ModifiedHealth NetPolicy CP PHAR.265

Clinical Policy: Vedolizumab (Entyvio)

Defines medical necessity, dosing, and coverage criteria for vedolizumab (Entyvio) for adults with moderately to severely active ulcerative colitis or Crohn's disease under Centene-affiliated Health Net Medicaid.

Policy Summary

PayerHealth Net

PolicyVedolizumab (Entyvio) coverage criteria

Policy CodePolicy CP PHAR.265

Change TypeFormulation, dosing and coding updates

Effective Date07.16

Next Review Date

Key ActionSubmit prior authorization with documentation (including Mayo or modified Mayo score for UC) demonstrating that initial and trial therapy criteria are met.

SourceLink

POLICY UPDATE CHANGES

Added new dosage forms (prefilled syringe and Entyvio Pen) for subcutaneous injection and revised single-dose vial description to lyophilized powder for IV infusion.

Revised HCPCS code J3380 description and added C9399 and J3590 to HCPCS listings.

Added examples and updates to preferred biologic/adalimumab products and therapeutic alternatives across UC and CD criteria (multiple periodic updates).

IV 300 mg; SC 108 mgListed dosing options

Mayo ≥6 / Mod Mayo ≥5UC disease activity required

6 monthsInitial approval length (CD)

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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 or modified Mayo Score ≥ 5 (see Appendix F); 5. Failure of an 8-week trial of systemic corticosteroids unless contraindicated or clinically significant adverse effects are experienced; 6. Failure of one adalimumab product (examples: Hadlima, Simlandi, Yusimry, adalimumab-aaty, adalimumab-adaz, adalimumab-adbm, adalimumab-fkjp) unless the member has a history of failure of two TNF blockers; 7. Failure of one ustekinumab product (examples: Otulfi, Pyzchiva, Stelara biosimilars) used for ≥ 3 consecutive months unless contraindicated or clinically significant adverse effects are experienced; 8. Member does not have combination use with biological disease-modifying antirheumatic drugs (bDMARDs) or Janus kinase (JAK) inhibitors; 9. Requested dose does not exceed one of the following dosing regimens: a) 300 mg IV at weeks 0, 2, and 6, followed by maintenance 300 mg IV every 8 weeks; 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.

Use Appendix F for Mayo scoring details

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. Member has failed a ≥ 3 consecutive month trial of at least one immunomodulator (e.g., azathioprine, 6-MP, methotrexate) at maximally indicated doses unless clinically significant adverse effects or contraindications exist, OR medical justification supports inability to use immunomodulators (see Appendix E); 5. Either failure of one adalimumab product used for ≥ 3 consecutive months or history of failure of two TNF blockers; 6. Failure of a ≥ 3 consecutive month trial of one ustekinumab product unless contraindicated or clinically significant adverse effects are experienced; 7. Member does not have combination use with bDMARDs or JAK inhibitors; 8. Requested dose does not exceed one of the following dosing regimens: a) 300 mg IV at weeks 0, 2, and 6, followed by maintenance 300 mg IV every 8 weeks; 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.

Approval duration: 6 months

Continuation Therapy

Continued coverage when ALL of the following are met:

Continued Therapy: 1. Member is currently receiving the medication via the Centene benefit or has previously met initial approval criteria; 2. Member is responding positively to therapy; 3. If request is for a dose increase, the new dose does not exceed: a) IV: 300 mg every 8 weeks; or b) SC: 108 mg every 2 weeks; 4. Member does not have combination use with bDMARDs or JAK inhibitors.

Continuity of care provisions apply where relevant

Formulation and dosing updates

Policy revisions related to initial and continued therapy and formulation-specific approvals:

Formulation availability: Lyophilized powder in a single-dose vial for reconstitution for IV infusion: 300 mg; single-dose prefilled syringe for SC injection: 108 mg/0.68 mL; single-dose prefilled Entyvio Pen for SC injection: 108 mg/0.68 mL.

Product availability stated

UC dosing option: Updated to include SC maximum dose option in initial approval and continued therapy sections for ulcerative colitis.

Explicitly stated policy change

CD formulation note: For Crohn's disease, dosing language was revised across updates to add and later modify statements regarding IV versus SC formulation requests (e.g., earlier language added 'request is for IV formulation' and later updates added SC dosing for CD).

Formulation-specific request language present across revisions

Combination use of vedolizumab with other biological disease-modifying antirheumatic drugs (bDMARDs) or potent immunosuppressants is not authorized. The policy specifically lists classes such as TNF antagonists, interleukin agents, JAK inhibitors, anti-CD20 antibodies, selective co-stimulation modulators, other integrin receptor antagonists, tyrosine kinase 2 inhibitors, and sphingosine 1-phosphate receptor modulators and notes that combined use increases additive immunosuppression and the risk of serious infections; such combinations will not be approved under this policy.

Uses of vedolizumab that are not FDA‑approved and are not specifically addressed in this policy are excluded unless there is sufficient documentation to support off‑label use per the applicable off‑label policy (CP PMN.53) or other formal coverage documents. For non‑formulary or newly approved indications not reflected in this policy, refer to the referenced non‑formulary or no‑coverage policies as applicable.

The inclusion of HCPCS or other billing codes in this policy is informational and does not by itself guarantee coverage. Providers should rely on current professional coding guidance and payer billing rules when submitting claims; presence of a code in the document does not establish medical necessity or automatic reimbursement.

Requests that seek to combine vedolizumab with the specified immunosuppressive biologics or other potent immunosuppressants are not authorized under this policy due to the increased risk of additive immunosuppression and serious infections. Such combination regimens should not be submitted for approval unless justified under separate, specific coverage guidance.

Coding entries shown in this policy are provided for reference only; they do not ensure coverage or payment. Prior authorization and medical necessity determinations are based on the clinical criteria in this policy and supporting documentation, not solely on listed codes.

Product Codes, Dosing, and Scoring Thresholds

Product formulations and dosesmixed

300 mg IV	Lyophilized powder in a single-dose vial for reconstitution for IV infusion: 300 mg
108 mg SC	Single-dose prefilled syringe or Entyvio Pen for SC injection: 108 mg/0.68 mL

Covered HCPCS (referenced)HCPCS

J3380

Injection, vedolizumab, intravenous, 1 mg.

Additional HCPCS referencedHCPCS

C9399	Unclassified or biologicals drugs
J3590	Unclassified biologic/other drug (listed in HCPCS additions)

Mayo / Modified Mayo thresholds — UC documentation

Required UC disease-activity thresholdMayo Score ≥ 6 OR Modified Mayo Score ≥ 5 required in documentation for ulcerative colitis coverage (see Appendix F)

Mayo Score range and interpretation0–12 scale; remission 0–2, mild 3–5, moderate 6–10, severe >10

Modified Mayo Score range and interpretation0–9 scale (no physician global assessment); FDA-accepted for UC trials

Modified Mayo Score — documentation requirement

Documentation threshold (Modified Mayo)Modified Mayo Score ≥ 5 required for UC documentation (supplemental information added to Appendix F)

Where documented

Provider Requirements, Prior Authorization, and Step Therapy

Prior Authorization

Prior Authorization Required

Prior authorization is required. Provider must submit clinical documentation demonstrating that initial and trial therapy criteria are met (e.g., office chart notes, relevant labs, treatment history) to support that the member fulfills the policy’s approval criteria.

Prior authorization may reference specific HCPCS/NDC codes and formulation (IV vs SC) requested — include formulation-specific rationale (e.g., request for IV formulation) when applicable.
Documentation must include Modified Mayo Score when applicable (see criterion: Modified Mayo Score ≥ 5; see Appendix F for scoring details).

Billing Rule

Code- and Formulation‑Specific Prior Authorization / Coding Notice

Policy updates include formulation- and code-specific guidance. When submitting a prior authorization request, indicate the exact product, formulation, and code(s). Inclusion of a code in this policy does not guarantee coverage; providers must use current professional coding guidance when submitting claims.

Background on Vedolizumab (Entyvio)

Vedolizumab (Entyvio) is an integrin receptor antagonist indicated for adults with moderately to severely active ulcerative colitis and Crohn’s disease. The product is available for intravenous infusion as a 300 mg lyophilized single‑dose vial for reconstitution and for subcutaneous administration as a 108 mg single‑dose prefilled syringe or Entyvio Pen. Disease severity for ulcerative colitis must be documented using the Mayo score or modified Mayo score per policy thresholds when seeking coverage.

Definitions and Scoring

Definitions — Mayo and Modified Mayo scoring

Mayo Score componentsFour parameters: stool frequency, rectal bleeding, endoscopic evaluation, and physician's global assessment; each 0–3; total 0–12

Modified Mayo componentsThree parameters: stool frequency, rectal bleeding, endoscopic evaluation (no physician global assessment); total 0–9

Severity categoriesRemission 0–2; Mild 3–5; Moderate 6–10; Severe >10

Use in policyAppendix F provides the scoring details used to confirm UC disease activity for coverage decisions

Immunomodulator — definition and examples

DefinitionImmunomodulator: systemic agents used to treat Crohn's disease that modify immune response (examples used in criteria)