Coverage Policies

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Effective Date: 04/01/2015 Title: Entyvio (Vedolizumab)
Revision Date: 10/01/2019 Document: BI478:00
CPT Code(s): C9026, J3380
Public Statement

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Entyvio (Vedolizumab) requires prior authorization.

2)    Entyvio is used to treat Ulcerative Colitis and Crohn’s Disease.

Medical Statement

Entyvio (Vedolizumab) is considered medically necessary for patients with moderate to severely active Ulcerative Colitis or moderate to severely active Crohn’s Disease (K50.00 - K50.919) AND  the following:

1)    For Ulcerative Colitis, inadequate response with, or lost response to or was not able to tolerate a) either Stelara, or Simponi AND b) Xeljanz/XR

2)    For Crohn’s Disease, inadequate response with, or lost response to or was not able to tolerate two (2) of Humira, Cimzia, and Stelara.

3)    For both UC and Crohn’s Disease, inadequate response with, or lost response to or demonstrated dependence on corticosteroids AND

Reauthorization requires documentation that patient is responding positively to therapy.


Codes Used In This BI:


C9026 – Injection, Vedolizumab, 1mg (deleted 12/31/2015)

J3380 – Injection, Vedolizumab, 1mg (Entyvio) effective 1/1/2016


1)    Entyvio Prescribing Information.  Takeda Pharmaceuticals.  May 2014.

2)    Clinical Pharmacology.  Accessed online 3/2/2015.

3)    Sands, B, Peyrin-Biroulet L, Loftus, Jr. E, et al. Vedolizumab versus Adalimumab for Moderate-to-Severe Ulcerative Colitis.  N Engl J Med 2019; 381:1215-1226. September 2019.

Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.
Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.
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