ModifiedcountycarePolicy 5007.CC

Entyvio (vedolizumab) Coverage Criteria

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This clinical guideline governs coverage review and authorization of Entyvio (vedolizumab) for providers. It addresses initial and reauthorization criteria for Crohn's disease, ulcerative colitis, and immune checkpoint inhibitor-related toxicity.

Policy Summary

Payercountycare

PolicyEntyvio (vedolizumab) Coverage Criteria

Policy CodePolicy 5007.CC

Change TypeModified

Effective DateAug 1, 2025

Next Review DateN/A

Key ActionSubmit Entyvio (vedolizumab) requests through the Health Plan's prior authorization process.

SourceLink

POLICY UPDATE CHANGES

The June 2025 revision updated initial and reauthorization criteria, including prerequisite requirements, diagnostic criteria, and indication-specific reauthorization requirements.

The June 2025 revision added immune checkpoint inhibitor-related toxicity as a supported off-label indication.

The February 2023 revision changed the approval duration to one year.

Initial and reauthorization criteria were updated, including prerequisite requirements, diagnostic criteria for both established indications, and indication-specific reauthorization requirements.

Immune checkpoint inhibitor-related toxicity was added as a new indication.

3Covered clinical indications

18+

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ModifiedcountycarePolicy 5007.CC

Entyvio (vedolizumab) Coverage Criteria

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Policy Summary

Payercountycare

PolicyEntyvio (vedolizumab) Coverage Criteria

Policy CodePolicy 5007.CC

Change TypeModified

Effective DateAug 1, 2025

Next Review DateN/A

Key ActionSubmit Entyvio (vedolizumab) requests through the Health Plan's prior authorization process.

SourceLink

POLICY UPDATE CHANGES

The June 2025 revision updated initial and reauthorization criteria, including prerequisite requirements, diagnostic criteria, and indication-specific reauthorization requirements.

The June 2025 revision added immune checkpoint inhibitor-related toxicity as a supported off-label indication.

The February 2023 revision changed the approval duration to one year.

Initial and reauthorization criteria were updated, including prerequisite requirements, diagnostic criteria for both established indications, and indication-specific reauthorization requirements.

Immune checkpoint inhibitor-related toxicity was added as a new indication.

3Covered clinical indications

18+

Minimum age for Crohn's and ulcerative colitis

6 monthsTB testing recency

14 weeksTherapeutic benefit deadline

1 yearAuthorization duration

J3380Covered HCPCS code

Coverage Criteria Overview

General initial therapy

Covered for initial therapy when ALL general criteria are met.

General initial criteria: The prescribed dose is within the manufacturer's dosing guidelines based on diagnosis, weight, and FDA-approved labeling; a negative tuberculosis skin test or acceptable IGRA was collected within the last 6 months; the member is not receiving a biologic DMARD or targeted synthetic DMARD; there is no evidence of infection; and immunizations are current according to applicable guidelines before starting vedolizumab.TB test within 6 months

Acceptable tests include Tuberculin PPD, QuantiFERON-TB Gold In-Tube, or T-SPOT.TB.

Crohn's disease initial therapy

Covered for Crohn's disease when ALL of the following are met.

Crohn's disease initial criteria

Prior therapy failure: Failure of at least one of the following: an adalimumab product or Cimzia.1 of 2
An adequate trial of at least 3 months is required.

Ulcerative colitis initial therapy

Covered for ulcerative colitis when ALL of the following are met.

Ulcerative colitis initial criteria

Ulcerative colitis severity evidence: Dependency on or refractory to corticosteroids; severe endoscopic disease activity such as ulcers; high risk of colectomy; Mayo Clinic score 6-12 with endoscopic subscore 2 or 3; or hospitalization with at least 6 bloody bowel movements daily and at least 1 systemic toxicity marker.One severity criterion
Systemic toxicity markers include heart rate >90 beats/min, temperature >37.8 C, hemoglobin <10.5 g/dL, and/or erythrocyte sedimentation rate >=30 mm/h.
Required prior therapy failures: Failure of an adalimumab product and Xeljanz, unless contraindicated.Both therapies unless contraindicated

Immune checkpoint inhibitor-related toxicity

Covered for the off-label immune checkpoint inhibitor-related toxicity indication when ALL criteria are met.

Immune checkpoint inhibitor-related toxicity: The prescriber is a gastroenterologist, hematologist, or oncologist; the member has immune checkpoint inhibitor-related diarrhea or colitis; and the member had an inadequate response to systemic corticosteroids or infliximab.Inadequate response to corticosteroids or infliximab

This is an off-label supported indication.

General continuation therapy

Covered for continuation when ALL general reauthorization criteria are met.

General continuation criteria: The prescribed dose remains within the manufacturer's dosing guidelines based on diagnosis, weight, and FDA-approved labeling; the drug is not used with a biologic DMARD or targeted synthetic DMARD; and there is evidence of therapeutic benefit by treatment week 14.Therapeutic benefit by week 14

If therapeutic benefit is not demonstrated by week 14, therapy must be discontinued per FDA-approved labeling.

Crohn's disease continuation

Crohn's disease continuation requires recent chart documentation of low disease activity or improvement from baseline in at least ONE measure.

Crohn's disease response: Achievement or maintenance of a positive clinical response shown by low disease activity or improvement from baseline in abdominal pain or tenderness, diarrhea, body weight, abdominal mass, hematocrit, mucosal appearance on endoscopy, CTE, MRE, or intestinal ultrasound, or a disease activity score such as the CDAI.At least 1 response measure

Recent chart note documentation is required.

Ulcerative colitis continuation

Ulcerative colitis continuation requires recent chart documentation of low disease activity or improvement from baseline in at least ONE measure.

Ulcerative colitis response: Achievement or maintenance of a positive clinical response shown by low disease activity or improvement from baseline in stool frequency, rectal bleeding, urgency of defecation, C-reactive protein, fecal calprotectin, mucosal appearance on endoscopy, CTE, MRE, or intestinal ultrasound, or a disease activity score such as UCEIS or Mayo score.At least 1 response measure

Recent chart note documentation is required.

Concurrent use excluded: Entyvio must not be used in combination with a biologic disease-modifying antirheumatic drug (DMARD) or a targeted synthetic DMARD.

Safety prerequisites: Initial treatment is excluded when there is evidence of infection or required immunizations are not current. Before starting vedolizumab, the member must have a negative tuberculosis test collected within the last 6 months and be up to date on immunizations according to applicable guidelines.

Initial requests must meet all applicable criteria. Coverage requires the general criteria and the diagnosis-specific criteria for the requested indication, including the required specialist involvement, age, disease severity, and prerequisite treatment history. Requests that do not meet all applicable criteria are not medically necessary under this guideline and may be referred for Medical Director review.

Continuation requires documented benefit. Therapeutic benefit must be demonstrated by treatment week 14; otherwise, therapy must be discontinued in accordance with FDA-approved labeling. Annual renewal requests must also include recent indication-specific documentation showing low disease activity or improvement from baseline in at least one required Crohn's disease or ulcerative colitis response measure.

Initial Authorization Requirements

General initial requirements

Initial requests must meet ALL general safety, dosing, and utilization requirements.

Initial drug requirements: Use a dose within the manufacturer's dosing guidelines based on diagnosis, weight, and FDA-approved labeling; obtain a negative tuberculosis skin test or acceptable IGRA within 6 months; do not combine vedolizumab with a biologic DMARD or targeted synthetic DMARD; confirm no evidence of infection; and bring immunizations up to date according to current guidelines before starting vedolizumab.TB test within 6 months

Provider documentation or attestation is required. Acceptable tests include Tuberculin PPD, QuantiFERON-TB Gold In-Tube, or T-SPOT.TB.

Annual Reauthorization Requirements

Annual continuation therapy

Annual reauthorization requires ALL general continuation criteria and the applicable disease-specific response criteria.

Annual continuation requirements: The dose is within the manufacturer's dosing guidelines; vedolizumab is not combined with a biologic DMARD or targeted synthetic DMARD; therapeutic benefit is demonstrated by treatment week 14; and recent documentation shows the required disease-specific clinical response.Benefit by week 14; annual review

Approval is for up to one year. Crohn's disease renewal requires at least one documented response measure from the Crohn's disease criteria; ulcerative colitis renewal requires at least one documented response measure from the ulcerative colitis criteria. Reauthorization requests for immune checkpoint inhibitor-related toxicity must meet initial criteria.

Covered Code and Clinical Thresholds

Covered HCPCS CodeHCPCSCovered

J3380

Injection, vedolizumab, 1mg

Tuberculosis test recency

Tuberculosis testNegative tuberculosis skin test or acceptable IGRA required

RecencyTest must be collected within the last 6 months

Acceptable examplesTuberculin PPD, QuantiFERON-TB Gold In-Tube, or T-SPOT.TB

Prerequisite treatment trial

Minimum trialAt least 3 months

Crohn’s diseaseFailure of at least one adalimumab product or Cimzia after an adequate trial

Ulcerative colitis

Authorization and Documentation Actions

Prior Authorization

Prior Authorization and Medical Necessity Review

Submit Entyvio (vedolizumab) requests through the prior authorization process for review of medical necessity using FDA criteria. Requests that do not meet established criteria may be referred to a Medical Director when required by the plan and request level.

Provide the clinical information needed to support the medical-necessity determination and Medical Policy Committee approval.

Prior Authorization

Prior Authorization Required

Entyvio is subject to prior authorization when requested under the Health Plan’s medical benefit. This guideline applies to practitioners involved in providing the requested drug.

Verify that the request is being submitted under the medical benefit.
Obtain authorization before administering or providing therapy when required.

Policy Scope

This guideline addresses coverage of Entyvio (vedolizumab) for inflammatory bowel disease, including moderately to severely active or fistulizing Crohn's disease and moderately to severely active ulcerative colitis in adults. It also supports coverage for the off-label indication of immune checkpoint inhibitor-related diarrhea or colitis when the applicable criteria are met.

Disease Severity Definitions

Moderate-to-severe Crohn’s disease

CDAI range220–450

Prior treatmentFailure of treatment for mild-to-moderate disease

Clinical featuresProminent symptoms may include fever, weight loss, abdominal pain or tenderness, intermittent nausea or vomiting, or anemia

Endoscopic diseaseModerate-to-severely active endoscopic disease may be present

Severe-fulminant Crohn’s disease

CDAI range>450

Persistent symptomsSymptoms persist despite glucocorticoids or biologic agents

Prerequisite Treatment Pathways

Indication	Required prerequisite therapy	Trial duration	Failure or exception
Crohn's disease
Fail at least one of an adalimumab product or Cimzia before Entyvio.
At least 3 months
Inadequate response, significant side effects or toxicities, or contraindication.

Indication	Required prerequisite therapies	Trial duration	Failure or exception
Ulcerative colitis
Fail each of an adalimumab product and Xeljanz before Entyvio.
At least 3 months for each therapy
Unless contraindicated.

Indication	Required prior therapy	Trial duration	Failure requirement
Immune checkpoint inhibitor-related diarrhea or colitis (off-label supported indication)
Systemic corticosteroids or infliximab
Not specified
Inadequate response

Policy Summary

Payercountycare

PolicyEntyvio (vedolizumab) Coverage Criteria

Policy CodePolicy 5007.CC

Change TypeModified

Effective DateAug 1, 2025

Next Review DateN/A

Key ActionSubmit Entyvio (vedolizumab) requests through the Health Plan's prior authorization process.

SourceLink

On This Page

Failure of both an adalimumab product and Xeljanz after adequate trials, unless contraindicated

Mayo Clinic score

Mayo Clinic score6–12

Endoscopic subscore2 or 3

Clinical useQualifies as one criterion for moderate-to-severely active ulcerative colitis

Hospitalized ulcerative colitis activity

HospitalizationPatient must be hospitalized for qualifying ulcerative colitis activity

Bowel movementsAt least 6 bloody bowel movements per day

Systemic toxicityAt least 1 systemic toxicity marker must also be present

Systemic toxicity markers

Heart rate>90 beats/min

Temperature>37.8 C

Hemoglobin<10.5 g/dL

Erythrocyte sedimentation rate>=30 mm/h

Crohn’s disease activity

Moderate-to-severe diseaseCDAI 220–450

Severe-fulminant diseaseCDAI >450

Classification source2018 ACG Clinical Guidelines classification

Prior Authorization

Annual Reauthorization

All prior authorization renewals are reviewed annually for medical necessity. Reauthorization must continue to satisfy the general and diagnosis-specific criteria; requests for immune checkpoint inhibitor-related toxicity must meet the initial criteria.

Initial authorization: up to 1 year.
Reauthorization: same duration as the initial authorization.

Step Therapy

Crohn’s Disease Prerequisite Therapy

For Crohn’s disease, document an adequate trial of at least 3 months and failure of at least one required therapy, demonstrated by inadequate response, significant side effects or toxicities, or a contraindication.

Required prior-therapy options include an adalimumab product or Cimzia (certolizumab pegol).

Step Therapy

Ulcerative Colitis Prerequisite Therapy

For ulcerative colitis, document an adequate trial of at least 3 months and failure of each required therapy, unless contraindicated.

Required prior therapies are an adalimumab product and Xeljanz (tofacitinib).
Document the inadequate response, significant side effects or toxicities, or applicable contraindication for each therapy.

Step Therapy

Checkpoint Inhibitor Toxicity Prerequisite

For immune checkpoint inhibitor-related diarrhea or colitis, document an inadequate response to systemic corticosteroids or infliximab before requesting Entyvio.

This is an off-label supported indication.
The prescriber must be, or consult with, a gastroenterologist, hematologist, or oncologist.

Documentation Required

Tuberculosis Testing Required

Submit or attest to qualifying negative tuberculosis testing collected within the six months before treatment.

Acceptable testing includes a tuberculin PPD test or an interferon-gamma release assay (IGRA), such as QuantiFERON-TB Gold In-Tube or T-SPOT.TB.

Documentation Required

Safety Attestation

Before starting vedolizumab, provide provider documentation or attestation that required safety conditions are satisfied.

Entyvio is not being used with a biologic DMARD or targeted synthetic DMARD, including examples such as Xeljanz, Olumiant, or Otezla.
There is no evidence of infection.
The member is current on immunizations according to current guidelines, including applicable ACIP recommendations.

Documentation Required

Initial Clinical Documentation

Initial requests must include clinical documentation sufficient to establish the diagnosis-specific criteria and the requested treatment history.

Diagnosis and disease severity, including the applicable clinical findings or disease-activity measures.
Member age and prescribing specialist or qualifying consultation.
Prior treatment trials, duration, response or failure, adverse effects or toxicities, and contraindications, as applicable.
For checkpoint inhibitor-related toxicity, documentation of the qualifying toxicity and prior systemic corticosteroid or infliximab response.

Documentation Required

Continuation Response Documentation

For continuation requests, submit recent chart notes demonstrating achievement or maintenance of a positive clinical response, shown by low disease activity or improvement from baseline.

Crohn’s disease: document improvement in at least one relevant measure, such as abdominal symptoms, diarrhea, weight, abdominal mass, hematocrit, mucosal appearance, or a disease-activity score.
Ulcerative colitis: document improvement in at least one relevant measure, such as stool frequency, rectal bleeding, urgency, CRP, fecal calprotectin, mucosal appearance, or a disease-activity score.

Denial Risk

Criteria Not Met

If established criteria are not met, the request may be denied or referred to a Medical Director when required for the plan and level of request.

Ensure all general and diagnosis-specific requirements are addressed before submission.

Denial Risk

Dose or Drug-Combination Violation

Use only the manufacturer’s FDA-approved dosing guidelines, including diagnosis- and weight-based requirements, and do not combine Entyvio with prohibited therapies.

Do not use with a biologic DMARD or targeted synthetic DMARD, including Xeljanz, Olumiant, or Otezla.
A dose outside FDA-approved manufacturer guidance may result in nonapproval.

Denial Risk

Safety Prerequisites Absent

Requests lacking required tuberculosis testing or safety prerequisites are not approvable until the deficiencies are resolved.

Negative qualifying TB testing must have been collected within the prior six months.
There must be no evidence of infection.
Required immunizations must be current before starting vedolizumab.
The provider must document or attest to these safety requirements.

Denial Risk

Indication or Prerequisite Failure

The requested indication must meet the applicable age, specialist, disease-severity, and diagnosis requirements; failure of any required indication element can prevent approval.

Crohn’s disease: member must be at least 18, have moderately to severely active or fistulizing disease, and be prescribed by or in consultation with a gastroenterologist.
Ulcerative colitis: member must be at least 18, have moderate to severe disease supported by a qualifying clinical finding, and be prescribed by or in consultation with a gastroenterologist.
Checkpoint inhibitor-related toxicity: document immune checkpoint inhibitor-related diarrhea or colitis and prescribing by or consultation with a gastroenterologist, hematologist, or oncologist.

Denial Risk

No Benefit by Week 14

For continuation therapy, therapeutic benefit must be demonstrated by treatment week 14. If benefit is not documented by that deadline, therapy must be discontinued under FDA-approved labeling.

Submit continuation documentation showing low disease activity or clinically meaningful improvement by week 14.
No demonstrated benefit by week 14 may result in denial of continuation.

Severe clinical featuresHigh fever, persistent vomiting, intestinal obstruction, peritoneal signs, cachexia, or evidence of an abscess may be present

Moderate-to-severely active ulcerative colitis

Corticosteroid statusDependency on or refractory to corticosteroids

Endoscopic activitySevere endoscopic disease activity, such as the presence of ulcers

Disease severity measuresHigh risk of colectomy or Mayo Clinic score 6–12 with endoscopic subscore 2 or 3

Hospitalization criterionAt least 6 bloody bowel movements per day plus at least 1 systemic toxicity marker