Entyvio (vedolizumab) — Intravenous infusion medical benefit policy
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Medical policy governing medical-benefit coverage and prior authorization criteria for intravenously administered Entyvio (vedolizumab) for UnitedHealthcare Commercial and Individual Exchange plans.
Coverage criteria were revised to require either prior failure of specified conventional therapies or prior treatment with a systemic targeted immunomodulator for initial therapy in Crohn's disease and ulcerative colitis.
Continuation criteria now require that patients are not receiving Entyvio in combination with another systemic targeted immunomodulator for the same indication.
Previous requirements for failure of at least one TNF blocker, immunomodulator, or corticosteroid for some indications were removed.
List of systemic targeted immunomodulators that must not be used in combination with Entyvio was updated (e.g., Zeposia added; some agents removed).
Policy template updated and Application section added specifying applicability to UnitedHealthcare Commercial and Individual Exchange benefit plans.
Coverage Criteria for Entyvio (vedolizumab)
Crohn's Disease
Covered when ALL of the following are met
CD initial therapy
- Prior therapy options: History of failure to one conventional therapy at up to maximally indicated doses unless contraindicated or clinically significant adverse effects are experienced (corticosteroids such as prednisone, methylprednisolone, budesonide; 6‑mercaptopurine; azathioprine; methotrexate) OR patient has been previously treated with a systemic targeted immunomodulator FDA‑approved for Crohn's disease OR patient is currently on Entyvio therapy
Crohn's Disease — Continuation
For continuation of therapy, ALL of the following:
Ulcerative Colitis
Covered when ALL of the following are met
UC initial therapy
- Prior therapy options: Prior or concurrent inadequate response to a therapeutic course of oral corticosteroids and/or immunosuppressants (e.g., azathioprine, 6‑mercaptopurine) OR patient has been previously treated with a systemic targeted immunomodulator FDA‑approved for ulcerative colitis OR patient is currently on Entyvio therapy
Ulcerative Colitis — Continuation
For continuation of therapy, ALL of the following:
Immune Checkpoint Inhibitor–Related Toxicities
Covered when ALL of the following are met
Gastrointestinal Acute Graft‑Versus‑Host Disease
Covered when ALL of the following are met
Crohn's Disease (CD) Initial Therapy
Covered when ONE of the following is met:
Entyvio must be prescribed by or in consultation with a gastroenterologist.
Crohn's Disease Continuation of Therapy
Covered when ALL of the following are met:
Examples of systemic targeted immunomodulators are listed in the policy; Entyvio prescribed by or in consultation with a gastroenterologist.
Ulcerative Colitis (UC) Initial Therapy
Covered when ONE of the following is met:
Entyvio must be prescribed by or in consultation with a gastroenterologist.
Ulcerative Colitis Continuation of Therapy
Covered when ALL of the following are met:
Examples of systemic targeted immunomodulators are listed in the policy.
Immune Checkpoint Inhibitor-Related Toxicities Continuation
Covered when BOTH are met:
Reauthorization will be for no more than 3 doses of Entyvio.
Subcutaneous, self‑administered Entyvio (vedolizumab) is obtained under the pharmacy benefit unless the member's benefit plan documents specify otherwise. Exception: for members enrolled in UnitedHealthcare of California plans where a delegated provider group conducts the prior authorization review, the self‑administered formulation may be obtained under the medical benefit.
Entyvio must not be used in combination with another systemic targeted immunomodulator for treatment of the same indication. Concurrent use with any of the listed systemic targeted immunomodulators (examples in policy include adalimumab, certolizumab, mirikizumab, upadacitinib, risankizumab, guselkumab, ustekinumab, among others) is an exclusion and may result in denial of coverage.
Use of Entyvio without meeting the policy's specified initial therapy criteria — for example, when there is no documented history of required prior conventional therapies at maximally indicated doses (unless contraindicated) or no documentation of prior treatment with a systemic targeted immunomodulator where required — is considered not medically necessary. Similarly, requests for Entyvio while the patient is receiving another systemic targeted immunomodulator for the same indication are considered not medically necessary.
Coding and Authorization Durations
| 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 |
| K50.111 | Crohn's disease of large intestine with rectal bleeding |
| 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 |
| K50.111 | Crohn's disease of large intestine with rectal bleeding |
Provider Requirements, Prior Authorization, and Denial Triggers
Prior authorization required for IV Entyvio (medical benefit)
Prior authorization is required under the medical benefit for intravenous Entyvio for UnitedHealthcare Commercial and Individual Exchange plans; self‑administered subcutaneous Entyvio is obtained under the pharmacy benefit unless otherwise specified in the member's benefit plan documents (exception for delegated California plans).
Authorization requires documented prior therapies or prior targeted immunomodulator
Prior authorization must follow the Medical Benefit Drug Policy: initial therapy approvals require documentation of either prior failure of the listed conventional therapies at up to maximally indicated doses, prior treatment with a systemic targeted immunomodulator, or that the patient is currently on Entyvio; continuation requires documentation of clinical response and that the patient is not receiving Entyvio in combination with another systemic targeted immunomodulator for the same indication.
Document prior failure/contraindication to conventional therapies or prior targeted therapy
For Crohn's disease and ulcerative colitis initial therapy, the provider must document history of failure, contraindication, or intolerance to specified conventional immunomodulatory therapies (e.g., corticosteroids, 6‑mercaptopurine, azathioprine, methotrexate) OR prior treatment with a systemic targeted immunomodulator, or that the patient is currently receiving Entyvio.
Step therapy: conventional therapy failure or prior systemic targeted immunomodulator
Initial therapy criteria include step elements: either failure of one listed conventional therapy at up to maximally indicated doses unless contraindicated, or prior use of a systemic targeted immunomodulator; these function as required step(s) before IV Entyvio in many cases.
Follow FDA dosing and involve a gastroenterologist for IBD
Prescriptions must be initiated and titrated according to FDA‑labeled dosing; for Crohn's disease and ulcerative colitis, Entyvio must be prescribed by or in consultation with a gastroenterologist as required by the policy.
Document prior therapies, current Entyvio use, and gastroenterology consultation
Provider must document prior therapies (corticosteroids, immunomodulators, or systemic targeted immunomodulators) or indicate that the patient is currently on Entyvio therapy; documentation of gastroenterology consultation and member‑specific benefit plan should be referenced for benefit exceptions.
Denial risk: concurrent systemic targeted immunomodulator or non‑compliant dosing/criteria
Requests may be denied if Entyvio is prescribed in combination with another systemic targeted immunomodulator for the same indication, if FDA‑labeled dosing is not followed, or if the diagnosis/coverage criteria are not met.
Denial triggers: missing prior‑therapy documentation or unauthorized prior targeted use
Denial risks include failure to document inadequate response to the specified conventional therapies (at maximally indicated doses unless contraindicated) when required for initial therapy, or prior use of a systemic targeted immunomodulator without meeting the policy's initial‑therapy options; concurrent use of Entyvio with another systemic targeted immunomodulator for the same indication may also lead to non‑approval.
Definitions and Examples
Background
Vedolizumab (Entyvio) is a humanized monoclonal antibody that binds the α4β7‑integrin, inhibiting migration of memory T‑lymphocytes into inflamed gastrointestinal tissue. It is indicated in this policy for treatment of moderately to severely active Crohn's disease and ulcerative colitis, and the policy also addresses use for immune checkpoint inhibitor–related GI toxicities and steroid‑refractory gastrointestinal acute graft‑versus‑host disease with specified dose limits and coverage criteria.
Policy Revision History
Coverage criteria revised: initial therapy for Crohn's disease and ulcerative colitis now require either prior failure of specified conventional therapies or prior treatment with a systemic targeted immunomodulator; continuation criteria require no concurrent use of Entyvio with another systemic targeted immunomodulator for the same indication; lists of systemic targeted immunomodulators were updated (Zeposia added; some agents removed/renamed).
Policy template updated and Application section added to indicate applicability to UnitedHealthcare Commercial and Individual Exchange benefit plans; clarified that self-administered subcutaneous Entyvio is obtained under the pharmacy benefit unless plan specifies otherwise (exception for certain UnitedHealthcare of California delegated reviews).
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