Entyvio Subcutaneous

Coverage Summary

Cigna prior authorization policy for Entyvio (vedolizumab) subcutaneous covers adults with moderately to severely active Crohn's disease and ulcerative colitis and specifies medical necessity criteria for initial therapy and established therapy, approval durations, exclusions, and coding guidance. Initial approvals generally require documentation of age ≥ 18, that the patient is receiving or will receive Entyvio IV induction within 2 months of starting SC, specialist prescribing (gastroenterologist), and disease‑specific prior therapy or clinical features; initial approvals are granted for 6 months. Established therapy requires ≥ 6 months on Entyvio IV or SC with objective or symptomatic improvement and is approved for 1 year. Concomitant use with another biologic or targeted synthetic oral small molecule for inflammatory conditions is excluded. HCPCS examples for billing include C9399 and J3590.

Key Policy Facts

FDA-Approved IndicationsCrohn's disease (adults), Ulcerative colitis (adults)

Standard induction regimenEntyvio IV 300 mg at weeks 0, 2, and 6; may switch to SC after week 6 or at any scheduled IV infusion in responders

Maintenance SC dose108 mg subcutaneously every 2 weeks

Initial approval duration6 months

Established therapy approval duration1 year

Minimum age for approval18 years and older

Policy effective date / last reviewEffective date: 09/01/2025; Last review: 05/15/2025

Initial Therapy Criteria Crohn's Disease

Continuation (Established) Therapy Criteria — Crohn's Disease

Crohn's Disease — B) Established Therapy

B) Patient is currently receiving Entyvio IV or SC (Established Therapy) (approve for 1 year)

Patient has been established on Entyvio subcutaneous or intravenous for at least 6 months
Must meet ONE of
- When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (examples: fecal markers, serum markers (CRP), imaging (MRE, CTE), endoscopic assessment, and/or reduced corticosteroid dose)
- Compared with baseline, patient experienced an improvement in at least one symptom (e.g., decreased pain, fatigue, stool frequency, and/or blood in stool)

Initial Therapy Criteria — Ulcerative Colitis

Ulcerative Colitis — A) Initial Therapy

A) Initial Therapy (approve for 6 months)

Patient is ≥ 18 years of age
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
The medication is prescribed by or in consultation with a gastroenterologist

Continuation (Established) Therapy Criteria — Ulcerative Colitis

Ulcerative Colitis — B) Established Therapy

B) Patient is currently receiving Entyvio IV or SC (Established Therapy) (approve for 1 year)

Patient has been established on Entyvio subcutaneous or intravenous for at least 6 months
Must meet ONE of
- When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (examples: fecal calprotectin, CRP, endoscopic assessment, and/or reduced corticosteroid dose)
- Compared with baseline, patient experienced an improvement in at least one symptom (e.g., decreased pain, fatigue, stool frequency, and/or decreased rectal bleeding)

Prescriber, Prior Authorization & Approval Durations

Initial prescriber requirement / approvals

Prior Authorization is required for Entyvio subcutaneous
Initial approval requires Entyvio subcutaneous to be prescribed by or in consultation with a physician who specializes in the condition being treated (gastroenterologist for CD/UC)
Approvals are provided for specified durations: initial approvals = 6 months; established therapy approvals = 1 year
Receipt of sample product does not satisfy criteria requirements for coverage

Documentation Requirements & Denial Risks

Documentation Required

Prior therapy and clinical response documentation

For initial Crohn's disease therapy, document prior trials or qualifying clinical features per criteria: trial of systemic corticosteroids (or contraindication), or trial of one conventional systemic therapy (examples: azathioprine, 6‑mercaptopurine, methotrexate; mesalamine does not count) — with an exception if the patient has already tried at least one biologic other than the requested drug — or presence of enterocutaneous (perianal or abdominal) or rectovaginal fistulas, or history of ileocolonic resection. For established therapy, document the patient has been on Entyvio SC or IV for at least 6 months and has experienced a beneficial clinical response from baseline by at least one objective measure (e.g., fecal markers, CRP, imaging, endoscopy, or reduced steroid dose) or improvement in at least one symptom.

Denial Risk

Combination biologic/targeted therapy excluded

Concurrent use of Entyvio subcutaneous with another biologic or with a targeted synthetic oral small molecule drug for an inflammatory condition is considered not medically necessary and may be denied.

Applicable Codes

HCPCS codes for Entyvio subcutaneous billing when medically necessaryHCPCSCovered

C9399	Unclassified drugs or biologicals
J3590	Unclassified biologics

Unproven / Exclusions

Conditions Not Covered

Conditions Not Covered (Not Medically Necessary)

Concurrent use with another biologic or with a targeted synthetic oral small molecule drug used for an inflammatory condition
Does not exclude combination with conventional synthetic DMARDs (e.g., methotrexate, leflunomide, hydroxychloroquine, sulfasalazine)

Background

Entyvio (vedolizumab) subcutaneous is indicated for adults with moderately to severely active Crohn's disease or ulcerative colitis. Standard induction is with 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 subcutaneously every 2 weeks.

Conventional systemic therapy (for Crohn's disease): Examples include azathioprine, 6‑mercaptopurine, or methotrexate; note that mesalamine does not count.

Established on Entyvio: Patient has been on Entyvio subcutaneous or intravenous for at least 6 months.

Clinical Evidence & Guidelines

Evidence sources cited in the policy include the Entyvio prescribing information (Entyvio PI, May 2024) and clinical practice guideline documents (ACG 2025; AGA 2021 and AGA living guideline 2024).

Revision History

11/01/2024added

New policy created with initial effective date 11/01/2024

05/15/2025revised

Annual revision dated 05/15/2025 declared 'No criteria changes.'

09/01/2025revisedLatest

Selected revision dated 09/01/2025: For Ulcerative Colitis initial therapy, removed options of approval that required a prior trial of one systemic therapy or pouchitis with prior antibiotic/probiotic/corticosteroid enema or mesalamine enema.