requirements apply to initial therapy for ulcerative colitis and Crohn's disease prior to approval of vedolizumab (Entyvio)

Provider Requirements and Prior Authorization Actions

Prior Authorization

Prior Authorization Required

Prior authorization is required. Approvals are indication- and criteria-specific; submit all required documentation to support medical necessity for the requested indication and duration.

Prior authorization required for Entyvio (vedolizumab) for all covered indications
Approval durations: initial UC/CD authorizations typically up to 4 months; continuation up to 6 months when criteria met; ICI-related colitis up to 3 doses for acute management

Step Therapy

Step Therapy / Prior Biologic Requirements

Step therapy and prior biologic requirements must be documented. For patients with moderately to severely active ulcerative colitis or Crohn's disease, the prescriber must document prior trials and outcomes with specified biologics (failure, contraindication, or intolerance) and meet the minimum duration requirements before Entyvio will be authorized.

Ulcerative colitis: documented failure, contraindication, or inadequate response to a minimum 3-month trial of infliximab IV at maximum tolerated doses; and for biologic‑experienced patients, a minimum 6‑month trial of ustekinumab at maximum tolerated doses unless contraindicated

Background

Vedolizumab (Entyvio) is a gut-selective anti-integrin biologic; this policy covers its use for the FDA-approved indications of moderately to severely active ulcerative colitis and Crohn’s disease, and for the compendia-supported use in the management of immune checkpoint inhibitor–related diarrhea/colitis (administered as Entyvio IV). Baseline infection screening, including tuberculosis evaluation, and specialist involvement (prescribed by or in consultation with a gastroenterology specialist) are required per the policy criteria.

Definitions and Compendia Support

Compendia-supported indication — immune checkpoint inhibitor–related diarrhea/colitis

Definition of compendia-supported useCompendia-supported indication refers specifically to management of immune checkpoint inhibitor–related diarrhea/colitis (use as Entyvio IV)

Covered settingEntyvio IV is listed as the compendia-supported formulation for this indication

LimitationsAll other indications outside FDA-approved and compendia-supported uses are considered experimental/investigational and are not covered

Documentation Required

Required Clinical Documentation

Required clinical documentation must be submitted with the prior authorization request. Providers must supply objective baseline disease measures and the clinical history supporting medical necessity.

Submit the patient chart or medical record documenting baseline disease severity using objective measures/tools (e.g., Mayo score or UCEIS for ulcerative colitis; CDAI or Harvey‑Bradshaw Index for Crohn's disease; lactoferrin/calprotectin and endoscopic findings where applicable)
Document prior therapy history, including drug names, doses, treatment durations, and reason for discontinuation (failure, intolerance, contraindication)
For ICI‑related diarrhea/colitis: document current or prior immune checkpoint inhibitor therapy, grade of diarrhea/colitis, supportive stool or biomarker testing (e.g., positive lactoferrin/calprotectin), and prior treatments attempted
Documentation of TB screening and absence of active severe infection; assessment that patient is ≥18 years of age; and specialist involvement (prescribed by or in consultation with a gastroenterologist) must be included