ModifiedUnitedHealthcarePolicy CS2O25D0053W

Entyvio (vedolizumab) intravenous infusion

This UnitedHealthcare Medical Benefit Drug Policy governs coverage and medical necessity criteria for vedolizumab (Entyvio) IV for indications including Crohn's disease, ulcerative colitis, immune checkpoint inhibitor-related GI toxicities, and GI acute graft-versus-host disease for members in applicable states.

Policy Summary

PayerUnitedHealthcare

PolicyEntyvio (vedolizumab) intravenous infusion

Policy CodePolicy CS2O25D0053W

Change TypeMaterial revisions to indications, drug list, and added aGVHD coverage

Effective DateJuly 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of diagnosis, prior therapy failure/contraindication/intolerance and dosing; initial aGVHD authorizations are limited to no more than 4 doses.

SourceLink

POLICY UPDATE CHANGES

Added language that Entyvio (vedolizumab) is proven and medically necessary for GI acute graft-versus-host disease (aGVHD) when specified criteria are met.

Revised coverage criteria for immune checkpoint inhibitor-related toxicities and added additional immunotherapy-related diagnoses eligible for coverage.

Updated list of targeted immunomodulators that must not be used in combination with Entyvio; added and removed specific agents.

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

J3380listed HCPCS code for vedolizumab

≤12 moauthorization period for IBD

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Coverage and Medical Necessity Criteria

Crohn's Disease - Initial Therapy

Covered when ALL of the following are met for initial therapy in Crohn's disease:

Crohn's disease initial therapy: Diagnosis of moderately to severely active Crohn's disease

Prior therapy requirement: History of failure, contraindication, or intolerance to at least one conventional therapy (e.g., a TNF blocker, corticosteroid, or immunomodulator) OR corticosteroid dependence

Dosing: Entyvio is initiated and titrated according to the U.S. Food and Drug Administration (FDA) labeled dosing for Crohn's disease

Drug combinations: Patient is not receiving Entyvio in combination with natalizumab (Tysabri)

Authorization length: Initial authorization for no more than 12 months

Crohn's Disease - Continuation Therapy

Covered when ALL of the following are met for continuation of therapy:

Dosing adherence: Entyvio dosing for Crohn's disease is in accordance with the FDA labeled dosing

Clinical response: Documentation of positive clinical response to Entyvio

Reauthorization length: Reauthorization will be for no more than 12 months

Ulcerative Colitis - Initial Therapy

Covered when ALL of the following are met for initial therapy in ulcerative colitis:

UC diagnosis: Diagnosis of moderately to severely active ulcerative colitis

Prior therapy requirement: History of failure, contraindication, or intolerance to at least one conventional therapy (e.g., immunomodulator or corticosteroid) OR corticosteroid dependence

Dosing: Entyvio is initiated and titrated according to the U.S. Food and Drug Administration (FDA) labeled dosing for ulcerative colitis

Drug combinations: Patient is not receiving Entyvio in combination with natalizumab (Tysabri)

Ulcerative Colitis - Continuation Therapy

Covered when ALL of the following are met for continuation of therapy:

Dosing adherence: Entyvio dosing for ulcerative colitis is in accordance with the FDA labeled dosing

Clinical response: Documentation of positive clinical response to Entyvio

Reauthorization length: Reauthorization will be for no more than 12 months

Immune Checkpoint Inhibitor-Related GI Toxicities

Covered when ALL of the following are met for initial and continuation therapy:

Clinical presentation: Moderate to severe esophagitis, gastritis, or duodenitis not improved on corticosteroids or budesonide OR mild (G1) diarrhea/colitis that is persistent or progressive with positive lactoferrin or calprotectin OR moderate (G2) or severe (G3-4) immunotherapy-related diarrhea or colitis

Checkpoint inhibitor exposure: Patient is receiving a checkpoint inhibitor (e.g., pembrolizumab, nivolumab)

Prior infliximab: History of failure, contraindication, or intolerance to infliximab

Authorization length: Authorization will be for no more than 3 doses of Entyvio

GI aGVHD - Initial Therapy

Covered when ALL of the following are met for initial therapy:

Diagnosis of steroid-refractory acute gastrointestinal (GI) aGVHD

Steroid intolerance or combination: Patient is intolerant to systemic corticosteroid therapy OR is receiving Entyvio in combination with systemic corticosteroids

Initial authorization length: Initial authorization is for no more than 4 doses

GI aGVHD - Continuation Therapy

Covered when ALL of the following are met for continuation of therapy:

Clinical response: Documentation of positive clinical response

Ongoing condition: Patient continues to experience acute GI aGVHD

Steroid intolerance or combination: Patient is receiving Entyvio in combination with systemic corticosteroids OR is intolerant to systemic corticosteroid therapy

Authorization length: Authorization is for no more than 4 doses

GI aGVHD (Initial and Continuation Therapy)

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

aGVHD Initial Therapy: Diagnosis of steroid-refractory acute GI aGVHD AND (patient is receiving Entyvio in combination with systemic corticosteroids OR is intolerant to systemic corticosteroid therapy)Initial authorization for no more than 4 doses

aGVHD Continuation Therapy: Documentation of positive clinical response AND patient continues to experience acute GI aGVHD AND (patient is receiving Entyvio with systemic corticosteroids OR is steroid-intolerant)Authorization for no more than 4 doses for continuation

Immune checkpoint inhibitor-related GI toxicities

Coverage for immune checkpoint inhibitor-related GI toxicities when specified conditions are met:

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

The policy explicitly prohibits use of Entyvio (vedolizumab) in combination with natalizumab (Tysabri). Requests where the patient is receiving Entyvio together with Tysabri do not meet the coverage criteria and should be considered non-permissible per the policy language.

The policy lists specific targeted immunomodulators that the patient must not be receiving in combination with Entyvio. Examples named in the document include agents such as adalimumab, Cimzia (certolizumab), Omvoh (mirikizumab‑mrkz), Simponi (golimumab), Skyrizi (risankizumab), Tremfya (guselkumab), ustekinumab, Enbrel (etanercept), and Rinvoq (upadacitinib); the policy revision also notes that infliximab and Xeljanz XR were removed from the list. Verify the member is not concurrently receiving any of the listed targeted immunomodulators before approving Entyvio.

The excerpted document does not include explicit 'not medically necessary' determinations in the provided text. For full statements that designate specific uses as not medically necessary, reviewers must consult the complete policy document.

The policy notes FDA approvals for Entyvio for ulcerative colitis and Crohn's disease for informational purposes only. FDA approval alone is not a basis for coverage; coverage decisions are determined by the policy's medical necessity criteria and applicable benefit terms.

Applicable Billing and Diagnosis Codes

Applicable HCPCS/CPT CodesHCPCS

J3380

Injection, vedolizumab, intravenous, mg

Applicable ICD-10 Diagnosis CodesICD-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

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Applicable ICD-10 Diagnosis CodesICD-10

D89.810

Immunotherapy-related adverse event (specific context added by policy)

aGVHD Dosing Limits

Maximum initial/continuation doses for aGVHDno more than 4 doses

Initial authorization for aGVHDInitial authorization is for no more than 4 doses

Continuation authorization for aGVHDAuthorization for continuation is for no more than 4 doses

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Entyvio (vedolizumab) for all indications described in this policy. Submit documentation supporting the diagnosis, prior therapy history, dosing schedule, and evidence of clinical response as noted below. Initial and continuation authorizations are time-limited per indication.

Initial authorizations: Crohn's disease and ulcerative colitis — up to 12 months; aGVHD — up to 4 doses.
Providers must document FDA‑labeled dosing and that Entyvio is not being used in combination with contraindicated agents (e.g., natalizumab/Tysabri) unless specified.
Include clear clinical notes, prior therapy failure/contraindication/intolerance documentation, and response assessments for reauthorization requests.

Denial Risk

Missing Required Prior Therapy or Diagnosis — Denial Risk

For Crohn's disease and ulcerative colitis, requests lacking documentation of the required prior therapies, or missing a confirmed diagnosis of moderately to severely active disease, are at risk for denial. For aGVHD, requests that exceed the initial dosing limit or do not document steroid‑refractory acute GI aGVHD may be denied or require additional review.

Clinical Background and Context

Vedolizumab (Entyvio) is a humanized monoclonal antibody that targets the alpha‑4‑beta‑7 integrin to inhibit T‑lymphocyte trafficking into inflamed gastrointestinal tissue, thereby reducing GI inflammation. The policy’s background and revisions reference this mechanism and position Entyvio as a biologic indicated for moderate‑to‑severe ulcerative colitis and Crohn's disease, with additional coverage criteria added for gastrointestinal acute graft‑versus‑host disease (aGVHD) under specified conditions.

Definitions and Guideline Context

Vedolizumab mechanism of action

Mechanism of actionBinds alpha-4-beta-7 integrin and blocks interaction with MAdCAM-1 to inhibit T-lymphocyte migration into GI tissue

Molecular typeHumanized monoclonal antibody targeting alpha-4-beta-7 integrin

Physiologic effectReduces trafficking of memory T-lymphocytes across endothelium into inflamed gastrointestinal tissue

ACG / Guideline context

ACG recommendations - Crohn's diseaseVedolizumab is effective for induction of symptomatic remission in moderately to severely active Crohn's disease and should be considered; recommended for maintenance of vedolizumab-induced remission

ACG recommendations - Ulcerative colitis

Policy Revision History

07/01/2025material_revisionLatest

Added coverage for gastrointestinal acute graft-versus-host disease (aGVHD) with criteria for initial and continuation therapy and initial authorization limited to no more than 4 doses; revised immune checkpoint inhibitor-related toxicity criteria to add eligible diagnoses and updated list of excluded concomitant targeted immunomodulators (added mirikizumab, golimumab, risankizumab, guselkumab; removed infliximab and Xeljanz XR; standardized ustekinumab naming).

(date not specified)code_update

Added ICD-10 diagnosis code D89.810 to applicable codes (policy record notes addition).