ModifiedmhnPolicy CP.PHAR.555

Efgartigimod alfa-fcab and Efgartigimod/hyaluronidase (Vyvgart, Vyvgart Hytrulo) coverage

Medical necessity and prior authorization criteria for Vyvgart and Vyvgart Hytrulo for adults with generalized myasthenia gravis (AChR-positive) and for Vyvgart Hytrulo for chronic inflammatory demyelinating polyneuropathy (CIDP); applies to Centene-affiliated health plans and lines of business listed.

Policy Summary

Payermhn

PolicyEfgartigimod alfa-fcab and Efgartigimod/hyaluronidase (Vyvgart, Vyvgart Hytrulo) coverage

Policy CodePolicy CP.PHAR.555

Change TypeMultiple material updates (indication added, exclusions added, dosing/authorization changes)

Effective DateDec 17, 2021

Next Review Date

Key ActionSubmit prior authorization with documentation of diagnosis, prior therapy trials, current weight, and supporting clinical notes to demonstrate the member meets the stated criteria.

SourceLink

POLICY UPDATE CHANGES

Added new indication of CIDP for Vyvgart Hytrulo.

For gMG, added exclusion for concurrent therapy with Bkemv, Epqml?, Zilbrysq, and an FcRn antagonist; for CIDP, added exclusion for concurrent therapy with a complement inhibitor or FcRn antagonist.

Added HCPCS codes J9332 and J9334 for efgartigimod products.

Revised requirement for prior trial of two non-steroidal immunosuppressant therapies to a trial of at least one; added requirement for documentation of member's current weight for dose calculation.

Added HCPCS code J9334.

Commercial approval durations updated from 6/12 months to '6 months or to the member's renewal date, whichever is longer' for injectable agent.

New indication of CIDP added for Vyvgart Hytrulo.

For gMG, exclusion added for concurrent therapy with Bkemv, Epysqli, Zilbrysq, and an FcRn antagonist.

For CIDP, exclusion added for concurrent therapy with a complement inhibitor or FcRn antagonist.

Updated to include new Vyvgart Hytrulo prefilled syringe formulation.

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2FDA-approved indications described

≥18Minimum patient age

6 monthsApproval duration

≥5MG-ADL threshold

gMG, CIDPIndications covered

J9332,J9334HCPCS codes added

Coverage and Medical Necessity Criteria

Initial Therapy for gMG

Initial Approval Criteria — Generalized Myasthenia Gravis (ALL required):

gMG initial: Member has a diagnosis of generalized myasthenia gravis; prescribed by or in consultation with a neurologist; age >= 18 years; Myasthenia Gravis-Activities of Daily Living (MG-ADL) score >= 5 at baseline; greater than 50% of the baseline MG-ADL score is due to non-ocular symptoms; MGFA clinical classification of Class II to IV; positive serologic test for anti-AChR antibodies; failure of a cholinesterase inhibitor unless contraindicated; failure of a corticosteroid unless contraindicated; failure of at least one immunosuppressive therapy unless contraindicated or intolerant; agent is not prescribed concurrently with a complement inhibitor (e.g., Soliris/Ultomiris/Bkemv/Epysqli/Zilbrysq) or another FcRn antagonist (e.g., Rystiggo); for Vyvgart requests, documentation of the member's current weight (kg) is provided; proposed dosing does not exceed product-specific limits (Vyvgart IV <= 10 mg/kg, max 1,200 mg per infusion for >=120 kg; Vyvgart Hytrulo SC <= 1,008 mg/11,200 units once weekly x4 per 8-week cycle).see individual nodes

Includes prior therapy requirements, concurrent therapy exclusions, weight documentation, and dosing limits per labeling

Initial Therapy for CIDP

Initial Approval Criteria — Chronic Inflammatory Demyelinating Polyneuropathy (ALL required):

CIDP initial: Request is for Vyvgart Hytrulo; diagnosis of chronic inflammatory demyelinating polyneuropathy (CIDP); prescribed by or in consultation with a neurologist or neuromuscular specialist; age >= 18 years; disease course progressive or relapsing for >= 2 months; either (a) typical CIDP with progressive or relapsing symmetric proximal and distal muscle weakness of upper and lower limbs plus sensory involvement of >= 2 limbs AND absent or reduced tendon reflexes in all limbs, OR (b) one of the CIDP variants (distal, multifocal, focal, motor, sensory); diagnosis confirmed via electrodiagnostic testing; exclusion of alternative causes (no Borrelia burgdorferi/diphtheria/drug- or toxin-induced neuropathy; no hereditary demyelinating neuropathy; no prominent sphincter disturbance; no multifocal motor neuropathy; no IgM monoclonal gammopathy with high-titer anti-MAG antibodies; no other causes such as POEMS, osteosclerotic myeloma, diabetic or non-diabetic lumbosacral radiculoplexus neuropathy); failure of at least one immune globulin therapy unless contraindicated or intolerant; for members without pure motor symptoms, failure of a corticosteroid unless contraindicated; Vyvgart Hytrulo is not prescribed concurrently with immune globulin therapy, a complement inhibitor (e.g., Soliris/Bkemv/Epysqli, Ultomiris), or another FcRn antagonist (e.g., Rystiggo); dosing does not exceed 1,008 mg/11,200 units SC once weekly for the first 4 weeks (product-specific presentation limits apply).see criteria

Includes diagnostic confirmation, exclusion of alternative causes, prior therapy requirement, concurrent therapy exclusions, and dosing limits

Continuation Therapy for gMG

Continuation/Repeat Authorization — Generalized Myasthenia Gravis (ALL required):

gMG continuation: Member currently receiving medication via the Centene benefit or previously met initial approval criteria OR member is in a jurisdiction with continuity of care; member is responding to therapy as evidenced by a >= 2-point reduction in MG-ADL total score; the agent is not prescribed concurrently with a complement inhibitor (e.g., Soliris/Bkemv/Epysqli, Ultomiris, Zilbrysq) or another FcRn antagonist (e.g., Rystiggo); for Vyvgart requests, documentation of the member's current weight (kg) is provided; proposed dose does not exceed product-specific limits (Vyvgart IV <= 10 mg/kg, max 1,200 mg per infusion for >=120 kg; Vyvgart Hytrulo SC <= 1,008 mg/11,200 units once weekly).>=2 point reduction in MG-ADL

Response required for continuation; dose increase rules apply

Continuation Therapy for CIDP

Continuation/Repeat Authorization — CIDP (ALL required):

CIDP continuation: Member currently receiving medication via the Centene benefit or previously met initial approval criteria OR member is in a jurisdiction with continuity of care; request is for Vyvgart Hytrulo; member is responding to therapy as evidenced by improvement or stabilization on a CIDP disability or impairment scale, disability improvement, or symptom improvement in affected limbs; Vyvgart Hytrulo is not prescribed concurrently with immune globulin therapy, a complement inhibitor (e.g., Soliris/Bkemv/Epysqli, Ultomiris), or another FcRn antagonist (e.g., Rystiggo); if request is for a dose increase, the new dose does not exceed 1,008 mg/11,200 units SC once weekly (product-specific presentation limits apply).clinical improvement or stabilization

Response required for continuation; concurrent therapy exclusions and dosing limits apply

Coverage criteria for indications and dosing

Coverage applies when dosing, indication, and contraindication criteria are met per labeling and policy revisions.

gMG initial dosing and retreatment: Initial IV regimen for gMG: Vyvgart 10 mg/kg IV once weekly for the first 4 weeks of an 8-week cycle (maximum 1,200 mg per infusion for members >= 120 kg); subsequent treatment cycles based on clinical evaluation; safety not established to start subsequent cycles sooner than approximately 50 days from the start of the previous cycle; MG-ADL >= 5 at baseline is the initial threshold used in trials and policy; trial of at least one non-steroidal immunosuppressant required per revised policy; documentation of current weight required for dosing calculations; concurrent therapy exclusions apply.MG-ADL >= 5 per policy for initial approval; subsequent response per MG-ADL

Includes dosing limits, minimum interval between cycles (~50 days), prior therapy and documentation requirements

Vyvgart Hytrulo gMG initial dosing: Vyvgart Hytrulo SC dosing (syringe): 1,000 mg efgartigimod alfa + 10,000 units hyaluronidase once weekly x4 weeks; (vial): 1,008 mg + 11,200 units once weekly x4 weeks; subsequent cycles based on clinical evaluation; safety not established to initiate subsequent cycles sooner than ~50 days from prior cycle; concurrent therapy exclusions and prior therapy requirements apply.MG-ADL responder status per ADAPT trial (>=2-point improvement)

Requests for indications that are not FDA‑approved and are not specifically addressed in this policy are excluded unless the request includes sufficient documentation of efficacy and safety consistent with the applicable off‑label use policies (see CP.CPA.09 for commercial, HIM.PA.154 for marketplace, and CP.PMN.53 for Medicaid).

Concurrent use of Vyvgart Hytrulo with immune globulin therapy (for CIDP), complement inhibitors (for example, Soliris/Ultomiris/Bkemv/Epysqli), or other FcRn antagonists is excluded and will prevent approval under this policy.

Vyvgart and Vyvgart Hytrulo are contraindicated in individuals with a history of serious hypersensitivity to efgartigimod alfa products or any excipient. In addition, Vyvgart Hytrulo is contraindicated in individuals with a history of serious hypersensitivity to hyaluronidase.

For generalized myasthenia gravis (gMG), concurrent therapy with Bkemv, Epysqli, Zilbrysq and any other FcRn antagonist is excluded per the 1Q 2025 update. For chronic inflammatory demyelinating polyneuropathy (CIDP), concurrent therapy with a complement inhibitor or another FcRn antagonist is excluded.

Use of Vyvgart or Vyvgart Hytrulo for non‑FDA‑approved indications that lack sufficient supporting documentation of efficacy and safety per the applicable off‑label use policies is considered not authorized and may be denied.

Requests for treatment of non‑FDA‑approved indications without adequate evidence of benefit and safety as required by off‑label use policies will not be authorized under this clinical policy.

Concurrent use with the agents excluded in this policy for the listed indications (for example, the specified FcRn antagonists and complement inhibitors for gMG or CIDP, and immune globulin therapy for CIDP) is considered not eligible for coverage and may trigger denial of authorization.

Billing Codes, Dosing Limits and Key Values

Drug codesNDC

NDC(s) not listed

No NDCs provided in this part of the document

Clinical scalesmixed

MG-ADL

Clinical scale referenced for response assessment

HCPCS CodesHCPCS

J9332	Injection, efgartigimod alfa-fcab, 2 mg
J9334	Injection, efgartigimod alfa, 2 mg and hyaluronidase-qvfc

Covered HCPCS Codes (added)HCPCSCovered

J9334

efgartigimod alfa-fcab (exact HCPCS code added in policy)

inv-18: MG-ADL baseline

MG-ADL baseline threshold>= 5 (Myasthenia Gravis-Activities of Daily Living score at baseline)

Use in initial approval for gMGRequired baseline MG-ADL >= 5 to qualify for initial Vyvgart/Vyvgart Hytrulo therapy

Source appendix referenceMG-ADL defined in Appendix A as the Myasthenia Gravis-Activities of Daily Living scale

inv-19: Vyvgart IV dosing limit — <= 10 mg/kg (max 1,200 mg per infusion for ≥120 kg) weekly x4 per 8-week cycle

IV dosing limit (Vyvgart)<= 10 mg/kg per infusion; maximum 1,200 mg per infusion for members weighing >= 120 kg; administered IV once weekly for the first 4 weeks of every 8-week cycle

Authorization, Documentation and Step Therapy Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Providers must demonstrate the member meets the specific clinical criteria listed for initial approval and continuation per the policy. Requests may be denied if criteria are not met.

Prior authorization required for efgartigimod products billed under HCPCS codes J9332 and J9334.
Providers must document that the member meets all clinical criteria for the requested indication (see Initial and Continued Approval sections).
Commercial approval durations: 6 months or to the member's renewal date, whichever is longer, for injectable formulations.

Documentation Required

Required Documentation

Provider must submit supporting clinical documentation at time of request. Acceptable documentation includes office chart notes, relevant laboratory results, diagnostic testing (e.g., electrodiagnostic testing for CIDP), MG‑ADL scores, and current weight for dose calculation where applicable.

Clinical Background and Drug Information

Efgartigimod products are neonatal Fc receptor (FcRn) antagonists that reduce circulating pathogenic IgG. Vyvgart (intravenous formulation) is indicated for adults with AChR‑antibody positive generalized myasthenia gravis (gMG). Vyvgart Hytrulo is a subcutaneous formulation (efgartigimod alfa plus hyaluronidase) indicated for the same gMG population and was added to this policy with an additional FDA‑approved indication for chronic inflammatory demyelinating polyneuropathy (CIDP) in adults per the RT4 update.

Definitions and Diagnostic Criteria

inv-37: MG-ADL — Myasthenia Gravis-Activities of Daily Living scale (abbreviation listed in Appendix A).

MG-ADL abbreviationMG-ADL: Myasthenia Gravis-Activities of Daily Living scale (see Appendix A)

Appendix locationDefined in Appendix A: MG-ADL listed in abbreviation/acronym key

UsageReferenced as the baseline and response assessment tool in approval criteria

inv-38: MGFA — Myasthenia Gravis Foundation of America clinical classification (abbreviation listed in Appendix A).

MGFA abbreviationMGFA: Myasthenia Gravis Foundation of America clinical classification (see Appendix A)

Appendix locationMGFA listed in Appendix A abbreviation/acronym key

Policy Changes and Version History

2025-04-23formulation_addedLatest

Policy updated to include the new Vyvgart Hytrulo prefilled syringe formulation.

2024-11-20concurrent_therapy_exclusions_added

1Q 2025 annual review added exclusions for concurrent therapy: for gMG (Bkemv, Epysqli, Zilbrysq, and an FcRn antagonist) and for CIDP (a complement inhibitor or FcRn antagonist).

2023-10-27hcpcs_code_added

Policy Summary

Payermhn

PolicyEfgartigimod alfa-fcab and Efgartigimod/hyaluronidase (Vyvgart, Vyvgart Hytrulo) coverage

Policy CodePolicy CP.PHAR.555

Change TypeMultiple material updates (indication added, exclusions added, dosing/authorization changes)

Effective DateDec 17, 2021

Next Review Date

Key ActionSubmit prior authorization with documentation of diagnosis, prior therapy trials, current weight, and supporting clinical notes to demonstrate the member meets the stated criteria.

SourceLink

On This Page

Dosing limits per product presentation; documentation and exclusions apply

Vyvgart Hytrulo CIDP dosing: Vyvgart Hytrulo SC dosing for CIDP: syringe presentation 1,000 mg/10,000 units once weekly; vial presentation 1,008 mg/11,200 units once weekly; maximum doses per product presentation; indication of CIDP for Vyvgart Hytrulo was added in the policy update; concurrent therapy exclusions for CIDP include immune globulin therapy, complement inhibitors, and FcRn antagonists.Diagnosis of CIDP per EAN/PNS criteria (typical or variant with supportive criteria as needed)

CIDP added as an indication for Vyvgart Hytrulo; dosing and concurrent therapy exclusions per labeling and policy update

Cycle frequencyInitial regimen: once weekly x4 weeks per 8-week treatment cycle; subsequent cycles based on clinical evaluation

Dose-increase guidanceIf request is for a dose increase, new dose must not exceed 10 mg/kg (1,200 mg for >=120 kg) IV once weekly x4 per 8-week cycle

inv-20: Vyvgart Hytrulo SC dosing limit — <= 1,008 mg/11,200 units once weekly x4 per 8-week cycle

SC dosing limit (Vyvgart Hytrulo vial)<= 1,008 mg efgartigimod alfa with 11,200 units hyaluronidase once weekly for the first 4 weeks of every 8-week cycle

SC dosing limit (Vyvgart Hytrulo syringe presentation)Syringe: 1,000 mg efgartigimod alfa with 10,000 units hyaluronidase once weekly for the first 4 weeks (per dosing regimen descriptions)

Dose-increase guidanceIf request is for a dose increase, new dose must not exceed 1,008 mg/11,200 units SC once weekly for the first 4 weeks

inv-21: Minimum interval between cycles — Subsequent cycles not established sooner than 50 days (approximately) from start of previous cycle

Minimum interval between cyclesSubsequent treatment cycles are not established sooner than 50 days (approximately 8 weeks) from the start of the previous cycle

Clinical basisSubsequent cycles are administered according to individual clinical response; ADAPT trial specified not sooner than 8 weeks from initiation of previous cycle

ApplicabilityApplies to Vyvgart IV and Vyvgart Hytrulo retreatment scheduling per dosage guidance

inv-22: Approval duration — 6 months or to the member's renewal date, whichever is longer

Approval duration (commercial)6 months or to the member's renewal date, whichever is longer

ScopeStandardized commercial approval duration for injectable formulations including Vyvgart Hytrulo

Policy update noteCommercial approval durations updated during RT4 to this standardized duration

Chart notes supporting diagnosis and specialty consultation (neurologist or neuromuscular specialist as required).
Baseline and follow-up MG‑ADL scores (for gMG) including documentation that baseline MG‑ADL ≥ 5 and >50% non‑ocular symptoms when applicable.
Electrodiagnostic testing confirming CIDP diagnosis (for CIDP requests).
Documentation of prior therapy trials (agents, dates, reasons for discontinuation) and current weight in kilograms for dosing.
Any additional information requested to demonstrate medical necessity per policy.

Step Therapy

Required Prior Therapy

Prior therapy must be documented before approval. Specific required trials differ by indication and are outlined below.

gMG: Documented failure (or contraindication/intolerance) of a cholinesterase inhibitor and a corticosteroid, plus failure of at least one immunosuppressive therapy (revised from two to at least one non‑steroidal immunosuppressant per labeling).
gMG continuation: Member must be responding to therapy (≥2‑point reduction in MG‑ADL) and not receiving concurrent excluded therapies.
CIDP (Vyvgart Hytrulo): Documented failure of at least one immune globulin therapy unless contraindicated or not tolerated; disease progressive or relapsing ≥2 months.
Concurrent therapy exclusions: Not approved when prescribed concurrently with a complement inhibitor (e.g., Soliris/Bkemv/Epysqli, Ultomiris), another FcRn antagonist (e.g., Rystiggo), and for CIDP, concurrent immune globulin therapy is not permitted.

Denial Risk

Off‑label Use / Denial Risk

Requests for non‑FDA approved indications that are not addressed in this policy may be denied unless sufficient documentation is submitted per the off‑label use policies.

Off‑label uses require evidence of efficacy and safety and adherence to CP.CPA.09 (commercial), HIM.PA.154 (Marketplace), or CP.PMN.53 (Medicaid) as applicable.

Denial Risk

Concurrent Therapy Exclusions

Concurrent use with certain agents will prevent approval. Verify medication list and prior or current therapies before submission.

For gMG: concurrent therapy exclusion includes Bkemv, Epysqli, Zilbrysq, complement inhibitors (Soliris/Ultomiris) and other FcRn antagonists (Rystiggo).
For CIDP: concurrent use with a complement inhibitor, immune globulin therapy (for CIDP), or another FcRn antagonist will prevent approval.

Role in criteriaUsed to define clinical class II-IV requirement for gMG initial approval

inv-39: MG-ADL — An 8-item patient-reported scale measuring MG functional status; each item scored 0-3; a 2-point decrease is clinically meaningful.

MG-ADL descriptionAn 8-item patient-reported scale measuring MG functional status; each item scored 0-3

Scoring interpretationTotal score ranges by summation of 8 domains (0 = normal to 3 = most severe per item)

Clinically meaningful changeA 2-point decrease in total MG-ADL score is considered clinically meaningful

inv-40: CIDP diagnostic support — If electrodiagnostic studies are 'possible CIDP', then ≥2 additional supportive criteria (response to standard treatment, CSF analysis, n...)

CIDP diagnostic support ruleIf electrodiagnostic studies are 'possible CIDP', then ≥2 additional supportive criteria (response to standard treatment, cerebrospinal fluid analysis, nerve imaging, nerve biopsy) can be used to support diagnosis

Guideline referenceRefer to 2021 EAN/PNS CIDP guideline for diagnostic criteria and variant-specific rules

LimitationsNot all CIDP diagnostic categories allow for 2 supportive criteria to substitute for electrodiagnostic criteria

inv-41: Vyvgart Hytrulo prefilled syringe — Vyvgart Hytrulo prefilled syringe — a new subcutaneous formulation of efgartigimod/hyaluronidase-qvfc added to the policy.

Vyvgart Hytrulo prefilled syringeVyvgart Hytrulo prefilled syringe: new subcutaneous formulation of efgartigimod/hyaluronidase-qvfc added to the policy

Policy updatePrefilled syringe presentation included in RT4 policy update

ImplicationBoth syringe and vial presentations are addressed in dosing and coverage criteria

HCPCS code J9334 was added to the policy for efgartigimod products (J9334).