Vedolizumab (Entyvio) is a monoclonal antibody and integrin receptor antagonist used for the treatment of moderately to severely active Crohn’s disease (CD) and ulcerative colitis (UC) in adults. Vedolizumab (Entyvio) reduces chronically inflamed gastrointestinal tissue associated with UC/CD by binding to the α4β7 integrin receptor and inhibiting its interaction with mucosal addressin cell adhesion molecule-1 (MAdCAM-1). This results in the inhibition of memory T-lymphocyte movement across the endothelium of the inflamed gastrointestinal tissues.
Coverage is subject to the specific terms of the member’s benefit plan.
Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.
Vedolizumab (Entyvio) may be considered medically necessary when an individual meets the criteria for ANY ONE of the following indications:
Crohn’s Disease (CD):
Ulcerative Colitis (UC):
Vedolizumab (Entyvio) for any other indication is considered experimental/investigational and therefore non-covered. Scientific evidence has not established the effectiveness for any other indication.
J3380 |
Reauthorization Criteria
Continuation of therapy with vedolizumab (Entyvio) may be considered medically necessary when the following criteria are met:
Vedolizumab (Entyvio) for any other indication is considered experimental/investigational and therefore non-covered. Scientific evidence has not established the effectiveness for any other indication.
J3380 |
Vedolizumab (Entyvio) is considered not medically necessary for an individual with ANY of the following:
Vedolizumab (Entyvio) for any other indication is considered experimental/investigational and therefore non-covered. Scientific evidence has not established the effectiveness for any other indication.
J3380 |
NOTE:In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines. Blue Cross Blue Shield of North Dakota may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.
K50.00 |
K50.011 |
K50.012 |
K50.013 |
K50.014 |
K50.018 |
K50.019 |
K50.10 |
K50.111 |
K50.112 |
K50.113 |
K50.114 |
K50.118 |
K50.119 |
K50.80 |
K50.811 |
K50.812 |
K50.813 |
K50.814 |
K50.818 |
K50.819 |
K50.90 |
K50.911 |
K50.912 |
K50.913 |
K50.914 |
K50.918 |
K50.919 |
K51.00 |
K51.011 |
K51.012 |
K51.013 |
K51.014 |
K51.018 |
K51.019 |
K51.20 |
K51.211 |
K51.212 |
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K51.219 |
K51.30 |
K51.311 |
K51.312 |
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K51.314 |
K51.318 |
K51.319 |
K51.40 |
K51.411 |
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K51.418 |
K51.419 |
K51.50 |
K51.511 |
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K51.519 |
K51.80 |
K51.811 |
K51.812 |
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K51.814 |
K51.818 |
K51.819 |
K51.90 |
K51.911 |
K51.912 |
K51.913 |
K51.914 |
K51.918 |
K51.919 |
Not Applicable
Original Effective Date July 1, 2018
Internal Medical Policy Committee 3-16-2020 Updated criteria to match other biologic immunomodulator criteria, update preferred products for UC, added reauthorization criteria
Internal Medical Policy Committee 5-19-2020 Removed preferred product language
Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving and the Company reserves the right to review and update medical policy periodically.