Medicare Advantage

EFGARTIGIMOD ALFA-FCAB (VYVGART) AND EFGARTIGIMOD ALFA AND HYALURONIDASE-QVFC (VYVGART HYTRULO)

Generalized myasthenia gravis (gMG)

Efgartigimod alfa-fcab (Vyvgart) and efgartigimod alfa and hyaluronidase-qvfc (Vyvgart Hytrulo) are considered medically necessary and, therefore, covered for the treatment of adult individuals with generalized myasthenia gravis (gMG) when all of the following criteria are met including dosing and frequency​: 

• The individual is anti-acetylcholine receptor (AChR) antibody-positive.
• The individual meets Myasthenia Gravis Foundation of America (MGFA) Clinical Classification Class II to IV.
• The individual has a Myasthenia Gravis–Specific Activities of Daily Living scale (MG-ADL) total score of five or greater.
  
• The individual is on a stable dose of gMG therapy either in combination or alone of any of the following medications: 
• Acetylcholinesterase (AChE) inhibitors 
• Steroids
  
• Nonsteroidal immunosuppressive therapies (NSISTs)
  
• Dosing and frequency for:
• Efgartigimod alfa-fcab (Vyvgart)*
• The recommended dosage is 10 mg/kg administered as an intravenous infusion over 1 hour once weekly for 4 weeks. 
• In individuals weighing 120 kg or more, 1200 mg per infusion. 

• ​Efgartigimod alfa and hyaluronidase-qvfc (Vyvgart Hytrulo)*​ once weekly injections for 4 weeks:
  
• Prefilled syringe: 1000 mg efgartigimod alfa and 10,000 units hyaluronidase 
• Vial: 1008 mg efgartigimod alfa and 11,200 units hyaluronidase

*Per package insert: subsequent treatment cycles based on clinical evaluation; safety of initiating subsequent cycles sooner than 50 days from the start of the previous treatment cycle has not been established.​​

EFGARTIGIMOD ALFA AND HYALURONIDASE-QVFC (VYVGART HYTRULO)

Chronic inflammatory demyelinating polyneuropathy (CIDP)

Efgartigimod alfa and hyaluronidase-qvfc (Vyvgart Hytrulo) is considered medically necessary and, therefore, covered for the treatment of adult individuals with​ chronic inflammatory demyelinating polyneuropathy (CIDP) when all of the following criteria are met:

• The individual is 18 years of age or older

• The individual has a diagnosis of CIDP when all of the following criteria are met:

• The individual has progressive or relapsing motor or sensory impairment caused by neuropathy in more than one limb for at least 2 months 
• The individual has at least one of the following electrodiagnostic findings of demyelination: 
• Motor distal latency prolongation in two nerves 
• Reduction of motor conduction velocity in two nerves 
• Prolongation of F-wave latency in two nerves 
  
• Absence of F waves in at least one nerve 
• Motor conduction block in at least one nerve 
• Abnormal temporal dispersion in at least two nerves 
• Distal compound muscle action potential (CMAP) duration increase in at least one nerve ​​
• The individual is being treated by or under the supervision of a neurologist
• The​ individual has had previous treatment with, or has contraindication or intolerance to, an intravenous immune globulin (IVIG) or subcutaneous immune globulin (SCIG) product  
• Dosing and frequency for efgartigimod alfa and hyaluronidase-qvfc (Vyvgart Hytrulo) once weekly injections for 4 weeks:
  
• ​Prefilled syringe: 1000 mg efgartigimod alfa and 10,000 units hyaluronidase 
• Vial: 1008 mg efgartigimod alfa and 11,200 units hyaluronidase 

NOTE: Evio has been selected by the Company to administer clinical outcomes monitoring for individuals receiving certain high-cost drug therapies. Vyvgart and Vyvgart Hytrulo​ are included in the portfolio of high-cost drug/biologic therapies for which Evio will be tracking clinical outcomes. If an individual meets all medical policy criteria, the requesting professional provider and/or individual being treated must agree to providing clinical outcomes data and information via Evio's secure web portal as requested. ​

EXPERIMENTAL/INVESTIGATIONAL

All other uses for efgartigimod alfa-fcab (Vyvgart) and efgartigimod alfa and hyaluronidase-qvfc (Vyvgart Hytrulo), are considered experimental/investigational and, therefore, not covered unless the indication is supported as an accepted off-label use, as defined in the Company medical policy on off-label coverage for prescription drugs and biologics.

REQUIRED DOCUMENTATION

An individual's medical record must reflect the medical necessity for the care provided. These medical records may include but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.

When coverage of efgartigimod alfa-fcab (Vyvgart) or efgartigimod alfa and hyaluronidase-qvfc​ (Vyvgart Hytrulo) is requested outside of the Dosing and Frequency Requirements listed in this policy, the prescribing professional provider must supply documentation (i.e., published peer-reviewed literature) to the Company that supports this request.​

BILLING REQUIREMENTS  

For drugs that have more than one method of administration, the appropriate modifier must be appended to indicate the route of administration. To report the intravenous route of administration, append the following modifier: JA Administered Intravenously

Inclusion of a code in this policy does not imply reimbursement. Eligibility, benefits, limitations, exclusions, utilization management/referral requirements, provider contracts, and Company policies apply.