ModifiedAnthemPolicy CC-0071

Entyvio (vedolizumab) — Medical Drug Clinical Criteria

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Medical necessity and coverage criteria for intravenous and subcutaneous vedolizumab (Entyvio) for Crohn's disease, ulcerative colitis, acute GVHD, and immune checkpoint inhibitor–related GI toxicities under Anthem's medical benefit.

Policy Summary

PayerAnthem

PolicyEntyvio (vedolizumab) — Medical Drug Clinical Criteria

Policy CodePolicy CC-0071

Change TypeRevised — material clinical and operational updates

Effective Date03/26/2026

Last ReviewFeb 20, 2026

Next Review DateFeb 20, 2026

Key ActionSubmit prior authorization for initial and continuation Entyvio requests with documentation of indication, formulation (IV vs SC), dosing (including escalation justification), and clinical response.

SourceLink

POLICY UPDATE CHANGES

Quantity limits and override rules updated to specify vial and syringe/pen limits and an algorithm for dose escalation to every 4 weeks with criteria and durations.

Remove prerequisite conventional therapy requirements for Crohn's disease and ulcerative colitis for the subcutaneous formulation.

Update uses in immunotherapy-related toxicities per NCCN and include graft-versus-host disease for IV formulation.

Escalated dosing continued approval duration updated to 1 year.

Separated continuation criteria for subcutaneous and intravenous formulations.

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ModifiedAnthemPolicy CC-0071

Entyvio (vedolizumab) — Medical Drug Clinical Criteria

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Policy Summary

PayerAnthem

PolicyEntyvio (vedolizumab) — Medical Drug Clinical Criteria

Policy CodePolicy CC-0071

Change TypeRevised — material clinical and operational updates

Effective Date03/26/2026

Last ReviewFeb 20, 2026

Next Review DateFeb 20, 2026

SourceLink

POLICY UPDATE CHANGES

Quantity limits and override rules updated to specify vial and syringe/pen limits and an algorithm for dose escalation to every 4 weeks with criteria and durations.

Remove prerequisite conventional therapy requirements for Crohn's disease and ulcerative colitis for the subcutaneous formulation.

Update uses in immunotherapy-related toxicities per NCCN and include graft-versus-host disease for IV formulation.

Escalated dosing continued approval duration updated to 1 year.

Separated continuation criteria for subcutaneous and intravenous formulations.

2 pens/28dSC quantity limit

1 vial/56dIV quantity limit

q4wmay escalate to q4w

16 wksinitial escalation approval

1 yrcontinued escalation approval

ICI & GVHDNCCN referenced uses

Coverage Criteria for Entyvio (vedolizumab)

Continuation IV Entyvio

Covered when ALL of the following are met:

IV continuation: Individual has been receiving and is maintained on a stable dose of intravenous Entyvio; AND there is clinically significant improvement or stabilization in clinical signs and symptoms of the diseasestable dose and clinical improvement/stabilization

Initial SC Entyvio (maintenance)

Covered when ANY of the following maintenance pathways are met (AND all applicable subcriteria):

UC SC maintenance: Individual is 18 years of age or older with moderate to severe ulcerative colitis AND has completed intravenous induction doses with Entyvio and is using subcutaneous Entyvio for maintenance therapy, OR has been stabilized on intravenous Entyvio maintenance therapy and is switching to maintenance therapy with subcutaneous Entyvioage >= 18

Applies to UC; requires prior IV induction or stable IV maintenance

Continuation SC Entyvio

Covered when ALL of the following are met:

SC continuation: Individual has been receiving and is maintained on a stable dose of subcutaneous Entyvio; AND there is clinically significant improvement or stabilization in clinical signs and symptoms of the diseasestable dose and clinical improvement/stabilization

Entyvio for acute GVHD

Covered when ALL of the following are met:

GVHD: Individual has a diagnosis of steroid-refractory acute graft-versus-host disease; AND vedolizumab is being initiated in combination with systemic corticosteroids

NCCN 2A

Entyvio for immune checkpoint inhibitor–related GI toxicities

Covered when ALL of the following are met:

ICI-related diarrhea/colitis: Individual is undergoing immune checkpoint inhibitor therapy for a cancer diagnosis; AND is experiencing moderate to severe diarrhea or colitis as a result of ICI treatment; AND symptoms persist despite treatment with corticosteroidsmoderate to severe; steroid-refractory

NCCN 2A

ICI-related upper GI: Individual is experiencing moderate to severe esophagitis, gastritis, or duodenitis as a result of ICI treatment; AND symptoms have not improved on corticosteroids or budesonidemoderate to severe; steroid/budesonide-refractory

NCCN 2A

Entyvio (vedolizumab) will not be approved when prescribed in combination with specified oral or topical agents or certain biologic immunomodulators. Specifically, combination use with JAK inhibitors, ozanimod, etrasimod, deucravacitinib, or any of the listed biologic agents (including TNF antagonists, IL‑23/IL‑17/IL‑6/IL‑1 inhibitors, ustekinumab, abatacept, rituximab, or natalizumab) is excluded and such requests are subject to denial unless other coverage criteria are independently met.

Policy history documents that the exclusions for prior infection and progressive multifocal leukoencephalopathy were removed effective 02/20/2026. Providers should consult the full policy for the current complete list of exclusions and any remaining safety considerations.

Escalation of vedolizumab dosing is constrained by clinical response criteria: increased dosing is not approved for individuals who had no response to standard maintenance dosing (every 8 weeks) or when escalation is requested in the absence of clinical signs or symptoms (for example, based solely on therapeutic drug level or anti‑drug antibody testing). Continued approval for increased dosing has defined durations (see full policy).

The fragment does not include an exhaustive list of conditions that are considered not medically necessary. Refer to the full policy for explicit not medically necessary conditions and the complete rationale for exclusions.

Coding and Supply Information

HCPCSHCPCS

J3380	Injection, vedolizumab, intravenous, 1 mg [Entyvio]
J3590	Unclassified biologics (when specified as injection, vedolizumab, 108 mg/0.68 mL prefilled syringe/pen [Entyvio SC].

HCPCS (additional)HCPCS

C9399	Unclassified drugs or biologicals [when specified as Entyvio SC (vedolizumab subcutaneous)]
J3590	Unclassified biologics [when specified as Entyvio SC (vedolizumab subcutaneous)]

ICD-10 DiagnosisICD-10

D89.810	Acute graft-versus-host disease
D89.812	Acute on chronic graft-versus-host disease
K20.90-K20.91	Esophagitis, unspecified [immune checkpoint inhibitor-related toxicity]
K29.70-K29.91	Gastritis, duodenitis, gastroduodenitis, unspecified [immune checkpoint inhibitor-related toxicity]
K50.00-K50.919	Crohn's disease (regional enteritis)
K51.00-K51.919	Ulcerative colitis
K52.1	Toxic gastroenteritis and colitis [immune checkpoint inhibitor-related toxicity]
R19.7	Diarrhea, unspecified [immune checkpoint inhibitor-related toxicity]
T45.AX5A-T45.AX5S	Adverse effect of immune checkpoint inhibitors and immunostimulant drugs

ICD-10 DiagnosisICD-10

D89.810	Acute graft-versus-host disease
D89.812	Acute on chronic graft-versus-host disease
K20.90	Esophagitis, unspecified [immune checkpoint inhibitor-related toxicity]
K20.91	Esophagitis (other) [immune checkpoint inhibitor-related toxicity]
K29.70	Gastritis and duodenitis, unspecified [immune checkpoint inhibitor-related toxicity]
K29.91	Gastritis, unspecified [immune checkpoint inhibitor-related toxicity]
K50.00-K50.919	Crohn's disease (regional enteritis)
K51.00-K51.919	Ulcerative colitis
K52.1	Toxic gastroenteritis and colitis [immune checkpoint inhibitor-related toxicity]
R19.7	Diarrhea, unspecified [immune checkpoint inhibitor-related toxicity]

1–10 of 11

1/2

ICD-10 Diagnosis (Entyvio SC specific mapping)ICD-10

K50.00-K50.919	Crohn's disease (regional enteritis)
K51.00-K51.919	Ulcerative colitis

HCPCS (Entyvio SC)HCPCS

C9399	Unclassified drugs or biologicals [when specified as Entyvio SC (vedolizumab subcutaneous)]
J3590	Unclassified biologics [when specified as Entyvio SC (vedolizumab subcutaneous)]

inv-18: SC Entyvio supply — supply limits (pens/syringes per 28 days)

Supply limit2 syringes/prefilled pens (108 mg/0.68 mL each) per 28 days

Unit descriptionEach prefilled syringe/pen contains 108 mg vedolizumab in 0.68 mL

Billing implicationQuantity limit is applied monthly for the subcutaneous formulation

inv-19: IV Entyvio supply — vial limit (300 mg per 56 days)

Supply limit1 vial (300 mg) per 56 days (8 weeks)

Unit description

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior authorization required for Entyvio

Prior authorization is required for all initial and continuation requests for Entyvio (vedolizumab) — applies to intravenous and subcutaneous formulations and approvals are granted when the policy’s age, diagnosis, induction/maintenance, and response/stability criteria are met.

Applies to both Entyvio IV and Entyvio SC
Approvals require meeting the applicable indication-specific initial or continuation criteria

Billing Rule

Prior authorization and billing codes

Submit prior authorization using the HCPCS code that corresponds to the formulation: J3380 for intravenous vedolizumab; and C9399 or J3590 when specified as Entyvio SC (subcutaneous).

Background and Definitions

Vedolizumab (Entyvio) is a gut‑selective integrin receptor antagonist that binds the α4β7 integrin and inhibits migration of memory T‑lymphocytes into inflamed gastrointestinal tissue. The product is available in both an intravenous (IV) formulation used for induction and maintenance and a subcutaneous (SC) formulation primarily used for maintenance following IV induction or for switching from IV maintenance, consistent with guideline positioning for moderate‑to‑severe inflammatory bowel disease.

inv-30: Vedolizumab (Entyvio) definition — drug class and formulation availability

Drug classIntegrin receptor antagonist (binds α4β7)

Formulations availableIntravenous and subcutaneous formulations

Primary indication contextIV approved for Crohn's disease and ulcerative colitis; SC approved for maintenance in Crohn's disease and ulcerative colitis following IV induction

inv-31: Induction vs Maintenance — notes on IV induction and SC maintenance usage

Policy Summary

PayerAnthem

PolicyEntyvio (vedolizumab) — Medical Drug Clinical Criteria

Policy CodePolicy CC-0071

Change TypeRevised — material clinical and operational updates

Effective Date03/26/2026

Last ReviewFeb 20, 2026

Next Review DateFeb 20, 2026

SourceLink

On This Page

Vial contains 300 mg vedolizumab for intravenous administration

Frequency noteQuantity limit applied on an 8‑week (56‑day) basis for the IV formulation

inv-20: Escalated dosing continued approval duration — duration for continued escalated dosing

Continued approval durationContinued approval for escalated dosing: 1 year

Initial escalation approvalInitial approval for increased dosing: 16 weeks (per policy)

Documentation required for continuationDocumentation must demonstrate regained or adequate clinical response, absence of unacceptable adverse effects, and plans for reassessment and dose de‑escalation

J3380 — Injection, vedolizumab, intravenous, 1 mg
C9399 or J3590 — Unclassified codes when specified as Entyvio SC (108 mg/0.68 mL prefilled syringe/pen)

Note

Positioning relative to other advanced therapies

Position vedolizumab among biologic advanced therapies per guideline recommendations: vedolizumab is an option for induction and maintenance of moderately to severely active Crohn’s disease and ulcerative colitis and may be used after TNF inhibitor failure or depending on prior exposure per AGA/ACG guidance.

AGA/ACG list vedolizumab among biologics for induction and maintenance in moderate-to-severe IBD
Vedolizumab can be used after TNFi nonresponse or as an option based on prior therapy exposure

Step Therapy

Step therapy update for Entyvio SC

For the subcutaneous formulation, prerequisite conventional therapy requirements for Crohn’s disease and ulcerative colitis were removed (effective 11/14/2025); SC Entyvio may be used for maintenance after IV induction or when switching from IV maintenance without requiring prior conventional therapy.

SC Entyvio approved for maintenance in adults who completed IV induction or are switching from IV maintenance
Removal of prerequisite conventional therapy requirements for CD and UC for Entyvio SC noted in document history (11/14/2025)

Documentation Required

Documentation for continued escalated dosing

When requesting continued escalated dosing, provide documentation that the individual has regained or achieved an adequate clinical response (examples: reduction in stool frequency or bloody stools, improvement in abdominal pain, or endoscopic response), is not experiencing unacceptable adverse effects, and will be reassessed regularly for dose de‑escalation.

Requested dosing must not exceed one vial (300 mg) every 4 weeks
Evidence of regained or adequate response must be documented
Document absence of unacceptable adverse effects and plan for regular reassessment

Documentation Required

Required documentation for request

Include in the prior authorization documentation: the clinical indication, formulation (IV vs SC), current dosing (including any escalated dosing and duration), justification for escalation if requested, prior treatments when applicable, and rationale referencing NCCN guidance for immunotherapy‑related toxicities or GVHD where relevant.

Specify IV versus SC formulation and mapped ICD‑10 diagnosis codes
Provide prior treatment history and clinical rationale for chosen formulation/dosing
Reference NCCN guidance for ICI‑related toxicities or graft‑versus‑host disease when applicable

Denial Risk

Do not approve requests for disallowed combination therapy

Requests will not be approved for Entyvio when used concurrently with specified agents — including oral or topical JAK inhibitors, ozanimod, etrasimod, deucravacitinib, or the listed biologic immunomodulators — or when the policy’s clinical criteria are not met.

Combination exclusion includes: oral/topical JAK inhibitors, ozanimod, etrasimod, deucravacitinib
Biologic immunomodulator exclusions include TNF antagonists, IL‑23/17/6/1 inhibitors, ustekinumab, abatacept, rituximab, natalizumab

Denial Risk

Denial risk if criteria or limits are unmet

Failure to meet the policy’s clinical criteria (initial or continuation), or to adhere to the updated quantity/administration limits (including syringe/pen or vial supply and escalation rules), may result in denial of the request.

Noncompliance with indication‑specific criteria or continuation requirements risks denial
Exceeding quantity limits or lacking required escalation justification may lead to denial

Induction may be given intravenously (IV)

Maintenance routeSubcutaneous (SC) formulation is used for maintenance after completion of IV induction or for switching from IV maintenance to SC maintenance

Age considerationsSC maintenance criteria specify adults (≥18 years) for UC and CD in this policy fragment

inv-32: Immune checkpoint inhibitor-related toxicity diagnoses — ICD-10 codes list for ICI toxicities

EsophagitisK20.90 — Esophagitis, unspecified; K20.91 — Esophagitis (other)

Gastritis/duodenitisK29.70 — Gastritis and duodenitis, unspecified; K29.91 — Gastritis, unspecified

Toxic gastroenteritis/colitis & diarrheaK52.1 — Toxic gastroenteritis and colitis; R19.7 — Diarrhea, unspecified

Adverse effect codesT45.AX5A–T45.AX5S — Adverse effect of immune checkpoint inhibitors and immunostimulant drugs

GVHD (contextual codes present in IV mapping)D89.810 — Acute graft‑versus‑host disease; D89.812 — Acute on chronic graft‑versus‑host disease