All Policies and Precertification
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Crizanlizumab (Adakveo®) is a humanized IgG2 kappa monoclonal antibody that functions by binding to P-selectin, preventing the interaction with P-selectin glycoprotein ligand 1. Blocking P-selectin on the surface of activated endothelium and platelets blocks interactions between endothelial cells, platelets, red blood cells, and leukocytes, which in turn reduces the frequency of vaso-occlusive crises (VOCs) in individuals with sickle cell disease.
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.
The use of crizanlizumab (Adakveo) may be considered medically necessary to reduce the frequency of VOCs in sickle cell disease when the individual meets ALL of the following criteria:
The use of crizanlizumab (Adakveo) for any other indication is considered experimental/investigational as the published peer reviewed literature does not support its efficacy or safety for any other indications.
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.
Covered Diagnosis Codes for Procedure Codes J0971
D57.00
D57.01
D57.02
D57.03
D57.09
D57.1
D57.20
D57.211
D57.212
D57.213
D57.218
D57.219
D57.40
D57.411
D57.412
D57.413
D57.418
D57.419
D57.42
D57.431
D57.432
D57.433
D57.438
D57.439
D57.44
D57.451
D57.452
D57.453
D57.458
D57.459
D57.80
D57.811
D57.812
D57.813
D57.818
D57.819
Not Applicable
Internal Medical Policy Committee 1-22-2020 New Policy for North Dakota
Internal Medical Policy Committee 3-16-2020 Added new code C9053, added additional diagnosis codes
Internal Medical Policy Committee 7-22-2020 Removed C9053, added new code, J0791 effective 7-1-2020
Internal Medical Policy Committee 9-21-2020 Updated diagnosis codes
Internal Medical Policy Committee 11-19-2020 No clinical content change
References (PDF)
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.
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 North Dakota may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.
D57.81