CurrentMass General Brigham Health PlanPolicy N/A

Entyvio SC (vedolizumab) coverage

Defines prior authorization and pharmacy benefit requirements for Entyvio subcutaneous (vedolizumab) for commercial/exchange members, including initial and continuation criteria, quantity limits, and specialty pharmacy requirements.

Policy Summary

PayerMass General Brigham Health Plan

PolicyEntyvio SC (vedolizumab) coverage

Policy CodePolicy N/A

Change TypeQuantity limit addedapproval length revised

Effective DateMay 1, 2026

Next Review DateMay 1, 2026

Key ActionSubmit medical records (e.g., chart notes) demonstrating current treatment or improvement to support authorization or reauthorization.

SourceLink

POLICY UPDATE CHANGES

Reauthorization criteria wording changed to require 'submission of medical records (e.g., chart notes) demonstrating an improvement' instead of prior phrasing.

Approval length updated (effective 05/01/2026).

Quantity limit applied: Entyvio SC pen, 2 pens per 28 days.

Commercial/ExchangePlan applicability

Prior AuthorizationProgram type

24 monthsApproval length

2 pens/28dQuantity limit

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Coverage Criteria for Entyvio SC (vedolizumab)

Initial Therapy - Ulcerative Colitis

Covered when ALL of the following are met:

UC Initial Therapy: Member has diagnosis of moderately to severely active ulcerative colitis (UC)

UC Prior therapy: Member meets ONE of: (a) trial and failure, intolerance, or contraindication to ONE conventional therapy (6-mercaptopurine; aminosalicylate e.g., mesalamine, olsalazine, sulfasalazine; azathioprine; corticosteroids such as prednisone) OR (b) disease severity warrants systemic biologic as first-line therapy

UC formulation/biologic prior: Member meets ONE of: (a) Entyvio subcutaneous formulation will be used as maintenance following at least two doses of Entyvio IV induction; (b) member started therapy with at least two doses of Entyvio IV and is continuing treatment with the subcutaneous formulation; (c) trial and failure, contraindication, or intolerance to TWO of the following biologics: Humira (Abbvie), Hadlima, Simlandi, Yuflyma

Initial Therapy - Crohn's Disease

Covered when ALL of the following are met:

CD Initial Therapy: Member has diagnosis of moderately to severely active Crohn's disease (CD)

CD Prior therapy: Member meets ONE of: (a) trial and failure, intolerance, or contraindication to ONE conventional therapy (6-mercaptopurine; azathioprine; corticosteroids such as prednisone; methotrexate) OR (b) disease severity warrants systemic biologic as first-line therapy

CD formulation/biologic prior: Member meets ONE of: (a) Entyvio subcutaneous formulation will be used as maintenance following at least two doses of Entyvio IV induction; (b) member started therapy with at least two doses of Entyvio IV and is continuing treatment with the subcutaneous formulation; (c) trial and failure, contraindication, or intolerance to TWO of the following biologics: Cimzia; Humira (Abbvie), Hadlima, Simlandi, Yuflyma; Omvoh; Rinvoq; Skyrizi; Selarsdi, Steqeyma, Yesintek; Tremfya

Continuity of Therapy for New Members

Alternative coverage pathway for members new to the plan:

New member continuity: If member is new to the plan (coverage effective date less than or equal to 90 days), submission of medical records documenting that the member is currently receiving treatment with the requested drug (excluding medication obtained as samples or via manufacturer patient assistance programs) can support authorization; OR authorization may be granted if the member meets all diagnosis-specific criteria for the requested indication

Required medical records (e.g., chart notes) should be provided as described in policy

Continuation of Therapy

Continuation of therapy / Reauthorization:

Reauthorization criteria: Submission of medical records (e.g., chart notes) demonstrating an improvement in the member's condition, as evidenced by low disease activity or improvement in signs and symptoms of the condition

This policy applies to Entyvio subcutaneous (vedolizumab) under the pharmacy benefit for Commercial/Exchange members and is managed through the Plan’s prior authorization program. The medication is designated as specialty and must be dispensed through a contracted specialty pharmacy. This document does not govern medical benefit coverage for Entyvio.

Use of Entyvio SC that does not meet the policy’s listed prior therapy, induction, or formulation requirements — or when documentation supporting those criteria is not provided — will not meet medical necessity. Examples that may result in noncoverage include failure to document required trials of conventional therapies or biologics, absence of documentation of completed Entyvio IV induction (when required), or lack of submitted medical records demonstrating current treatment or improvement on reauthorization.

Coding and Quantity Limits

Policy-level coding referencesmixed

N/A	No explicit CPT/HCPCS/ICD-10 or NDC codes listed in the document; quantity limit specified for Entyvio SC pen.

inv-08: Quantity limit — Entyvio SC pen limit

Quantity limitEntyvio SC pen: 2 pens per 28 days

Approval durationInitial approvals and reauthorizations granted for 24 months

Applies toPharmacy benefit with specialty pharmacy dispensing required

Provider Actions, Documentation, and Denial Triggers

Prior Authorization

Prior Authorization and Specialty Fill

Prior authorization required under the pharmacy benefit for Commercial/Exchange members. This medication is designated specialty and must be dispensed by a contracted specialty pharmacy.

Pharmacy prior authorization required for Commercial/Exchange members
Specialty pharmacy dispensing requirement

Step Therapy

Step / Previous Therapy Requirements

Trials of specified conventional therapies or biologics are required for most initial approvals unless an exception applies (disease severity warrants systemic biologic first-line or documented intolerance/contraindication).

UC: trial and failure/intolerance/contraindication to ONE of 6‑mercaptopurine, aminosalicylate (e.g., mesalamine, olsalazine, sulfasalazine), azathioprine, or corticosteroids — OR documentation that disease severity warrants biologic first-line
CD: trial and failure/intolerance/contraindication to ONE of 6‑mercaptopurine, azathioprine, corticosteroids, or methotrexate — OR documentation that disease severity warrants biologic first-line

Definitions

inv-14: Entyvio SC (vedolizumab) — definition and indication for use

Agent and formulationEntyvio (vedolizumab) subcutaneous (SC) formulation

IndicationsAdults with moderately to severely active ulcerative colitis (UC) and moderately to severely active Crohn's disease (CD)

Use in maintenanceSC formulation may be used as maintenance following at least two doses of Entyvio IV induction or for members who started with at least two IV doses and are continuing with SC

Prior therapy considerationsApproval requires trial and failure/intolerance/contraindication to specified conventional therapies or biologics for UC and CD unless disease severity warrants systemic biologic first-line therapy

Background

Vedolizumab (Entyvio) is an integrin receptor antagonist indicated in adults for the treatment of moderately to severely active ulcerative colitis and Crohn’s disease. The subcutaneous formulation may be used as maintenance therapy following an appropriate IV induction course (typically at least two IV doses) or for patients who have already received two IV induction doses and are transitioning to or continuing with SC dosing. Policy criteria specify required prior trials of conventional therapies or biologics unless disease severity warrants systemic biologic first-line therapy, and detail continuation/reauthorization requirements based on documented clinical improvement.