CurrentCignaPolicy CNF817

Inflammatory Conditions - Entyvio Subcutaneous Prior Authorization Policy - (CNF817)

Cigna prior authorization policy for coverage of Entyvio (vedolizumab subcutaneous injection) for FDA‑approved indications (Crohn's disease and ulcerative colitis) including initial and continuation criteria, excluded uses (concomitant biologic/targeted synthetic small molecule therapy), and appendix of biologic and oral agents. Applies to prescription benefit plans administered by Cigna companies.

Policy Summary

PayerCigna

PolicyInflammatory Conditions - Entyvio Subcutaneous Prior Authorization Policy - (CNF817)

Policy CodePolicy CNF817

Change TypeMaterial revisions (indication added, criteria simplified, exclusions updated)

Effective Date

Next Review Date

Key ActionPrior authorization is required for Entyvio subcutaneous; submit documentation of prescriber specialty and for continuation approvals provide at least one objective measure or symptom improvement versus baseline.

SourceLink

POLICY UPDATE CHANGES

Crohn's disease newly approved indication added to the policy.

Ulcerative colitis initial therapy requirement: added patient must be ≥ 18 years of age.

Conditions Not Covered: concurrent use with a biologic or targeted synthetic oral small molecule drug changed wording and examples.

Initial therapy criteria for Crohn's disease and ulcerative colitis were simplified (removed prior requirements for trials of systemic therapies and other specific history).

Approval durations standardized: initial approvals for 6 months, continuation approvals for 1 year.

2Covered Indications (FDA)

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Major exclusion: concurrent biologic/targeted synthetic

6 mo / 1 yrApproval durations (initial/continuation)

≥18Minimum age for initial therapy

Coverage Summary

Cigna prior authorization policy for Entyvio (vedolizumab) subcutaneous for inflammatory bowel disease (Crohn's disease and ulcerative colitis) in adults. Covered with criteria that specify initial therapy requirements (including age and IV induction timing), continuation requirements for established therapy, prescriber specialty consultation, excluded concurrent biologic/targeted synthetic use, and defined approval durations.

Policy thresholds / quick facts

Minimum age for initial therapy≥ 18 years

Established therapy duration for continuation≥ 6 months on Entyvio (SC or IV)

Initial approval duration6 months (initial therapy)

Continuation approval duration1 year (established therapy)

Prescriber consultation / IV induction windowIV induction must occur within 2 months before or after initiating SC (per prescriber) and prescribed by or in consultation with a gastroenterologist

Initial Therapy Criteria (FDA‑Approved Indications)

Initial Therapy Criteria — Ulcerative Colitis

Continuation Therapy Criteria

Conditions Not Covered (Exclusions)

Prescriber & Documentation Requirements

Prescriber Requirement

Prescriber Requirement: Initial approval requires Entyvio subcutaneous to be prescribed by or in consultation with a physician who specializes in the condition being treated (gastroenterologist)

Prior Authorization

Prior authorization required

Prior authorization is required for Entyvio (vedolizumab) subcutaneous under the prescription benefit. Approvals are provided for the durations specified: 6 months for initial therapy and 1 year for continuation (1 month = 30 days).

Documentation Required

Document objective response for continuation

Applicable Codes

No procedure/drug billing codes listed in policy bodymixed

No codes listed

Clinical Evidence & References

Evidence includes the product Prescribing Information: Entyvio prescribing information, Takeda; February 2026, and clinical practice guideline citations: the ACG and AGA clinical practice guidelines for Crohn's disease and ulcerative colitis (2024–2025).

Background

Entyvio SC (vedolizumab) is an integrin receptor antagonist indicated for adults with moderately to severely active Crohn's disease and ulcerative colitis. Standard induction is intravenous vedolizumab 300 mg at Weeks 0, 2, and 6, with the option to switch to subcutaneous dosing at Week 6 or at any scheduled IV infusion in patients with clinical response or remission. The recommended maintenance dose for Entyvio SC is 108 mg every 2 weeks.

Drug quick facts

Drug nameEntyvio (vedolizumab)

FormulationSubcutaneous injection (SC); IV induction formulation available

Standard IV induction schedule300 mg IV at Weeks 0, 2, and 6

Option to switch to SCMay switch to SC at Week 6 or at any scheduled IV infusion in responders

SC maintenance dose & frequency108 mg SC once every 2 weeks

Definitions

Objective measure: Laboratory or imaging/endoscopic assessments such as fecal lactoferrin, fecal calprotectin, C-reactive protein, MRE, CTE, or endoscopy; or reduced dose of corticosteroids. (Used to document beneficial clinical response from baseline for continuation approval.)

Revision History

04/24/2024added

Early Annual Revision: Crohn's disease newly approved indication added to the policy.

04/24/2024revised

Early Annual Revision: Ulcerative colitis initial therapy requirement: added patient must be ≥ 18 years of age.

09/11/2024revised

Selected Revision: Conditions Not Covered wording changed for concurrent use with a biologic or targeted synthetic oral small molecule drug (updated examples and terminology).

Policy Summary

PayerCigna

PolicyInflammatory Conditions - Entyvio Subcutaneous Prior Authorization Policy - (CNF817)

Policy CodePolicy CNF817

Change TypeMaterial revisions (indication added, criteria simplified, exclusions updated)

Effective Date

Next Review Date

SourceLink

On This Page

For continuation requests, document objective evidence of a beneficial clinical response from baseline OR documented symptomatic improvement versus baseline.

Fecal markers (e.g., fecal lactoferrin, fecal calprotectin)
Serum markers (e.g., C-reactive protein)
Imaging studies (MRE, CTE)
Endoscopic assessment
Reduced dose of corticosteroids
Symptomatic improvement (e.g., decreased pain, fatigue, stool frequency, rectal bleeding/blood in stool)

Documentation Required

Prescriber specialty documentation

Initial approval requires the medication to be prescribed by or in consultation with a physician who specializes in the condition being treated (gastroenterologist). Ensure the record documents that a gastroenterologist prescribed the drug or was consulted.

Denial Risk

Concurrent biologic/targeted synthetic therapy exclusion

Entyvio subcutaneous is considered not medically necessary and claims may be denied if it is administered concurrently with another biologic or with a targeted synthetic oral small molecule drug for an inflammatory condition.

07/23/2025revised

Selected Revision: Initial therapy criteria for ulcerative colitis simplified by removing prior requirement options (e.g., trials of systemic therapy, pouchitis-specific options).

02/11/2026revisedLatest

Selected Revision: Initial therapy criteria for Crohn's disease simplified by removing prior requirement options (e.g., systemic corticosteroid or conventional systemic therapy trials, fistula/operative history); appendix updated (e.g., addition of Otezla XR).

clarifiedLatest

Approval durations standardized: initial approvals for 6 months and continuation approvals for 1 year; policy specifies 1 month = 30 days.