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UnitedHealthcare Entyvio (vedolizumab) Coverage Update | OpenPayer

ModifiedUnitedHealthcarePolicy IEXD0053.08

Entyvio (vedolizumab) intravenous infusion — Medical Benefit Drug Policy (Individual Exchange)

This policy governs medical benefit coverage and authorization criteria for vedolizumab (Entyvio) intravenous infusion for Individual Exchange benefit plans (with some state exceptions) and describes indications, dosing alignment with FDA labeling, and authorization durations.

Policy Summary

PayerUnitedHealthcare

PolicyEntyvio (vedolizumab) intravenous infusion — Medical Benefit Drug Policy (Individual Exchange)

Policy CodePolicy IEXD0053.08

Change TypeMaterial revisions to aGVHD authorization limits and immunotherapy-related GI toxicity criteria

Effective DateJul 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of diagnosis, prior therapy failure/contraindication/intolerance or steroid dependence and request authorization limited per indication (e.g., up to 12 months for CD/UC, up to 3 doses for checkpoint inhibitor-related toxicities, up to 4 doses for GI aGVHD).

SourceLink

POLICY UPDATE CHANGES

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

Revised coverage criteria for immune checkpoint inhibitor-related toxicities to include specific GI diagnoses and testing thresholds.

Updated list of targeted immunomodulators that must not be used in combination with Entyvio for certain indications, adding several agents and removing others.

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

Updated FDA and references sections to reflect current information.

12 monthsinitial auth duration (CD/UC)

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Coverage Criteria for Entyvio (vedolizumab)

Initial therapy — Crohn's disease

Covered when ALL of the following are met

Crohn's disease initial therapy: Diagnosis of moderately to severely active Crohn's disease; Entyvio (vedolizumab) is initiated and titrated according to FDA-labeled dosing; patient is not receiving Entyvio in combination with targeted immunomodulators or natalizumab; initial authorization will be for no more than 12 months

AND one of: history of failure, contraindication, or intolerance to at least one conventional therapy (TNF blocker, immunomodulator, or corticosteroid) OR corticosteroid dependent

Continuation therapy — Crohn's disease

Covered when ALL of the following are met

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

Initial therapy — Ulcerative colitis

Covered when ALL of the following are met

Ulcerative colitis initial therapy: Diagnosis of moderately to severely active ulcerative colitis; Entyvio (vedolizumab) is initiated and titrated according to FDA-labeled dosing; patient is not receiving Entyvio in combination with targeted immunomodulators or natalizumab; initial authorization will be for no more than 12 months

AND one of: history of failure, contraindication, or intolerance to at least one conventional therapy (TNF blocker, immunomodulator, or corticosteroid) OR corticosteroid dependent

Continuation therapy — Ulcerative colitis

Covered when ALL of the following are met

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

Immune checkpoint inhibitor-related toxicities

Covered when ALL of the following are met

Checkpoint inhibitor-related GI toxicities: Diagnosis of one of the specified immunotherapy-related GI toxicities (moderate–severe esophagitis, gastritis, or duodenitis with no improvement on corticosteroids or budesonide; OR mild (G1) diarrhea or colitis if persistent/progressive symptoms with positive lactoferrin or calprotectin; OR moderate (G2) or severe (G3-4) immunotherapy-related diarrhea or colitis); patient is receiving a checkpoint inhibitor; AND one of: history of failure, contraindication, or intolerance to infliximab OR patient has immune-related hepatitis; authorization is limited to no more than 3 doses3 doses

Applies to initial and continuation as specified; NCCN supports vedolizumab for moderate (G2) and severe (G3-4) immunotherapy-related diarrhea/colitis

GI acute graft-versus-host disease

Covered when ALL of the following are met

GI acute graft-versus-host disease initial therapy: Diagnosis of steroid-refractory acute GI aGVHD; AND one of: 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 doses4 doses

Continuation requires documentation of positive clinical response and ongoing aGVHD

Acute GI graft-versus-host disease (aGVHD) — Initial and Continuation Therapy

Covered when ALL of the following are met

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 therapyinitial authorization: no more than 4 doses

Initial authorization limited to no more than 4 doses

Continuation Therapy: Documentation of positive clinical response AND 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 therapycontinuation authorization: no more than 4 doses

Continuation requires demonstration of positive clinical response

Immune checkpoint inhibitor-related GI toxicities — Revised coverage

Revised coverage criteria allow vedolizumab in specified circumstances

Covered presentations: One of the following immunotherapy-related diagnoses: moderate to severe esophagitis, gastritis, or duodenitis with no improvement on corticosteroids or budesonide; OR mild (G1) diarrhea or colitis if persistent or progressive symptoms and positive lactoferrin/calprotectin; OR moderate (G2) or severe (G3-4) diarrhea or colitisclinical nonresponse to steroids or positive fecal inflammatory markers as specified

Per NCCN and policy revisions; consider vedolizumab for moderate–severe and selected mild cases

Use of Entyvio (vedolizumab) in combination with other targeted immunomodulators or with natalizumab is not permitted. This prohibition applies when assessing eligibility for initiation or continuation of therapy for Crohn's disease and ulcerative colitis and is a basis for denial if documentation shows concurrent use.

Policy examples list specific targeted immunomodulators that patients must not be receiving in combination with Entyvio for certain indications. The updated examples include additions such as mirikizumab (Omvoh), golimumab (Simponi), risankizumab (Skyrizi), and guselkumab (Tremfya), with other agents removed or renamed as noted in the revision history.

This section does not contain explicit statements of services that are not medically necessary; procedure and diagnosis codes listed (for example, J3380) are provided for reference only and do not by themselves indicate coverage or non‑coverage.

Applicable Coding

Applicable HCPCS CodesHCPCSCovered

J3380

Injection, vedolizumab, intravenous, 1 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

1–10 of 80

1/8

Applicable ICD-10 CodesICD-10

D89.810

Newly added ICD-10 diagnosis code listed in Applicable Codes section

Prior Authorization, Documentation, and Limits

Prior Authorization

Prior Authorization Required

Prior authorization required — Prior authorization required with documentation of diagnosis, prior therapy failure/contraindication/intolerance or steroid dependence.

Initial authorization limits: Crohn's disease and ulcerative colitis — initial authorization will be for no more than 12 months (Crohn's disease) or no more than 3 doses (ulcerative colitis initial induction as specified).
Continuation/reauthorization limits: Reauthorization for Crohn's disease and ulcerative colitis will be for no more than 12 months; continuation for aGVHD may be authorized for up to 4 doses if criteria met.
Combination therapy limits: Entyvio must not be used in combination with targeted immunomodulators (examples include adalimumab, certolizumab [Cimzia], mirikizumab [Omvoh], upadacitinib [Rinvoq], golimumab [Simponi], risankizumab [Skyrizi], guselkumab [Tremfya], ustekinumab, tofacitinib [Xeljanz]) or natalizumab (Tysabri).
Requests exceeding the specified initial or reauthorization durations or for use in combination with disallowed agents may be denied.

Documentation Required

Background and Context

Vedolizumab is a humanized monoclonal antibody that binds the α4β7 integrin, blocking lymphocyte trafficking into inflamed gastrointestinal tissue. It is used to treat moderately to severely active ulcerative colitis and Crohn's disease, and has been added in this policy as a treatment option for steroid‑refractory gastrointestinal acute graft‑versus‑host disease when specified criteria are met.

Definitions

Corticosteroid dependent

DefinitionUnable to successfully taper corticosteroids without a return of the symptoms of Crohn's disease or ulcerative colitis.

ContextUsed as an exception to step therapy requirements — corticosteroid‑dependent patients need not meet prior failure to conventional therapy for initiation of Entyvio in UC or CD.

Source noteDefinition appears in the policy's IBD initial therapy criteria for Crohn's disease and ulcerative colitis.

Steroid‑refractory acute GI aGVHD

DefinitionAcute gastrointestinal graft‑versus‑host disease that does not respond to systemic corticosteroid therapy.

Clinical implicationSteroid‑refractory status is required for initial Entyvio use in GI aGVHD; patient must be receiving Entyvio with systemic corticosteroids or be steroid‑intolerant per policy.

Revision History and Policy Changes

07/01/2025material_additionLatest

Added coverage rationale establishing Entyvio (vedolizumab) as proven and medically necessary for treatment of gastrointestinal acute graft-versus-host disease (aGVHD), with initial and continuation authorization criteria and limits of no more than 4 doses each.

07/01/2025material_revision

Revised coverage criteria for immune checkpoint inhibitor-related toxicities to specify covered presentations (moderate–severe esophagitis/gastritis/duodenitis refractory to corticosteroids or budesonide; persistent/progressive mild (G1) diarrhea/colitis with positive lactoferrin/calprotectin).