Crizanlizumab-tmca (Adakveo)

Policy ID: I-218-006

Section: Injections

Effective Date: February 01, 2020

Revised Date: February 23, 2021

Revision Effective Date: May 01, 2021

Last Reviewed: March 17, 2021

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

J0791

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.

Diagnosis Codes

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

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

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

Internal Medical Policy Committee 3-17-2021 Annual review, no clinical content change

Links

References (PDF)

Disclaimer

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.

Policy ID: I-218-005

Section: Injections

Effective Date: February 01, 2020

Revised Date: October 21, 2020

Revision Effective Date: December 01, 2020

Last Reviewed: November 19, 2020

Archived Date: April 30, 2021

Description

Criteria

Coverage is subject to the specific terms of the member’s benefit plan.

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.

Procedure Codes

J0791

Diagnosis Codes

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

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

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

Links

References (PDF)

Disclaimer

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.

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