Betibeglogene autotemcel (Zynteglo) (ARCHIVED)

Policy ID: I-9014-005

Section: Injections

Effective Date: August 18, 2022

Revised Date: October 27, 2024

Revision Effective Date: December 08, 2024

Last Reviewed: November 19, 2024

Applies To: Commercial Only

This policy has been Archived effective December 08, 2024. Click the Archive tab above for more information.

Policy ID: I-9014-005

Section: Injections

Effective Date: August 18, 2022

Revised Date: October 27, 2024

Revision Effective Date: December 08, 2024

Last Reviewed: November 19, 2024

Archived Date: December 08, 2024

Applies To: Commercial Only

Description

Betibeglogene autotemcel (Zynteglo) is an autologous hematopoietic stem cell-based gene therapy.

Policy Application

All claims submitted for this policy will be processed according to the policy effective date and associated revision effective dates in effect on the date of service.

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.

Betibeglogene autotemcel (Zynteglo) may be considered medically necessary when the following criteria are met:

The individual has a diagnosis of transfusion dependent Beta-thalassemia (β-thalassemia major or TDT); and
ONE of the following:
- The individual is less than 12 years of age AND BOTH of the following:
  - If the individual is less than five (5) years of age BOTH of the following:
    - The individual weighs greater than or equal to six (6) kg; and
    - The prescriber has determined that the individual is able to provide the minimum number of cells; and
  - ONE of the following:
    - The individual has a history of at least 100 mL/kg/year of packed red blood cells (pRBC) in the previous 12 months; or
    - The individual has required greater than or equal to eight (8) pRBC transfusions in the past 12 months; or
- The individual is at least 12 years of age but less than or equal to 50 years of age AND ONE of the following:
  - The individual has a history of at least 100 mL/kg/year of packed red blood cells (pRBC) in the past 12 months; or
  - The individual has required greater than or equal to eight (8) pRBC transfusions in the past 12 months; and
The individual is clinically stable and able to undergo a hematopoietic stem cell transplant (HSCT); and
The individual does NOT have a white blood cell count less than 3 X 10^9/L and/or a platelet count less than 100 X10^9/L; and
The individual does NOT have evidence of an uncorrected bleeding disorder; and
ONE of the following:
- The individual does NOT have any prior or current malignancy that required systemic therapy; or
- The individual had adequately treated cone-biopsied in situ carcinoma of the cervix uteri; or
- The individual had an adequately treated basal or squamous cell carcinoma of the skin; and
The individual does NOT have advanced liver dysfunction as defined by any of the following:
- ALT (alanine transaminase) three (3) times the upper limit of normal; and
- Bilirubin above three (3) times the upper limit of normal; and
- Alkaline phosphatase above three (3) times the upper limit of normal; and
- INR (international normalized ratio) greater than or equal to 1.4; and
The individual does NOT have a T2* less than 10 ms by magnetic resonance imaging (MRI); and
The individual does NOT have severe iron overload that in the provider's opinion warrants exclusion; and
The individual is NOT HIV positive; and
BOTH of the following:
- The individual has a negative hepatitis B surface antigen (HBsAg); and
- ONE of the following:
  - The individual's hepatitis B core antibody (HBcAB) is negative; or
  - The individual's HBcAB is positive due to a resolved hepatitis B infection AND the individual's HBV virus DNA is negative; and
ONE of the following:
- The individual's hepatitis C virus (HCV) antibody is negative; or
- The individual's HCV antibody is positive AND the individual's HCV RNA is negative; and
The individual does NOT have another active infection; and
The individual has NOT had previous gene therapy for the requested diagnosis.

Length of Approval: One (1) course per lifetime

The use of betibeglogene autotemcel (Zynteglo) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.

Procedure Code

J3393

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the United States Food and Drug Administration (U.S. FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines.

Diagnosis Code

D56.1

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 9-21-2022 - Effective August 18, 2022

Adopted new precertification policy

Internal Medical Policy Committee 9-28-2022 - Effective October 1, 2022

Added another 'or' criteria for individuals less than five (5) years of age, 'The individual has required greater than or equal to eight (8) pRBC transfusions in the past 12 months;'

Internal Medical Policy Committee 9-12-2023 Annual review, no clinical content change

Internal Medical Policy Committee 5-14-2024 Effective July 01, 2024

Added new code, J3393, to the policy

Internal Medical Policy Committee 11-19-2024 Effective December 08, 2024

Archived policy

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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