Modifiedsierra health and lifePolicy 2025D0053P

Entyvio (vedolizumab) — Intravenous Infusion Coverage Criteria

Clinical medical benefit drug policy governing coverage criteria, coding, and authorization requirements for intravenous vedolizumab (Entyvio) under the commercial medical benefit.

Policy Summary

Payersierra health and life

PolicyEntyvio (vedolizumab) — Intravenous Infusion Coverage Criteria

Policy CodePolicy 2025D0053P

Change TypeRevised coverage criteria and updated excluded concomitant agentsaGVHD criteria added

Effective DateJul 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of diagnosis, prior therapy history, and dosing consistent with FDA labeling; aGVHD requests limited to up to 4 doses.

SourceLink

POLICY UPDATE CHANGES

Entyvio (vedolizumab) is proven and medically necessary for treatment of gastrointestinal acute graft-versus-host disease (aGVHD) when all specified criteria are met.

Coverage criteria for immune checkpoint inhibitor-related toxicities were revised to add coverage for specific immunotherapy-related diagnoses including moderate-severe esophagitis/gastritis/duodenitis and persistent mild (G1) diarrhea/colitis with positive lactoferrin/calprotectin.

Updated the list of targeted immunomodulators that must not be used in combination with Entyvio for Crohn's disease and ulcerative colitis (several agents added and some removed).

ICD-10 diagnosis code D89.810 was added to applicable codes.

12 monthsinitial authorization duration for IBD indications

3 dosesauthorization limit for immune checkpoint inhibitor-related toxicities

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria for Entyvio (vedolizumab)

Crohn's disease - Initial therapy

Covered when ALL of the following are met:

CD initial: Diagnosis of moderately to severely active Crohn's disease (CD); AND one of: history of failure, contraindication, or intolerance to at least one conventional therapy (tumor necrosis factor [TNF] blocker, immunomodulator, or corticosteroid) OR corticosteroid dependent (unable to taper corticosteroids without return of symptoms); AND Entyvio is initiated and titrated according to US FDA labeled dosing for Crohn's disease; AND patient is not receiving Entyvio in combination with a targeted immunomodulator (examples: adalimumab, Cimzia [certolizumab], Omvoh [mirikizumab-mrkz], Rinvoq [upadacitinib], Simponi [golimumab], Skyrizi [risankizumab], Tremfya [guselkumab], ustekinumab, Xeljanz [tofacitinib]) or natalizumab (Tysabri); AND initial authorization will be for no more than 12 months.

Crohn's disease - Continuation therapy

Covered when ALL of the following are met:

CD continuation: Documentation of positive clinical response to Entyvio; AND Entyvio dosing for Crohn's disease is in accordance with the US FDA labeled dosing; AND reauthorization will be for no more than 12 months.

Ulcerative colitis - Initial therapy

Covered when ALL of the following are met:

UC initial: Diagnosis of moderately to severely active ulcerative colitis (UC); AND one of: history of failure, contraindication, or intolerance to at least one conventional therapy (TNF blocker, immunomodulator, or corticosteroid) OR corticosteroid dependent; AND Entyvio is initiated and titrated according to US FDA labeled dosing for ulcerative colitis; AND patient is not receiving Entyvio in combination with a targeted immunomodulator (examples: adalimumab, Cimzia [certolizumab], Enbrel [etanercept], Omvoh [mirikizumab-mrkz], Rinvoq [upadacitinib], Simponi [golimumab], Skyrizi [risankizumab], Tremfya [guselkumab], ustekinumab, Xeljanz [tofacitinib]) or natalizumab (Tysabri); AND initial authorization will be for no more than 12 months.

Ulcerative colitis - Continuation therapy

Covered when ALL of the following are met:

UC continuation: Documentation of positive clinical response to Entyvio; AND Entyvio dosing for ulcerative colitis is in accordance with the US FDA labeled dosing; AND reauthorization will be for no more than 12 months.

Immune checkpoint inhibitor-related toxicities

Covered when ALL of the following are met (initial and continuation):

ICI-related GI toxicity: One of the following immunotherapy-related diagnoses: moderate to severe esophagitis, gastritis, or duodenitis with no improvement on corticosteroids or budesonide; OR mild (G1) diarrhea or colitis if persistent or progressive with positive lactoferrin or calprotectin; OR moderate (G2) or severe (G3-4) immunotherapy-related diarrhea or colitis; AND patient is receiving a checkpoint inhibitor (e.g., pembrolizumab, nivolumab); AND one of: history of failure, contraindication, or intolerance to infliximab OR patient has immune-related hepatitis; AND authorization will be for no more than 3 doses of Entyvio.

GI acute graft-versus-host disease (aGVHD)

Covered when ALL of the following are met for initial therapy:

aGVHD initial: Diagnosis of steroid-refractory acute GI graft-versus-host disease (aGVHD); AND one of: patient is receiving Entyvio in combination with systemic corticosteroids OR patient is intolerant to systemic corticosteroid therapy; AND initial authorization is for no more than 4 doses.

aGVHD - Continuation

Covered when ALL of the following are met for continuation:

aGVHD continuation: Documentation of positive clinical response; AND patient continues to experience acute GI aGVHD; AND one of: patient is receiving Entyvio in combination with systemic corticosteroids OR patient is intolerant to systemic corticosteroid therapy; AND authorization is for no more than 4 doses.

Initial Therapy — acute GI aGVHD

Entyvio (vedolizumab) is proven and medically necessary for treatment of gastrointestinal acute graft-versus-host disease (aGVHD) when ALL of the following are met for Initial Therapy:

Initial Therapy for GI aGVHD: 1) Diagnosis of steroid-refractory acute GI aGVHD; 2) One of: (a) patient is receiving Entyvio in combination with systemic corticosteroids OR (b) patient is intolerant to systemic corticosteroid therapy; 3) Initial authorization is for no more than 4 doses.

From policy summary of changes

Continuation Therapy — acute GI aGVHD

Continuation of Therapy for GI aGVHD — covered when ALL of the following are met:

Continuation Therapy for GI aGVHD: 1) Documentation of positive clinical response; 2) Patient continues to experience acute GI aGVHD; 3) One of: (a) patient is receiving Entyvio in combination with systemic corticosteroids OR (b) patient is intolerant to systemic corticosteroid therapy; 4) Authorization is for no more than 4 doses.

From policy summary of changes

Immune Checkpoint Inhibitor–Related Toxicities

Coverage for immune checkpoint inhibitor-related GI toxicities — revised criteria:

Immunotherapy-related diagnoses eligible for coverage when criteria met: One of the following immunotherapy-related diagnoses may be covered: (a) moderate to severe esophagitis, gastritis, or duodenitis if no improvement on corticosteroids or budesonide; (b) mild (G1) diarrhea or colitis if persistent or progressive symptoms and positive lactoferrin/calprotectin.

Added to coverage rationale

Coverage excludes concomitant use of Entyvio (vedolizumab) with targeted immunomodulators and with Tysabri (natalizumab). Examples of targeted immunomodulators listed in the policy include agents such as adalimumab and Cimzia (certolizumab) among others; requests documenting concurrent administration of Entyvio with these agents or with natalizumab will not meet coverage criteria.

The policy updates the list of targeted immunomodulators that must not be used concurrently with Entyvio. For Crohn's disease, the examples newly added include Omvoh (mirikizumab-mrkz), Simponi (golimumab), Skyrizi (risankizumab), and Tremfya (guselkumab); the policy removes infliximab and Xeljanz XR from that example list and standardizes the naming of ustekinumab. For ulcerative colitis, examples added include Cimzia (certolizumab), Enbrel (etanercept), Omvoh (mirikizumab-mrkz), Skyrizi (risankizumab), and Tremfya (guselkumab), while infliximab and Xeljanz XR were removed from the example list. Providers must ensure Entyvio is not prescribed in combination with any of the disallowed targeted immunomodulators or with Tysabri (natalizumab) as part of meeting coverage requirements.

Coding and Authorization Limits

Covered HCPCSHCPCSCovered

J3380

Injection, vedolizumab, IV, 1 mg.

Relevant ICD-10 diagnosis codes (partial list)ICD-10

D89.810	Acute graft-versus-host disease
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
K50.111	Crohn's disease of large intestine with rectal bleeding
K50.113	Crohn's disease of large intestine with fistula

1–10 of 31

1/4

Adverse effect diagnosis codesICD-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

Applicable ICD-10 CodesICD-10

D89.810

Newly added applicable ICD-10 diagnosis code

Authorization dose limits

Immune checkpoint inhibitor-related toxicitiesAuthorization limited to no more than 3 doses of Entyvio for initial or continuation therapy when criteria are met.

GI acute graft-versus-host disease (aGVHD) — InitialInitial authorization is for no more than 4 doses for steroid-refractory acute GI aGVHD when criteria are met.

GI acute graft-versus-host disease (aGVHD) — ContinuationAuthorization for continuation is for no more than 4 doses with documentation of positive clinical response and ongoing aGVHD.

Provider Actions, Documentation, and Authorization

Prior Authorization

Prior Authorization Required — aGVHD (Entyvio)

Prior authorization required for treatment of steroid-refractory acute GI aGVHD with Entyvio (vedolizumab). Requests must include diagnosis and meet the specified initial or continuation criteria; initial authorization is limited to no more than 4 doses and continuation authorization is for no more than 4 doses.

Initial authorization limit: ≤ 4 doses
Continuation authorization limit: ≤ 4 doses
Diagnosis required: steroid-refractory acute GI aGVHD

Documentation Required

Documentation must include the diagnosis, prior treatment history, details of current and prior therapies (including corticosteroid use), and evidence of positive clinical response for continuation. Providers should show whether Entyvio is being used in combination with systemic corticosteroids or if the patient is intolerant to systemic corticosteroid therapy.

Background and Clinical Context

Vedolizumab (Entyvio) is a humanized monoclonal antibody that selectively targets the α4β7 integrin, blocking its interaction with MAdCAM‑1 and thereby inhibiting trafficking of memory T‑lymphocytes into inflamed gastrointestinal tissue. This gut‑selective mechanism underlies its FDA‑labeled indications for induction and maintenance therapy in moderately to severely active ulcerative colitis and Crohn's disease, and informs the policy requirement that dosing follow the US FDA labeled regimen for the specific indication.

Definitions and Dosing

Mechanism of action

MechanismBinds the alpha-4-beta-7 integrin receptor, blocking interaction with mucosal addressing cell adhesion molecule-1 (MAdCAM-1) and inhibiting migration of memory T‑lymphocytes into inflamed gastrointestinal tissue.

TargetAlpha-4-beta-7 integrin on lymphocytes.

EffectReduces lymphocyte trafficking to gut mucosa, decreasing GI inflammation.

FDA labeled dosing

Continuation dosingReauthorization requires Entyvio dosing to be in accordance with FDA labeled dosing and documentation of positive clinical response.

aGVHD and ICI toxicitiesRequests for these indications must also adhere to FDA dosing where applicable and meet the indication-specific authorization limits.

Policy Revision History

2025-07-01material_additionLatest

Added coverage for gastrointestinal acute graft-versus-host disease (aGVHD) with initial and continuation criteria and authorization limits of up to 4 doses.

2025-07-01material_revision

Revised coverage criteria for immune checkpoint inhibitor–related toxicities to add coverage for moderate–severe esophagitis/gastritis/duodenitis refractory to corticosteroids or budesonide and for persistent mild (G1) diarrhea/colitis with positive lactoferrin/calprotectin.

2025-07-01