CurrentcignaPolicy IP0674

Entyvio Intravenous Prior Authorization Policy

Defines Cigna prior authorization requirements, coverage criteria, dosing, durations, and not-covered uses for vedolizumab IV (Entyvio) across FDA-approved indications (Crohn's disease, ulcerative colitis) and select evidence-supported uses (checkpoint-inhibitor–related GI toxicity, graft-versus-host disease). Includes prescribing specialist requirements and continuation criteria.

Policy Summary

Payercigna

PolicyEntyvio Intravenous Prior Authorization Policy

Policy CodePolicy IP0674

Change Typeselected revisions; additions of indications and dosing updates

Effective DateMar 15, 2026

Next Review Date

Key ActionSubmit prior authorization for Entyvio IV; initial approval requires prescribing by or consultation with a specialist in the treated condition.

SourceLink

POLICY UPDATE CHANGES

Policy shows multiple selected revisions between 11/01/2024 and 03/15/2026 including additions of indications (checkpoint-inhibitor GI toxicity, GVHD) and dosing updates (option for Week 0 and 2 dosing; option for every 4-week dosing for current recipients).

3FDA-Approved / Supported Indications Listed

1HCPCS drug code

1Required specialist consultation

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Scope: This policy covers Entyvio (vedolizumab IV) for FDA‑approved indications in adults with moderately to severely active Crohn’s disease and ulcerative colitis, and for select evidence‑supported uses including gastrointestinal toxicity associated with immune checkpoint inhibitors and steroid‑refractory acute graft‑versus‑host disease. (See policy criteria for indication‑specific requirements.)

Background: Entyvio is an integrin receptor antagonist indicated for CD and UC. Standard IV induction and maintenance described in the policy is 300 mg IV at Weeks 0, 2, and 6, then no more frequently than every 8 weeks, with the option in some circumstances to switch to subcutaneous dosing or to shorten the interval for patients who lose response. Alternatives and shortened intervals for loss of response are discussed in the policy and supporting trial extension data. Initial prescribing and continuation are subject to specialist prescribing/consultation and prior authorization requirements per the policy.

Key Coverage Thresholds

Minimum prior therapy for continuation (CD/UC)Established on drug ≥ 6 months for continuation (approve for 1 year)

Minimum prior therapy for GVHD continuationEstablished on therapy ≥ 1 month for continuation (approve for 3 months)

Standard maintenance dosing intervalSubsequent doses no more frequently than once every 8 weeks (standard maintenance)

Maximum dosing frequency for current recipientsUp to 300 mg IV no more frequently than once every 4 weeks for patients currently receiving IV or SC

Crohn's Disease — Criteria

Crohn's Disease - FDA-Approved Indications

Approve if the patient meets ONE of the following (A or B):

ANY of the following

A) Initial Therapy
- Patient is ≥ 18 years of age
- The medication is prescribed by or in consultation with a gastroenterologist
B) Patient is Currently Receiving Entyvio Intravenous or Subcutaneous
- Patient has been established on the requested drug for at least 6 months
- Response criteria (one required)
  - When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (prior to initiating the requested drug)
    Examples: fecal markers (fecal lactoferrin, fecal calprotectin), serum markers (CRP), imaging (MRE, CTE), endoscopic assessment, and/or reduced dose of corticosteroids.
  - Compared with baseline, patient experienced an improvement in at least one symptom (e.g., decreased pain, fatigue, stool frequency, and/or blood in stool).

refStripTags': 'b1_0

ref": "b1_0

title": "Crohn's Disease - FDA-Approved Indications"

ref":

Crohn's Disease - Dosing

Approve ONE of the following dosage regimens (A or B):

ANY of the following

A) Initial Therapy
- 300 mg IV infusion at Weeks 0, 2, and 6, and then no more frequently than once every 8 weeks thereafter
- 300 mg IV infusion administered at Week 0 and 2
B) Patient Currently Receiving Entyvio IV or SC
- Up to a maximum dose of 300 mg IV no more frequently than once every 4 weeks

refStripTags': 'b1_1

Ulcerative Colitis — Criteria

Ulcerative Colitis - FDA-Approved Indications

Approve if the patient meets ONE of the following (A or B):

ANY of the following

A) Initial Therapy
- Patient is ≥ 18 years of age
- The medication is prescribed by or in consultation with a gastroenterologist
B) Patient is Currently Receiving Entyvio IV or SC
- Patient has been established on Entyvio IV or SC for at least 6 months
- Response criteria (one required)
  - When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline
    Examples: fecal calprotectin, CRP, endoscopic assessment, and/or reduced dose of corticosteroids.
  - Compared with baseline, patient experienced an improvement in at least one symptom (e.g., decreased pain, fatigue, stool frequency, and/or decreased rectal bleeding).

refStripTags': 'b2_0

ref": "b2_0

title": "Ulcerative Colitis - FDA-Approved Indications"

ref":

Ulcerative Colitis - Dosing

Approve ONE of the following dosage regimens (A or B):

ANY of the following

A) Initial Therapy
- 300 mg IV infusion at Week 0, 2, and 6, and then no more frequently than once every 8 weeks thereafter
- 300 mg IV infusion administered at Week 0 and 2
B) Patient Currently Receiving Entyvio IV or SC
- Up to a maximum dose of 300 mg IV no more frequently than once every 4 weeks

refStripTags': 'b2_1

Checkpoint Inhibitor–Associated GI Toxicity — Criteria

Gastrointestinal Toxicity Associated with Checkpoint Inhibitor Therapy (Other Use with Supportive Evidence)

Approve if the patient meets ONE of the following (A or B):

ANY of the following

A) Initial Therapy
- Patient is ≥ 18 years of age
- According to the prescriber, patient developed gastrointestinal toxicity while receiving a checkpoint inhibitor
- Patient is symptomatic despite a trial of at least ONE systemic corticosteroid
  Examples: methylprednisolone, prednisone
- The medication is prescribed by or in consultation with a gastroenterologist or an oncologist
B) Patient is Currently Receiving Entyvio IV
- Patient has been established on therapy for at least 6 months
- Response criteria (one required)
  - When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline
    Examples: clinically significant improvement or normalization of serum markers (CRP), fecal markers (fecal calprotectin), endoscopic assessment, and/or reduced dosage of corticosteroids.
  - Compared with baseline, patient experienced an improvement in at least one symptom (e.g., decreased pain, fatigue, stool frequency, decreased rectal bleeding).

refStripTags': 'b3_0

ref": "b3_0

title": "Gastrointestinal Toxicity Associated with Checkpoint Inhibitor Therapy (Other Use with Supportive Evidence)"

ref":

Gastrointestinal Toxicity - Dosing

Approve if dosage regimen meets BOTH of the following (A and B):

ALL of the following

300 mg IV infusion administered at Week 0, 2, and 6
Subsequent doses are separated by at least 8 weeks

refStripTags': 'b3_1

ref": "b3_1

title": "Gastrointestinal Toxicity - Dosing"

ref":

Graft-Versus-Host Disease — Criteria

Graft-Versus-Host Disease (Other Use with Supportive Evidence)

Approve if the patient meets ONE of the following (A or B):

ANY of the following

A) Initial Therapy
- Patient is ≥ 18 years of age
- Patient has acute graft-versus-host disease
- Patient has tried at least one systemic medication for graft-versus-host disease
  Examples: corticosteroids (methylprednisolone), antithymocyte globulin, cyclosporine, tacrolimus, mycophenolate mofetil, ruxolitinib, basiliximab, etanercept, infliximab, sirolimus, pentostatin, tocilizumab
- The medication is prescribed by or in consultation with an oncologist, hematologist, or a physician affiliated with a transplant center
B) Patient is Currently Receiving Entyvio IV
- Patient has been established on therapy for at least 1 month
- Response criteria (one required)
  - When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline
    Examples: improvement on endoscopic assessment, normalization of liver function tests, RBC count, or platelet count; or resolution of fever or rash.
  - Compared with baseline, patient experienced an improvement in at least one symptom (e.g., improvement in oral mucosal or GI symptoms such as diarrhea, nausea, vomiting, anorexia) or decreased fatigue.

refStripTags': 'b4_0

ref": "b4_0

title": "Graft-Versus-Host Disease (Other Use with Supportive Evidence)"

ref":

Graft-Versus-Host Disease - Dosing

Approve if dosage regimen meets BOTH of the following (A and B):

ALL of the following

300 mg IV infusion administered at Week 0, 2, and 6
Subsequent doses are separated by at least 8 weeks

refStripTags': 'b4_1

ref": "b4_1

title": "Graft-Versus-Host Disease - Dosing"

ref":

General Policy & Prescriber Requirements

General Policy Requirements

Prior Authorization and prescriber requirements

ALL of the following

Prior Authorization is required for benefit coverage of Entyvio intravenous
Initial approval requires Entyvio IV to be prescribed by or in consultation with a physician who specializes in the condition being treated
Examples: gastroenterologist for CD/UC; oncologist for checkpoint-toxicity; hematologist/oncologist/transplant physician for GVHD
Requests for doses outside established dosing in this policy will be considered on a case-by-case basis by a clinician (Medical Director or Pharmacist)
Extended approvals are allowed if the patient continues to meet the Criteria and Dosing

refStripTags': 'b5_0

ref": "b5_0

title": "General Policy Requirements"

ref":

Prior Authorization

Prior authorization required

Submit prior authorization for Entyvio IV; approval is required before benefit coverage. Initial approval requires prescribing by or in consultation with a specialist in the condition being treated.

J3380

Documentation Required

Document duration on therapy for continuation requests

For 'currently receiving' continuation requests, document duration on Entyvio (≥6 months for Crohn's disease/ulcerative colitis and checkpoint inhibitor–associated GI toxicity; ≥1 month for graft‑versus‑host disease) and document objective or symptomatic improvement from baseline.

See definition: Established on therapy / currently receiving (≥6 months for CD/UC/checkpoint-toxicity; ≥1 month for GVHD)

Documentation Required

Specialist consultation documentation

Document that the medication is prescribed by or in consultation with an appropriate specialist: gastroenterologist for Crohn's disease or ulcerative colitis; gastroenterologist or oncologist for checkpoint inhibitor–associated GI toxicity; oncologist, hematologist, or transplant‑affiliated physician for graft‑versus‑host disease.

Billing Rule

Dose exceptions handled case-by-case

Requests for doses outside the established dosing in this policy will be reviewed on a case‑by‑case basis by a clinician (Medical Director or Pharmacist).

Denial Risk

Not covered for combination biologic/targeted synthetic use

Entyvio IV used concurrently with another biologic or with a targeted synthetic oral small molecule drug for an inflammatory condition is considered not medically necessary and may be denied.

Exclusions / Not Covered Uses

Conditions Not Covered

Entyvio IV is considered not medically necessary for any other use, including:

Concurrent use with another biologic or with a targeted synthetic oral small molecule drug for an inflammatory condition

Does NOT exclude use of conventional synthetic DMARDs (e.g., methotrexate, leflunomide, hydroxychloroquine, sulfasalazine).

Clinical Evidence & Background

Evidence and sources: the policy cites the Entyvio prescribing information (Takeda, April 2024) as the primary product labeling reference and clinical guidelines from ACG (2025), AGA (2024/2025), and NCCN (2024/2025) to support use in the listed indications and other evidence‑supported uses.

Mechanism: Entyvio (vedolizumab) is described in the policy as an integrin receptor antagonist, consistent with the Appendix mechanism listing for Entyvio.

Dosing overview (supportive, not criteria): the source labeling and policy summarize IV dosing as 300 mg IV induction at Weeks 0, 2, and 6 with maintenance no more frequently than every 8 weeks, note an option to switch to subcutaneous maintenance (108 mg SC every 2 weeks), and note evidence that shortening dosing interval may recapture response in loss of efficacy.

Key Evidence Highlights

Number of FDA‑approved / supported indications listed3

Covered HCPCS drug codeJ3380 (Injection, vedolizumab, 1 mg) — 1 code

Initial approval specialist requirementInitial approval requires prescribing by or in consultation with a specialist in the treated condition

Definitions

Definitions: "Established on therapy / currently receiving" is defined in the policy for continuation criteria as follows: for Crohn’s disease, ulcerative colitis, and checkpoint inhibitor–associated GI toxicity, the patient must have been on Entyvio for at least 6 months to qualify as "currently receiving" for the continuation approval; for graft‑versus‑host disease, the patient must have been on therapy for at least 1 month to qualify as "currently receiving."

Revision History

11/01/2024new_policy

New policy created.

06/01/2025annual_revision

Added dosing option for initial therapy: 300 mg IV administered at Week 0 and 2 for Crohn's disease and ulcerative colitis.

09/01/2025selected_revision

Added condition and criteria: Gastrointestinal toxicity associated with checkpoint inhibitor therapy (criteria and dosing added).

10/15/2025selected_revision

Added indications and dosing updates including graft-versus-host disease as a covered supportive-use condition; for patients currently receiving Entyvio added option of up to 300 mg IV no more frequently than once every 4 weeks.

03/15/2026selected_revisionLatest

Policy updated (selected revision). Includes additions of indications for checkpoint-inhibitor–associated GI toxicity and graft-versus-host disease and dosing updates: option for Week 0 and 2 induction dosing and option for every-4-week IV dosing for current recipients.

Policy Summary

Payercigna

PolicyEntyvio Intravenous Prior Authorization Policy

Policy CodePolicy IP0674

Change Typeselected revisions; additions of indications and dosing updates

Effective DateMar 15, 2026

Next Review Date

Key ActionSubmit prior authorization for Entyvio IV; initial approval requires prescribing by or consultation with a specialist in the treated condition.

SourceLink

On This Page

OpenPayer

Entyvio Intravenous Prior Authorization Policy

Coverage Summary & Indications

Crohn's Disease — Criteria

Ulcerative Colitis — Criteria

Checkpoint Inhibitor–Associated GI Toxicity — Criteria

Graft-Versus-Host Disease — Criteria

General Policy & Prescriber Requirements

Applicable Codes

Exclusions / Not Covered Uses

Clinical Evidence & Background

Definitions

Revision History