Description

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.

Criteria

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 individual is sixteen (16) years of age or older; and
• The individual has a diagnosis of sickle cell disease; and
• The individual has a history of VOCs; and
• EITHER ONE of the following:
  • The individual is currently receiving hydroxyurea therapy, and hydroxyurea therapy will continue with the addition of crizanlizumab (Adakveo); or
  • The individual has experienced a therapeutic failure, intolerance, or contraindication to hydroxyurea therapy.

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.

Procedure Codes

Outpatient HCPCS (C Codes)

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.

Diagnosis Codes

Covered Diagnosis Codes for Procedure Codes J3590 and C9053

Professional Statements and Societal Positions Guidelines

NA