Medicare Advantage

Medical Policy

Title:

Efgartigimod alfa-fcab (Vyvgart) and efgartigimod-alfa and hyaluronidase-qvfc (Vyvgart Hytrulo)

Policy #:

MA08.142f

Policy

In the absence of coverage criteria from applicable Medicare statutes, regulations, NCDs, LCDs, CMS manuals, or other Medicare coverage documents, this policy uses internal coverage criteria developed by the Company in consideration of peer-reviewed medical literature, clinical practice guidelines, and/or regulatory status.

The Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition.

MEDICALLY NECESSARY

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 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)

Requested medication will not be used in combination with any of the following:

another neonatal Fc rereceptor (FcRn) blocker (e.g., Imaavy, Rystigo)
complement inhibitor (e.g., Soliris, Ultomiris, Zilbrysq)
Immune globulin (e.g., intravenous immunoglobulin [IVIG])

The individual is being treated by or in consultation with a neurologist
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

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 at least two nerves
Reduction of motor conduction velocity in at least two nerves
Prolongation of F-wave latency in at least 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:

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.

Guidelines

There is no Medicare coverage determination addressing efgartigimod-alfa and hyaluronidase-qvfc (Vyvgart Hytrulo); therefore, the Company policy is applicable.

DRUG INFORMATION

In accordance with US Food and Drug Administration (FDA) prescribing information, efgartigimod alfa-fcab (Vyvgart) is administered as an intravenous infusion, 10 mg/kg over 1 hour once weekly for 4 weeks. In individuals weighing 120 kg or more, the recommended dose of efgartigimod alfa-fcab (Vyvgart) is 1200 mg per infusion. Efgartigimod alfa and hyaluronidase-qvfc (Vyvgart Hytrulo) is administered subcutaneously, 1008 mg/11,200 units (1008 mg efgartigimod-alfa and 11,200 units hyaluronidase) over approximately 30 to 90 seconds in cycles of once weekly injections for 4 weeks.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable Evidence of Coverage, efgartigimod alfa-fcab (Vyvgart) and efgartigimod-alfa and hyaluronidase-qvfc (Vyvgart Hytrulo) are covered under the medical benefits of the Company’s products when the medical necessity criteria listed in this medical policy are met.

MYASTHENIA GRAVIS FOUNDATION OF AMERICA (MGFA) CLINICAL CLASSIFICATION

Class I: Any ocular muscle weakness; may have weakness of eye closure. All other muscle strength is normal.
Class II: Mild weakness affecting muscles other than ocular muscles; may also have ocular muscle weakness of any severity.

A. IIa. Predominantly affecting limb, axial muscles, or both. May also have lesser involvement of oropharyngeal muscles.
B. IIb. Predominantly affecting oropharyngeal, respiratory muscles, or both. May also have lesser or equal involvement of limb, axial muscles, or both.

Class III: Moderate weakness affecting muscles other than ocular muscles; may also have ocular muscle weakness of any severity.

A. IIIa. Predominantly affecting limb, axial muscles, or both. May also have lesser involvement of oropharyngeal muscles.
B. IIIb. Predominantly affecting oropharyngeal, respiratory muscles, or both. May also have lesser or equal involvement of limb, axial muscles, or both.

Class IV: Severe weakness affecting muscles other than ocular muscles; may also have ocular muscle weakness of any severity.

A. IVa. Predominantly affecting limb, axial muscles, or both. May also have lesser involvement of oropharyngeal muscles.
B. IVb. Predominantly affecting oropharyngeal, respiratory muscles, or both. May also have lesser or equal involvement of limb, axial muscles, or both.

Class V: Defined as intubation, with or without mechanical ventilation, except when employed during routine postoperative management. The use of a feeding tube without intubation places the individual in class IVb.

MG Activities of Daily Living (MG-ADL) Profile

Grade	Score
Activities of Daily Living (ADL)	0	1	2	3
Talking	normal	Intermittent slurring or nasal speech	Constant slurring or nasal, but can be understood	Difficult to understand speech
Chewing	normal	Fatigue with solid food	Fatigue with soft food	Gastric tube
Swallowing	normal	Rare episode of choking	Frequent choking necessitating changes in diet	Gastric tube
Breathing	normal	Shortness of breath with exertion	Shortness of breath at rest	Ventilator dependence
Impairment of ability to brush teeth or comb hair	none	Extra effort, but no rest periods needed	Rest periods needed	Cannot do one of these functions
Impairment of ability to arise from a chair	none	Mild, sometimes uses arms	Moderate, always uses arms	Severe, requires assistance
Double vision	none	Occurs, but not daily	Daily, but not constant	Constant
Eyelid droop	none	Occurs, but not daily	Daily, but not constant	Constant

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

Efgartigimod alfa-fcab (Vyvgart) was approved by the FDA on December 17, 2021, for the treatment of generalized myasthenia gravis (gMG) in adult individuals who are anti-acetylcholine receptor (AChR) antibody positive.

Efgartigimod alfa and hyaluronidase-qvfc (Vyvgart Hytrulo) was approved by the FDA on June 20, 2023, for the treatment of gMG in adult individuals who are anti-acetylcholine receptor (AChR) antibody positive.

PEDIATRIC USE

The safety and effectiveness of efgartigimod alfa-fcab (Vyvgart) or efgartigimod alfa and hyaluronidase-qvfc (Vyvgart Hytrulo) for gMG have not been established in the pediatric population.

Description

GENERALIZED MYASTHENIA GRAVIS

Generalized myasthenia gravis (gMG) is a chronic autoimmune neuromuscular disease that causes weakness in the skeletal muscles. The muscle weakness usually worsens after periods of activity and improves after periods of rest. Muscles that control movements of the eye and eyelid, facial expression, chewing, talking, and swallowing are often involved, but those that control breathing and neck and limb movements may also be involved. This weakness is a result of an antibody-mediated, T-cell dependent, immunological attack directed at proteins in the postsynaptic membrane of the neuromuscular junction. MG has an annual incidence of about 7 to 23 cases per million. It most often begins before the age of 40 in women and after age 60 in men.

CHRONIC INFLAMMATORY DEMYELINATING POLYNEUROPATHY (CIDP)

CIDP is an autoimmune condition that affects the myelin sheath around the peripheral nerves. This condition causes worsening symptoms, like muscle weakness and abnormal sensations, over at least 8 weeks. CIDP is treatable, but it can come back (relapse), which may require ongoing treatment.

PEER-REVIEWED LITERATURE

SUMMARY

The safety, efficacy, and tolerability of efgartigimod alfa-fcab (Vyvgart) was demonstrated in the multicenter, randomized, placebo-controlled Phase 3 ADAPT trial. The ADAPT trial demonstrated that significantly more anti-AChR antibody-positive gMG individuals responded, based on the Myasthenia Gravis Activities of Daily Living (MG-ADL) scale, following treatment with efgartigimod alfa-fcab (Vyvgart) compared with placebo (68% vs. 30%; P<0.0001). Responders were defined as having at least a two-point reduction on the MG-ADL scale sustained for 4 or more consecutive weeks during the first treatment cycle. Additionally, there were significantly more responders on the Quantitative Myasthenia Gravis (QMG) scale following treatment with efgartigimod alfa-fcab (Vyvgart) compared with placebo (63% vs. 14%; P<0.0001). Responders were defined as having at least a three-point reduction on the QMG scale sustained for 4 or more consecutive weeks during the first treatment cycle. The most common adverse events in the ADAPT trial were respiratory tract infection (33% vs. 29% placebo), headache (32% vs. 29% placebo), and urinary tract infection (10% vs. 5% placebo).

The ADAPT trial established the effectiveness of efgartigimod alfa-fcab (Vyvgart) intravenous (IV) formulation for the treatment of AChR antibody–positive gMG in adult individuals. In the trial ADAPTsc, efgartigimod alfa and hyaluronidase-qvfc (Vyvgart Hytrulo) demonstrated a comparable pharmacodynamic effect on AChR antibody reduction to the efgartigimod alfa-fcab (Vyvgart) IV formulation, which established the efficacy of efgartigimod alfa and hyaluronidase-qvfc (Vyvgart Hytrulo). This study enrolled 110 randomly assigned individuals who received one cycle of once weekly administrations for 4 weeks, of either efgartigimod alfa and hyaluronidase-qvfc (Vyvgart Hytrulo) subcutaneously (n=55) or efgartigimod alfa-fcab (Vyvgart) intravenously (n=55).

The maximum mean reduction in AChR-Ab level was observed at week 4, with a mean reduction of 62.2% and 59.7% in the efgartigimod alfa and hyaluronidase-qvfc (Vyvgart Hytrulo) SC and efgartigimod alfa-fcab (Vyvgart) IV arm, respectively. The decrease in total IgG levels followed a similar pattern.

The most common adverse events were injection site reactions and occurred in 38% of individuals receiving efgartigimod alfa and hyaluronidase-qvfc (Vyvgart Hytrulo).

The primary endpoint was met, with a comparable mean reduction in total IgG with the subcutaneous versus the IV formulation. Secondary endpoints were met in 69.1% of individuals who responded on the MG-ADL score and 65.5% of individuals who responded on the QMG score. From this study, individuals could enter an open label to receive efgartigimod alfa and hyaluronidase-qvfc (Vyvgart Hytrulo) to evaluate the long-term safety and tolerability of subcutaneous formulation.

In a placebo-controlled study in individuals with CIDP (Study 3, stage B), 221 individuals were randomly assigned to receive once-weekly administration of either efgartigimod alfa and hyaluronidase-qvfc (Vyvgart Hytrulo) 1008 mg/11,200 units subcutaneously (n=111) or placebo (n=110) [see Clinical Studies (14.2)]. The mean duration of treatment with efgartigimod alfa and hyaluronidase-qvfc (Vyvgart Hytrulo) in stage B was 25 weeks. The overall safety profile observed in individuals with CIDP treated with efgartigimod alfa and hyaluronidase-qvfc (Vyvgart Hytrulo) was consistent with the known safety profile of efgartigimod alfa and hyaluronidase-qvfc (Vyvgart Hytrulo) and of efgartigimod alfa-fcab (Vyvgart) administered intravenously.

In Study 3, injection site reactions occurred in 15% of individuals treated with efgartigimod alfa and hyaluronidase-qvfc (Vyvgart Hytrulo) compared to 6% of individuals who received placebo. The most common of these injection site reactions were injection site bruising and injection site erythema. All injection site reactions were mild to moderate in severity. Most injection site reactions occurred during the first 3 months of treatment.

The efficacy of intravenous efgartigimod alfa‑fcab (EFG IV) in adult individuals with gMG who are anti‑AChR antibody negative was demonstrated in an 8‑week, randomized, double‑blind, placebo‑controlled trial (Study 2 Part A; NCT06298552). Individuals received EFG IV according to the recommended intravenous dosing regimen. In the open‑label extension (Part B), individuals continued treatment with two additional cycles using the same dosing schedule, followed by further cycles administered at variable intervals of at least 7 days, for up to 2 years. Efgartigimod alfa-fcab exhibits linear pharmacokinetics, and following single doses of efgartigimod alfa-fcab, exposures increase proportionally up to 50 mg/kg (five times the recommended dosage).

The individuals had moderate disease (MGFA II–IV, MG-ADL ≥5) and were on stable background therapy. The result (primary endpoint) was significant improvement in MG-ADL at week 4. Efgartigimod alfa-fcab (Vyvgart) demonstrated statistically significant, modest improvement in functional symptoms in AChR-negative gMG, supporting efficacy in this harder-to-treat population.

OFF-LABEL INDICATIONS

There may be additional indications contained in the policy section of this document due to evaluation of criteria highlighted in the company's off-label policy, and/or review of clinical guidelines issued by leading professional organizations and government entities.

References

American Hospital Formulary Service (AHFS). Drug Information. Efgartigimod alfa - fcab (Vyvgart). [Lexicomp Web site] 06/16/26. Available at: https://online.lexi.com/lco/action/doc/retrieve/docid/complete_ashp/6684461 [via subscription only]. Accessed June 3, 2026.

American Academy of Neurology (AAN). Myasthenia gravis activities of daily living profile. [ANN Web site]. 04/01/1999.

ClinicalTrials.gov. An Efficacy and Safety Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness (ADAPT). ClinicalTrials.gov Identifier: NCT03669588. First Posted: March, 07 2024; Last Update Posted: November, 5 2025. Available at: https://clinicaltrials.gov/ct2/show/NCT03669588. Accessed June 3, 2026.

ClinicalTrials.gov. A Phase 3 Study to Evaluate the Efficacy and Safety of Efgartigimod IV in Patients With Acetylcholine Receptor Binding Antibody Seronegative Generalized Myasthenia Gravis (ADAPT SERON). ClinicalTrials.gov Identifier: NCT06298552. First Posted: September 13, 2018; Last Update Posted: February 8, 2022. Available at: https://clinicaltrials.gov/ct2/show/NCT03669588. Accessed June 3, 2026.

ClinicalTrials.gov. Evaluating the Pharmacodynamic Noninferiority of Efgartigimod PH20 SC Administered Subcutaneously as Compared to Efgartigimod Administered Intravenously in Patients With Generalized Myasthenia Gravis (ADAPTsc). ClinicalTrials.gov Identifier: NCT04735432. First Posted: February 3, 2021; Last Update Posted: February 28, 2023. Available at: Researcher View | NCT04735432 | Evaluating the Pharmacodynamic Noninferiority of Efgartigimod PH20 SC Administered Subcutaneously as Compared to Efgartigimod Administered Intravenously in Patients With Generalized Myasthenia Gravis | ClinicalTrials.gov. Accessed June 3, 2026.

Elsevier’s Clinical Pharmacology Compendium. Efgartigimod alfa - fcab (Vyvgart).[Clinical Key Web site]. 08/03/25. Available at: https://www.clinicalkey.com/#!/ [via subscription only]. Accessed June 3, 2026.

Jaretzki A 3rd, Barohn RJ, Ernstoff RM. Myasthenia gravis: recommendations for clinical research standards. Task Force of the Medical Scientific Advisory Board of the Myasthenia Gravis Foundation of America. Neurology. 2000;55(1):16-23.

Lexi-Drugs Compendium. Efgartigimod alfa - fcab (Vyvgart). [Lexicomp Online Web site]. 05/18/2026. Available at: http://online.lexi.com/lco/action/home [via subscription only]. Accessed June 3, 2026.

Lewis RA, Muley SA. Chronic demyelinating polyneuropathy: treatment and prognosis. 07/06/2023. UpToDate Website. Available at: Chronic inflammatory demyelinating polyneuropathy: Treatment and prognosis - UpToDate. Accessed June 3, 2026.

Oaklander AL, Lunn MP, Hughes RA, et al. Treatments for chronic inflammatory demyelinating polyradiculoneuropathy (CIDP): an overview of systematic reviews. Cochrane Database Syst Rev. 2017; Jan 13;1:CD010369. Accessed June 3, 2026.

Sathasivam S. Diagnosis and management of myasthenia gravis. Prog Neurol Psychiatry. 2014;18(1):6-14.

Truven Health Analytics Inc. Micromedex® 2.0 Healthcare Series. DrugDex®. Efgartigimod alfa - fcab. [Micromedex Web site]. 05/29/26. Available at: http://www.micromedexsolutions.com/micromedex2/librarian [via subscription only]. Accessed June 3, 2026.

US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Drugs @ FDA. Efgartigimod alfa - fcab (Vyvgart). Package insert. [FDA Web site]. 05/08/2026. Available at: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process. Accessed June 3, 2026.

US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Drugs@FDA. Efgartigimod alfa - fcab (Vyvgart). [FDA Web site]. Original: 12/17/21. Available at: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm. Accessed June 3, 2026.

US Food and Drug Administration (FDA). Efgartigimod alfa - fcab (Vyvgart) prescribing information & approval letter. [FDA Web site]. 05/2026. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761195s000lbl.pdf. Accessed June 3, 2026.

Van den Bergh PYK, van Doorn PA, Hadden RDM, et al. European Academy of Neurology/Peripheral Nerve Society guideline on diagnosis and treatment of chronic inflammatory demyelinating polyradiculoneuropathy: Report of a joint Task Force—Second revision. Available at: https://onlinelibrary.wiley.com/doi/epdf/10.1111/ene.14959. Accessed June 3, 2026.

Coding

CPT Procedure Code Number(s)

N/A

ICD - 10 Procedure Code Number(s)

N/A

ICD - 10 Diagnosis Code Number(s)

Report the most appropriate diagnosis code in support of medically necessary criteria as listed in the policy.

HCPCS Level II Code Number(s)

J9332 Injection, efgartigimod alfa-fcab, 2mg

J9334 Injection, efgartigimod alfa, 2 mg and hyaluronidase-qvfc

Revenue Code Number(s)

N/A

MPMiscCodesNarrativesPub
Modifiers

JA Administered Intravenously

JB Administered Subcutaneously

Coding and 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
To report the subcutaneous route of administration, append the following modifier: JB Administered Subcutaneously

Cross Reference

Policy History

Revisions From MA08.14f:

10/26/2026

This version of the policy will become effective 10/26/2026.

The following was added to this policy:

Efgartigimod alfa-fcab (Vyvgart)

Requested medication will not be used in combination with any of the following:

Another neonatal Fc receptor (FcRn) blocker (e.g., Imaavy, Rystigo)
Complement inhibitor (e.g.,Soliris, Ultomiris, Zilbrysq)
Immune globulin (e.g., IVIG)

The individual is being treated by or in consultation with a neurologist.

The following was removed from this policy:

Efgartigimod alfa-fcab (Vyvgart) is 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 following was removed from this policy for CDIP indication Dosing &Friequency:

for 4 weeks:

The following was updated in this policy:

The individual has at least one of the following electrodiagnostic findings of demyelination:

Revisions From MA08.142e:

01/01/2026

This version of the policy will become effective 01/01/2026.

The following was added to this policy:

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

All of the ICD-10 CM codes have been removed from this policy. Report the most appropriate diagnosis code in support of medically necessary criteria as listed in the policy.

Revisions From MA08.142d:

10/07/2024

This version of the policy will become effective 10/07/2024.

This policy has been updated to communicate the Company’s coverage position and criteria for efgartigimod alfa and hyaluronidase-qvfc (Vyvgart Hytrulo) for chronic inflammatory demyelinating polyneuropathy (CIDP).

The following was added to this policy:

Dosing and frequency for :

Efgartigimod alfa-fcab (Vyvgart)*

The recommended dosage is 10 mg/kg administered as an intravenous infusion over one hour once weekly for four weeks.
In individuals weighing 120 kg or more, 1200 mg per infusion.

Efgartigimod alfa and hyaluronidase-qvfc (Vyvgart Hytrulo)* once weekly injections for four weeks:

Prefilled syringe: 1,000 mg efgartigimod alfa and 10,000 units hyaluronidase
Vial: 1,008 mg efgartigimod alfa and 11,200 units hyaluronidase

The following have been added to this policy:

NOTE: Evio has been selected by the Company to administer clinical outcomes monitoring for individuals receiving certain high-cost drug therapies. Vygart 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.

This language was approved by Medical Claim Payment Policy management and the Legal team.

The following ICD-10 code has been added to this policy:

G61.81 Chronic inflammatory demyelinating polyneuritis

Revisions From MA08.142c:

01/02/2024

This policy has been identified for the HCPCS code update, effective 01/02/2024.

The following HCPCS codes termed from this policy:

C9399 Unclassified drugs or biologics
J3590 Unclassified biologics

The following HCPCS code has been added to this policy:

J9334 Injection, efgartigimod alfa, 2 mg and hyaluronidase-qvfc

Revisions From MA08.142b:

01/01/2024	Effective 01/01/2024 this policy applies to New Jersey Medicare Advantage (MA) lines of business.
10/09/2023	This version of the policy will become effective 10/09/2023. This policy has been updated to communicate the Company’s coverage position and criteria for hyaluronidase-qvfc (Vyvgart Hytrulo). The following HCPCS codes have been added to this policy: THE FOLLOWING CODES ARE USED TO REPRESENT HYALURONIDASE-QVFC (VYVGART HYTRULO®): C9399 Unclassified drugs or biologics J3590 Unclassified biologics

01/01/2024

Effective 01/01/2024 this policy applies to New Jersey Medicare Advantage (MA) lines of business.

10/09/2023

This version of the policy will become effective 10/09/2023.

This policy has been updated to communicate the Company’s coverage position and criteria for hyaluronidase-qvfc (Vyvgart Hytrulo).

The following HCPCS codes have been added to this policy:

THE FOLLOWING CODES ARE USED TO REPRESENT HYALURONIDASE-QVFC (VYVGART HYTRULO®):

C9399 Unclassified drugs or biologics

J3590 Unclassified biologics

Revisions From MA08.142a:

04/19/2023	This policy has been reissued in accordance with the Company's annual review process.
07/01/2022	This policy has been identified for the HCPCS code update, effective 07/01/2022. The following HCPCS codes termed from this policy: C9399 Unclassified drugs or biologics J3590 Unclassified biologics The following HCPCS codes have been added to this policy: J9332 Injection, efgartigimod alfa-fcab, 2mg

Revisions From MA08.142:

3/14/2022

This version of the policy will become effective 3/14/2022.

This new policy has been issued to communicate the Company’s coverage position and criteria for efgartigimod-alfa (Vyvgart).

Version Effective Date:

10/26/2026

Version Issued Date:

10/26/2026

Version Reissued Date:

Medicare Advantage

Medical Policy

Notification

Policy

Guidelines

Description

References

Coding

CPT Procedure Code Number(s)

ICD - 10 Procedure Code Number(s)

ICD - 10 Diagnosis Code Number(s)

HCPCS Level II Code Number(s)

Revenue Code Number(s)

MPMiscCodesNarrativesPubModifiers

Coding and Billing Requirements

Cross Reference

Policy History

MPMiscCodesNarrativesPub
Modifiers