Medicare Advantage

Medical Policy

Title:

Efgartigimod-alfa (VyvgartTM)

Policy #:

MA08.142a

Policy

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 ™)

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:

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 MG therapy either in combination or alone of any of the following medication:

acetylcholinesterase (AChE) inhibitors
steroids
non-steroidal immunosuppressive therapies (NSISTs)

IgG levels of at least 6 g/L

EXPERIMENTAL/INVESTIGATIONAL

All other uses for efgartigimod alfa-fcab (Vyvgart), 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) 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.

Guidelines

DRUG INFORMATION

In accordance with US Food and Drug Administration (FDA) prescribing information, efgartigimod alfa-fcab (Vyvgart) is administered as an intravenous infusion is 10 mg/kg over one hour once weekly for 4 weeks. In individuals weighing 120 kg or more, the recommended dose of VYVGART is 1200 mg per infusion.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, efgartigimod alfa-fcab (Vyvgart) is 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.

PEDIATRIC USE

The safety and effectiveness of efgartigimod alfa-fcab (Vyvgart) for generalized myasthenia gravis (gMG) have not been established in the pediatric population.

Description

GENERALIZED MYASTHENIA GRAVIS

Myasthenia gravis (MG) 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.

PEER-REVIEWED LITERATURE

SUMMARY

The safety, efficacy, and tolerability of VYVGART was demonstrated in the multicentre, randomized, placebo-controlled Phase 3 ADAPT trial. The ADAPT trial demonstrated that significantly more anti-AChR antibody-positive gMG individuals responded, based on the MG-ADL scale, following treatment with 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 four 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 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 four or more consecutive weeks during the first treatment cycle. The most common adverse events in ADAPT trial were respiratory tract infection (33% vs 29% placebo), headache (32% vs 29% placebo), and urinary tract infection (10% vs. 5% placebo).

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

Argenx BV., Zwijnaarde, Belgium. Efgartigimod alfa - fcab (Vyvgart) labeling.12/2021. Available at: https://argenx.com/product/vyvgart-prescribing-information.pdf. Accessed January 12, 2022.

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: September 13, 2018; Last Update Posted: March 18, 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03669588. Accessed January 12, 2022.

Elsevier’s Clinical Pharmacology Compendium .Efgartigimod alfa - fcab (Vyvgart).[Clinical Key Web site]. 12/21/21. Available at: https://www.clinicalkey.com/#!/ [via subscription only]. Accessed January 12, 2022.

Lexi-Drugs Compendium. Efgartigimod alfa - fcab (Vyvgart). [Lexicomp Online Web site]. 12/20/2021. Available at: http://online.lexi.com/lco/action/home [via subscription only]. Accessed January 12, 2022.

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.

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]. 01/05/22. Available at: http://www.micromedexsolutions.com/micromedex2/librarian [via subscription only]. Accessed January 12, 2022.

US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Drugs @ FDA. Efgartigimod alfa - fcab (Vyvgart). Package insert. [FDA Web site]. 12/17/2021. Available at:https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process. Accessed January 12, 2022.

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 January 12, 2022.

US Food and Drug Administration (FDA). Efgartigimod alfa - fcab (Vyvgart) prescribing information & approval letter. [FDA Web site]. 12/2021. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761195s000lbl.pdf. Accessed January 12, 2022.

Coding

CPT Procedure Code Number(s)

N/A

ICD - 10 Procedure Code Number(s)

N/A

ICD - 10 Diagnosis Code Number(s)

G70.00 Myasthenia gravis without (acute) exacerbation

G70.01 Myasthenia gravis with (acute) exacerbation

HCPCS Level II Code Number(s)

THE FOLLOWING CODES ARE USED TO REPRESENT EFGARTIGIMOD ALFA-FCAB (VYVGART ™):

J9332

Injection, efgartigimod alfa-fcab, 2mg

Revenue Code Number(s)

N/A

MPMiscCodesNarrativesPub

Coding and Billing Requirements

Cross Reference

Policy History

Version Effective Date:

7/1/2022

Version Issued Date: