ModifiedUnitedHealthcarePolicy 2025D0053P

Entyvio (vedolizumab) intravenous infusion — coverage criteria

Clinical coverage policy governing medical necessity and authorization requirements for vedolizumab (Entyvio) IV for Crohn's disease, ulcerative colitis, immune checkpoint inhibitor-related GI toxicities, and acute GI graft-versus-host disease for UnitedHealthcare members.

Policy Summary

PayerUnitedHealthcare

PolicyEntyvio (vedolizumab) intravenous infusion — coverage criteria

Policy CodePolicy 2025D0053P

Change TypeMaterial revisions to indications, authorization limits, and excluded combination agents

Effective DateJul 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization documenting FDA‑labeled dosing, prior/concurrent therapy history or failures, and for GI aGVHD limit initial authorization to no more than 4 doses.

SourceLink

POLICY UPDATE CHANGES

Entyvio (vedolizumab) is proven and medically necessary for the treatment of gastrointestinal acute graft-versus-host disease (aGVHD) when specified criteria are met.

Coverage criteria for immune checkpoint inhibitor-related toxicities were revised to add specific immunotherapy-related diagnoses that may be covered.

Updated examples list of targeted immunomodulators not to be used in combination with Entyvio for Crohn's disease and ulcerative colitis (several agents added, some removed).

ICD-10 diagnosis code D89.810 was added to applicable codes.

12 monthsIBD reauth max

≤3 dosesImmune‑toxicity limit

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Coverage Criteria for Vedolizumab (Entyvio)

Crohn's disease (initial and continuation)

Entyvio is proven and medically necessary for the treatment of Crohn's disease when ALL of the following are met:

Crohn's - initial therapy: Diagnosis of moderately to severely active Crohn's disease; and one of the following: history of failure, contraindication, or intolerance to at least one conventional therapy (a TNF blocker OR an immunomodulator OR a corticosteroid) OR corticosteroid dependence (unable to successfully taper corticosteroids without return of symptoms); and Entyvio is initiated and titrated according to FDA-labeled dosing for Crohn's disease; and patient is not receiving Entyvio in combination with a targeted immunomodulator (examples listed in policy) or natalizumab (Tysabri); and initial authorization will be for no more than 12 months.

Crohn's - continuation: Documentation of positive clinical response to Entyvio; and Entyvio dosing for Crohn's disease is in accordance with FDA-labeled dosing; and reauthorization will be for no more than 12 months.

Ulcerative colitis (initial and continuation)

Entyvio is proven and medically necessary for the treatment of ulcerative colitis when ALL of the following are met:

UC - initial therapy: Diagnosis of moderately to severely active ulcerative colitis; and one of the following: history of failure, contraindication, or intolerance to at least one conventional therapy (a TNF blocker OR an immunomodulator OR a corticosteroid) OR corticosteroid dependence (unable to successfully taper corticosteroids without return of symptoms); and Entyvio is initiated and titrated according to FDA-labeled dosing for ulcerative colitis; and patient is not receiving Entyvio in combination with a targeted immunomodulator (examples listed in policy) or natalizumab (Tysabri); and initial authorization will be for no more than 12 months.

UC - continuation: Documentation of positive clinical response to Entyvio; and Entyvio dosing for ulcerative colitis is in accordance with FDA-labeled dosing; and reauthorization will be for no more than 12 months.

Immune checkpoint inhibitor-related GI toxicities

Entyvio is proven and medically necessary for specified immune checkpoint inhibitor-related GI toxicities when ALL of the following are met:

Eligible immunotherapy-related diagnoses: Moderate to severe esophagitis, gastritis, or duodenitis if no improvement on corticosteroids or budesonide; OR mild (G1) diarrhea or colitis if persistent or progressive symptoms with positive lactoferrin or calprotectin; OR moderate (G2) or severe (G3-4) immunotherapy-related diarrhea or colitis.

Patient must be receiving a checkpoint inhibitor.

Checkpoint inhibitor therapy and prior infliximab or hepatitis: Patient is receiving a checkpoint inhibitor (e.g., pembrolizumab, nivolumab); and one of the following: history of failure, contraindication, or intolerance to infliximab OR patient has immune-related hepatitis; authorization will be for no more than 3 doses of Entyvio.no more than 3 doses

GI acute graft-versus-host disease (initial and continuation)

Entyvio is proven and medically necessary for GI acute graft-versus-host disease (aGVHD) when ALL of the following are met:

aGVHD - initial therapy: Diagnosis of steroid-refractory acute GI aGVHD; and one of the following: patient is receiving Entyvio in combination with systemic corticosteroids OR patient is intolerant to systemic corticosteroid therapy; initial authorization is for no more than 4 doses.no more than 4 doses

aGVHD - continuation: Documentation of positive clinical response to Entyvio; patient continues to experience acute GI aGVHD; and one of the following: patient is receiving Entyvio in combination with systemic corticosteroids OR patient is intolerant to systemic corticosteroid therapy; authorization is for no more than 4 doses.no more than 4 doses

Initial Therapy

Covered when ALL of the following are met

Initial Therapy for GI aGVHD: Diagnosis of steroid-refractory acute GI aGVHD; and one of the following: patient is receiving Entyvio in combination with systemic corticosteroids OR patient is intolerant to systemic corticosteroid therapy; initial authorization is for no more than 4 doses.no more than 4 doses

Initial authorization limit specified

Continuation of Therapy

Covered when ALL of the following are met

Continuation Therapy for GI aGVHD: Documentation of positive clinical response; patient continues to experience acute GI aGVHD; and one of the following: patient is receiving Entyvio in combination with systemic corticosteroids OR patient is intolerant to systemic corticosteroid therapy; authorization is for no more than 4 doses.no more than 4 doses

Continuation authorization limit specified

Use of Entyvio (vedolizumab) in combination with other targeted immunomodulators or with natalizumab (Tysabri) is excluded by the coverage criteria. Requests for coverage that propose concurrent therapy with another targeted immunomodulator or natalizumab will not meet medical necessity and may be denied.

Examples of targeted immunomodulators listed in the policy as not to be given in combination with Entyvio include: adalimumab, Cimzia (certolizumab), Omvoh (mirikizumab-mrkz), Rinvoq (upadacitinib), Simponi (golimumab), Skyrizi (risankizumab), Tremfya (guselkumab), ustekinumab, and Xeljanz (tofacitinib) for Crohn's disease and similar agents (including Enbrel (etanercept) and others) for ulcerative colitis as listed in the policy examples.

As reiterated in the coverage criteria for Crohn's disease and ulcerative colitis, a patient must not be receiving Entyvio in combination with either a listed targeted immunomodulator or Tysabri (natalizumab); meeting this exclusion is a required element for initial and continuation authorization.

Policy revision effective 07/01/2025 updated the examples list of targeted immunomodulators: several agents were added (for example, Omvoh [mirikizumab-mrkz], Simponi [golimumab], Skyrizi [risankizumab], Tremfya [guselkumab], and others) and some were removed (for example, infliximab and Xeljanz XR); the policy history documents these specific changes.

Applicable Codes and Authorization Durations

Applicable HCPCSHCPCS

J3380

Injection, vedolizumab, IV,1 mg

Applicable ICD-10 Codes (Crohn's disease and Ulcerative colitis and aGVHD etc.)ICD-10

D89.810	Acute graft-versus-host disease
K50.00	Crohn's disease of small intestine without complications
K50.011	Crohn's disease of small intestine with rectal bleeding
K50.012	Crohn's disease of small intestine with intestinal obstruction
K50.013	Crohn's disease of small intestine with fistula
K50.014	Crohn's disease of small intestine with abscess
K50.018	Crohn's disease of small intestine with other complication
K50.019	Crohn's disease of small intestine with unspecified complications
K50.10	Crohn's disease of large intestine without complications
K50.111	Crohn's disease of large intestine with rectal bleeding

1–10 of 36

1/4

Applicable ICD-10 Codes (adverse effects)ICD-10

T45.1X5A	Adverse effect of antineoplastic and immunosuppressive drugs, initial encounter
T45.1X5D	Adverse effect of antineoplastic and immunosuppressive drugs, subsequent encounter
T45.1X5S	Adverse effect of antineoplastic and immunosuppressive drugs, sequela

Applicable Diagnosis Codes (added)ICD-10

D89.810

added ICD-10 diagnosis code (policy history)

Authorization duration

Immune checkpoint inhibitor–related GI toxicitiesAuthorization limited to no more than 3 total doses for this indication when criteria are met.

GI acute graft-versus-host disease (aGVHD) — initialInitial authorization limited to no more than 4 doses for steroid-refractory acute GI aGVHD when criteria are met.

GI acute graft-versus-host disease (aGVHD) — continuationContinuation authorization for GI aGVHD is limited to no more than 4 doses with documentation of positive clinical response and continued acute GI aGVHD.

Dosing compliance requirementAll authorizations require Entyvio to be initiated and titrated according to US FDA–labeled dosing for the specific indication.

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization and Dosing Compliance

Prior authorization is required for Entyvio (vedolizumab). Requests must document that dosing will follow the FDA‑labeled regimen for the indicated condition (e.g., Crohn's disease, ulcerative colitis) and that initial/continuation durations do not exceed the policy limits. Initial authorizations for IBD indications are limited to no more than 12 months per the FDA‑labeled dosing schedule. For GI acute graft‑versus‑host disease (aGVHD), initial authorization is limited to no more than 4 doses when criteria are met. Continuation requests must include documentation of a positive clinical response and ongoing clinical need.

Entyvio must be initiated and titrated according to FDA‑labeled dosing for the specific indication.
Initial authorization limits: IBD indications — up to 12 months; GI aGVHD — up to 4 doses.
Continuation/reauthorization requires documentation of positive clinical response and ongoing need; reauthorization periods align with the indication-specific limits.

Denial Risk

Prohibited Combinations

Definitions and Clinical Response

Positive clinical response — documentation expectations

DefinitionPositive clinical response: documentation that the patient experienced clinical improvement on vedolizumab compared with baseline per treating clinician assessment.

Required documentation for continuationProviders must document the positive clinical response and ongoing need for therapy (e.g., symptom improvement vs baseline) for reauthorization; dosing must remain consistent with FDA labeling.

Timing of assessmentContinuation/reauthorization intervals follow the authorization duration (e.g., up to 12 months for IBD), with clinical response documented before reauthorization.

Context-specific expectationFor GI aGVHD continuation, documentation must show patient continues to experience acute GI aGVHD and is receiving systemic corticosteroids or is intolerant to them along with positive response to Entyvio.

Steroid-refractory acute GI aGVHD — policy definition and limits

Background

Vedolizumab (Entyvio) is a humanized monoclonal antibody that selectively binds the α4β7 integrin, blocking its interaction with mucosal addressin cell adhesion molecule-1 (MAdCAM‑1) and inhibiting lymphocyte trafficking into inflamed gastrointestinal tissue. It is FDA‑indicated for moderately to severely active ulcerative colitis and Crohn's disease, and clinical guideline reviews support its use for induction and maintenance in appropriately selected patients.

Revision History and Policy Changes

07/01/2025material_revisionLatest

Added coverage for gastrointestinal acute graft-versus-host disease (aGVHD) with initial and continuation authorization limits (initial and continuation authorization limited to no more than 4 doses); revised immune checkpoint inhibitor–related toxicity criteria to add specific diagnoses; and updated the list of targeted immunomodulators (several agents added, some removed).

07/01/2025coding_change

Added ICD-10 diagnosis code D89.810 to the applicable diagnosis codes list.