J3380 — Injection, vedolizumab, intravenous, 1 mg
HCPCS/CPT
Prior Authorization
No Prior Auth Required
Code is covered without prior authorization (high confidence)
Medicare Pricing
Work RVU
0.00
Facility
N/A
Non-Facility
N/A
Documentation Required
- Documentation of diagnosis: moderately to severely active Crohn's disease or moderately to severely active ulcerative colitis (as applicable).
- Documentation of one of the following prior to initial therapy for CD/UC: failure, contraindication, or intolerance to at least one conventional therapy (examples: TNF blocker such as adalimumab or certolizumab; immunomodulator such as azathioprine or 6-mercaptopurine; corticosteroid; or corticosteroid dependence).
- Documentation that Entyvio is initiated and titrated according to US FDA labeled dosing for the specific indication (Crohn's disease or ulcerative colitis).
- Documentation that the patient is not receiving Entyvio in combination with disallowed targeted immunomodulators (examples provided in policy) or natalizumab (Tysabri).
Key Coverage Criteria
- Crohn's disease when all of the following criteria are met:
- For initial therapy, all of the following:
- Diagnosis of moderately to severely active Crohn's disease (CD); and
- One of the following: History of failure, contraindication, or intolerance to at least one of the following conventional therapies: Tumor necrosis factor (TNF) blocker [e.g., adalimumab, Cimzia (certolizumab)] Immunomodulator (e.g., azathioprine, 6-mercaptopurine) Corticosteroid Corticosteroid dependent (e.g., unable to successfully taper corticosteroids without a return of the symptoms of CD); and
- Entyvio is initiated and titrated according to US Food and Drug Administration (FDA) labeled dosing for Crohn's disease; and
- Patient is not receiving Entyvio in combination with either of the following: Targeted immunomodulator [e.g., adalimumab, Cimzia (certolizumab), Omvoh (mirikizumab-mrkz), Rinvoq (upadacitinib), Simponi (golimumab), Skyrizi (risankizumab), Tremfya (guselkumab), ustekinumab, Xeljanz (tofacitinib)] Tysabri (natalizumab)
15 Active Policies
AETNA-CPB-0732 — Guillain-Barre Syndrome Treatments
UHC-POL-entyvio-vedolizumab — Entyvio (Vedolizumab)
UHC-POL-provider-administered-drugs-soc — Provider Administered Drugs – Site of Care
UMR-POL-UMR-entyvio-vedolizumab — Entyvio (Vedolizumab)
UMR-POL-UMR-provider-administered-drugs-soc — Provider Administered Drugs – Site of Care
Related Codes
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