CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Entyvio (vedolizumab) IV — Coverage Criteria

Medical necessity and utilization management criteria for intravenous Entyvio (vedolizumab) for treatment of moderate to severe Crohn's disease, ulcerative colitis, and immune checkpoint inhibitor-related diarrhea/colitis for Neighborhood Health Plan of Rhode Island members (Medicaid, Commercial, MMP).

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyEntyvio (vedolizumab) IV — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date01/01/2020

Next Review DateN/A

Key ActionObtain prior authorization with documentation that Entyvio is prescribed by or in consultation with a gastroenterology specialist and that the patient meets required prior therapy and screening criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

4 monthsinitial authorization length

6 monthsrenewal interval

300 mgIV dose

J3380billing J-code

NDC 67464-0300Entyvio NDC

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~40 ICD-10covered dx codes

Coverage Criteria for Intravenous Vedolizumab (Entyvio)

Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met

General requirements: 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); Entyvio will not be used concomitantly with injectable biologic response modifiers (e.g., TNF inhibitors, IL inhibitors) or specified oral non-biologic agents; baseline disease severity assessed using an objective measure/tool.

Crohn's disease prior therapy requirements (by line of business): Member has documented moderate to severe Crohn's disease AND meets one of the following depending on enrollment: For Medicaid and MMP: documented failure, contraindication, or ineffective response at maximum tolerated doses to a minimum 3-month trial of infliximab IV or adalimumab AND documented failure, contraindication, or ineffective response at maximum tolerated doses to a minimum 6-month trial of ustekinumab; For Commercial: 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) OR documented failure, contraindication, or ineffective response at maximum tolerated doses to a minimum 3-month trial of a TNF modifier (adalimumab, certolizumab, or infliximab).

Ulcerative colitis prior therapy requirements: Documented moderate to severe ulcerative colitis AND documented failure, contraindication, or ineffective response to at least a 3-month trial of infliximab IV at maximum tolerated doses; AND for biologic-experienced patients, documented failure, contraindication, or ineffective response to at least a 6-month trial of ustekinumab at maximum tolerated doses.

Renewal Therapy — Renewal is allowed when ALL of the following are met

Renewal is allowed when ALL of the following are met

General renewal criteria: Patient continues to meet initial approval criteria; ongoing monitoring for presence of tuberculosis or other active infections; absence of unacceptable toxicity to vedolizumab (examples: anaphylaxis or other serious allergic reactions, severe infections, progressive multifocal leukoencephalopathy (PML), jaundice or other evidence of significant liver injury).

Crohn's disease response: Objective improvement in signs and symptoms compared to baseline (examples: endoscopic activity, number of liquid stools, abdominal pain, presence of abdominal mass, body weight compared to IBW, hematocrit, presence of extra-intestinal complications, decreased use of anti-diarrheal drugs, tapering/discontinuation of corticosteroids, or improvement on a disease activity scoring tool such as CDAI or the Harvey-Bradshaw Index).

Ulcerative colitis response: Objective improvement in signs and symptoms compared to baseline (examples: stool frequency, rectal bleeding, endoscopic activity), tapering/discontinuation of corticosteroids, normalization of CRP or fecal calprotectin, or improvement on a disease activity scoring tool such as UCEIS or the Mayo Score.

Immune Checkpoint Inhibitor-Related Diarrhea/Colitis — Covered when ALL of the following are met

Covered for immune checkpoint inhibitor-related diarrhea/colitis when ALL of the following are met

ICI-related colitis requirements: Patient is receiving an immune checkpoint inhibitor AND has either: (a) mild (Grade 1) diarrhea or colitis related to immunotherapy with persistent or progressive symptoms and a positive lactoferrin or fecal calprotectin; OR (b) moderate (Grade 2) to severe (Grade 3–4) diarrhea or colitis related to immunotherapy.

Dose and renewal limits: Dose regimen: 300 mg IV (300 billable units) administered at weeks 0, 2, and 6 (three doses total). Therapy may not be renewed beyond these three doses; renewal requests for ICI-related diarrhea/colitis are not permitted.

General coverage basis — Covered when aligned with FDA labeling and plan's clinical coverage criteria as adopted by P&T

Covered when aligned with FDA labeling and plan's clinical coverage criteria as adopted by P&T

P&T adoption and indication alignment: Use must be for a medically accepted indication and consistent with FDA-approved labeling and/or relevant clinical literature; plan criteria adopted by the Pharmacy & Therapeutics Committee will be applied. For INTEGRITY (Medicare–Medicaid Plan) members, these criteria apply only in the absence of an applicable NCD or LCD. Individual consideration will be given based on prescriber-submitted information.

Entyvio (vedolizumab) must not be used concomitantly with other injectable biologic response modifiers or certain specified oral non‑biologic agents. Examples of excluded injectable biologics include TNF inhibitors (e.g., adalimumab, infliximab), IL inhibitors (e.g., secukinumab, guselkumab, tildrakizumab, ustekinumab, risankizumab, bimekizumab, mirikizumab), and excluded oral agents include apremilast, tofacitinib, baricitinib, upadacitinib, and etrasimod. Requests that indicate concurrent use with these agents may be denied.

When applicable, National Coverage Determinations (NCDs) and Local Coverage Determinations (LCDs) take precedence over these plan criteria. Compliance with CMS NCD/LCD policy is required where such determinations exist; additional indications may be considered at the plan's discretion.

For immune checkpoint inhibitor‑related diarrhea/colitis, therapy with Entyvio is limited to the initial course of 300 mg IV administered at weeks 0, 2, and 6 (three doses total). Requests to renew therapy beyond this initial 3‑dose course are considered not medically necessary and will not be approved.

The plan will ensure Entyvio is used for medically accepted indications and according to the adopted clinical criteria. If submitted clinical information does not demonstrate that the request meets these criteria (including specialist involvement, age and infection screening requirements, and absence of excluded concomitant therapies), the plan may deny the request. Individual consideration will be given based on prescriber‑submitted documentation and other information available to the plan.

Billing and Diagnosis Codes

J-codeHCPCSCovered

J3380

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

NDCNDC

67464-0300-xx

Entyvio 300 mg single use vial NDC

NDCNDC

67464-0300-xx

Entyvio 300 mg single use vial NDC

Covered Diagnosis Codes (Appendix 1)ICD-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 72

1/8

Medicare Part B Administrative Contractor Jurisdictionsmixed

No codes listed

Medicare NCD/LCD applicability

RequirementCompliance with applicable National Coverage Determinations (NCDs) and Local Coverage Determinations (LCDs) is required where they exist.

Where to find NCDs/LCDsCMS Medicare Coverage Database: http://www.cms.gov/medicare-coverage-database/search/advancedsearch.aspx.

PrecedenceIf an applicable NCD or LCD exists, that coverage guidance takes precedence over the plan's clinical criteria for Medicare-covered services.

Plan discretionAdditional indications may be covered at the discretion of the health plan when no NCD/LCD applies.

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior authorization required with clinical prerequisites

Prior authorization is required. Entyvio must be prescribed by or in consultation with a gastroenterology specialist; the patient must be aged 18 years or older; be free of any active, severe infections; and have been screened for tuberculosis per local practice. The prescriber must document baseline disease severity using an objective measure/tool and confirm Entyvio will not be used concomitantly with excluded biologic or specified oral non-biologic agents.

Prescribed by or in consultation with a gastroenterology specialist
Patient aged 18 years or older
No active, severe infections
TB screening per local practice
Baseline disease severity documented with an objective tool
Not used concomitantly with injectable biologic response modifiers or specified oral non-biologic agents

Prior Authorization

Prior authorization and product identifier

Background on Vedolizumab (Entyvio)

Vedolizumab (Entyvio) is a monoclonal antibody integrin receptor antagonist indicated for the intravenous induction and maintenance treatment of moderate to severe Crohn’s disease and ulcerative colitis. Clinical evidence demonstrates benefits for induction and maintenance of clinical response and remission, and the plan’s P&T committee adopted coverage criteria to align use with FDA labeling and relevant literature while managing safety and cost‑effectiveness.

Definitions and Special Plan Notes

Entyvio (vedolizumab) — definition and indication

Generic name / brandVedolizumab (Entyvio)

Drug classIntegrin receptor antagonist; monoclonal antibody indicated for moderate to severe Crohn's disease and ulcerative colitis.

Indications summarizedIntravenous therapy to induce and maintain remission in moderate to severe Crohn's disease and ulcerative colitis per FDA labeling and clinical literature.

Safety profileFavorable safety profile reported in trials; common adverse events include headache, nasopharyngitis, and abdominal pain.

Dose (documented elsewhere in policy)Loading and maintenance IV dose referenced as 300 mg per administration.

INTEGRITY (Medicare-Medicaid Plan) — applicability

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyEntyvio (vedolizumab) IV — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date01/01/2020

Next Review DateN/A

SourceLink

On This Page

Requests are reviewed against criteria adopted by the plan's Pharmacy & Therapeutics (P&T) Committee; individual consideration will be given based on prescriber-submitted information. The product identifier (Entyvio 300 mg single-use vial) and NDC are listed for billing/administrative purposes.

Coverage criteria adopted by P&T and applied to requests
Individual consideration based on prescriber-submitted information
Entyvio 300 mg single-use vial NDC: 67464-0300-xx

Step Therapy

Step therapy and exemptions

Step therapy requirements vary by line of business: Medicaid and MMP members who received Entyvio within the prior 365 days are exempt from step therapy; otherwise, specified prior therapy trials or failures are required before approval.

MMP members previously receiving the medication within 365 days are not subject to step therapy
Medicaid/MMP: documented failure/contraindication/ineffective response to ≥3 months infliximab IV or adalimumab AND ≥6 months ustekinumab at max tolerated doses
Commercial: documented failure/contraindication/ineffective response to ≥3 months corticosteroids or immunomodulators OR ≥3 months prior TNF modifier therapy

Note

Use of cost-effective options

The coverage criteria were designed to promote use of cost‑effective treatment options first where appropriate; the P&T‑adopted criteria and prior‑therapy requirements support this intent.

Criteria ensure members use Entyvio for medically accepted indications while encouraging cost‑effective options first

Documentation Required

Required clinical documentation

Submit clinical documentation that includes a specialist prescription or documentation of consultation, patient age (≥18), tuberculosis screening status, and an objective baseline disease severity assessment using a validated tool.

Specialist prescription or consultation note
Patient age documented (≥18 years)
TB screening per local practice documented
Baseline disease severity using objective measures (e.g., CDAI, Harvey‑Bradshaw, UCEIS, Mayo Score)

Documentation Required

Prior therapy documentation

For prior biologic exposure and step/failure pathways, provide documentation of prior therapy trials including medications used, duration of each trial, and outcomes (failure, contraindication, or ineffective response) at maximum tolerated doses.

Name of prior biologic or therapy
Duration of trial (e.g., minimum 3 months for infliximab/adalimumab; 6 months for ustekinumab where specified)
Outcome of trial: failure, contraindication, or ineffective response
Confirmation that prior therapies were at maximum tolerated doses

Documentation Required

Documentation required for individual consideration

Neighborhood will give individual consideration to requests using the information submitted by the prescriber and other information available to the plan; ensure all relevant clinical details are included to support medical necessity.

Provide comprehensive prescriber-submitted clinical rationale and supporting records
Plan will use prescriber information and other available data for individual consideration

Denial Risk

Concomitant biologic therapy exclusion

Do not prescribe Entyvio concomitantly with injectable biologic response modifiers (e.g., TNF‑inhibitors, IL‑inhibitors) or certain oral non‑biologic agents; such concomitant use is excluded and will trigger denial.

Examples of excluded concomitant injectable biologics: adalimumab, etanercept, infliximab, ustekinumab, secukinumab, risankizumab, mirikizumab, etc.
Examples of excluded oral non‑biologic agents: apremilast, tofacitinib, baricitinib, upadacitinib, etrasimod

Denial Risk

No renewal for ICI-related colitis

For immune checkpoint inhibitor‑related diarrhea/colitis, therapy is limited to the induction course of 300 mg IV at weeks 0, 2, and 6 (three doses total); renewal beyond the initial 3‑dose course is not allowed and renewal requests will be denied.

Induction dosing for ICI‑related colitis: 300 mg IV at weeks 0, 2, and 6
No renewals beyond the initial 3 doses (renewal requests not medically necessary)

Denial Risk

Coverage consideration and potential denial risk

Requests may be denied if submitted information does not demonstrate that Entyvio is being used for a medically accepted indication or that the member meets the P&T‑adopted clinical coverage criteria; include all supporting documentation to avoid denial.

Plan enforces use for FDA‑approved or compendia‑recommended indications per adopted criteria
Incomplete or unsupported clinical information may lead to denial

Applicability for INTEGRITY membersThese coverage criteria apply to INTEGRITY (Medicare-Medicaid Plan) members only in the absence of an applicable NCD or LCD.

Individual considerationNeighborhood will give individual consideration to requests based on prescriber-submitted information and other information available to the plan.

Alignment requirementWhen applied, plan criteria were adopted to ensure use is consistent with FDA-approved labeling and relevant clinical literature.