Currentmedical mutual - ohioPolicy N/A

Entyvio (vedolizumab) subcutaneous — Medical Benefit Prior Authorization and Coverage Criteria

Defines medical benefit prior authorization, clinical criteria, dosing, and approval durations for Entyvio subcutaneous use in adult ulcerative colitis and Crohn's disease patients, including site-of-care restrictions and medication sourcing considerations for Medical Mutual - Ohio members.

Policy Summary

Payermedical mutual - ohio

PolicyEntyvio (vedolizumab) subcutaneous — Coverage Criteria

Policy CodePolicy N/A

Change TypeMinor/No material change

Effective DateDec 19, 2023

Next Review DateN/A

Key ActionObtain prior authorization and ensure the prescriber is a specialist (or in consultation with one) and that the patient completed IV induction before switching to subcutaneous maintenance.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2Indications covered

6Initial approval (months)

12Extended approval (months)

108 mg q2wMaintenance dosing

Coverage Criteria for Entyvio (vedolizumab) Subcutaneous

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Ulcerative Colitis (Initial)

Covered when ALL of the following are met for Ulcerative Colitis:

UC main criteria: a) According to the prescriber, the patient is currently receiving Entyvio intravenous or will receive induction dosing with Entyvio intravenous within 2 months of initiating therapy with Entyvio subcutaneous; b) The patient is 18 years of age or older; c) The patient has tried at least one TNF blocker or one immunomodulator for UC unless intolerant or has had an inadequate response, was intolerant to, or demonstrated dependence on corticosteroids; d) Entyvio is prescribed by or in consultation with a gastroenterologist; e) Site of care medical necessity is met.

Dosing: Following the first two IV doses at Week 0 and Week 2, Entyvio may be switched to subcutaneous injection at Week 6. Administer 108 mg SC every 2 weeks thereafter.

Crohn's Disease (Initial)

Covered when ALL of the following are met for Crohn's Disease:

CD main criteria: a) According to the prescriber, the patient is currently receiving Entyvio intravenous or will receive induction dosing with Entyvio intravenous within 2 months of initiating therapy with Entyvio subcutaneous; b) The patient is 18 years of age or older; c) The patient has tried at least one TNF blocker or one immunomodulator for Crohn's disease for at least 2 months unless intolerant or has had an inadequate response, was intolerant to, or demonstrated dependence on corticosteroids; d) Entyvio is prescribed by or in consultation with a gastroenterologist; e) Site of care medical necessity is met.

Dosing: Following the first two IV doses at Week 0 and Week 2, Entyvio may be switched to subcutaneous injection at Week 6. Administer 108 mg SC every 2 weeks thereafter.

Duration and continuation

Approval durations and continuation criteria:

Approval durations: Initial approval: 6 months. Extended approval: approve for an additional 12 months if the patient has responded (e.g., decreased stool frequency or rectal bleeding), as determined by the prescribing physician, and the patient has been established on Entyvio subcutaneous or intravenous for at least 6 months.

Patient may not have full response by Week 14 but should show some response by then.

Concurrent administration of Entyvio (vedolizumab) with another biologic for an inflammatory condition is not recommended. The combination has not been evaluated for efficacy or safety, and Entyvio’s mechanism—binding to α4β7 integrin and blocking interaction with MAdCAM‑1—carries a warning concerning infection. Co‑administration may increase immunosuppression and infection risk.

Coverage is not recommended for uses that are not specifically listed in the Recommended Authorization Criteria. The policy will be updated if new published data become available to support additional indications or circumstances.

Use of Entyvio in combination with other biologic agents is considered not recommended and may be denied as not medically necessary or potentially unsafe due to added immunosuppression and limited supporting data.

Provider Actions and Requirements

Prior Authorization

Prior Authorization and Site-of-Care Requirements

Prior authorization is required for some or all procedure codes listed in this Corporate Drug Policy. Initial and renewal requests for the medication(s) listed in this policy are subject to site of care management. When billed under the medical benefit, administration of the medication will be restricted to a non-hospital facility-based location (e.g., home infusion provider, provider's office, free-standing ambulatory infusion center) unless the member meets the site of care exception criteria. To view the exception criteria and a list of medications subject to site of care management please click here.

Prior authorization required
Site of care management applies; non-hospital facility-based administration restricted unless exception met

Prior Authorization

Specialist Prescriber Expectations

For Entyvio, initial approval requires the drug be prescribed by or in consultation with a physician who specializes in the condition being treated (e.g., gastroenterologist for UC or Crohn's). Approvals for initial therapy are provided for the initial approval duration noted in the Criteria; reauthorization generally requires documented response to therapy.

Specialist prescriber expectation: prescribed by or in consultation with a specialist (gastroenterologist)
Initial approvals time-limited; continuation requires response to therapy unless noted

Step Therapy

Step Therapy Requirement

Step therapy: the patient must have tried at least one TNF blocker or one immunomodulator for the indicated disease (Ulcerative Colitis or Crohn's Disease) unless intolerant, had an inadequate response, or demonstrated corticosteroid dependence. Specific examples include Humira, Remicade, Cimzia, Simponi, or a relevant immunomodulator.

UC/CD: trial of ≥1 TNF blocker or ≥1 immunomodulator required unless exception applies
Examples of TNF blockers: Humira, Remicade, Cimzia, Simponi

Documentation Required

Supporting Documentation and Denial Risks

The Company reserves the right to request additional documentation as part of its coverage determination process. Documentation that may be requested includes patient medical records, test results, and credentials of the provider ordering or performing the service. Providers must make additional documentation supporting medical necessity available upon request. The Company may deny reimbursement when the drug or services are not medically necessary, are investigational/experimental, fall outside the member's benefit scope, or when inappropriate or excessive billing/practice patterns are identified. The Company also reserves the right to modify or interpret this policy at its sole discretion.

Documentation may include patient records, test results, and provider credentials
Company may deny reimbursement if services/drugs are not medically necessary, investigational, or outside benefit scope
Providers must furnish additional documentation upon request

Definitions and Key Terms

Entyvio mechanism — Integrin receptor antagonist

Drug classIntegrin receptor antagonist

Agent (generic)Vedolizumab

Agent (brand)Entyvio (subcutaneous)

Indications (excerpt)Treatment of moderate to severe ulcerative colitis and Crohn's disease in adults (per policy overview)

Induction-to-maintenance transition — IV induction at Week 0 and Week 2 then switch to SC at Week 6

IV induction scheduleEntyvio intravenous doses at Week 0 and Week 2

Switch to SCMay switch to subcutaneous injection at Week 6 following the two IV induction doses

Maintenance SC dosingAdminister 108 mg subcutaneously once every 2 weeks thereafter

ApplicabilityDosing and switch described for both Ulcerative Colitis and Crohn's Disease in the policy dosing sections

C9399	Unclassified drugs or biologicals
J3590	Unclassified biologics

C9399	C9399
J3590	J3590

OpenPayer

Entyvio (vedolizumab) subcutaneous — Medical Benefit Prior Authorization and Coverage Criteria

Coverage Criteria for Entyvio (vedolizumab) Subcutaneous

Billing and Coding

Provider Actions and Requirements

Background

Definitions and Key Terms