ModifiedmhnPolicy CP.PHAR.265

Clinical Policy: Vedolizumab (Entyvio)

Medical necessity and coverage criteria for vedolizumab (Entyvio) for adults with moderately to severely active ulcerative colitis or Crohn's disease under the specified Medicaid line of business.

Policy Summary

Payermhn

PolicyClinical Policy: Vedolizumab (Entyvio)

Policy CodePolicy CP.PHAR.265

Change TypeAdded SC formulationHCPCS codes revised/added

Effective DateJul 16, 2016

Next Review Date

Key ActionSubmit prior authorization with specialty prescriber documentation, age ≥18, disease severity measures, prior therapy history, and dosing matching the requested formulation.

SourceLink

POLICY UPDATE CHANGES

Added subcutaneous dosage forms (prefilled syringe and Entyvio Pen) and SC dosing options to the dosing regimen and product availability.

Revised HCPCS code J3380 description and added HCPCS codes C9399 and J3590 to the policy.

For Crohn disease initial and continued therapy sections, added subcutaneous formulation to dosing regimen and removed the phrase 'request is for IV formulation'.

18minimum age for coverage

12 moapproval duration

300 mg IV / 108 mg SCdosing regimens

Mayo ≥6 / Mod Mayo ≥5 / Endo ≥2UC disease thresholds

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300 mgIV vial strength

108 mgSC syringe/pen strength

Coverage Criteria for Vedolizumab (Entyvio)

Initial Therapy — Ulcerative Colitis

Covered when ALL of the following are met:

UC initial: 1. Diagnosis of ulcerative colitis; 2. Prescribed by or in consultation with a gastroenterologist; 3. Age ≥ 18 years; 4. Documentation of a Mayo Score ≥ 6, modified Mayo Score ≥ 5, or Mayo Endoscopic Score ≥ 2; 5. Failure of an 8-week trial of systemic corticosteroids unless contraindicated, intolerant, or member previously failed a biologic for UC; 6. Failure of one of the following, used ≥ 3 consecutive months, unless clinically significant adverse effects or contraindications: (a) one adalimumab product OR (b) one ustekinumab product; 7. No combination use with biological disease-modifying antirheumatic drugs (bDMARDs) or Janus kinase (JAK) inhibitors; 8. Dose does not exceed one of the following induction/maintenance regimens: (a) 300 mg IV at weeks 0, 2, and 6, then 300 mg IV every 8 weeks maintenance OR (b) 300 mg IV at weeks 0 and 2, then 108 mg SC at week 6, followed by 108 mg SC every 2 weeks maintenance. Approval duration: 12 months.

Initial Therapy — Crohn's Disease

Covered when ALL of the following are met:

CD initial: 1. Diagnosis of Crohn's disease; 2. Prescribed by or in consultation with a gastroenterologist; 3. Age ≥ 18 years; 4. Either: (a) failure of a ≥ 3 consecutive month trial of at least one immunomodulator (e.g., azathioprine, 6-MP, methotrexate) at maximally indicated doses unless adverse effects/contraindicated/previous biologic failure OR (b) medical justification supporting inability to use immunomodulators; 5. Either: (a) failure of one adalimumab product used ≥ 3 consecutive months OR (b) history of failure of two TNF blockers; 6. Failure of a ≥ 3 consecutive month trial of one ustekinumab product unless adverse effects or contraindicated; 7. No combination use with bDMARDs or JAK inhibitors; 8. Dose does not exceed one of the following induction/maintenance regimens: (a) 300 mg IV at weeks 0, 2, and 6, then 300 mg IV every 8 weeks maintenance OR (b) 300 mg IV at weeks 0 and 2, then 108 mg SC at week 6, followed by 108 mg SC every 2 weeks maintenance. Approval duration: 12 months.

Continuation Therapy

Covered when ALL of the following are met:

Continuation: 1. Member currently receiving medication via Centene benefit or has previously met initial approval criteria, or continuity of care applies; 2. Member is responding positively to therapy; 3. Member does not have combination use with bDMARDs or JAK inhibitors; 4. If request is for a dose increase, new dose does not exceed one of the following: (a) IV: 300 mg every 8 weeks; (b) SC: 108 mg every 2 weeks. Approval duration: 12 months.

Dosing and maximum dose

Dosing and maximum dose specifications

Initial dosing (CD, UC): Initial dose: 300 mg IV at weeks 0 and 2, followed by 300 mg IV or 108 mg SC at week 6

Maintenance dosing (CD, UC): Maintenance dose: 300 mg IV every 8 weeks or 108 mg SC every 2 weeks

Maximum dose: Maximum Dose = IV: 300 mg every 8 weeks; SC: 108 mg every 2 weeks

Non–FDA approved indications for vedolizumab are not addressed by this policy unless there is sufficient documentation to support off‑label use per the payer's off‑label use policy (CP.PMN.53) or other evidence of coverage documentation. Requests for combination use with other biological disease‑modifying antirheumatic drugs (bDMARDs) or potent immunosuppressants are not authorized due to the risk of additive immunosuppression, increased neutropenia, and greater risk of serious infections. Examples of agents that must not be used in combination with vedolizumab include, but are not limited to, tumor necrosis factor (TNF) antagonists, interleukin agents, Janus kinase inhibitors (JAKi), anti‑CD20 monoclonal antibodies, selective co‑stimulation modulators, other integrin receptor antagonists, tyrosine kinase 2 inhibitors, and sphingosine‑1‑phosphate receptor modulators.

Inclusion or exclusion of any billing or HCPCS codes in this policy is for informational purposes only and does not guarantee coverage. Providers must verify coding and reimbursement guidance from current professional coding resources before submitting claims. Incorrect or unsupported coding may result in denial of payment.

Product Formulations and Billing Codes

Referenced HCPCSHCPCS

J3380	Injection, vedolizumab, intravenous, 1 mg
C9399	Unclassified drugs or biologicals
J3590	Unclassified drugs or biologicals

Additional HCPCS addedHCPCS

C9399	Unclassified drugs or biologicals
J3590	Unclassified drugs or biologicals

Maximum IV dose — 300 mg every 8 weeks

Maximum IV dose300 mg every 8 weeks

Maximum SC dose — 108 mg every 2 weeks

Maximum SC dose108 mg every 2 weeks

Modified Mayo Score — threshold value used in policy

Modified Mayo Score≥ 5

Mayo Endoscopic Score — threshold value used in policy

Mayo Endoscopic Score≥ 2

Prior Authorization, Documentation, and Prescriber Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for vedolizumab (Entyvio) requests. The PA must be for the supplied formulation and match the HCPCS/administration indicated on the claim. Providers must submit documentation supporting that the member meets all approval criteria, including disease severity scores and prior therapy history.

HCPCS: J3380 — Injection, vedolizumab, intravenous, 1 mg
HCPCS/NDC/other: C9399, J3590 — Unclassified drugs or biologicals (use only when appropriate per payer guidance)
Ensure PA corresponds to the formulation requested (IV vs SC) and the HCPCS code billed

Documentation Required

Documentation of Disease Severity Required

Documentation must include objective disease severity measures referenced in the policy and supporting clinical information. Lack of adequate documentation may result in denial.

Background

Vedolizumab (Entyvio) is an integrin receptor antagonist indicated for adults with moderately to severely active ulcerative colitis or Crohn's disease. Coverage under this policy is limited to those indications and requires documentation of diagnosis, prior therapy trials or justifications where applicable, and dosing within the approved regimens. Providers should note coding guidance for vedolizumab (for example, HCPCS code J3380 for vedolizumab IV) when submitting authorization requests, but code listings in the policy are informational and do not by themselves establish coverage.

Definitions and Scoring

inv-24: Disease activity scoring for UC — Mayo Score, Modified Mayo Score, Mayo Endoscopic Score descriptions and thresholds

Mayo Score (overall)0 to 12; assesses stool frequency, rectal bleeding, endoscopy, physician global assessment. Policy threshold: Mayo Score ≥ 6

Modified Mayo Score0 to 9; three parameters (stool frequency, rectal bleeding, endoscopic); policy threshold: ≥ 5

Mayo Endoscopic Score0 to 3 based on endoscopic findings; policy threshold: > 2 (≥ 3 or >2 per policy language denotes moderate-to-severe)

Policy useAny one of these thresholds (Mayo ≥6, modified Mayo ≥5, or Mayo endoscopic >2) qualifies disease activity for UC initial approval

inv-25: Immunomodulator medical justification (CD) — justification criteria for immunomodulator failure or intolerance

Acceptable justifications for inability to use immunomodulators

Policy Revision History

2025-09-04policy_updateLatest

For ulcerative colitis, added Mayo Endoscopic Score > 2 as an option to define moderate-to-severe disease and allowed bypass of conventional therapies if a member has failed a biologic; initial approval durations extended to 12 months for chronic conditions.

2025-04-23policy_change

Added criteria requiring use of one preferred Stelara biosimilar and revised UC step therapy options to include stepping through a preferred adalimumab or ustekinumab product.

2025-01-23

Policy Summary

Payermhn

PolicyClinical Policy: Vedolizumab (Entyvio)

Policy CodePolicy CP.PHAR.265

Change TypeAdded SC formulationHCPCS codes revised/added

Effective DateJul 16, 2016

Next Review Date

Key ActionSubmit prior authorization with specialty prescriber documentation, age ≥18, disease severity measures, prior therapy history, and dosing matching the requested formulation.

SourceLink

On This Page

Ulcerative colitis: Modified Mayo Score ≥ 5, Mayo Score ≥ 6, or Mayo Endoscopic Score ≥ 2 (see Appendix F for scoring details)
Crohn's disease: clinical documentation of diagnosis and supporting records per criteria (see policy sections I.B and appendices)
Required supporting materials: office chart notes, endoscopy reports, laboratory results, medication trial documentation, and specialist consultation notes

Step Therapy

Step Therapy and Prior Biologic/JAK Requirements

Prior therapy and step therapy history must be documented. Approval depends on meeting the policy's required trials or documented reasons for bypass.

Ulcerative colitis initial criteria: failure of an 8-week trial of systemic corticosteroids (unless contraindicated or prior biologic failure) AND failure of either one adalimumab product (≥ 3 months) or one ustekinumab product (≥ 3 months), unless contraindicated or prior biologic failure is documented
Crohn's disease initial criteria: failure of ≥ 3 month trial of one immunomodulator (e.g., azathioprine, 6-MP, methotrexate) or documented contraindication, AND failure of one adalimumab product (≥ 3 months) or history of failure of two TNF blockers, AND failure of one ustekinumab product (≥ 3 months) unless contraindicated
Policy allows bypass of conventional therapies if member has failed a biologic agent (i.e., do not require stepping back to conventional therapy after biologic failure)
Do not authorize combination use with other bDMARDs or JAK inhibitors — document absence of concurrent bDMARD/JAKi therapy

Inability to induce short-term symptomatic remission with a 3-month trial of systemic glucocorticoids

High-risk disease features supporting immunomodulator avoidanceExtensive ileal/ileocolonic/proximal GI involvement, perianal/severe rectal disease, fistulizing disease, deep ulcerations, penetrating/stricturing phenotype, intestinal obstruction or abscess

Perioperative or recurrence risk factorsLess than 10 years from diagnosis to surgery, disease in ileum and colon, perianal fistula, prior surgical resection, corticosteroid use prior to surgery

inv-26: IV formulation — lyophilized 300 mg vial for reconstitution

IV formulation descriptionLyophilized powder in a single-dose vial for reconstitution for IV infusion: 300 mg

Induction/maintenance strength300 mg vial used for IV initiation and IV maintenance dosing (300 mg IV every 8 weeks)

Policy implicationHCPCS coding and prior authorization must match IV formulation and vial strength

inv-27: SC formulation — single-dose prefilled syringe or Entyvio Pen 108 mg/0.68 mL

SC formulation descriptionSingle-dose prefilled syringe or Entyvio Pen for subcutaneous injection: 108 mg/0.68 mL

Dosing use108 mg SC at week 6 option following IV initiation or 108 mg SC q2w maintenance per policy

Product availability noteEntyvio Pen and prefilled syringe forms were added to product availability and coding implications

coding_and_criteria_update

Added HCPCS codes C9399 and J3590, updated section III.B and Appendix F (modified Mayo Score documentation), removed redirection to preferred adalimumab products per 2024 AGA guidance, and revised redirection to Zeposia with bypass allowance.

2024-05-06clarification

For Crohn disease initial and continued therapy sections, removed the phrase 'request is for IV formulation' and allowed subcutaneous dosing forms in dosing regimen language.

2024-02-22coding_revision

Revised HCPCS code J3380 description.

2023-10-05product_availability_added

Added new subcutaneous dosage forms (prefilled syringe and Entyvio Pen) to product availability and SC dosing to sections V and VI.

2021-02-23clinical_revision

Annual review added combination bDMARDs under Section III and updated references; documented as part of 2Q 2021 updates.