ModifiedAnthemPolicy CC-0207

Vyvgart and Vyvgart Hytrulo (efgartigimod products) — Clinical coverage criteria

Clinical coverage criteria, prior authorization and quantity limits for Vyvgart (IV efgartigimod alfa-fcab) and Vyvgart Hytrulo (subcutaneous efgartigimod alfa with hyaluronidase) for adults with AChR-antibody positive generalized myasthenia gravis and for Vyvgart Hytrulo in CIDP; intended for providers and payers administering or authorizing these drugs under Anthem medical benefit plans.

Policy Summary

PayerAnthem

PolicyVyvgart and Vyvgart Hytrulo (efgartigimod products) — Clinical coverage criteria

Policy CodePolicy CC-0207

Change TypeSeparation of productsadded CIDP indicationadded combination exclusion and step therapycoding/quantity updates

Effective DateOct 1, 2025

Next Review Date

Key ActionObtain prior authorization consistent with the clinical criteria and quantity limits (J9332 for Vyvgart; J9334 for Vyvgart Hytrulo).

SourceLink

POLICY UPDATE CHANGES

Add nipocalimab to combination exclusion criteria; add new step therapy for Vyvgart Hytrulo in CIDP.

Separated Vyvgart and Vyvgart Hytrulo into distinct criteria and added CIDP indication for Vyvgart Hytrulo.

Added quantity limits and new HCPCS code J9334 for Vyvgart Hytrulo.

Updated HCPCS description for J9332 and separated coding for Vyvgart and Vyvgart Hytrulo.

18+min age

>=5MG-ADL threshold

26 wksgMG initial approval

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

6 moCIDP initial approval

multipledoc history entries

Coverage Criteria

Initial Therapy — Vyvgart Hytrulo (gMG)

Covered when ALL of the following are met for adults with AChR-Ab+ generalized myasthenia gravis

Eligibility

A: Acetylcholinesterase inhibitor: Individual has had a trial and inadequate response or intolerance to an acetylcholinesterase inhibitor; OR is on a stable dose of an acetylcholinesterase inhibitor; OR has a contraindication to acetylcholinesterase inhibitors.
B: Immunosuppressive therapy: Individual has had a trial and inadequate response or intolerance to one or more immunosuppressive agents (including but not limited to systemic corticosteroids or non-steroidal immunosuppressants); OR is on a stable dose of one or more immunosuppressive agents; OR has a contraindication to systemic corticosteroids and non-steroidal immunosuppressants.

Continuation Therapy — Vyvgart Hytrulo (gMG)

Covered when ALL of the following are met for continued use

Continuation criteria: I. Individual has experienced a prior clinical response to efgartigimod treatment defined by: A. Reduction in signs or symptoms that impact daily function; AND B. Documentation of at least a 2-point reduction in MG-ADL total score from pretreatment baseline; II. Individual requires continued treatment to maintain response or to regain clinically meaningful response.>=2-point MG-ADL improvement

Initial approval duration: 26 weeks; continuation approval duration: 1 year

Initial Therapy — Vyvgart Hytrulo (CIDP)

Covered when ALL of the following are met for adults with CIDP

Eligibility CIDP: I. Individual is 18 years of age or older; II. Diagnosis of chronic inflammatory demyelinating polyneuropathy (CIDP); III. Diagnosis verified by: A. Clinical presentation consistent with typical or atypical CIDP per EFNS/PNS criteria; AND B. Characteristic electrodiagnostic findings in at least one nerve; IV. Documentation of objective functional impairment from CIDP (for example, requiring support to walk or upper limb symptoms affecting certain functions); V. Vyvgart Hytrulo prescribed by or in consultation with a neurologist; VI. Documentation of a trial and inadequate response or intolerance to one of: A. Immunoglobulins (IV or SC); OR B. Plasma exchange; OR C. Corticosteroids (daily oral or pulsed high-dose).

Initial approval duration: 6 months

Continuation Therapy — Vyvgart Hytrulo (CIDP)

Covered when the following is met for continued use in CIDP

Continuation CIDP: Documentation is provided that there is clinically significant improvement in neurological symptoms on physical examination (for example, an objective change in function that is clinically meaningful).

Continuation approval duration: 1 year

Initial and Continuation Therapy — Vyvgart (IV, gMG)

Covered when ALL of the following are met for Vyvgart (IV) in adults with AChR-Ab+ gMG

Eligibility IV gMG: I. Individual is 18 years of age or older; II. Diagnosis of acetylcholine receptor antibody-positive (AChR-Ab+) generalized myasthenia gravis; III. Documentation is provided that individual has a positive serologic test for the presence of anti-acetylcholine receptor antibodies (AChR-Ab+); IV. Individual has MGFA Clinical Classification Class II–IV disease; V. Documentation is provided that individual has a Myasthenia Gravis Activities of Daily Living (MG-ADL) score of at least 5 or higher; VI. Documentation is provided that individual meets both of the following (A and B): A. Trial and inadequate response or intolerance to an acetylcholinesterase inhibitor OR stable dose OR contraindication; AND B. Trial and inadequate response or intolerance to one or more immunosuppressive agents OR stable dose OR contraindication to systemic corticosteroids and non-steroidal immunosuppressants; VII. Other causes of neuropathy ruled out as appropriate.

Initial approval duration: 26 weeks; continuation requires >=2-point MG-ADL improvement and ongoing need; Vyvgart IV induction cycle defined as 4 weekly doses per cycle

Summary of coverage-related updates

Policy updates and coverage-related items noted in document history and coding sections:

Updates and implications: Policy separates Vyvgart and Vyvgart Hytrulo with distinct criteria; Vyvgart Hytrulo has an added indication for CIDP and a new step therapy requirement; combination exclusions have been updated to include nipocalimab in addition to previously listed agents; coding was updated to list distinct HCPCS codes J9332 (Vyvgart) and J9334 (Vyvgart Hytrulo) and quantity limits were added for Vyvgart Hytrulo.

See full policy for complete medical necessity language and operational details (prior authorization, quantity limits, and required documentation).

Requests for Vyvgart products will not be approved when used concurrently with certain other immune-targeted therapies. Specifically, use in combination with maintenance immunoglobulin treatment, eculizumab, nipocalimab, ravulizumab, rituximab, rozanolixizumab, or zilucoplan is excluded from coverage; such combination therapy is a basis for denial even if other criteria are met. This exclusion applies to both Vyvgart (IV) and Vyvgart Hytrulo when the combination is requested in the same episode of care or overlapping treatment courses.

The policy's combination-exclusion list was updated on 08/15/2025 to explicitly add nipocalimab to the agents that preclude concurrent use with efgartigimod products. Historical document entries also show prior additions of agents such as zilucoplan, rozanolixizumab, ravulizumab and others; providers should review the current exclusion list before requesting concurrent therapies and consult the full policy history for prior changes.

Requests that do not meet the specific clinical criteria outlined for each product and indication are not approved. This includes requests for indications other than the listed uses (for example, Vyvgart and Vyvgart Hytrulo are covered only for the specified adult indications: AChR‑antibody positive generalized myasthenia gravis and, for Vyvgart Hytrulo, chronic inflammatory demyelinating polyneuropathy). Additionally, use in combination with excluded agents (see combination exclusion) is not medically necessary and will be denied.

The procedure and diagnosis codes listed in the coding section are provided for informational purposes only and do not themselves guarantee coverage or reimbursement. Inclusion or exclusion of a procedure, diagnosis, or device code does not constitute or imply member coverage; determine coverage based on the member's contract benefits and the authorization decision.

Coding and Quantity Limits

HCPCS (Vyvgart)HCPCSCovered

J9332

Injection, efgartigimod alfa-fcab, 2mg [Vyvgart]

ICD-10 Diagnosis (Myasthenia gravis)ICD-10

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

Vyvgart HCPCSHCPCS

J9332

Injection, efgartigimod alfa-fcab, 2mg [Vyvgart]

Vyvgart Hytrulo HCPCSHCPCS

J9334

Injection, efgartigimod alfa, 2 mg and hyaluronidase-qvfc [Vyvgart Hytrulo]

ICD-10 Diagnosis - Myasthenia gravisICD-10Covered

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

ICD-10 Diagnosis - CIDPICD-10Covered

G61.81

Chronic inflammatory demyelinating polyneuritis

inv-17: MG-ADL score — minimum threshold for initiation

MG-ADL minimum for initiation (gMG)MG-ADL score >= 5

Applies toAdults (>= 18 years) with AChR-Ab+ generalized myasthenia gravis

Documentation requiredProvider must supply MG-ADL score in records to support initiation request

inv-18: Quantity limits — Vyvgart IV dosing per cycle and Hytrulo limit (vials/prefilled syringes)

Vyvgart (IV) dosing per cycle10 mg/kg once weekly for 4 weeks (one cycle); additional cycles may be approved no sooner than 50 days from the start of the previous cycle

Provider Actions and Prior Authorization

Prior Authorization

Prior Authorization and Coding

Prior authorization is required consistent with clinical criteria and applicable quantity limits. Providers must request prior authorization before initiating therapy with Vyvgart (J9332) or Vyvgart Hytrulo (J9334). Inclusion or exclusion of codes does not guarantee coverage — verify member benefits.

Affected HCPCS: J9332 (Vyvgart)
Affected HCPCS: J9334 (Vyvgart Hytrulo)
Prior authorization required per clinical criteria and quantity limits

Prior Authorization

Prior Authorization for Vyvgart Products

Prior authorization is required specifically for Vyvgart products. Requests for J9332 and J9334 must include documentation that meets the product-specific clinical criteria (see respective sections for Vyvgart and Vyvgart Hytrulo). Quantity limits apply based on product formulation and weight-based dosing or vial/syringe limits.

J9332 — Injection, efgartigimod alfa-fcab, 2 mg [Vyvgart]

Background

Efgartigimod products are neonatal Fc receptor (FcRn)-targeting agents that reduce pathogenic IgG levels and are approved for adult patients with AChR‑antibody positive generalized myasthenia gravis (AChR‑Ab+ gMG). The subcutaneous coformulation, Vyvgart Hytrulo, is additionally approved for chronic inflammatory demyelinating polyneuropathy (CIDP). gMG is an autoimmune neuromuscular disorder characterized by fluctuating motor weakness mediated by pathogenic IgG autoantibodies; CIDP is an acquired immune‑mediated demyelinating neuropathy diagnosed by clinical features plus characteristic electrodiagnostic findings.

Definitions

inv-28: Acetylcholine receptor antibody-positive generalized myasthenia gravis (AChR-Ab+ gMG)

DefinitionAcetylcholine receptor antibody-positive generalized myasthenia gravis (AChR-Ab+ gMG): generalized myasthenia gravis with positive serologic test for anti‑AChR antibodies, typically MGFA class II–IV

Age requirementAdults (>= 18 years)

Required diagnostic evidencePositive serologic test for anti‑AChR antibodies (AChR‑Ab+)

Functional threshold for treatment initiationMG‑ADL score of at least 5

inv-29: Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) — diagnostic requirements summary

DefinitionChronic Inflammatory Demyelinating Polyneuropathy (CIDP): acquired immune‑mediated demyelinating neuropathy diagnosed by clinical features consistent with typical or atypical CIDP and characteristic electrodiagnostic findings per EFNS/PNS guidance

Revision History

2025-08-15Annual review - clinical updateLatest

Added nipocalimab to the combination exclusion criteria and added a new step therapy requirement for Vyvgart Hytrulo in CIDP; administrative update to documentation (coding reviewed with no changes).

2025-06-09Select review - coding/limits

Added a quantity limit for the new Vyvgart Hytrulo prefilled syringe; updated the HCPCS description for J9332 and separated Vyvgart and Vyvgart Hytrulo (removed G61.81 from Vyvgart).

2024-08-16

Policy Summary

PayerAnthem

PolicyVyvgart and Vyvgart Hytrulo (efgartigimod products) — Clinical coverage criteria

Policy CodePolicy CC-0207

Change TypeSeparation of productsadded CIDP indicationadded combination exclusion and step therapycoding/quantity updates

Effective DateOct 1, 2025

Next Review Date

Key ActionObtain prior authorization consistent with the clinical criteria and quantity limits (J9332 for Vyvgart; J9334 for Vyvgart Hytrulo).

SourceLink

On This Page

Vyvgart (IV) vial limitsFor individuals <120 kg: use 400 mg/20 mL vial; for >=120 kg: limit = 1200 mg (total of 3 vials) once weekly for 4 weeks per cycle

Vyvgart Hytrulo (subcutaneous) limit - vialsLimit = 4 single‑dose vials per 28 days (1,008 mg efgartigimod alfa and 11,200 units hyaluronidase per 5.6 mL vial)

Vyvgart Hytrulo (subcutaneous) limit - prefilled syringesLimit = 4 prefilled syringes per 28 days (1,000 mg efgartigimod alfa and 10,000 units hyaluronidase per 5 mL prefilled syringe)

J9334 — Injection, efgartigimod alfa and hyaluronidase-qvfc [Vyvgart Hytrulo]

Follow product-specific dosing/quantity limits when requesting authorization

Denial Risk

Combination Therapy Exclusion

Vyvgart and Vyvgart Hytrulo must not be used in combination with certain therapies. Requests for coverage will be denied if the product is prescribed concomitantly with listed agents.

Combination therapies excluded: maintenance immunoglobulin treatment, eculizumab, nipocalimab, ravulizumab, rituximab, rozanolixizumab, zilucoplan
Use with excluded agents will not be approved

Documentation Required

Documentation Requirement (Administrative)

Administrative documentation must be provided with prior authorization requests. Providers should include required clinical documentation (diagnosis, positive AChR-Ab serology where applicable, MGFA class, MG‑ADL score, prior medication trials or reasons for contraindication/stability, objective functional impairment for CIDP, and treating/consulting neurologist when applicable).

Provide serologic test results confirming AChR‑Ab+ when applicable
Include MGFA classification and MG‑ADL score (≥5) for gMG requests
Document prior trials or stable dosing/contraindications for acetylcholinesterase inhibitors and immunosuppressive agents
For CIDP, include objective functional impairment documentation and neurologist involvement
Administrative update added documentation requirement (08/15/2025)

Step Therapy

Step Therapy for Vyvgart Hytrulo in CIDP

Step therapy requirements apply for Vyvgart Hytrulo when requested for CIDP. Prior to approval, documented trial and inadequate response or intolerance to first-line CIDP therapies is required per criteria; new step therapy was added in the 08/15/2025 update.

CIDP step therapy: trial and inadequate response or intolerance to one of — immunoglobulins (IVIG/SCIG), plasma exchange, or corticosteroids
New step therapy for Vyvgart Hytrulo in CIDP effective 08/15/2025

Diagnostic requirements summaryClinical presentation consistent with CIDP AND characteristic electrodiagnostic findings in one or more nerves (eg, prolonged distal latency, reduced conduction velocity, prolonged F‑wave latency, conduction block)

Additional documentationObjective functional impairment from CIDP and diagnosis verification per EFNS/PNS; prescribed by or in consultation with a neurologist

inv-30: Vyvgart — definition, formulation and code reference

Product definitionVyvgart (efgartigimod alfa‑fcab): an IV formulation of efgartigimod alfa‑fcab that targets FcRn for treatment of AChR‑Ab+ generalized myasthenia gravis

FormulationIntravenous (IV) administration; 400 mg/20 mL vial strength referenced in quantity limits

HCPCS codeJ9332 — Injection, efgartigimod alfa‑fcab, 2 mg [Vyvgart]

inv-31: Vyvgart Hytrulo — definition, formulation and code reference

Product definitionVyvgart Hytrulo (efgartigimod alfa and hyaluronidase‑qvfc): subcutaneous coformulation of efgartigimod alfa with hyaluronidase enabling SC administration; indicated for AChR‑Ab+ gMG and CIDP

Formulations availableSingle‑dose vial: 1,008 mg efgartigimod alfa + 11,200 units hyaluronidase per 5.6 mL; Prefilled syringe: 1,000 mg efgartigimod alfa + 10,000 units hyaluronidase per 5 mL

HCPCS codeJ9334 — Injection, efgartigimod alfa, 2 mg and hyaluronidase‑qvfc [Vyvgart Hytrulo]

Annual review - indication and exclusions

Separated Vyvgart and Vyvgart Hytrulo criteria, added a CIDP indication for Vyvgart Hytrulo, added zilucoplan to the combination exclusion list, and updated Hytrulo quantity limits (administrative documentation added; coding reviewed added ICD-10-CM G61.81).

2023-08-18Annual review - dosing/coding

Included the new dosage form Vyvgart Hytrulo in clinical criteria, added a quantity limit for Hytrulo, updated the combination exclusion list to include rozanolixizumab, and made wording/formatting updates; coding changes temporarily added HCPCS J3490 and C9399 and later established J9334 effective 2024-01-01 and removed J3490/C9399.

2022-08-19Annual review - exclusion update

Added ravulizumab to the combination exclusion list with wording and formatting updates (coding reviewed; no changes).

2022-01-04Select review - policy creation and coding

Created the clinical criteria document for Vyvgart (efgartigimod), added administrative documentation language, and established HCPCS J9332 effective 2022-07-01 after initial coding entries; earlier temporary codes (J3490, J3590, C9399) were removed.

Note

Material change: nipocalimab added to exclusion; CIDP step therapy added (08/15/2025)

Document history (08/15/2025) notes addition of nipocalimab to the combination exclusion list and the addition of a new step therapy requirement for Vyvgart Hytrulo in CIDP.