ModifiedColorado Rocky Mountain Health PlansPolicy CS2026D0053Y

Vedolizumab (Entyvio) intravenous infusion — coverage and medical necessity criteria

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This policy governs medical-benefit coverage and medical necessity criteria for vedolizumab (Entyvio) intravenous infusion for Crohn's disease, ulcerative colitis, immune checkpoint inhibitor-related toxicities, and GI acute graft-versus-host disease for Colorado Rocky Mountain Health Plans members; the subcutaneous formulation is handled under the pharmacy benefit.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyVedolizumab (Entyvio) intravenous infusion — coverage and medical necessity criteria

Policy CodePolicy CS2026D0053Y

Change TypeCriteria revisions and benefit assignment

Effective DateAug 1, 2026

Next Review Date

Key ActionSubmit prior authorization with documentation of diagnosis, prior targeted therapy or inadequate response to corticosteroids/immunosuppressants, and evidence of gastroenterology involvement.

SourceLink

POLICY UPDATE CHANGES

Added language that Entyvio for self-administered subcutaneous injection is obtained under the pharmacy benefit.

Replaced references to 'targeted immunomodulator' with 'systemic targeted immunomodulator' and updated lists of agents that cannot be combined with Entyvio.

Added criterion requiring patients not receive Entyvio in combination with another systemic targeted immunomodulator for continuation of therapy.

For UC and CD initial therapy, added requirement that Entyvio be prescribed by or in consultation with a gastroenterologist and that patients have prior/inadequate response to corticosteroids and/or immunosuppressants or prior treatment with a systemic targeted immunomodulator.

Removed criterion requiring prior failure, contraindication, or intolerance to at least one TNF blocker, immunomodulator, or corticosteroid for initial therapy.

Updated continuation criteria for immune checkpoint inhibitor-related toxicities to require documentation of positive clinical response and ongoing toxicity; removed several prior diagnostic and drug-related requirements.

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ModifiedColorado Rocky Mountain Health PlansPolicy CS2026D0053Y

Vedolizumab (Entyvio) intravenous infusion — coverage and medical necessity criteria

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Sign up for Colorado Rocky Mountain Health Plans Policy CS2026D0053Y alerts

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Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyVedolizumab (Entyvio) intravenous infusion — coverage and medical necessity criteria

Policy CodePolicy CS2026D0053Y

Change TypeCriteria revisions and benefit assignment

Effective DateAug 1, 2026

Next Review Date

SourceLink

POLICY UPDATE CHANGES

Added language that Entyvio for self-administered subcutaneous injection is obtained under the pharmacy benefit.

Replaced references to 'targeted immunomodulator' with 'systemic targeted immunomodulator' and updated lists of agents that cannot be combined with Entyvio.

Added criterion requiring patients not receive Entyvio in combination with another systemic targeted immunomodulator for continuation of therapy.

Removed criterion requiring prior failure, contraindication, or intolerance to at least one TNF blocker, immunomodulator, or corticosteroid for initial therapy.

12 monthsmaximum initial authorization for CD and UC

J3380listed drug HCPCS code (vedolizumab IV, 1 mg)

3 dosesinitial authorization limit for immune checkpoint toxicities

4 dosesinitial authorization limit for GI aGVHD

pharmacy benefitEntyvio subcutaneous assigned to pharmacy benefit

updated listsystemic targeted immunomodulator lists revised

Coverage Criteria for Vedolizumab (Entyvio) IV

Crohn's Disease (Initial and Continuation)

Entyvio (vedolizumab) IV is proven and medically necessary for Crohn's disease when the following criteria are met.

Initial therapy for Crohn's disease

Diagnosis of moderately to severely active Crohn's disease (CD).
Conventional therapy failure: History of failure to one of the following conventional therapies at up to maximally indicated doses unless contraindicated or intolerant: corticosteroids (e.g., prednisone, methylprednisolone, budesonide); 6-mercaptopurine; azathioprine; methotrexate.
Prior targeted therapy: Patient has been previously treated with a systemic targeted immunomodulator FDA-approved for Crohn's disease (examples listed in policy).
Dosing and combination: Entyvio is initiated and titrated according to FDA-labeled dosing for Crohn's disease and is not used in combination with another systemic targeted immunomodulator (examples listed in policy).
Prescriber: Prescribed by or in consultation with a gastroenterologist.
Authorization length: Initial authorization will be for no more than 12 months.

Continuation therapy for Crohn's disease

Clinical response: Documentation of positive clinical response to Entyvio.
Dosing: Entyvio dosing for Crohn's disease is in accordance with FDA-labeled dosing.
No combination therapy: Patient is not receiving Entyvio in combination with another systemic targeted immunomodulator (examples listed in policy).
Reauthorization length: Reauthorization will be for no more than 12 months.

Authorization administrative note: Entyvio IV (medical benefit) — subcutaneous formulation is obtained under the pharmacy benefit (see policy exclusions).

Ulcerative Colitis (Initial and Continuation)

Entyvio IV is proven and medically necessary for ulcerative colitis when the following criteria are met.

Initial therapy for Ulcerative Colitis

Diagnosis of moderately to severely active ulcerative colitis (UC).
Prior/concurrent therapy: Patient has had prior or concurrent inadequate response to a therapeutic course of oral corticosteroids and/or immunosuppressants (e.g., azathioprine, 6-mercaptopurine).
Prior targeted therapy: Patient has been previously treated with a systemic targeted immunomodulator FDA-approved for UC (examples listed in policy).
Dosing and combination: Entyvio is initiated and titrated according to FDA-labeled dosing for UC and is not used in combination with another systemic targeted immunomodulator (examples listed in policy).

Immune Checkpoint Inhibitor-Related Toxicities

Entyvio IV is proven and medically necessary for immunotherapy-related GI toxicities when the following criteria are met.

Initial therapy for immunotherapy-related toxicities

Eligible diagnoses: One of: moderate to severe esophagitis, gastritis, or duodenitis refractory to corticosteroids or budesonide; persistent/progressive mild (G1) diarrhea or colitis with positive lactoferrin/calprotectin; moderate (G2) or severe (G3-4) immunotherapy-related diarrhea or colitis.
Checkpoint inhibitor exposure: Patient is receiving a checkpoint inhibitor (e.g., pembrolizumab, nivolumab) where applicable (documentation of exposure should be provided).
Infliximab failure or immune-hepatitis: Either history of failure/contraindication/intolerance to infliximab OR patient has immune-related hepatitis.
Authorization length:

GI acute graft-versus-host disease

Entyvio IV is proven and medically necessary for steroid-refractory GI acute graft-versus-host disease when the following criteria are met.

Initial therapy for GI aGVHD

Diagnosis of steroid-refractory acute GI aGVHD.
Concomitant therapy or steroid intolerance: Either patient is receiving Entyvio in combination with systemic corticosteroids OR patient is intolerant to systemic corticosteroid therapy.
Authorization length: Initial authorization will be for no more than 4 doses of Entyvio.

Continuation therapy for GI aGVHD

Clinical response: Documentation of positive clinical response.

Initial and Continuation Therapy (summary)

Revised coverage criteria highlights (see policy for full criteria):

Initial Therapy - UC/CD (summary): Entyvio must be prescribed by or in consultation with a gastroenterologist AND the patient has prior or concurrent inadequate response to a therapeutic course of oral corticosteroids and/or immunosuppressants or has been previously treated with a systemic targeted immunomodulator per indication-specific requirements.NA

Policy removed prior requirement for failure of at least one TNF blocker/immunomodulator/corticosteroid in some pathways; see full policy for specific pathways.

Continuation Therapy (summary): Patient must demonstrate ongoing clinical benefit/positive clinical response and must NOT be receiving Entyvio in combination with another systemic targeted immunomodulator for the same indication.Documentation of positive clinical response

Applies across indications including immune checkpoint inhibitor-related toxicities; specified documentation requirements were updated.

Benefit assignment note:

Entyvio (vedolizumab) administered by subcutaneous injection is excluded from this medical benefit policy and must be obtained under the pharmacy benefit.

Entyvio must not be used in combination with another systemic targeted immunomodulator for treatment of the same indication; the policy provides examples of systemic targeted agents that must not be received concurrently with Entyvio.

The policy explicitly prohibits concurrent combination therapy: for initial and continuation therapy the member must not be receiving Entyvio in combination with another systemic targeted immunomodulator (examples listed include agents such as adalimumab, certolizumab, mirikizumab, upadacitinib, risankizumab, guselkumab, and ustekinumab).

Continuation of Entyvio therapy may be considered not medically necessary if there is no documentation of a positive clinical response to treatment or if the patient is receiving Entyvio in combination with another systemic targeted immunomodulator for the same indication.

Billing and Coding

Applicable HCPCS CodesHCPCS

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

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Referenced agents and productsmixed

Entyvio

vedolizumab (brand name Entyvio) — policy references for coverage; no discrete CPT/HCPCS/NDC codes listed in this document excerpt.

Initial authorization duration (CD/UC)

Initial authorization duration (CD/UC)Initial authorization will be for no more than 12 months; reauthorization up to 12 months.

Applies toCrohn's disease and ulcerative colitis initial and continuation therapy when policy criteria are met.

Prescriber requirementEntyvio must be prescribed by or in consultation with a gastroenterologist.

Initial authorization doses (immune checkpoint inhibitor-related toxicities)

Initial authorization dosesInitial authorization will be for no more than 3 doses of Entyvio for immune checkpoint inhibitor-related toxicities.

Continuation/Reauthorization

Prior Authorization, Documentation, and Prescriber Requirements

Prior Authorization

Prior authorization required for vedolizumab (IV)

Prior authorization is required for vedolizumab (intravenous Entyvio) under the medical benefit; authorization requests must include clinical documentation supporting the indication-specific criteria and will be granted for specified durations (e.g., up to 12 months for Crohn's disease and ulcerative colitis; up to 3 doses for checkpoint inhibitor‑related toxicities; up to 4 doses for GI aGVHD).

Use HCPCS J3380 when billing for vedolizumab IV.
Include documentation that meets the indication-specific requirements (diagnosis, prior therapies, prescriber/gastroenterology involvement, dosing per FDA labeling).

Prior Authorization

Subcutaneous Entyvio assigned to pharmacy benefit — PA criteria revised

The policy clarifies that self‑administered subcutaneous Entyvio is obtained under the pharmacy benefit and is not covered under this medical‑benefit prior authorization; prior authorization criteria for the medical‑benefit IV formulation were revised accordingly.

Submit prior authorization for intravenous vedolizumab (Entyvio IV) under the medical benefit (J3380).

Clinical Background

Vedolizumab (Entyvio) is a humanized monoclonal antibody that selectively binds the alpha4beta7 integrin, inhibiting lymphocyte trafficking to inflamed gastrointestinal tissue and thereby reducing GI inflammation; the policy distinguishes the intravenous formulation (medical benefit) from the self-administered subcutaneous formulation (pharmacy benefit).

Definitions and Key Terms

Entyvio (vedolizumab) definition

MechanismHumanized monoclonal antibody that binds the alpha-4-beta-7 integrin, blocking interaction with MAdCAM-1 and inhibiting lymphocyte trafficking into inflamed gastrointestinal tissue.

Therapeutic effectReduces chronically inflamed gastrointestinal parenchymal tissue associated with ulcerative colitis and Crohn's disease.

Formulation noteIV Entyvio is covered under the medical benefit; the subcutaneous formulation is handled under the pharmacy benefit (policy distinction).

Moderately to severely active Crohn's disease

Diagnostic requirementDiagnosis of moderately to severely active Crohn's disease is required for initial therapy.

Prior conventional therapyHistory of failure to one of the following at maximally indicated doses unless contraindicated/intolerant: corticosteroids (e.g., prednisone, methylprednisolone, budesonide); 6-mercaptopurine; azathioprine; methotrexate.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyVedolizumab (Entyvio) intravenous infusion — coverage and medical necessity criteria

Policy CodePolicy CS2026D0053Y

Change TypeCriteria revisions and benefit assignment

Effective DateAug 1, 2026

Next Review Date

SourceLink

On This Page

Prescriber: Prescribed by or in consultation with a gastroenterologist.

Authorization length: Initial authorization will be for no more than 12 months.

Continuation therapy for Ulcerative Colitis

Clinical response: Documentation of positive clinical response to Entyvio.
Dosing: Entyvio dosing for ulcerative colitis is in accordance with FDA-labeled dosing.
No combination therapy: Patient is not receiving Entyvio in combination with another systemic targeted immunomodulator (examples listed in policy).
Reauthorization length: Reauthorization will be for no more than 12 months.

Authorization administrative note: Entyvio IV (medical benefit) — subcutaneous formulation is obtained under the pharmacy benefit (see policy exclusions).

Initial authorization will be for no more than 3 doses of Entyvio.

Continuation therapy for immunotherapy-related toxicities

Clinical response: Documentation of positive clinical response.
Ongoing toxicity: Patient continues to experience checkpoint inhibitor-related toxicities.
Reauthorization length: Reauthorization will be for no more than 3 doses of Entyvio.

Policy update note: Continuation criteria updated to require documentation of positive clinical response and ongoing toxicity; some prior diagnostic/drug-related requirements were removed in this revision.

Ongoing disease: Patient continues to experience acute GI aGVHD.

Reauthorization length: Reauthorization will be for no more than 4 doses of Entyvio.

Policy revision note: Some prior requirements related to corticosteroid combination/intolerance were removed in the latest revision; see full policy history for details.

Entyvio subcutaneous formulation is obtained under the pharmacy benefit; IV Entyvio is covered under the medical benefit per this policy.

Reauthorization will be for no more than 3 doses, contingent on documentation of positive clinical response and ongoing toxicity.

Prior therapy requirementRequires history of failure/contraindication/intolerance to infliximab or presence of immune-related hepatitis (per criteria).

Initial authorization doses (GI acute aGVHD)

Initial authorization dosesInitial authorization will be for no more than 4 doses of Entyvio for steroid-refractory GI acute aGVHD.

Continuation/ReauthorizationReauthorization will be for no more than 4 doses, contingent on documentation of positive clinical response and ongoing disease.

Concomitant therapyInitial therapy may be given with systemic corticosteroids or when the patient is intolerant to systemic corticosteroids (per criteria).

Obtain subcutaneous Entyvio via pharmacy benefit—do not submit medical‑benefit PA requests for the subcutaneous formulation.

Step Therapy

Document prior/conventional therapy and prior targeted therapy for initial CD/UC

For initial therapy of Crohn's disease and ulcerative colitis, the member must have documented failure (or contraindication/intolerance) to specified conventional therapies and must have been previously treated with a systemic targeted immunomodulator as described in the criteria.

Crohn's disease: history of failure to one conventional therapy (e.g., corticosteroids, 6‑mercaptopurine, azathioprine, methotrexate) and prior treatment with a systemic targeted immunomodulator.
Ulcerative colitis: prior or concurrent inadequate response to a therapeutic course of oral corticosteroids and/or immunosuppressants (e.g., azathioprine, 6‑mercaptopurine) and prior treatment with a systemic targeted immunomodulator.

Step Therapy

Step therapy updated — removed some prior failure requirements

The policy removed a prior requirement that patients must have failed at least one TNF blocker, immunomodulator, or corticosteroid in some initial‑therapy pathways; instead, initial pathways now require prior/inadequate response to corticosteroids/immunosuppressants or prior exposure to a systemic targeted immunomodulator depending on the indication.

Do not rely on the removed TNF/immunomodulator/corticosteroid failure criterion for all initial‑therapy pathways; follow the updated indication‑specific requirements in the policy.

Documentation Required

Document prior targeted therapy, dosing plan, and gastroenterology involvement

Prescribers must document prior treatment with a systemic targeted immunomodulator and indicate that Entyvio will be initiated and titrated according to FDA‑labeled dosing; include evidence of gastroenterology consultation or that the prescription is by/with a gastroenterologist for CD/UC.

Provide records showing previous systemic targeted immunomodulator therapy (agent name and dates).
Include planned or administered dosing per FDA labeling for the indication.

Documentation Required

Submit indication‑specific specialty documentation (immunotherapy toxicities, GI aGVHD)

For immune checkpoint inhibitor‑related toxicities and for GI acute aGVHD, submit documentation of the specific diagnosis, prior failure/intolerance to infliximab when required (for immunotherapy toxicities), current receipt of a checkpoint inhibitor (for immunotherapy toxicities), and steroid‑refractory status where applicable (for aGVHD).

Immunotherapy toxicities: document checkpoint inhibitor exposure (e.g., pembrolizumab, nivolumab) and history of infliximab failure/contraindication/intolerance or presence of immune‑related hepatitis.
GI aGVHD: document steroid‑refractory status or corticosteroid intolerance and whether Entyvio will be given with systemic corticosteroids.

Documentation Required

Prescriber must be/consult gastroenterologist and document prior therapy

Documentation must show Entyvio is prescribed by or in consultation with a gastroenterologist and include prior or concurrent evidence of inadequate response to a therapeutic course of oral corticosteroids and/or immunosuppressants (for UC) or prior treatment with a systemic targeted immunomodulator where required.

Include consultation notes or a gastroenterologist signature on the treatment plan.
Attach clinical notes, labs, or imaging that support inadequate response to corticosteroids/immunosuppressants or prior systemic targeted therapy.

Denial Risk

Denial risk: insufficient CD diagnosis or conventional therapy documentation

For Crohn's disease initial therapy, failure to document a diagnosis of moderately to severely active Crohn's disease or lack of documentation of prior failure/intolerance/contraindication to listed conventional therapies may result in denial.

Provide documentation confirming disease severity and prior conventional therapy history (agents and treatment dates).

Denial Risk

Denial risk: missing UC prior therapy documentation

For ulcerative colitis, lack of documentation of prior inadequate response to corticosteroids and/or immunosuppressants and lack of prior treatment with a systemic targeted immunomodulator may trigger denial of the request.

Include records of therapeutic corticosteroid or immunosuppressant courses and evidence of inadequate response, plus prior systemic targeted agent names and dates.

Denial Risk

Denial risk: combination therapy with another systemic targeted immunomodulator

Requests may be denied if Entyvio is prescribed in combination with another systemic targeted immunomodulator for the same indication; continuation criteria explicitly require the patient is not receiving Entyvio with another systemic targeted immunomodulator.

Do not prescribe Entyvio concurrently with agents listed as systemic targeted immunomodulators (examples include adalimumab, certolizumab, mirikizumab, upadacitinib, risankizumab, guselkumab, ustekinumab, ozanimod, tofacitinib/XR).
Provide medication reconciliation showing no concurrent systemic targeted immunomodulator therapy.

Prior targeted therapyPatient must have been previously treated with a systemic targeted immunomodulator FDA-approved for Crohn's disease (examples listed in policy).

Entyvio (vedolizumab) indication summary (UC and CD)

Indications (FDA)Indicated for treatment of adult patients with moderately to severely active ulcerative colitis and moderately to severely active Crohn's disease (informational).

Policy-covered usesIV Entyvio is proven and medically necessary for CD and UC when policy criteria (diagnosis, prior therapy, dosing, gastroenterology involvement) are met.

Benefit distinctionIV formulation covered under medical benefit; subcutaneous Entyvio is assigned to the pharmacy benefit (per policy).

Systemic targeted immunomodulator — examples list (updated agents list)

Examples of systemic targeted immunomodulatorsAdalimumab; certolizumab (Cimzia); mirikizumab (Omvoh); upadacitinib (Rinvoq); risankizumab (Skyrizi); guselkumab (Tremfya); ustekinumab.

Additional agents notedPolicy history adds Zeposia (ozanimod) and standardizes Xeljanz/Xeljanz XR (tofacitinib); removes certain agents such as natalizumab in updates.

Combination therapy prohibitionEntyvio must not be used in combination with another systemic targeted immunomodulator for the same indication (examples listed in policy).