ModifiedEmblemHealthPolicy MG.MM.PH.78

Entyvio (vedolizumab) Intravenous and Subcutaneous

Clinical coverage criteria and utilization management for vedolizumab (Entyvio) intravenous and subcutaneous formulations for adults, including Crohn's disease, ulcerative colitis, immune checkpoint inhibitor-related diarrhea/colitis, and steroid-refractory acute graft-versus-host disease for EmblemHealth members.

Policy Summary

PayerEmblemHealth

PolicyEntyvio (vedolizumab) Intravenous and Subcutaneous

Policy CodePolicy MG.MM.PH.78

Change TypeMaterial coverage additions and renewal language updates

Effective Date

Next Review DateApr 4, 2025

Key ActionSubmit prior authorization with clinical evidence demonstrating the member meets indication-specific criteria, including baseline severity and prior therapy trials.

SourceLink

POLICY UPDATE CHANGES

Addition of Acute Graft Versus Host Disease with initial and renewal criteria.

Addition to Crohn's disease and ulcerative colitis IV criteria for patients with high-risk disease or already established on a biologic.

Addition of Ulcerative Colitis subcutaneous criteria including post-ileocolonic resection and fistula conditions.

Updated length of authorization: initial coverage provided for 14 weeks and may be renewed every 6 months thereafter.

Addition of NDC 64764-0108-21 for Entyvio 108 mg subcutaneous pen.

14 weeksinitial authorization length

108 mgsubcutaneous maintenance dose

3 months

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Coverage Criteria for Vedolizumab (Entyvio)

Initial Approval — General eligibility and Crohn's disease (IV)

Covered when ALL of the following are met and the Crohn's-specific criteria are satisfied:

General eligibility: Prescribed by or in consultation with a gastroenterology specialist; patient aged 18 years or older; free of active, severe infections; screened for tuberculosis per local practice (if applicable); not on concurrent treatment with another TNF-inhibitor, biologic response modifier, or certain nonbiologic agents (e.g., apremilast, tofacitinib, baricitinib); physician has assessed baseline disease severity using an objective measure/tool.

Crohn's disease requirements

i. Documented failure, contraindication, or ineffective response at maximum tolerated doses to a minimum 3-month trial of corticosteroids or immunomodulators (e.g., azathioprine, 6-mercaptopurine, methotrexate)
ii. Documented failure, contraindication, or ineffective response at maximum tolerated doses to a minimum 3-month trial on previous therapy with a TNF modifier (e.g., adalimumab, golimumab, infliximab)
iii. Evidence of high-risk disease for which corticosteroids or immunomodulators are inadequate and biologic therapy is necessary
iv. Patient is already established on a biologic or targeted synthetic therapy for treatment of Crohn's disease

Initial Approval — Ulcerative colitis (IV)

Covered when ALL of the following are met and the UC-specific criteria are satisfied:

General eligibility: Prescribed by or in consultation with a gastroenterology specialist; patient aged 18 years or older; free of active, severe infections; screened for tuberculosis per local practice (if applicable); not on concurrent treatment with another TNF-inhibitor, biologic response modifier, or certain nonbiologic agents; physician has assessed baseline disease severity using an objective measure/tool.

Ulcerative colitis requirements

i. Documented failure, contraindication, or ineffective response at maximum tolerated doses to a minimum 3-month trial of corticosteroids or immunomodulators (e.g., azathioprine, 6-mercaptopurine, methotrexate)
ii. Documented failure, contraindication, or ineffective response at maximum tolerated doses to a minimum 3-month trial on previous therapy with a TNF modifier such as adalimumab, golimumab, or infliximab
iii. Evidence of high-risk disease for which corticosteroids or immunomodulators are inadequate and biologic therapy is necessary

Initial Approval — Ulcerative colitis (Subcutaneous)

Covered when ALL of the following are met for SC administration:

SC-specific: Prescriber indicates patient is currently receiving Entyvio IV or will receive IV induction within 2 months of initiating SC, AND patient meets ONE of the following therapy conditions.

SC prior therapy options

i. Patient has had a trial of ONE systemic therapy (examples: 6-mercaptopurine, azathioprine, cyclosporine, tacrolimus, or a corticosteroid such as prednisone or methylprednisolone). A trial of mesalamine does NOT count as a systemic therapy. A prior biologic counts as one systemic agent.
ii. Patient has pouchitis AND has tried an antibiotic, probiotic, corticosteroid enema, or mesalamine enema (examples of antibiotics include metronidazole and ciprofloxacin; examples of corticosteroid enemas include hydrocortisone enema).
iii. Patient has enterocutaneous (perianal or abdominal) or rectovaginal fistulas.

Initial Approval — Immune checkpoint inhibitor-related diarrhea/colitis

Covered when ALL of the following are met:

ICI-related criteria: Patient is receiving therapy with an immune checkpoint inhibitor; AND either (a) mild (G1) diarrhea/colitis with persistent progressive symptoms and a positive lactoferrin or calprotectin, OR (b) moderate (G2) to severe (G3-4) diarrhea/colitis related to immunotherapy.

Initial Approval — Acute Graft Versus Host Disease (compendia-recommended)

Covered when ALL of the following are met:

aGVHD criteria: Patient received an allogeneic hematopoietic stem cell transplant; used for steroid-refractory acute graft-versus-host disease; AND used in combination with systemic corticosteroids as additional therapy following no response to first-line therapies.

Response assessment: Response to therapy for aGVHD requires improvement in one or more clinician assessments (e.g., NIH Skin Score, Upper GI Response Score, NIH Lung Symptom Score) OR patient-reported symptoms (e.g., Lee Symptom Scale).

Covered Indications and Key Criteria

Covered when specified clinical criteria are met for each indication (examples below drawn from document sections present):

Indications: Includes Crohn's disease, ulcerative colitis (IV and SC per specific criteria), management of immune checkpoint inhibitor-related diarrhea/colitis (moderate to severe), and acute graft-versus-host disease (steroid-refractory) with initial and renewal criteria.

Indications enumerated across policy and revision history.

Acute Graft Versus Host Disease response criteria: Response to therapy requires improvement in one or more clinician assessments (e.g., NIH Skin Score, Upper GI Response Score, NIH Lung Symptom Score) OR patient-reported symptoms (e.g., Lee Symptom Scale).

Used for initial and renewal response assessment.

Ulcerative Colitis subcutaneous initiation: Per SQ criteria: patient is currently receiving Entyvio IV or will receive IV induction within 2 months of initiating SQ; AND patient meets ONE of: trial of one systemic therapy (mesalamine does NOT count; a prior biologic counts as one systemic) OR pouchitis with prior trial of antibiotics/probiotics/corticosteroid enema/mesalamine enema OR enterocutaneous/rectovaginal fistulas OR prior ileocolonic resection.

Entyvio (vedolizumab) is not considered medically necessary for indications other than those explicitly listed in this policy. Coverage is limited to the conditions and criteria enumerated in the Coverage Criteria section; uses outside those specified are excluded due to insufficient evidence of therapeutic benefit.

The rationale for this determination is that there is insufficient evidence of therapeutic value to support coverage for unlisted indications. Therapeutic benefit, safety, and appropriate use for conditions not described in this policy have not been established to the degree required for coverage.

Any clinical indication or use of Entyvio that is not explicitly described in the policy’s Covered Indications and Criteria should be regarded as not medically necessary. Providers seeking coverage for uses outside the listed indications should not expect authorization under this policy.

Requests for Entyvio for purposes not listed in this policy will be evaluated as not medically necessary and are subject to denial. See the Limitations/Exclusions section for the policy rationale and scope.

Coding — Procedure, Drug & Diagnosis Codes

Applicable Procedure CodesHCPCSCovered

J3380

Injection, vedolizumab, 1 mg; 1 billable unit = 1 mg

Applicable NDCsNDCCovered

67464-0300-xx	Entyvio 300 mg single use vial
64764-0108-21	Entyvio 108 mg/0.68 ml Subcutaneous Pen

Applicable ICD-10 DiagnosesICD-10Covered

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
K50.112	Crohn's disease of large intestine with intestinal obstruction

1–10 of 71

1/8

Billing unit threshold

Billing unit definition1 billable unit = 1 mg for HCPCS code J3380 (Injection, vedolizumab)

HCPCS codeJ3380

Usage noteReport units administered in milligrams using J3380; 1 unit equals 1 mg.

Provider Actions, Authorization & Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required. Coverage will be provided for 14 weeks initially and may be renewed every 6 months thereafter. For immune checkpoint inhibitor–related diarrhea/colitis, coverage is limited to 3 doses and may not be renewed.

Documentation Required

Required Documentation and Prescriber

Requests must include clinician-submitted documentation showing the patient meets the clinical criteria and the prescribing clinician must be a specialist in gastroenterology or have consulted with one. If required clinical documentation is not provided, EmblemHealth will be unable to properly review the preauthorization or post-payment request.

Background on Vedolizumab (Entyvio)

Vedolizumab (Entyvio) is addressed in this policy only for the specific indications and clinical scenarios listed. Uses beyond those listed are excluded from coverage because the policy committee determined there is insufficient evidence to support their therapeutic value.

Definitions and Symbol Legend

Symbol legend

†FDA-approved indication(s)

‡Compendia-recommended indication(s)

ФOrphan drug

Clinical response measures

Clinician assessmentsExamples: NIH Skin Score, Upper GI Response Score, NIH Lung Symptom Score

Patient-reported instrumentsExamples: Lee Symptom Scale

Use caseThese measures may be used to document response to therapy for acute graft-versus-host disease