ModifiedAmerihealth Caritas Vip CarePolicy MA08.001h

Vedolizumab (Entyvio) for intravenous use

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This policy governs medical-benefit coverage and prior authorization for intravenous vedolizumab in Medicare Advantage members. It applies to adults with specified inflammatory bowel disease, immune checkpoint inhibitor-related diarrhea or colitis, or steroid-refractory acute graft-versus-host disease when medical-necessity and dosing requirements are met.

Policy Summary

PayerAmerihealth Caritas Vip Care

PolicyVedolizumab (Entyvio) for intravenous use

Policy CodePolicy MA08.001h

Change TypeModified

Effective DateDecember 15, 2025

Last ReviewSep 18, 2026

Next Review DateN/A

Key ActionSubmit accurate member and regimen information and obtain new approval whenever the vedolizumab dose, frequency, or regimen changes.

SourceLink

OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

ModifiedAmerihealth Caritas Vip CarePolicy MA08.001h

Vedolizumab (Entyvio) for intravenous use

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Sign up for amerihealth_caritas_vip_care Policy MA08.001h alerts

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Policy Summary

PayerAmerihealth Caritas Vip Care

PolicyVedolizumab (Entyvio) for intravenous use

Policy CodePolicy MA08.001h

Change TypeModified

Effective DateDecember 15, 2025

Last ReviewSep 18, 2026

Next Review DateN/A

Key ActionSubmit accurate member and regimen information and obtain new approval whenever the vedolizumab dose, frequency, or regimen changes.

SourceLink

POLICY UPDATE CHANGES

The HCPCS description for J3380 was revised to specify intravenous administration.

A prior biologic step-therapy criterion requiring failure, contraindication, or intolerance to infliximab or ustekinumab for biologic-naive adults with moderately to severely active ulcerative colitis was removed.

A hematopoietic cell transplantation criterion was added.

The immune checkpoint inhibitor-related toxicities criterion was updated.

Clinical criteria for moderately to severely active ulcerative colitis and severely active Crohn's disease were updated to align with the U.S. Food and Drug Administration.

The policy removed the prior requirement that biologic-naive adults with moderately to severely active ulcerative colitis fail, be intolerant of, or have a contraindication to infliximab or ustekinumab before vedolizumab coverage.

The policy added dosing and frequency requirements for vedolizumab coverage and a three-month trial timeframe for a tumor necrosis factor blocker or immunomodulator.

HCPCS code J3380 was added to the policy.

HCPCS codes C9026 and J3590 were deleted from the policy.

300 mg IVStandard induction dose

Every 8 weeksStandard maintenance frequency

3 monthsTNF blocker or immunomodulator trial

Week 14Discontinue UC or CD therapy without benefit

4Covered clinical settings

Under 18Pediatric use

Covered Indications and Exclusions

Initial and ongoing therapy for ulcerative colitis

Covered when all criteria for the indication, including dosing and frequency requirements, are met.

Adult moderately to severely active ulcerative colitis

Prior-treatment requirement
- ONE of
  - The individual has an inadequate response, lost response, or intolerance to a 3-month trial of a TNF blocker or immunomodulator.3-month trial
  - ONE of
    The individual has an inadequate response to corticosteroids.
    The individual is intolerant of corticosteroids.
    The individual has demonstrated dependence on corticosteroids.
Dosing requirement: Vedolizumab is administered at 300 mg by IV infusion at weeks 0, 2, and 6, then every 8 weeks thereafter.300 mg IV at weeks 0, 2, and 6, then every 8 weeks
Discontinue therapy if there is no evidence of therapeutic benefit by Week 14.

Initial and ongoing therapy for Crohn's disease

Covered when all criteria for the indication, including dosing and frequency requirements, are met.

Adult moderately to severely active Crohn's disease

Prior-treatment requirement
- ONE of
  - The individual has an inadequate response to, lost response to, or intolerance of a 3-month trial of a TNF blocker or immunomodulator.3-month trial
  - ONE of
    The individual has an inadequate response to corticosteroids.
    The individual is intolerant of corticosteroids.

Immune checkpoint inhibitor-related toxicities

Covered when all criteria are met.

Adult immune checkpoint inhibitor-related diarrhea or colitis

Qualifying toxicity
- Mild grade 1 diarrhea or colitis has persistent or progressive symptoms and positive lactoferrin or calprotectin.Persistent or progressive G1 symptoms with positive lactoferrin/calprotectin
- The individual has moderate grade 2 diarrhea or colitis.4–6 bowel movements above baseline per day; colitis symptoms not interfering with activities of daily living
- The individual has severe grade 3 or 4 diarrhea or colitis.G3: ≥7 stools per day above baseline; G3 colitis: peritoneal signs with ileus and fever consistent with bowel perforation

Acute GVHD after hematopoietic cell transplantation

Covered when all criteria are met.

Steroid-refractory acute graft-versus-host disease

The adult individual has acute GVHD after hematopoietic cell transplantation and has had no response to first-line therapy options, constituting steroid-refractory disease.
Vedolizumab is used as additional therapy in conjunction with systemic corticosteroids.
Therapy is often used in conjunction with the original immunosuppressive agent.
Dosing requirement: Administer an initial 300 mg IV dose at week 0, followed by 300 mg IV at weeks 2 and 6 and every 8 weeks thereafter.300 mg IV at weeks 0, 2, and 6, then every 8 weeks

All other uses of vedolizumab (Entyvio), including use in the pediatric population younger than 18 years of age, are considered experimental/investigational and are not covered unless the indication is supported as an accepted off-label use under the Company medical policy for off-label coverage of prescription drugs and biologics.

Billing and Diagnostic Coding

CPT Procedure Code Number(s)CPT

N/A

ICD-10 Procedure Code Number(s)ICD-10

N/A

ICD-10 Diagnosis Code Number(s)ICD-10Covered

D89.810	Acute graft-versus-host disease
D89.812	Acute on chronic graft-versus-host disease
D89.813	Graft-versus-host disease, unspecified
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

1–10 of 76

1/8

HCPCS Level II Code Number(s)HCPCSCovered

J3380

Injection, vedolizumab, 1 mg

Revenue Code Number(s)Revenue

N/A

HCPCS code revisionsHCPCS

C9026	Deleted from this policy
J3590	Deleted from this policy
J3380	Added to this policy

Grade 2 diarrhea

Diagnostic threshold4–6 bowel movements above baseline per day

Severity gradeGrade 2 diarrhea or colitis

Functional impactColitis symptoms do not interfere with activities of daily living

Grade 3 diarrhea

Diagnostic thresholdAt least 7 stools per day above baseline

Severity gradeGrade 3 diarrhea

Authorization, Documentation, and Denial Rules

Prior Authorization

Precertification and Regimen Changes

Precertification is required for the requested vedolizumab dose and frequency. If the member's dose, frequency, or regimen changes—for example, because of a change in weight or incomplete therapeutic response—the provider must submit the updated information for a new approval through the precertification process.

Standard regimen: 300 mg IV at Weeks 0, 2, and 6, then every 8 weeks thereafter, unless a covered indication specifies otherwise.
The Company may conduct postpayment review and audit procedures for submitted claims.

Step Therapy

Ulcerative Colitis Prerequisite Therapy

For adults with moderately to severely active ulcerative colitis, document an inadequate, lost, or intolerant response to a 3-month trial of a TNF blocker or immunomodulator, or an inadequate response to, intolerance of, or dependence on corticosteroids.

Examples of TNF blockers or immunomodulators include adalimumab, azathioprine, and 6-mercaptopurine.

Clinical Background

Inflammatory bowel disease includes ulcerative colitis and Crohn’s disease, chronic inflammatory disorders of the gastrointestinal tract. These conditions may cause diarrhea, rectal bleeding, urgency, abdominal pain, fever, and weight loss. Ulcerative colitis primarily affects the mucosal lining of the colon and rectum, whereas Crohn’s disease can affect the entire digestive system and produce ulcers extending deep into the intestinal wall. Vedolizumab is a humanized monoclonal antibody that inhibits leukocyte migration into inflamed gastrointestinal tissue and is used for specified adult inflammatory bowel disease indications.

Clinical Definitions and Measures

Inflammatory bowel disease

DefinitionChronic inflammatory disorder of the gastrointestinal tract of unknown etiology

Major categoriesUlcerative colitis and Crohn’s disease

Common symptomsDiarrhea, rectal bleeding, urgency, abdominal cramps, pain, fever, and weight loss

Ulcerative colitis

DefinitionInflammatory bowel disease primarily affecting the mucosal lining

Anatomic distributionGenerally limited to the colon and rectum

Typical manifestations

Initial Therapy

Ulcerative colitis or Crohn's disease induction

Initial therapy requires an approved adult indication, applicable prior-treatment history, and the specified induction dose.

Indication, prerequisite therapy, and induction dosing

Approved adult indication
- The individual is an adult with moderately to severely active ulcerative colitis.
- The individual is an adult with moderately to severely active Crohn's disease.
Applicable prerequisite therapy
- For ulcerative colitis, the individual has an inadequate response, lost response, or intolerance to a 3-month trial of a TNF blocker or immunomodulator.

Continuation and Discontinuation

Ulcerative colitis and Crohn's disease continuation

For ulcerative colitis and Crohn's disease, continuation requires the policy dosing frequency and discontinuation when there is no therapeutic benefit.

Continuation dosing and response assessment

Continue vedolizumab 300 mg IV every 8 weeks after induction at weeks 0, 2, and 6.Every 8 weeks
Discontinue therapy by Week 14 if there is no evidence of therapeutic benefit.

Acute GVHD continuation

For steroid-refractory acute GVHD after hematopoietic cell transplantation.

GVHD continuation dosing

Prerequisite and Step-Therapy Requirements

Step	Requirement	Qualifying criterion	Coverage
1	For adults with moderately to severely active ulcerative colitis, trial a tumor necrosis factor (TNF) blocker or immunomodulator.	Inadequate response, lost response, or intolerance to the 3-month trial; alternatively, inadequate response to, intolerance of, or demonstrated dependence on corticosteroids.	Covered when criteria are met

Step	Requirement	Qualifying criterion	Coverage
1	For adults with moderately to severely active Crohn's disease, trial a tumor necrosis factor (TNF) blocker or immunomodulator.	Inadequate response, loss of response, or intolerance to the 3-month trial; alternatively, inadequate response to, intolerance of, or demonstrated dependence on corticosteroids.	Covered when criteria are met

Step	Requirement	Qualifying criterion	Coverage
1	Use vedolizumab as additional therapy with systemic corticosteroids for acute graft-versus-host disease after first-line therapy.	No response to first-line therapy options, constituting steroid-refractory disease.	Covered when criteria are met

Step	Requirement	Trial timeframe	Coverage
1	Trial of a tumor necrosis factor blocker or immunomodulator.	3 months	Required for applicable coverage criteria

Dose and Frequency Limits

Vedolizumab (Entyvio) maintenance regimen

Induction dose300 mg IV at weeks 0, 2, and 6

Maintenance schedule300 mg IV every 8 weeks thereafter

Covered indicationsUlcerative colitis, Crohn’s disease, and acute graft-versus-host disease

Vedolizumab (Entyvio) induction-only regimen

Induction dose300 mg IV at weeks 0, 2, and 6

UseInduction only

Applicable conditionImmune checkpoint inhibitor-related diarrhea or colitis in adults meeting the specified toxicity criteria

Administration Setting

Billing Rule

Use the appropriate infusion setting

When vedolizumab administration can occur in multiple settings, reimbursement may be limited to the most appropriate and cost-effective setting consistent with the member's medical needs, condition, and required monitoring or additional services.

Policy Summary

PayerAmerihealth Caritas Vip Care

PolicyVedolizumab (Entyvio) for intravenous use

Policy CodePolicy MA08.001h

Change TypeModified

Effective DateDecember 15, 2025

Last ReviewSep 18, 2026

Next Review DateN/A

Key ActionSubmit accurate member and regimen information and obtain new approval whenever the vedolizumab dose, frequency, or regimen changes.

SourceLink

On This Page

The individual has demonstrated dependence on corticosteroids.

Dosing requirement: Vedolizumab is administered at 300 mg by IV infusion at weeks 0, 2, and 6, then every 8 weeks thereafter.300 mg IV at weeks 0, 2, and 6, then every 8 weeks

Discontinue therapy if there is no evidence of therapeutic benefit by Week 14.

Induction dosing: Vedolizumab is administered at 300 mg by IV infusion at weeks 0, 2, and 6 for induction only.300 mg IV at weeks 0, 2, and 6

Examples of immune checkpoint inhibitors include ipilimumab and nivolumab.

Related grade 3 colitis findingPeritoneal signs with ileus and fever consistent with bowel perforation

Mayo Score

Clinical useCombined endoscopic and clinical scale used to assess the severity of ulcerative colitis

Score range0–12 total score

Assessment componentsStool frequency, rectal bleeding, endoscopic findings, and physician global assessment

Document the qualifying prior treatment history in the medical record.

Step Therapy

Crohn's Disease Prerequisite Therapy

For adults with moderately to severely active Crohn's disease, document an inadequate or lost response to, or intolerance of, a 3-month trial of a TNF blocker or immunomodulator, or an inadequate response to, intolerance of, or dependence on corticosteroids.

Examples of TNF blockers or immunomodulators include adalimumab, azathioprine, 6-mercaptopurine, and methotrexate.
Document the qualifying prior treatment history in the medical record.

Step Therapy

Steroid-Refractory GVHD Prerequisite

For adult hematopoietic cell transplantation patients with acute graft-versus-host disease, vedolizumab is covered as additional therapy with systemic corticosteroids after no response to first-line therapy options (steroid-refractory disease).

Document failure or no response to first-line therapy.
Systemic corticosteroids must be used concurrently; therapy is often given with the original immunosuppressive agent.
Dosing is 300 mg IV at Week 0, followed by Weeks 2 and 6, then every 8 weeks thereafter.

Step Therapy

Three-Month TNF Blocker or Immunomodulator Trial

For ulcerative colitis or Crohn's disease, document an inadequate response, loss of response, or intolerance after a 3-month trial of a TNF blocker or immunomodulator when this pathway is used to establish eligibility.

The three-month timeframe was added to the policy criteria for a TNF blocker or immunomodulator trial.
The qualifying alternative corticosteroid pathway remains available when the individual has inadequate response, intolerance, or demonstrated dependence on corticosteroids.

Documentation Required

Medical-Record Support

The individual's medical record must reflect the medical necessity for the care provided. Maintain supporting records and make all documentation available to the Company upon request.

Records may include professional provider, hospital, nursing home, home health, therapy, and test reports.
Failure to produce requested information may result in denial for the drug.

Documentation Required

Exception-Regimen Support

When requesting coverage outside the policy's dosing and frequency requirements, the prescribing professional provider must submit published peer-reviewed literature supporting the requested exception regimen.

The Company may update dosing and frequency requirements based on FDA information, recognized pharmacology compendia, or published peer-reviewed clinical research.
Consult the Company's policy on off-label coverage for prescription drugs and biologics for the list of recognized pharmacology compendia.

Denial Risk

Noncovered or Investigational Use

All other uses of vedolizumab, including use in individuals younger than 18 years of age, are considered experimental or investigational and are not covered unless the indication qualifies as an accepted off-label use under the Company's medical policy for prescription drugs and biologics.

Pediatric use is excluded unless supported under the applicable accepted off-label coverage policy.

Denial Risk

Unsupported Dosing or Missing Records

Coverage may be denied when the requested dose or frequency is not supported by the policy, when a regimen change has not received new approval, or when required medical records are absent or insufficient.

Submit accurate member information and the current dose, frequency, and regimen with the precertification request.
Provide peer-reviewed literature for dosing or frequency outside the policy requirements.
All requested documentation must be produced for Company review or audit.

Billing Rule

Benefit or Site-of-Benefit Limitation

Coverage is subject to the member's Evidence of Coverage and its terms, conditions, and limitations. This policy addresses vedolizumab covered under the Medicare Advantage medical benefit (Part B), not instances covered under the pharmacy benefit (Part D).

The Company may reimburse only services furnished in the most appropriate and cost-effective setting appropriate to the member's medical needs and condition.
Confirm whether the drug is prescribed, dispensed, or administered under the medical benefit or pharmacy benefit before submitting the claim.

Diarrhea, rectal bleeding, urgency, abdominal cramps, pain, fever, and weight loss

Crohn’s disease

DefinitionInflammatory disease that can affect the entire digestive system

Anatomic involvementMay involve gastrointestinal areas beyond the colon and rectum

Characteristic tissue involvementCan produce ulcers extending deep into the intestinal wall

Immune checkpoint inhibitor-related toxicity grades

Grade 2 diarrhea or colitisFour to six bowel movements above baseline per day, with colitis symptoms that do not interfere with activities of daily living

Grade 3 diarrheaAt least 7 stools per day above baseline

Grade 3 colitisPeritoneal signs with ileus and fever consistent with bowel perforation

Mayo Score

Scale typeCombined endoscopic and clinical scale for assessing ulcerative colitis severity

Score rangeTotal score ranges from 0 to 12

SubscoresStool frequency, rectal bleeding, flexible proctosigmoidoscopy or colonoscopy findings, and physician global assessment

Clinical remission

DefinitionTotal Mayo score of 2 or less with no individual Mayo subscore greater than 1

Mayo scale range0–12, with higher scores indicating more severe disease

Clinical useClinical remission was the primary outcome assessed in the VARSITY trial at week 52

I² statistic

What it measuresPercentage of variation across studies attributable to heterogeneity rather than chance

Low heterogeneityLess than 30%

Interpretation thresholds30–59% moderate, 60–75% substantial, and greater than 75% considerable heterogeneity

For Crohn's disease, the individual has an inadequate response to, lost response to, or intolerance of a 3-month trial of a TNF blocker or immunomodulator.

Corticosteroid alternative

The individual has an inadequate response to corticosteroids.
The individual is intolerant of corticosteroids.
The individual has demonstrated dependence on corticosteroids.

Vedolizumab is administered at 300 mg by IV infusion at weeks 0, 2, and 6.300 mg IV at weeks 0, 2, and 6

Immune checkpoint inhibitor-related toxicity induction

Initial therapy requires an eligible immune checkpoint inhibitor-related toxicity and induction dosing.

Toxicity and induction dosing

Eligible toxicity
- Mild grade 1 immune checkpoint inhibitor-related diarrhea or colitis has persistent or progressive symptoms and positive lactoferrin or calprotectin.
- The individual has moderate grade 2 immune checkpoint inhibitor-related diarrhea or colitis.4–6 bowel movements above baseline per day
- The individual has severe grade 3 or 4 immune checkpoint inhibitor-related diarrhea or colitis.G3: ≥7 stools per day above baseline
Vedolizumab is administered at 300 mg by IV infusion at weeks 0, 2, and 6 for induction only.300 mg IV at weeks 0, 2, and 6

Steroid-refractory acute GVHD induction

Initial therapy requires steroid-refractory acute GVHD and concurrent systemic corticosteroid therapy.

Acute GVHD induction

The adult individual has acute GVHD after hematopoietic cell transplantation.
The individual has had no response to first-line therapy options, constituting steroid-refractory disease.
Vedolizumab is used as additional therapy with systemic corticosteroids.
Vedolizumab is administered at 300 mg by IV infusion at weeks 0, 2, and 6.300 mg IV at weeks 0, 2, and 6

The individual has steroid-refractory acute GVHD after hematopoietic cell transplantation and continues vedolizumab as additional therapy with systemic corticosteroids.

After doses at weeks 0, 2, and 6, continue vedolizumab 300 mg IV every 8 weeks.Every 8 weeks