CurrentBlue Cross Blue Shield - IowaPolicy 05.02.08

Vedolizumab (Entyvio) drug policy — prior authorization and coverage criteria

Defines prior authorization, coverage criteria, documentation, prescriber requirements, and authorization durations for vedolizumab (Entyvio) for UC, CD, immune checkpoint inhibitor-related toxicity, and acute graft versus host disease for Wellmark/Blue Cross Blue Shield members.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyVedolizumab (Entyvio) drug policy — prior authorization and coverage criteria

Policy CodePolicy 05.02.08

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit prior authorization with chart notes or medical record documentation demonstrating medical necessity and positive clinical response or required prior therapies.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthstypical authorization length for UC, CD, acute GVHD

6 monthsauthorization length for immune checkpoint inhibitor-related toxicity

2/28 daysmaintenance quantity limit (adults)

J3380HCPCS code

4 listed

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Coverage and Medical Necessity Criteria

Coverage and continuation criteria

Covered when ALL of the following are met (per indication and continuation rules):

General coverage: Coverage consistent with product labeling, FDA guidance, standards of practice, compendial uses are considered covered when all approval criteria are met and the member has no exclusions.

Concomitant therapy restriction: Member cannot use the requested medication concomitantly with any other biologic drug or targeted synthetic drug for the same indication.

Explicit prohibition on concurrent biologic/targeted synthetic therapy.

UC initial/continuation: Authorization of 12 months may be granted for treatment of moderately to severely active ulcerative colitis when member achieves or maintains remission or a positive clinical response as evidenced by improvements from baseline in stool frequency, rectal bleeding, urgency of defecation, CRP, fecal calprotectin, mucosal appearance on endoscopy/CTE/MRE/intestinal ultrasound, or improvement on disease activity scoring tools (e.g., UCEIS, Mayo).

CD initial/continuation: Authorization of 12 months may be granted for treatment of moderately to severely active Crohn's disease when member achieves or maintains remission or a positive clinical response as evidenced by improvements from baseline in abdominal pain/tenderness, diarrhea, body weight, abdominal mass, hematocrit, mucosal appearance on endoscopy/CTE/MRE/intestinal ultrasound, or improvement on disease activity scoring tools (e.g., CDAI).

Immune Checkpoint Inhibitor-Related Toxicity: Authorization of 6 months may be granted for treatment of immune checkpoint inhibitor-related diarrhea or colitis when member has inadequate response, intolerance, or contraindication to systemic corticosteroids or infliximab.

Acute graft versus host disease: Authorization of 12 months may be granted when member has either inadequate response to systemic corticosteroids OR intolerance/contraindication to corticosteroids.

Continuation therapy requirement: All members requesting authorization for continuation must meet all initial authorization criteria and provide documentation of positive response or remission for continuation approvals.

Coverage with conditions

Coverage is granted when policy medical necessity criteria are met and dosing limits are adhered to.

Concomitant therapy restriction: Member must not use the requested medication concomitantly with any other biologic drug or targeted synthetic drug for the same indication.

From policy 'Other' section.

Dosing limits: Approvals may be subject to dosing limits in accordance with FDA-approved labeling, accepted compendia, and/or evidence-based practice guidelines.

From 'Dosage and Administration'.

Quantity limit (maintenance adults): Entyvio maintenance for ulcerative colitis and Crohn's disease (adults): 2 syringes or pens per 28 days.2 per 28 days

From 'Quantity Limits'.

Members currently receiving the requested medication as samples or through the manufacturer's patient assistance program must still meet the policy initial approval criteria. Documentation demonstrating that the member satisfies the same clinical requirements as other new starts is required to process authorization, ensuring equitable treatment regardless of how the member initially obtained medication.

For all indications, concomitant use of vedolizumab (Entyvio) with any other biologic drug or targeted synthetic drug for the same indication is explicitly prohibited and is a basis for denial of coverage.

Entyvio will be considered not medically necessary for members who do not meet the medical necessity criteria set forth in this policy. Requests that fail to demonstrate compliance with the stated clinical requirements may be denied.

If documentation does not substantiate that the member meets the policy's approval criteria, the use of Entyvio is deemed not medically necessary and authorization will not be granted.

Billing Codes and Quantity Limits

Prior Authorization

Provider actions: Prior Authorization, Required Documentation, and Billing

Prior authorization is required. Providers must document in the prior authorization request that the member meets all policy criteria for approval, including indication-specific requirements and that the member is not using another biologic or targeted synthetic agent concomitantly for the same indication. Members who previously received samples or medication through a manufacturer patient assistance program must still meet the criteria for initial approval. When billing, report the appropriate HCPCS code (e.g., J3380) and include supporting documentation demonstrating medical necessity and the information provided in the prior authorization (diagnosis, dosing, quantity, prior therapy history, and any relevant labs or clinical notes).

Prior authorization required before dispensing or billing.
Required documentation: indication, prior treatment history, confirmation of no concomitant biologic/targeted synthetic therapy for same indication, dosing and quantity requested, clinical rationale, and any relevant lab results or specialty consult notes.
Documentation and billing: use HCPCS J3380 for vedolizumab 1 mg; include the prior authorization approval number with the claim and attach or maintain supporting clinical documentation as required by payer policies.

Prior Authorization, Documentation, and Clinical Steps

Prior Authorization

Obtain prior authorization for specified durations

Prior authorization is required for Entyvio. When criteria are met, authorizations may be granted for 12 months for ulcerative colitis, Crohn's disease, and acute graft versus host disease, and for 6 months for immune checkpoint inhibitor-related toxicity.

Prior Authorization

Approval requires medical necessity and follow quantity limits

Prior authorization will only be approved when the member meets the policy's medical necessity criteria. Quantity limits apply for maintenance therapy in adults: 2 syringes or pens per 28 days.

Step Therapy

Require failure/intolerance to steroids or infliximab

For immune checkpoint inhibitor-related diarrhea or colitis, authorization is allowed only when the member has had an inadequate response, intolerance, or contraindication to systemic corticosteroids or infliximab.

Indications and Regulatory Status

FDA-approved and compendial indications

FDA-approved indications (adults)Moderately to severely active ulcerative colitis (UC); Moderately to severely active Crohn's disease (CD)

Compendial use: pediatric IBDModerately to severely active ulcerative colitis and Crohn's disease in pediatric patients

Compendial use: immune-related toxicityImmune checkpoint inhibitor-related toxicity

Compendial use: transplant-relatedAcute graft versus host disease (GVHD)

Clinical Background

Vedolizumab (Entyvio) is intended for treatment of moderately to severely active ulcerative colitis and Crohn's disease in adults and has compendial uses in pediatric inflammatory bowel disease, immune checkpoint inhibitor–related toxicity, and acute graft versus host disease. Coverage under this policy follows FDA labeling, accepted compendia, and evidence-based guidelines when the authorization criteria are met.