Efgartigmod alfa-fcab (Vyvgart) and Efgartigmod alfa and hyaluronidase-qvfc (Vyvgart Hytrulo)

Policy ID: I-9020-004

Section: Injections

Effective Date: January 10, 2022

Revised Date: November 14, 2023

Revision Effective Date: January 01, 2024

Last Reviewed: November 15, 2023

Applies To: Commercial Only

Description

Efgartigmod alfa-fcab (Vygart®) is an antibody fragment that binds to the neonatal Fc receptor (FcRn). The blockade of FcRn reduces IgG antibody levels, including the abnormal antiacetylcholine receptor (AChR) antibodies that are present in patients with generalized myasthenia gravis (gMG). In patients with myasthenia gravis who test positive for the antiacetylcholine receptor (AChR) antibody, the AChR antibodies interfere with communication between nerves and muscles, resulting in weakness.

Efgartigmod alfa and hyaluronidase-qvfc (Vyvgart® Hytrulo) is a combination of efgartigmod alfa and hyaluronidase. The hyalyronidase component increases the dispersion and absorption of efgartigmod alfa following subcutaneous administration by a healthcare professional.

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 efgartigmod alfa-fcab (Vyvgart) or efgartigmod alfa and hyaluronidase-qvfc (Vyvgart Hytrulo) may be considered medically necessary when ALL of the following criteria are met:

ONE of the following:
- The individual has a diagnosis of generalized Myasthenia Gravis (gMG) AND ALL of the following:
  - The individual has a positive serological test for anti-AChR antibodies (lab test must be submitted); and
  - The individual has a Myasthenia Gravis Foundation of America (MGFA) clinical classification class of II-IVb; and
  - The individual has a MG-Activities of Daily Living total score of greater than or equal to five (5); and
  - ONE of the following:
    - The prescriber has assessed the individual's current medications and discontinued any medications known to exacerbate myasthenia gravis (e.g., beta blockers, procainamide, quinidine, magnesium, anti-programmed death receptor-1 monoclonal antibodies, hydroxychloroquine, aminoglycosides); or
    - The prescriber has provided clinical rationale indicating that discontinuation of the offending agent is not clinically appropriate; and
  - ONE of the following:
    - The individual has tried and had an inadequate response to at least ONE conventional agent used for the treatment of myasthenia gravis (i.e., corticosteroids, azathioprine, cyclosporine, mycophenolate mofetil, tacrolimus, methotrexate, cyclophosphamide; or
    - The individual has an intolerance or hypersensitivity to ONE conventional agent used for the treatment of myasthenia gravis (i.e., corticosteroids, azathioprine, cyclosporine, mycophenolate mofetil, tacrolimus, methotrexate, cyclophosphamide; or
    - The individual has an FDA labeled contraindication to ALL conventional agents used for the treatment of myasthenia gravis (i.e., corticosteroids, azathioprine, cyclosporine, mycophenolate mofetil, tacrolimus, methotrexate, cyclophosphamide; or
    - The individual required chronic intravenous immunoglobulin (IVIG) (i.e., at least every 3 months over 12 months without symptom control); or
    - The individual required chronic plasmapheresis/plasma exchange (i.e., at least every 3 months over 12 months without symptom control); or
  - The individual has another FDA approved indication for the requested agent; and
If the individual has an FDA approved indication, then ONE of the following:
- The individual's age is within FDA labeling for the requested indication for the requested agent; or
- The prescriber has provided information in support of using the requested agent for the individual's age for the requested indication; and
The prescriber is a specialist in the area of the individual's diagnosis (e.g., neurologist) or the prescriber has consulted with a specialist in the area of the individual's diagnosis; and
The individual will NOT be using the requested agent in combination with eculizumab (Soliris), rozanolixizumab-noli (Rystiggo), or ravulizumab-cwvz (Ultomiris) for the requested indication.

Initial Length of Approval: Six (6) months

The use of efgartigmod alfa-fcab (Vyvgart) or efgartigmod alfa and hyaluronidase-qvfc (Vyvgart Hytrulo) 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 Codes

J9332

J9334

Reauthorization Criteria

Continuation of treatment with efgartigmod alfa-fcab (Vyvgart) or efgartigmod alfa and hyaluronidase-qvfc (Vyvgart Hytrulo) beyond six (6) months after initiation of therapy may be considered medically necessary when individuals meet ALL of the following:

The individual has been previously approved for the requested agent through Blue Cross Blue Shield of North Dakota's precertification process; and
The prescriber has provided information that the individual has had clinical benefit with the requested agent (e.g., improved MG-ADL total score, improved quantitative myasthenia gravis total score); and
The prescriber is a specialist in the area of the individual's diagnosis (e.g., neurologist) or the prescriber has consulted with a specialist in the area of the individual's diagnosis; and
The individual will NOT be using the requested agent in combination with eculizumab (Soliris), rozanolixizumab-noli (Rystiggo), or ravulizumab-cwvz (Ultomiris) for the requested indication.

Procedure Codes

J9332

J9334

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 Codes

G70.00

G70.01

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 1-20-2022 - Effective January 10, 2022

Adopted new precertification policy

Internal Medical Policy Committee 7-21-2022 - Effective July 01, 2022

Updated criteria and initial length of approval from three (3) months to six (6) months; and
Updated coding
- Removed Procedure code: J3490
- Added Procedure code J9332

Internal Medical Policy Committee 7-26-2023 - Effective September 01, 2023

Updated description
Added efgartigmod alfa and hyaluronidase-qvfc (Vyvgart Hytrulo) to the policy
Added 'conventional' agent
Updated combination agents list

Internal Medical Policy Committee 11-15-2023 Effective January 01, 2024

Added new code J9334 for efgartigmod alfa and hyaluronidase-qvfc (Vyvgart Hytrulo)

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-9020-003

Section: Injections

Effective Date: January 10, 2022

Revised Date: July 20, 2023

Revision Effective Date: September 01, 2023

Last Reviewed: July 26, 2023

Archived Date: December 31, 2023

Applies To: Commercial Only

Description

Criteria

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

The use of efgartigmod alfa-fcab (Vyvgart) or efgartigmod alfa and hyaluronidase-qvfc (Vyvgart Hytrulo) may be considered medically necessary when ALL of the following criteria are met:

ONE of the following:
- The individual has a diagnosis of generalized Myasthenia Gravis (gMG) AND ALL of the following:
  - The individual has a positive serological test for anti-AChR antibodies (lab test must be submitted); and
  - The individual has a Myasthenia Gravis Foundation of America (MGFA) clinical classification class of II-IVb; and
  - The individual has a MG-Activities of Daily Living total score of greater than or equal to five (5); and
  - ONE of the following:
    - The prescriber has assessed the individual's current medications and discontinued any medications known to exacerbate myasthenia gravis (e.g., beta blockers, procainamide, quinidine, magnesium, anti-programmed death receptor-1 monoclonal antibodies, hydroxychloroquine, aminoglycosides); or
    - The prescriber has provided clinical rationale indicating that discontinuation of the offending agent is not clinically appropriate; and
  - ONE of the following:
    - The individual has tried and had an inadequate response to at least ONE conventional agent used for the treatment of myasthenia gravis (i.e., corticosteroids, azathioprine, cyclosporine, mycophenolate mofetil, tacrolimus, methotrexate, cyclophosphamide; or
    - The individual has an intolerance or hypersensitivity to ONE conventional agent used for the treatment of myasthenia gravis (i.e., corticosteroids, azathioprine, cyclosporine, mycophenolate mofetil, tacrolimus, methotrexate, cyclophosphamide; or
    - The individual has an FDA labeled contraindication to ALL conventional agents used for the treatment of myasthenia gravis (i.e., corticosteroids, azathioprine, cyclosporine, mycophenolate mofetil, tacrolimus, methotrexate, cyclophosphamide; or
    - The individual required chronic intravenous immunoglobulin (IVIG) (i.e., at least every 3 months over 12 months without symptom control); or
    - The individual required chronic plasmapheresis/plasma exchange (i.e., at least every 3 months over 12 months without symptom control); or
  - The individual has another FDA approved indication for the requested agent; and
If the individual has an FDA approved indication, then ONE of the following:
- The individual's age is within FDA labeling for the requested indication for the requested agent; or
- The prescriber has provided information in support of using the requested agent for the individual's age for the requested indication; and
The prescriber is a specialist in the area of the individual's diagnosis (e.g., neurologist) or the prescriber has consulted with a specialist in the area of the individual's diagnosis; and
The individual will NOT be using the requested agent in combination with eculizumab (Soliris), rozanolixizumab-noli (Rystiggo), or ravulizumab-cwvz (Ultomiris) for the requested indication.

Initial Length of Approval: Six (6) months

Procedure Codes

J3590

J9332

Reauthorization Criteria

The individual has been previously approved for the requested agent through Blue Cross Blue Shield of North Dakota's precertification process; and
The prescriber has provided information that the individual has had clinical benefit with the requested agent (e.g., improved MG-ADL total score, improved quantitative myasthenia gravis total score); and
The prescriber is a specialist in the area of the individual's diagnosis (e.g., neurologist) or the prescriber has consulted with a specialist in the area of the individual's diagnosis; and
The individual will NOT be using the requested agent in combination with eculizumab (Soliris), rozanolixizumab-noli (Rystiggo), or ravulizumab-cwvz (Ultomiris) for the requested indication.

Procedure Codes

J3590

J9332

Diagnosis Codes

G70.00

G70.01

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 1-20-2022 - Effective January 10, 2022

Adopted new precertification policy

Internal Medical Policy Committee 7-21-2022 - Effective July 01, 2022

Updated criteria and initial length of approval from three (3) months to six (6) months; and
Updated coding
- Removed Procedure code: J3490
- Added Procedure code J9332

Internal Medical Policy Committee 7-26-2023 - Effective September 01, 2023

Updated description
Added efgartigmod alfa and hyaluronidase-qvfc (Vyvgart Hytrulo) to the policy
Added 'conventional' agent
Updated combination agents list

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Efgartigmod alfa-fcab (Vyvgart) and Efgartigmod alfa and hyaluronidase-qvfc (Vyvgart Hytrulo)

Description

Criteria

Procedure Codes

Procedure Codes

Diagnosis Codes

Professional Statements and Societal Positions Guidelines

ND Committee Review

Links

Disclaimer

Description

Criteria

Procedure Codes

Procedure Codes

Diagnosis Codes

Professional Statements and Societal Positions Guidelines

ND Committee Review

Links

Disclaimer