CurrentCignaPolicy IP0675

Entyvio Subcutaneous Prior Authorization Policy

Defines prior authorization requirements and medical necessity criteria for coverage of Entyvio subcutaneous for adult Crohn's disease and ulcerative colitis under Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyEntyvio Subcutaneous Prior Authorization Policy

Policy CodePolicy IP0675

Change TypeNew policymaterial revisions to initial therapy criteria

Effective DateMar 15, 2026

Next Review Date

Key ActionObtain prior authorization; initial approvals limited to 6 months and continuation approvals up to 1 year when established.

SourceLink

POLICY UPDATE CHANGES

New policy created covering Entyvio subcutaneous with defined criteria and requirements.

Ulcerative colitis initial therapy criteria were modified to remove prior requirements such as trying one systemic therapy and certain pouchitis options.

Crohn's disease initial therapy criteria were modified to remove prior requirements including prior systemic corticosteroid use, a trial of one conventional systemic therapy, presence of certain fistulas, and post-ileocolonic resection conditions.

2FDA‑approved indications covered (CD, UC)

6 moInitial approval duration

1 yrContinuation approval duration

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Minimum age for initial therapy

ProhibitedConcurrent biologic use

Coverage and Medical Necessity Criteria

FDA-Approved Indications

Entyvio subcutaneous is considered medically necessary when ONE of the following is met (1 or 2):

Indication group: 1. Crohn's Disease OR 2. Ulcerative Colitis (each with its own subcriteria)

Ulcerative Colitis - Initial Therapy (A)

i: Patient is ≥ 18 years of age.
ii: According to the prescriber, the patient is currently receiving Entyvio intravenous or will receive induction dosing with Entyvio intravenous within 2 months of initiating Entyvio subcutaneous.
iii: Medication is prescribed by or in consultation with a gastroenterologist.

Ulcerative Colitis - Continuing Therapy (B)

i: Patient has been established on Entyvio subcutaneous or intravenous for at least 6 months.≥ 6 months
A patient who has received < 6 months of therapy or who is restarting therapy is reviewed under Initial Therapy.
ii
- a: When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (prior to initiating the requested drug).
- b: Compared with baseline, patient experienced improvement in at least one symptom (e.g., decreased pain, fatigue, stool frequency, and/or decreased rectal bleeding).

Concurrent administration of Entyvio (vedolizumab) subcutaneous with another biologic or with a targeted synthetic oral small molecule drug for an inflammatory condition is considered not medically necessary and is excluded from coverage. The policy states combination therapy is generally not recommended due to a potentially higher rate of adverse events and lack of controlled clinical data supporting additive efficacy. This exclusion does not apply to combination with conventional synthetic DMARDs (for example, methotrexate, leflunomide, hydroxychloroquine, or sulfasalazine).

Use of Entyvio subcutaneous for any indication other than the FDA‑approved uses — Crohn's disease or ulcerative colitis — is considered not medically necessary. The policy lists off‑label and other non‑FDA indications under Conditions Not Covered and specifies coverage is limited to the approved indications.

Billing Codes, Dosing, and Related Key Facts

Considered medically necessary HCPCS codes when criteria metHCPCSCovered

C9399	Unclassified drugs or biologicals
J3590	Unclassified biologics

Established therapy duration

Established therapy durationPatient established on Entyvio (subcutaneous or intravenous) for at least 6 months is eligible for continuation approval (approve for 1 year).

Initial vs. continuation reviewPatients with <6 months of therapy or restarting therapy are reviewed under Initial Therapy criteria (not continuation).

Objective evidence for continuationContinuation approvals require documentation of benefit from baseline by objective measure OR symptom improvement (see objective measures list).

Age threshold

Minimum age for initial therapyPatient must be ≥ 18 years of age for Initial Therapy approval (Crohn's disease or ulcerative colitis).

Applies to both indications

Provider Requirements, Documentation, and Billing Risks

Prior Authorization

Prior Authorization Required

Prior Authorization is required. Initial approvals are time-limited: initial therapy approvals are for 6 months; continuation/maintenance approvals are provided for policy-defined durations (for example, 1 year for patients established on therapy).

Initial approval duration: 6 months (see Initial Therapy criteria)
Continuation approval duration: up to 1 year for patients established on Entyvio SC/IV

Step Therapy

Preferred Product Requirement

This product may require the use of preferred products prior to approval. Refer to the applicable Inflammatory Conditions Preferred Specialty Management policy for formulary and step requirements if Entyvio SC is covered under the Prescription Drug Benefit.

See PSM001, PSM002, or PSM017 for plan-specific preferred product requirements and exceptions

Background and Drug Information

Entyvio (vedolizumab) is an integrin receptor antagonist indicated for adults with moderately to severely active Crohn's disease and ulcerative colitis. Standard IV induction is 300 mg IV at Weeks 0, 2, and 6 with the option to transition to subcutaneous maintenance; the subcutaneous maintenance dose is 108 mg SC once every 2 weeks. Prior authorization is required for the subcutaneous formulation.

Dosing and Induction Definitions

Maintenance dosing

Maintenance doseEntyvio (vedolizumab) subcutaneous maintenance dose: 108 mg subcutaneously once every 2 weeks.

Route and frequencyAdministered subcutaneously every 2 weeks for maintenance therapy.

Switching from IVPatients may switch to the SC formulation for maintenance (per induction/switch guidance).

IV induction regimen

IV induction regimenEntyvio IV induction: 300 mg IV at Weeks 0, 2, and 6, then every 8 weeks thereafter.

Option to switch to SCPatients with clinical response or remission may switch to Entyvio SC at Week 6 or at any scheduled IV infusion thereafter.

Policy Revision Notes

2024-11-01policy_created

New policy IP0675 created for Entyvio (vedolizumab) subcutaneous with defined medical necessity criteria and prior authorization requirements.

2025-05-15criteria_revised

Crohn's disease initial therapy criteria were modified to remove prior requirements including prior systemic corticosteroid use, trial of one conventional systemic therapy, presence of certain fistulas, and post-ileocolonic resection conditions.

2025-05-15criteria_revised

Policy Summary

PayerCigna

PolicyEntyvio Subcutaneous Prior Authorization Policy

Policy CodePolicy IP0675

Change TypeNew policymaterial revisions to initial therapy criteria

Effective DateMar 15, 2026

Next Review Date

Key ActionObtain prior authorization; initial approvals limited to 6 months and continuation approvals up to 1 year when established.

SourceLink

On This Page

Age threshold applies to both Crohn's disease and ulcerative colitis initial therapy criteria.

Documentation expectationPrescriber attestation should confirm patient age as part of the initial authorization request.

Documentation Required

Required Clinical Documentation

Prescriber must document clinical information to support the request. For initial therapy this includes prescriber attestation that the patient is currently receiving Entyvio IV or will receive IV induction within 2 months of initiating SC, and that the patient meets age and specialist-prescription requirements. For continuation, documentation must show established use (≥6 months) and benefit from therapy by objective measures or symptom improvement.

Initial therapy: attestation of current Entyvio IV use or planned IV induction within 2 months
Continuation: documentation of ≥6 months established use and evidence of clinical benefit (objective measures or symptom improvement)

Documentation Required

Specialist Involvement Required

Because of the specialized skills required for evaluation and monitoring, Entyvio subcutaneous must be prescribed by or in consultation with a specialist (gastroenterologist) for initial approval.

Medication must be prescribed by or in consultation with a gastroenterologist for initial therapy requests

Billing Rule

Coding and Documentation Compliance

Claims must include covered diagnosis/procedure codes and meet all policy criteria. Claims submitted without covered codes or without required documentation will be denied as not covered.

Covered billing codes: HCPCS C9399 (Unclassified drugs or biologicals) and J3590 (Unclassified biologics) — confirm code applicability at time of service
Claims lacking covered diagnosis/procedure codes or not meeting policy criteria will be denied

Denial Risk

Combination Therapy Exclusion

Concurrent administration of Entyvio subcutaneous with another biologic or a targeted synthetic oral small molecule for inflammatory conditions is not covered.

Combination therapy with another biologic or targeted synthetic oral small molecule is excluded (does not exclude conventional synthetic DMARDs such as methotrexate)

Use in standard induction

Standard induction begins with IV vedolizumab per the 0, 2, 6 week schedule before maintenance.

Ulcerative colitis initial therapy criteria were modified to remove prior requirements such as trying one systemic therapy and certain pouchitis treatment options.