CurrentUnitedHealthcarePolicy N/A

Entyvio (vedolizumab) subcutaneous prior authorization

Prior authorization and medical necessity criteria for subcutaneous vedolizumab (Entyvio) for treatment of moderately to severely active ulcerative colitis and Crohn's disease for UnitedHealthcare members.

Policy Summary

PayerUnitedHealthcare

PolicyEntyvio (vedolizumab) subcutaneous prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJan 17, 2026

Next Review DateN/A

Key ActionSubmit prior authorization demonstrating diagnosis and either existing UnitedHealthcare authorization or documented current use (claims or medical records) and avoid combination use with other systemic targeted immunomodulators.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

UC & CDindications covered

12 moauthorization length

subcutaneousformulation governed

P&T: 4/2024–10/2025policy review dates

Coverage Criteria for Entyvio (vedolizumab) Subcutaneous

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Initial Authorization — Ulcerative Colitis

Covered when ALL of the following are met

UC Initial Authorization: 1) Diagnosis of moderately to severely active ulcerative colitis (UC).

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Established use: 2) Either: (a) patient has been established on therapy with Entyvio (vedolizumab) subcutaneous under an active UnitedHealthcare medical benefit prior authorization for the treatment of moderately to severely active UC; OR (b) patient is currently on Entyvio subcutaneous therapy as documented by claims history or medical records (document date and duration of therapy) and was not established solely via manufacturer‑supplied samples or manufacturer assistance programs.

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Concomitant therapy exclusion: 3) Patient is not receiving Entyvio subcutaneous in combination with another systemic targeted immunomodulator for treatment of the same indication (examples listed in policy).

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Prescriber specialty: 4) Prescribed by or in consultation with a gastroenterologist.

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Reauthorization — Ulcerative Colitis

Covered when ALL of the following are met

Clinical response: 1) Documentation of positive clinical response to Entyvio (vedolizumab) subcutaneous therapy.

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Concomitant therapy exclusion: 2) Patient is not receiving Entyvio subcutaneous in combination with another systemic targeted immunomodulator for treatment of the same indication (examples listed in policy).

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Initial Authorization — Crohn's Disease

Covered when ALL of the following are met

CD Initial Authorization: 1) Diagnosis of moderately to severely active Crohn's disease (CD).

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Established use: 2) Either: (a) patient has been established on therapy with Entyvio (vedolizumab) subcutaneous under an active UnitedHealthcare medical benefit prior authorization for the treatment of moderately to severely active CD; OR (b) patient is currently on Entyvio subcutaneous therapy as documented by claims history or medical records (document date and duration of therapy) and was not established solely via manufacturer‑supplied samples or manufacturer assistance programs.

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Reauthorization — Crohn's Disease

Covered when ALL of the following are met

Clinical response: 1) Documentation of positive clinical response to Entyvio (vedolizumab) subcutaneous therapy.

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Requests where the patient is receiving Entyvio (vedolizumab) subcutaneous in combination with another systemic targeted immunomodulator for treatment of the same indication will not meet approval criteria. Examples of excluded concomitant targeted immunomodulators include, but are not limited to: adalimumab, mirikizumab, upadacitinib, golimumab, risankizumab, guselkumab, tofacitinib, ustekinumab, ozanimod, certolizumab.

Initial Therapy Requirements

Initial therapy

Initial authorization requires diagnosis and either prior UnitedHealthcare medical benefit authorization for the same indication or documented current use (with caveat about manufacturer samples/assistance).

Initial therapy: 1) Diagnosis of moderately to severely active ulcerative colitis (UC) or Crohn's disease (CD).

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Evidence of prior authorization or current use: 2) Either: (a) patient has been established on Entyvio subcutaneous under an active UnitedHealthcare medical benefit prior authorization for the same indication; OR (b) patient is currently on Entyvio subcutaneous therapy as documented by claims history or medical records (document date and duration of therapy).

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Manufacturer sample caveat: 3) Patients whose apparent 'established use' is based on receipt of manufacturer‑supplied samples or manufacturer assistance must meet initial authorization criteria as if new to therapy (i.e., cannot rely on samples to satisfy established‑use pathway).

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Concomitant therapy exclusion: 4) Patient is not receiving Entyvio subcutaneous in combination with another systemic targeted immunomodulator for treatment of the same indication.

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Prescriber specialty: 5) Prescribed by or in consultation with a gastroenterologist.

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Continuation / Reauthorization Requirements

Continuation therapy / Reauthorization

Reauthorization (continuation) requires demonstration of benefit and excludes combination targeted immunomodulator therapy.

Reauthorization: 1) Documentation of positive clinical response to Entyvio (vedolizumab) subcutaneous therapy.

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Concomitant therapy exclusion: 2) Patient is not receiving Entyvio subcutaneous in combination with another systemic targeted immunomodulator for treatment of the same indication.

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Authorization length: 3) Authorization will be issued for 12 months when reauthorization criteria are met.12 months

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Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required for Entyvio (vedolizumab) subcutaneous for moderately to severely active ulcerative colitis or Crohn's disease. Requests must meet the medical necessity criteria and be submitted prior to treatment initiation or continuation under the pharmacy benefit when applicable.

Applies to Entyvio subcutaneous for moderately to severely active ulcerative colitis and Crohn's disease
Authorization based on documented diagnosis and meeting all initial/continuation criteria

Documentation Required

Evidence of Prior Therapy Required

If claiming the patient is an established user of Entyvio subcutaneous, submit objective evidence such as pharmacy or medical claims history or medical records documenting the date(s) and duration of prior Entyvio subcutaneous therapy. Evidence may include prior UnitedHealthcare medical benefit authorization records indicating active therapy.

Acceptable documentation: pharmacy claims, medical claims, office treatment records, or prior UnitedHealthcare authorization showing active Entyvio subcutaneous use
Documentation must include dates and duration of therapy

Denial Risk

Combination Therapy Exclusion

Combination therapy exclusion: Requests where the patient is receiving Entyvio subcutaneous in combination with another systemic targeted immunomodulator for the same indication will not meet criteria. Examples of excluded concomitant targeted agents include adalimumab, certolizumab (Cimzia), mirikizumab (Omvoh), upadacitinib (Rinvoq), risankizumab (Skyrizi), guselkumab (Tremfya), and ustekinumab.

Entyvio subcutaneous must not be used concurrently with another systemic targeted immunomodulator for the same disease indication
Provide medication list if there is concern for concurrent targeted therapy

Step	Requirement / Notes
1	No explicit step therapy (failure of prior agents) is specified in this policy; UnitedHealthcare may use automated approval or re‑approval based on prior claims/medication history, diagnosis codes, and/or claim logic per program.
	Supply limits may be applied per program.

OpenPayer

Entyvio (vedolizumab) subcutaneous prior authorization

Coverage Criteria for Entyvio (vedolizumab) Subcutaneous

Initial Therapy Requirements

Continuation / Reauthorization Requirements

Provider Actions and Documentation Requirements

Step Therapy and Program Automation

Site-of-Care and Supply Considerations

Definitions

Background