Efgartigmod alfa-fcab (Vygvart®) 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 hyaluronidase component increases the dispersion and absorption of efgartigmod alfa following subcutaneous administration by a healthcare professional. 

Myasthenia Gravis

Efgartigimod alfa-fcab (Vyvgart) or efgartigimod alfa and hyaluronidase-qvfc (Vyvgart Hytrulo) may be considered medically necessary for the treatment of individuals 18 years of age or older with a diagnosis of generalized myasthenia gravis when ALL of the following criteria are met:

• Individual is positive for antiacetylcholine receptor (AchR) antibodies; and
• Individual meets Myasthenia Gravis Foundation of America (MGFA) Clinical Classification Class II to IV*; and
• Individual has a Myasthenia Gravis-Specific Activities of Daily Living scale (MG-ADL) total score of five (5) or greater at initiation*; and
• Individual has experienced therapeutic failure, intolerance, or contraindication to treatment with two (2) or more classes of agents (acetylcholinesterase inhibitor, steroids and non-steroidal immunosuppressants), used alone or in combination; and
• Individual is not concurrently receiving eculizumab (Soliris), ravulizumab-cwvz (Ultomiris), zilucoplan (Zilbrysq) or immune globulin therapy; or
  • Individual transitioning to efgartigimod alfa-fcab (Vyvgart) should discontinue eculizumab (Soliris), ravulizumab-cwvz (Ultomiris), zilucoplan (Zilbrysq) or immune globulin therapy within four (4) weeks of starting efgartigimod alfa-fcab (Vyvgart); and
• Initial authorization period will be for six (6) months.

Reauthorization Criteria

Continuation of efgartigimod alfa-fcab (Vyvgart) or efgartigimod alfa and hyaluronidase-gvfc (Vyvgart Hytrulo) may be medically necessary for individuals when the following criteria are met:

• Individual demonstrates a clinically meaningful response regarding daily activities (greater than or equal to a two (2) point improvement in the MG-ADL from baseline) after initial therapy; and
• Reauthorization will be for a period of six (6) months.

Efgartigmod alfa-fcab (Vyvgart) or efgartigmod alfa and hyaluronidase-qvfc (Vyvgart Hytrulo) not meeting the criteria as listed in this policy is considered not medically necessary. 

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Efgartigimod alfa and hyaluronidase-qvfc (Vyvgart Hytrulo) may be considered medically necessary for the treatment of individuals 18 years of age or older with a diagnosis of chronic inflammatory demyelinating polyneuropathy (CIDP) with progressive symptoms for at least two (2) months when ALL of the following criteria are met:

• Progressive or relapsing motor and/or sensory dysfunction of more than one (1) limb or a peripheral nerve nature, developing over at least two (2) months; and
• Hypo- or areflexia (usually involving all four (4) limbs); and
• Nerve conduction studies strongly supportive of demyelination with at least ONE of the following (consistent with EFNS/PNS guidelines further defined in Professional Statements and Societal Positions section below):
  • Motor distal latency prolongation in at least two (2) nerves; or
  • Reduction of motor conduction velocity in at least two (2) nerves; or
  • Prolongation of F-wave latency in at least two (2) nerves; or
  • Absence of F-waves in at least two (2) nerves; or
  • Motor conduction block in at least one (1) nerve; or
  • Abnormal temporal dispersion in at least two (2) nerves; or
  • Distal CMAP duration prolongation in at least one (1) nerve; and
• Initial authorization will be for a period of 6 months.

Reauthorization Criteria

Continuation of efgartigimod alfa and hyaluronidase-gvtfc (Vyvgart Hytrulo) may be medically necessary for individuals when the following criteria are met:

• Individual has demonstrated clinically meaningful response as indicated by documentation of stable or improved symptoms; and
• Reauthorization will be for a period of 6 months.

Efgartigimod alfa-fcab (Vyvgart) may be considered medically necessary for individuals 18 years of age and older when applicable clinical criteria for individual medication policies are met and when administered in a physician’s office not affiliated with a hospital, specialized infusion centers not affiliated with a hospital or in the home.

Outpatient facility (Outpatient Hospital IV Infusion Department or Hospital-based Outpatient Clinical Level of Care) administration may be considered medically necessary if ANY of the following criteria are present to indicate the member is medically unstable for infusions in settings other than an outpatient facility setting:

• Member’s home is considered unsuitable for care by the home infusion provider; or
• Individual’s medical status requires enhanced monitoring beyond that which would routinely be needed for infusion therapy; or
• Previous severe adverse reaction (including but not limited to anaphylaxis, seizure, thromboembolism, myocardial infarction, renal failure) during or following administration of prescribed medication despite standard pre-medication; or
• Individual is receiving other medications that require close monitoring with a higher level of care (e.g., cytotoxic chemotherapy or blood products); or
• Individual is at high risk for complications due to medication administration (e.g., at risk for post-transplant complications, increased risk of infusion reactions due to presence of circulating antibodies, unstable vascular access, cardiopulmonary condition at risk for severe adverse reactions, unstable renal function with inability to safely tolerate IV volume loads, etc.); or 
• Individual is initiating therapy or re-initiating therapy after a period of at least six (6) months with no therapy; or
• Physically and/or cognitively impaired AND a home caregiver is not available to comply with the required treatment regimen and schedule.

Home health services may be considered medically necessary when utilized for the administration of home infusion therapy and when provided by licensed eligible provider. Each case will be addressed on an individual basis. 

The medications identified in this policy are considered not medically necessary if administered in an unapproved hospital outpatient setting when an approved site of care is a viable option for treatment.

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. Highmark may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits. 

*See Table Attachment for additional information.

Evidence-based guidelines support the administration of injectable medications in alternative sites of care such as the non-hospital physician’s office, non-hospital infusion center or in the home.  Administration of the injectable medications subject to this policy at alternate sites of care is based upon the professional judgment of the provider, and takes into account the clinical appropriateness for each individual member. Requests for administration of any dose of the drugs listed in this policy received from a hospital-based facility, physician’s office or specialized infusion center will be assessed for meeting the policy exception criteria based on the clinical documentation provided by the requesting practitioner.