Colorado Rocky Mountain HP — Entyvio Coverage

Coverage Criteria for Vedolizumab (Entyvio)

Crohn's disease — Initial therapy

Covered when ALL of the following are met

Crohn's initial therapy: Diagnosis of moderately to severely active Crohn's disease

Prior therapies: One of: history of failure, contraindication, or intolerance to at least one conventional therapy: a tumor necrosis factor (TNF) blocker (e.g., adalimumab, certolizumab), an immunomodulator (e.g., azathioprine, 6-mercaptopurine), or a corticosteroid; OR corticosteroid dependent (e.g., unable to successfully taper corticosteroids without return of symptoms)

Dosing: Entyvio is initiated and titrated according to the U.S. Food and Drug Administration (FDA) labeled dosing for Crohn's disease

Crohn's disease — Continuation therapy

Covered when ALL of the following are met

Response: Documentation of positive clinical response to Entyvio

Dosing consistency: Entyvio dosing for Crohn's disease is in accordance with the FDA labeled dosing

Authorization limit: Initial authorization and reauthorization will be for no more than 12 months

Ulcerative colitis — Initial therapy

Covered when ALL of the following are met

UC diagnosis: Diagnosis of moderately to severely active ulcerative colitis

Prior therapies: One of: history of failure, contraindication, or intolerance to at least one conventional therapy: a TNF blocker (e.g., adalimumab, golimumab), an immunomodulator (e.g., azathioprine, 6-mercaptopurine), or a corticosteroid; OR corticosteroid dependent (e.g., unable to successfully taper corticosteroids without return of symptoms)

Dosing: Entyvio is initiated and titrated according to the U.S. Food and Drug Administration (FDA) labeled dosing for ulcerative colitis

Prohibited concomitant therapies: Patient is not receiving Entyvio in combination with targeted immunomodulators (examples listed in policy) or natalizumab (Tysabri)

Ulcerative colitis — Continuation therapy

Covered when ALL of the following are met

Response: Documentation of positive clinical response to Entyvio

Dosing consistency: Entyvio dosing for ulcerative colitis is in accordance with the FDA labeled dosing

Authorization limit: Initial authorization and reauthorization will be for no more than 12 months

Immune checkpoint inhibitor–related GI toxicities

Covered when ALL of the following are met

Diagnosis options: One of: moderate to severe esophagitis, gastritis, or duodenitis not improved with corticosteroids or budesonide; mild (G1) diarrhea or colitis if persistent/progressive with positive lactoferrin or calprotectin; or moderate (G2) or severe (G3-4) immunotherapy-related diarrhea or colitis

Checkpoint inhibitor exposure: Patient is receiving a checkpoint inhibitor (e.g., pembrolizumab, nivolumab)

Prior therapy: History of failure, contraindication, or intolerance to infliximab; OR patient has immune-related hepatitis

Authorization limit: Authorization will be for no more than 3 doses of Entyvio

Acute GI aGVHD

Covered when ALL of the following are met

Diagnosis of steroid-refractory acute GI acute graft-versus-host disease (aGVHD)

Steroid context: One of: patient is receiving Entyvio in combination with systemic corticosteroids OR patient is intolerant to systemic corticosteroid therapy

Authorization limit: Initial authorization is for no more than 4 doses; continuation requires documentation of positive clinical response and ongoing acute GI aGVHD

Guideline-supported indications and considerations

Guideline-supported use cases cited in the document

ACG - Crohn's disease induction: For adults with moderately to severely active Crohn's disease and objective evidence of active disease, anti-integrin therapy (vedolizumab) with or without an immunomodulator should be considered for induction of symptomatic remission (strong recommendation, high level of evidence).

ACG 2018

ACG - Crohn's disease maintenance: Vedolizumab should be used for maintenance of vedolizumab-induced remission of Crohn's disease (conditional recommendation, moderate level of evidence).

ACG 2018

ACG - UC induction: In moderately to severely active ulcerative colitis, vedolizumab is recommended for induction of remission (strong recommendation, moderate quality of evidence), including after anti-TNF failure.

ACG 2019

Patient must not be receiving Entyvio in combination with specified targeted immunomodulators or natalizumab. Examples of prohibited concomitant targeted immunomodulators include adalimumab, certolizumab (Cimzia), mirikizumab (Omvoh), upadacitinib (Rinvoq), golimumab (Simponi), risankizumab (Skyrizi), guselkumab (Tremfya), ustekinumab, and tofacitinib (Xeljanz). The policy also prohibits simultaneous use of Tysabri (natalizumab) with Entyvio.

FDA approval and labeled indications for Entyvio are provided for informational purposes only and do not by themselves establish coverage. Coverage determinations must follow the member's applicable federal, state, or contractual benefit plan terms; in the event of a conflict, those benefit terms govern. Reviewers and providers should verify plan-specific requirements before applying this policy.

Applicable Coding

Applicable HCPCSHCPCS

J3380

Injection, vedolizumab, intravenous, 1 mg

Applicable ICD-10 (Crohn's and aGVHD partial list)ICD-10

D89.810	Acute graft-versus-host disease
K50.00	Crohn's disease of small intestine without complications
K50.011	Crohn's disease of small intestine with rectal bleeding
K50.012	Crohn's disease of small intestine with intestinal obstruction
K50.013	Crohn's disease of small intestine with fistula
K50.014	Crohn's disease of small intestine with abscess
K50.018	Crohn's disease of small intestine with other complication
K50.019	Crohn's disease of small intestine with unspecified complications
K50.10	Crohn's disease of large intestine without complications

Applicable ICD-10 (continued)ICD-10

K50.111	Crohn's disease of large intestine with rectal bleeding
K50.112	Crohn's disease of large intestine with intestinal obstruction
K50.113	Crohn's disease of large intestine with fistula
K50.114	Crohn's disease of large intestine with abscess
K50.118	Crohn's disease of large intestine with other complication
K50.119	Crohn's disease of large intestine with unspecified complications
K50.80	Crohn's disease of both small and large intestine without complications
K50.811	Crohn's disease of both small and large intestine with rectal bleeding
K50.812	Crohn's disease of both small and large intestine with intestinal obstruction
K50.813	Crohn's disease of both small and large intestine with fistula

Applicable ICD-10 (Ulcerative colitis partial list)ICD-10

K51.00	Ulcerative (chronic) pancolitis without complications
K51.011	Ulcerative (chronic) pancolitis with rectal bleeding
K51.012	Ulcerative (chronic) pancolitis with intestinal obstruction
K51.013	Ulcerative (chronic) pancolitis with fistula
K51.014	Ulcerative (chronic) pancolitis with abscess
K51.018	Ulcerative (chronic) pancolitis with other complication
K51.019	Ulcerative (chronic) pancolitis with unspecified complications
K51.20	Ulcerative (chronic) proctitis without complications

Applicable ICD-10 (drug adverse effect codes)ICD-10

T45.1X5A	Adverse effect of antineoplastic and immunosuppressive drugs, initial encounter
T45.1X5D	Adverse effect of antineoplastic and immunosuppressive drugs, subsequent encounter
T45.1X5S	Adverse effect of antineoplastic and immunosuppressive drugs, sequela

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required and Duration Limits

Prior authorization required. Initial approvals limited to no more than 12 months for IBD (Crohn's disease and ulcerative colitis). For immune checkpoint inhibitor–related toxicities initial authorization is limited to no more than 3 doses; for steroid‑refractory acute GI aGVHD initial authorization is for no more than 4 doses; reauthorizations/continuations are limited as noted in policy.

Initial authorization (IBD): ≤ 12 months
Continuation/reauthorization (IBD): ≤ 12 months
Immune checkpoint inhibitor–related toxicities: authorization ≤ 3 doses
GI acute aGVHD: initial and continuation authorization ≤ 4 doses

Denial Risk

Clinical Prerequisites for IBD Coverage

Coverage for Crohn's disease or ulcerative colitis requires a documented diagnosis of moderately to severely active disease and meeting step-therapy prerequisites before Entyvio is approved for initial therapy.

Background on Vedolizumab and Evidence

Vedolizumab (Entyvio) is a humanized monoclonal antibody that is gut-selective; it binds the alpha4beta7 (α4β7) integrin receptor and blocks interaction with MAdCAM-1, inhibiting memory T‑lymphocyte migration into inflamed gastrointestinal tissue and thereby reducing GI inflammation. The agent is FDA‑labeled for treatment of adults with moderately to severely active ulcerative colitis and Crohn's disease, and society guidelines and evidence reviews support its use for induction and maintenance of remission in these conditions as well as selected steroid‑refractory immune‑related GI toxicities and acute GI aGVHD.

Definitions and Guideline Evidence

Mechanism of action — vedolizumab

MechanismBinds the alpha-4-beta-7 integrin receptor, blocking interaction with MAdCAM-1 and inhibiting memory T‑lymphocyte migration into inflamed gastrointestinal tissue.

TargetAlpha-4-beta-7 integrin on lymphocytes, preventing gut-specific trafficking.

Resulting effectReduces lymphocyte movement across endothelium into inflamed GI tissue, decreasing gastrointestinal inflammation.

Guideline evidence supporting vedolizumab

Cochrane evidenceCochrane reviews (2014, 2015) conclude vedolizumab is superior to placebo for induction and maintenance of remission in ulcerative colitis and can improve health-related quality of life.

ACG Crohn's guidance (2018)ACG recommends anti‑integrin therapy (vedolizumab) for induction of symptomatic remission in moderately to severely active Crohn's disease and supports its use for maintenance of vedolizumab‑induced remission.

Policy Revision History and Notes

2026-04-01policy_effectiveLatest

Policy effective date updated; template updated and Louisiana-specific content removed per change summary.

2026-04-01prior_authorization_update

Clarified prior authorization durations and limits for indications (IBD up to 12 months; immune checkpoint inhibitor–related GI toxicities up to 3 doses; acute GI aGVHD up to 4 doses).

OpenPayer

Entyvio (vedolizumab) infusion therapy — Medical Benefit Drug Policy (coverage criteria)

Coverage Criteria for Vedolizumab (Entyvio)

Applicable Coding

Prior Authorization, Documentation, and Provider Requirements

Background on Vedolizumab and Evidence

Definitions and Guideline Evidence

Policy Revision History and Notes