Entyvio (vedolizumab) subcutaneous prior authorization
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Defines prior authorization and reauthorization criteria for subcutaneous vedolizumab (Entyvio) for adults with moderately to severely active ulcerative colitis or Crohn's disease for UnitedHealthcare members.
Added coverage criteria for Crohn's disease.
Updated combination therapy examples and language with no change to clinical intent.
Coverage Criteria for Entyvio (vedolizumab) subcutaneous
Initial Therapy - Ulcerative Colitis
Covered when ALL of the following are met for ulcerative colitis:
Authorization issued for 12 months
Authorization issued for 12 months
Reauthorization - Ulcerative Colitis
Covered when ALL of the following are met for ulcerative colitis reauthorization:
Authorization issued for 12 months
Authorization issued for 12 months
Initial Therapy - Crohn's Disease
Covered when ALL of the following are met for Crohn's disease:
Authorization issued for 12 months
Authorization issued for 12 months
Reauthorization - Crohn's Disease
Covered when ALL of the following are met for Crohn's disease reauthorization:
Authorization issued for 12 months
Authorization issued for 12 months
Concurrent use of Entyvio (vedolizumab) subcutaneous with a systemic targeted immunomodulator for the same indication is not allowed as part of the authorization criteria. Examples of systemic targeted immunomodulators listed in the policy include, but are not limited to, adalimumab, mirikizumab, upadacitinib, golimumab, risankizumab, guselkumab, tofacitinib, ustekinumab, and ozanimod for ulcerative colitis and similar agents such as adalimumab, certolizumab, mirikizumab, upadacitinib, risankizumab, guselkumab, and ustekinumab for Crohn's disease. Requests may be denied if Entyvio is used in combination with one of these systemic targeted immunomodulators for the same diagnosis.
Initial Authorization
Initial authorization will be approved when ALL of the following are met:
Authorization issued for 12 months
Authorization issued for 12 months
Reauthorization
Reauthorization will be approved when ALL of the following are met:
Authorization issued for 12 months
Authorization issued for 12 months
Provider Actions and Documentation Requirements
Prior authorization required for subcutaneous Entyvio
Prior authorization is required for Entyvio (vedolizumab) subcutaneous for adults with moderately to severely active ulcerative colitis or Crohn's disease; approvals are issued for 12 months.
Supply limits and potential automated approvals
Supply limits may apply and UnitedHealthcare may use automated approval or re-approval processes that consider prior claim/medication history and diagnosis codes.
- Supply limits may be in place.
- Automated approval/re-approval may be based on previous claim/medication history, ICD-10 diagnosis codes, and claim logic.
Document positive clinical response for reauthorization
For reauthorization, the provider must document a positive clinical response to Entyvio therapy; reauthorization also requires the patient not be receiving Entyvio in combination with a systemic targeted immunomodulator for the same indication.
- Documentation of positive clinical response is required for reauthorization.
- Authorization for reauthorization is issued for 12 months when criteria are met.
Combination therapy exclusion — avoid concurrent targeted immunomodulators
Requests may be denied if the patient is receiving Entyvio concurrently with a systemic targeted immunomodulator for the same indication; examples of disallowed concurrent agents are listed in the policy.
- Concurrent use with systemic targeted immunomodulators (examples include adalimumab, mirikizumab, upadacitinib, golimumab, risankizumab, guselkumab, tofacitinib, ustekinumab, ozanimod, certolizumab depending on indication) is not allowed.
- Both initial authorization and reauthorization criteria require absence of such combination therapy.
Background and Drug Information
Vedolizumab (Entyvio) for subcutaneous use is an integrin receptor antagonist indicated in adults for moderately to severely active ulcerative colitis or Crohn's disease. The policy establishes prior authorization requirements for initial and continued use, including diagnosis confirmation and exclusion of concurrent systemic targeted immunomodulator therapy; when criteria are met, authorizations are issued for 12 months.
Definitions
Quantity Limits and Supply
Site of Care Considerations
Infusion center: automated approvals and claim history review
Programs may use automated approval and re-approval processes for site-of-care claims (infusion center) and may consider previous claim/medication history and diagnosis codes when making decisions.
- "Use of automated approval and re-approval processes varies by program and/or therapeutic class."
- UnitedHealthcare "may approve initial and reauthorization based solely on previous claim/medication history, diagnosis codes (ICD-10) and/or claim logic."
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