CurrentCignaPolicy IP0674

Entyvio Intravenous Prior Authorization Policy

Defines formulary relationships and contextual appendix listing biologic agents and their indications relevant to Crohn's disease and ulcerative colitis; intended for Cigna medical and pharmacy reviewers and prescribing clinicians assessing coverage for Entyvio IV/SC.

Policy Summary

PayerCigna

PolicyEntyvio Intravenous Prior Authorization Policy

Policy CodePolicy IP0674

Change TypeNo material changes

Effective DateSep 1, 2025

Next Review Date

Key ActionObtain prior authorization for Entyvio when prescribing intravenous or subcutaneous formulations for Crohn's disease or ulcerative colitis.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

multipleagents referenced in appendix

IV & SCformulations noted

CD, UCdiseases listed

not all-inclusivecompleteness

Provider Actions & Coverage Highlights

Prior Authorization

Prior Authorization Required

Prior authorization is required for Entyvio (vedolizumab) in both IV and SC formulations when used for Crohn's disease or ulcerative colitis. Providers should submit requests that specify formulation (IV infusion or SC injection), diagnosis, and supporting clinical documentation per standard prior authorization procedures.

Applies to: Entyvio (vedolizumab) — IV infusion and SC injection
Indications noted in appendix: Crohn's disease (CD), Ulcerative colitis (UC)
Action: Include formulation, diagnosis, and supporting clinical documentation with PA request

Step Therapy

Appendix: Alternative Therapies (Informational)

The appendix lists many alternative biologic and oral targeted therapies by class (e.g., anti‑IL, anti‑IL‑23, anti‑IL‑17, JAK inhibitors, S1P modulators, PDE4 inhibitors). This appendix is informational and may be used to inform step‑therapy sequencing or therapeutic alternatives; prescribers should consider these alternatives in the context of plan-specific step‑therapy requirements.

Policy Summary

PayerCigna

PolicyEntyvio Intravenous Prior Authorization Policy

Policy CodePolicy IP0674

Change TypeNo material changes

Effective DateSep 1, 2025

Next Review Date

Key ActionObtain prior authorization for Entyvio when prescribing intravenous or subcutaneous formulations for Crohn's disease or ulcerative colitis.

SourceLink

On This Page

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Appendix includes alternative agents and formulations by drug class (biologics and targeted oral therapies)
Use: Informational — may guide step‑therapy sequencing and therapeutic alternatives for prescribers
Providers must follow any applicable step‑therapy rules in the clinical policy when choosing alternatives

Documentation Required

Prescribing Information: Consult PI

The appendix is not an all‑inclusive list of FDA‑approved indications. Providers should refer to the official prescribing information (PI) for each agent to confirm full FDA‑approved indications and dosing, and to determine any off‑label uses supported by guidelines.

Statement: Not an all‑inclusive list — consult each product's prescribing information for full FDA‑approved indications and dosing
Note: Some listed uses (e.g., Kineret in JIA) may be guideline‑supported off‑label uses — verify via PI and guidelines

Denial Risk

Denial Risk / Review Notes

No explicit denial triggers are stated within this appendix portion. Clinical denials (medical necessity or coverage denials) will follow standard prior authorization rules and the governing clinical policy; reviewers should apply usual documentation and coverage criteria when assessing requests.

There are no appendix‑specific denial conditions listed
Denial decisions will follow standard PA rules and the applicable clinical policy
Reviewers: apply normal documentation, medical necessity criteria, and step‑therapy/coverage rules when evaluating requests

Background and Appendix Scope

This appendix lists multiple biologic agents and targeted oral small molecules grouped by mechanism of action and common labeled indications relevant to inflammatory conditions, including examples for Crohn’s disease and ulcerative colitis. The table includes agents across classes (for example, TNF inhibitors, IL‑23/IL‑12 inhibitors, IL‑17 inhibitors, integrin receptor antagonists, sphingosine‑1‑phosphate receptor modulators, and JAK/TYK2 pathway inhibitors) and notes common formulation routes such as IV (intravenous) and SC (subcutaneous).

Entyvio (vedolizumab) is shown in the appendix as an integrin receptor antagonist and is listed with both IV infusion and SC injection formulations and the indications Crohn’s disease (CD) and ulcerative colitis (UC). The appendix entry is informational and does not restate the policy’s prior authorization criteria or dosing requirements; providers should continue to follow the main policy and prescribing information for specific coverage rules, dosing, and clinical criteria.

Abbreviations

IVIntravenous

SCSubcutaneous

TNFTumor necrosis factor

CDCrohn's disease

UCUlcerative colitis

ASAnkylosing spondylitis

Most actionableRefer to the prescribing information for FDA‑approved indications (appendix is not an all‑inclusive list)