Crizanlizumab-tmca (Adakveo)

Policy ID: I-218-007

Section: Injections

Effective Date: February 01, 2020

Revised Date: September 20, 2022

Revision Effective Date: November 01, 2022

Last Reviewed: September 12, 2023

Applies To: Commercial and Medicaid Expansion

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 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 (1) 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.

Reauthorization Criteria

Continuation of therapy with crizanlizumab (Adakveo) may be considered medically necessary when the following criteria are met:

The individual meets all above criteria; and
Provider attestation that individual has demonstrated a disease stability or beneficial response to therapy.

The use of crizanlizumab (Adakveo) for any other indication is considered experimental/investigational and therefore, non-covered. The safety and/or efficacy cannot be established by review of the available published peer-reviewed literature.

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.

NOTE: Crizanlizumab (Adakveo) is not to be used in combination with voxelotor (Oxbryta).

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, and
Added additional diagnosis codes

Internal Medical Policy Committee 7-22-2020 - Effective July 01, 2020

Removed C9053, and
Added new code, J0791

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

Internal Medical Policy Committee 3-23-2022 Annual review no clinical content change

Internal Medical Policy Committee 9-28-2022

Added reauthorization criteria, and
Added note: "Crizanlizumab (Adakveo) is not to be used in combination with voxelotor (Oxbryta)."
Updated experimental/investigational statement

Internal Medical Policy Committee 9-12-2023

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-218-006

Section: Injections

Effective Date: February 01, 2020

Revised Date: February 23, 2021

Revision Effective Date: May 01, 2021

Last Reviewed: March 23, 2022

Archived Date: October 31, 2022

Applies To: Commercial and Medicaid Expansion

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.

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

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

Internal Medical Policy Committee 3-23-2022 Annual review-no changes in criteria

Links

References (PDF)

Disclaimer

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