CurrentSecurity Health Plan of Wisconsin, Inc.Policy SHP-P0649

Vyvgart (efgartigimod alfa-fcab) Intravenous Coverage Criteria

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This policy governs prior authorization, dosing, initial approval, and renewal of intravenous Vyvgart, primarily for generalized myasthenia gravis and other FDA-labeled indications, and requires clinical documentation supporting medical necessity.

Policy Summary

PayerSecurity Health Plan of Wisconsin, Inc.

PolicyVyvgart (efgartigimod alfa-fcab) Intravenous Coverage Criteria

Policy CodePolicy SHP-P0649

Change TypeNo material changes

Effective DateN/A

Last ReviewDec 2, 2025

Next Review DateN/A

Key ActionSubmit supporting clinical documentation with each prior authorization request, including records supporting diagnosis, step therapy, and applicable clinical criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsInitial authorization

12 monthsRenewal authorization

600 unitsMaximum dose

MG-ADL ≥5gMG threshold

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CurrentSecurity Health Plan of Wisconsin, Inc.Policy SHP-P0649

Vyvgart (efgartigimod alfa-fcab) Intravenous Coverage Criteria

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Policy Summary

PayerSecurity Health Plan of Wisconsin, Inc.

PolicyVyvgart (efgartigimod alfa-fcab) Intravenous Coverage Criteria

Policy CodePolicy SHP-P0649

Change TypeNo material changes

Effective DateN/A

Last ReviewDec 2, 2025

Next Review DateN/A

Key ActionSubmit supporting clinical documentation with each prior authorization request, including records supporting diagnosis, step therapy, and applicable clinical criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsInitial authorization

12 monthsRenewal authorization

600 unitsMaximum dose

MG-ADL ≥5gMG threshold

Coverage Criteria

Initial approval criteria

Covered when ALL applicable requirements are met and ONE of the following indication pathways is satisfied.

Initial approval requirements

Covered indication pathway
- Generalized myasthenia gravis
  - gMG clinical criteria: The patient has generalized myasthenia gravis, positive anti-AChR antibody serology, MGFA clinical classification class II-IVb, and an MG-Activities of Daily Living total score greater than or equal to 5.MG-ADL ≥5; MGFA class II-IVb
    Medical records documenting the positive serological test are required.
  - Medication management
    The patient's current medications have been assessed and medications known to exacerbate myasthenia gravis have been discontinued.
    Examples include beta blockers, procainamide, quinidine, magnesium, anti-programmed death receptor-1 monoclonal antibodies, hydroxychloroquine, and aminoglycosides.
    Discontinuation of the offending agent is not clinically appropriate.
  - Prior treatment or rescue therapy
    The patient tried and had an inadequate response to at least one conventional agent used to treat myasthenia gravis.
    Conventional agents include corticosteroids, azathioprine, cyclosporine, mycophenolate mofetil, tacrolimus, methotrexate, and cyclophosphamide.
    The patient has an intolerance or hypersensitivity to at least one conventional agent used to treat myasthenia gravis.
    Conventional agents include corticosteroids, azathioprine, cyclosporine, mycophenolate mofetil, tacrolimus, methotrexate, and cyclophosphamide.
    The patient has an FDA-labeled contraindication to all conventional agents used to treat myasthenia gravis.
    Conventional agents include corticosteroids, azathioprine, cyclosporine, mycophenolate mofetil, tacrolimus, methotrexate, and cyclophosphamide.
    The patient required chronic intravenous immunoglobulin (IVIG).
    The patient required chronic plasmapheresis or plasma exchange.
  - No prohibited combination: The requested agent will not be used in combination with Rystiggo, Soliris, Bkemv, Epysqli, Ultomiris, Zilbrysq, Vyvgart Hytrulo, or Imaavy.
- Other FDA-labeled indication
  - The patient has another FDA-labeled indication for the requested agent and route of administration.
  - Age requirement
    The patient's age is within FDA labeling for the requested indication.
    There is support for using the requested agent for the patient's age for the requested indication.
General requirements
- The prescriber is a specialist in the area of the patient's diagnosis, or the prescriber has consulted with a specialist in that area.
  For example, a neurologist for myasthenia gravis.
- The patient does not have any FDA-labeled contraindications to the requested agent.
- The requested quantity or dose is within FDA-labeled dosing for the requested indication.

Renewal criteria

Renewal is covered when ALL of the following are met.

Renewal requirements

The patient was previously approved for the requested agent through the plan's Medical Drug Review process.
Patients not previously approved for the requested agent require initial evaluation review.
The patient has had clinical benefit with the requested agent.
The prescriber is a specialist in the area of the patient's diagnosis, or the prescriber has consulted with a specialist in that area.
For example, a neurologist for myasthenia gravis.
The requested agent will not be used in combination with Rystiggo, Soliris, Bkemv, Epysqli, Ultomiris, Zilbrysq, Vyvgart Hytrulo, or Imaavy.

Dosage and administration

For generalized myasthenia gravis:

Administration schedule

Administer Vyvgart as a 10 mg/kg intravenous infusion over one hour once weekly for 4 weeks.10 mg/kg IV over 1 hour once weekly for 4 weeks
For patients weighing 120 kg or more, administer 1200 mg (3 vials) per infusion.1200 mg (3 vials) per infusion for weight ≥120 kg
Administer subsequent treatment cycles based on clinical evaluation.

Vyvgart must not be used in combination with Rystiggo (rozanolixizumab-noli), Soliris (eculizumab), Bkemv (eculizumab-aeeb), Epysqli (eculizumab-aagh), Ultomiris (ravulizumab-cwvz), Zilbrysq (zilucoplan), Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc), or Imaavy (nipocalimab-aahu). This restriction applies to both initial approval and renewal.

Patients with an FDA-labeled contraindication to Vyvgart are not eligible for coverage. The requested dose or quantity must also remain within FDA-labeled dosing for the applicable indication.

Coding and Dose Parameters

HCPCS CodeHCPCSCovered

J9332

Injection, efgartigimod alfa-fcab, 2 mg; 1 billable unit = 2 mg

NDCNDCCovered

73475-3041-xx

Vyvgart 400 mg/20 mL single-dose vial

Covered Diagnosis CodesICD-10Covered

G70.00	Myasthenia gravis without (acute) exacerbation
G70.01	Myasthenia gravis with (acute) exacerbation

Dosing limit

Maximum billable units600 billable units

FrequencyWeekly

Coverage period4 doses per 56 days

MG-ADL total score

AssessmentMG-Activities of Daily Living (MG-ADL) total score

Minimum scoreGreater than or equal to 5

Application

Authorization and Documentation Requirements

Prior Authorization

Prior Authorization Duration

Prior authorization is required for Vyvgart. Initial authorization is valid for 6 months; renewal authorization may be granted every 12 months thereafter.

Documentation Required

Initial Authorization Requirements

Submit supporting clinical documentation with every authorization request to establish the covered diagnosis and medical necessity. Records must be provided through the PA web portal or by fax for review.

Medical records and chart notes
Laboratory results and confirmatory diagnostics
Documentation of diagnosis, step therapy, and applicable clinical markers

Policy Background

Vyvgart (efgartigimod alfa-fcab) is an intravenous therapy covered under this policy for generalized myasthenia gravis and other FDA-labeled indications. For generalized myasthenia gravis, coverage review considers the patient's clinical status, applicable treatment history, specialist involvement, and whether the requested use is consistent with FDA labeling.

Policy Summary

PayerSecurity Health Plan of Wisconsin, Inc.

PolicyVyvgart (efgartigimod alfa-fcab) Intravenous Coverage Criteria

Policy CodePolicy SHP-P0649

Change TypeNo material changes

Effective DateN/A

Last ReviewDec 2, 2025

Next Review DateN/A

Key ActionSubmit supporting clinical documentation with each prior authorization request, including records supporting diagnosis, step therapy, and applicable clinical criteria.

SourceLink

On This Page

The patient does not have any FDA-labeled contraindications to the requested agent.

The requested quantity or dose is within FDA-labeled dosing for the requested indication.

Required for generalized myasthenia gravis coverage criteria

Generalized myasthenia gravis dose

Weight-based dose10 mg/kg intravenously

Administration scheduleInfuse over one hour once weekly for 4 weeks

Maximum-weight adjustmentPatients weighing 120 kg or more receive 1200 mg (3 vials) per infusion

Renewal Authorization Requirements

Renewal requests require that the member was previously approved through the plan’s Medical Drug Review process, has documented clinical benefit, and continues to meet the applicable coverage requirements.

Prior approval through Medical Drug Review; patients without prior approval require initial evaluation
Documented clinical benefit with the requested agent
Specialist prescriber involvement or consultation
No prohibited combination therapy
No FDA-labeled contraindication and dosing within FDA labeling

Step Therapy

Treatment History

For gMG, document the required treatment history before initiation. The member must have qualifying conventional-therapy experience or another listed treatment circumstance.

Inadequate response to at least one conventional agent: corticosteroids, azathioprine, cyclosporine, mycophenolate mofetil, tacrolimus, methotrexate, or cyclophosphamide
Intolerance or hypersensitivity to at least one listed conventional agent
FDA-labeled contraindication to all listed conventional agents
Requirement for chronic intravenous immunoglobulin (IVIG)
Requirement for chronic plasmapheresis/plasma exchange

Documentation Required

Manage Exacerbating Medications

Assess the member’s current medications and discontinue medications known to exacerbate myasthenia gravis unless discontinuation is not clinically appropriate. Document the assessment and the clinical rationale when an offending medication is continued.

Examples include beta blockers, procainamide, quinidine, magnesium, anti-programmed death receptor-1 monoclonal antibodies, hydroxychloroquine, and aminoglycosides

Documentation Required

Required Clinical Records

Submit the records needed to evaluate medical necessity with the initial request. Missing supporting documentation may prevent approval.

Medical records and chart notes
Laboratory results
Confirmatory diagnostics
Documentation of diagnosis, step therapy, and applicable genetic or mutational testing

Documentation Required

Document gMG Disease Severity

For generalized myasthenia gravis, the request must establish the required disease severity and serologic findings.

Positive anti-AChR antibody serology
MGFA clinical classification II through IVb
MG-Activities of Daily Living (MG-ADL) total score greater than or equal to 5
Related clinical findings supporting generalized myasthenia gravis

Step Therapy

Document Prior Treatment

Document the applicable qualifying treatment history for gMG before requesting initial authorization.

Inadequate response, intolerance, or hypersensitivity to a conventional agent
FDA-labeled contraindication to all conventional agents
Chronic IVIG requirement
Chronic plasmapheresis or plasma exchange requirement

Documentation Required

Prescriber and Dosing Requirements

The prescriber must be a specialist in the area of the diagnosis, such as a neurologist, or must have consulted with an appropriate specialist. Confirm that the member has no FDA-labeled contraindication and that the requested quantity and dose comply with FDA labeling for the indication.

Specialist prescriber or documented specialist consultation
No FDA-labeled contraindication to Vyvgart
Dose and quantity within FDA-labeled limits

Documentation Required

Renewal Documentation

Renewal requests must document both prior plan approval and continued clinical benefit with Vyvgart.

Previous approval through the plan’s Medical Drug Review process
Documented clinical benefit with the requested agent

Denial Risk

Missing Supporting Documentation

Requests may be denied when the submitted records do not establish the diagnosis or medical necessity required by the policy.

Submit records with the request rather than relying on an unsupported diagnosis or treatment history
Failure to provide medical records may result in denial

Denial Risk

Prohibited Combination Therapy

Vyvgart must not be used in combination with the listed prohibited products. Such combination therapy may result in denial of coverage.

Rystiggo (rozanolixizumab-noli)
Soliris (eculizumab), Bkemv (eculizumab-aeeb), or Epysqli (eculizumab-aagh)
Ultomiris (ravulizumab-cwvz) or Zilbrysq (zilucoplan)
Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc)
Imaavy (nipocalimab-aahu)

Denial Risk

Contraindication or Excessive Dose

Coverage may be denied when the member has an FDA-labeled contraindication to Vyvgart or when the requested quantity or dose exceeds FDA-labeled limits for the indication.

Verify absence of FDA-labeled contraindications
Verify quantity and dose are within FDA-labeled dosing

Denial Risk

Failure to Meet gMG Criteria

Coverage may be denied when the request does not establish the required generalized myasthenia gravis criteria.

Positive anti-AChR antibody serology is required for the gMG pathway
MGFA classification must be II through IVb
MG-ADL total score must be greater than or equal to 5
Clinical documentation must support the generalized diagnosis and medical necessity