ModifiedCentenePolicy CP.PHAR.555

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

Defines medical necessity criteria, prior authorization requirements, and coverage limitations for Vyvgart and Vyvgart Hytrulo for adults with generalized myasthenia gravis (AChR antibody positive) and for Vyvgart Hytrulo in chronic inflammatory demyelinating polyneuropathy (CIDP). Applies to Centene-affiliated health plans and providers requesting coverage.

Policy Summary

PayerCentene

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

Policy CodePolicy CP.PHAR.555

Change TypeRevised, Added, Clarified

Effective DateDec 17, 2021

Next Review Date

Key ActionSubmit prior authorization with documentation showing member meets criteria and include current weight for Vyvgart dosing.

SourceLink

POLICY UPDATE CHANGES

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

Added new indication of CIDP for Vyvgart Hytrulo and included Vyvgart Hytrulo prefilled syringe formulation and vial dosing.

Clarified that immunosuppressive therapy for gMG should be non-steroidal and revised 'failure' to 'insufficient response' for immune globulin therapy in CIDP.

≥18Minimum age for covered indications

MG-ADL ≥5Required baseline severity (gMG)

10 mg/kg

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Max IV induction dose

1,008 mgMax SC induction dose (Hytrulo)

J9332, J9334HCPCS codes added

6 monthsCommercial approval duration

Coverage Criteria for Vyvgart and Vyvgart Hytrulo

Initial Therapy (gMG)

Covered when ALL of the following are met

gMG initial: 1. Diagnosis of generalized myasthenia gravis (gMG). 2. Prescribed by or in consultation with a neurologist. 3. Age ≥ 18 years. 4. Baseline Myasthenia Gravis‑Activities of Daily Living (MG‑ADL) score ≥ 5. 5. Greater than 50% of the baseline MG‑ADL score is attributable to non‑ocular symptoms. 6. Myasthenia Gravis Foundation of America (MGFA) clinical classification Class II–IV. 7. Positive anti‑AChR serology. 8. Failure of a cholinesterase inhibitor unless contraindicated or clinically significant adverse effects. 9. Failure of a corticosteroid unless contraindicated or clinically significant adverse effects. 10. Failure of at least one non‑steroidal immunosuppressive therapy unless contraindicated or clinically significant adverse effects. 11. Not prescribed concurrently with a complement inhibitor (e.g., Soliris, Ultomiris, Bkemv, Epysqli, Zilbrysq) or another FcRn antagonist (e.g., Imaavy, Rystiggo). 12. For Vyvgart (IV) requests: documentation of the member's current weight (kg). 13. Dosing limit met: Vyvgart IV does not exceed 10 mg/kg once weekly for the first 4 weeks of an 8‑week cycle (maximum 1,200 mg per infusion for members ≥120 kg) OR Vyvgart Hytrulo SC does not exceed 1,008 mg/11,200 units once weekly for the first 4 weeks of an 8‑week cycle.

Initial Therapy (CIDP)

Covered when ALL of the following are met

CIDP initial: 1. Request is for Vyvgart Hytrulo. 2. Diagnosis of chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). 3. Prescribed by or in consultation with a neurologist or neuromuscular specialist. 4. Age ≥ 18 years. 5. Disease is progressive or relapsing for ≥ 2 months. 6. Either: (a) typical CIDP with progressive/relapsing symmetric proximal and distal 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). 7. Diagnosis confirmed by electrodiagnostic testing. 8. No alternative causes for demyelinating neuropathy (e.g., Lyme disease, diphtheria, hereditary demyelinating neuropathy, multifocal motor neuropathy, IgM MG with high‑titer anti‑MAG, POEMS, osteosclerotic myeloma, diabetic or nondiabetic lumbosacral radiculoplexus neuropathy). 9. Insufficient response to at least one immune globulin therapy unless contraindicated or clinically significant adverse effects. 10. For members without pure motor symptoms: failure of corticosteroid at maximally indicated doses unless contraindicated or clinically significant adverse effects. 11. Vyvgart Hytrulo is not prescribed concurrently with immune globulin therapy, a complement inhibitor (e.g., Soliris, Ultomiris) or another FcRn antagonist (e.g., Rystiggo). 12. Dose does not exceed 1,008 mg/11,200 units SC once weekly for the first 4 weeks of a treatment cycle.

Continuation Therapy (gMG)

Covered for continuation when ALL of the following are met

gMG continuation: 1. Member is currently receiving medication via the Centene benefit or previously met initial approval criteria OR is in continuity of care per state rules. 2. Member is responding positively to therapy as evidenced by a ≥ 2‑point reduction in total MG‑ADL score (clinically meaningful response). 3. The requested agent is not prescribed concurrently with a complement inhibitor (e.g., Soliris, Ultomiris, Bkemv, Epysqli, Zilbrysq) or another FcRn antagonist (e.g., Imaavy, Rystiggo). 4. For Vyvgart (IV) requests: documentation of the member's current weight (kg). 5. If request is for a dose increase, the new dose does not exceed protocol maximums (Vyvgart IV ≤10 mg/kg once weekly for the first 4 weeks of an 8‑week cycle; Vyvgart Hytrulo SC ≤1,008 mg/11,200 units once weekly for the first 4 weeks).

Continuation Therapy (CIDP)

Covered for continuation when ALL of the following are met

CIDP continuation: 1. Member is currently receiving medication via the Centene benefit or previously met initial approval criteria OR is in continuity of care per state rules. 2. Request is for Vyvgart Hytrulo. 3. Member is responding positively to therapy as evidenced by improvement or stabilization in a CIDP disability or impairment scale (see Appendix E), disability improvement, or symptom improvement in affected limbs. 4. Vyvgart Hytrulo is not prescribed concurrently with immune globulin therapy, a complement inhibitor (e.g., Soliris, Ultomiris) or another FcRn antagonist (e.g., Rystiggo). 5. If request is for a dose increase, the new dose does not exceed 1,008 mg/11,200 units SC once weekly.

Other indications / Off-label

Other indications

Other uses: 1. If the drug has undergone a recent label change (within the last 6 months) not reflected in this policy (e.g., new indication, age expansion, new dosing), follow the relevant formulary or non‑formulary policies referenced for the line of business (see CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16, CP.CPA.09, HIM.PA.154, CP.PMN.53). 2. Uses not listed under approved or allowed continuation indications should be referred to the off‑label use policy for the applicable line of business; non‑FDA approved indications are not authorized under this policy unless sufficient documentation per off‑label policies or evidence of coverage is provided.

Coverage criteria (dosing, response, prior therapy, contraindications)

Coverage applies for FDA‑approved indications with documented dosing and response; subsequent cycles depend on clinical response measures.

gMG initial dosing: Administer Vyvgart (efgartigimod alfa‑fcab) 10 mg/kg IV once weekly for the first 4 weeks of a treatment cycle. Subsequent cycles are based on clinical evaluation and response (e.g., MG‑ADL).MG‑ADL improvement ≥2 points considered clinically meaningful

Maximum Vyvgart dose: 10 mg/kg/week (1,200 mg per infusion for members ≥120 kg).

gMG Hytrulo dosing: Vyvgart Hytrulo SC dosing options for gMG: Prefilled syringe — 1,000 mg efgartigimod alfa with 10,000 units hyaluronidase once weekly for the first 4 weeks; Vial — 1,008 mg efgartigimod alfa with 11,200 units hyaluronidase once weekly for the first 4 weeks. Subsequent cycles based on clinical evaluation.MG‑ADL improvement ≥2 points (or greater)

Documentation of current weight required for IV Vyvgart dose calculations.

Requests for indications that are not FDA‑approved under this policy are not authorized unless the provider supplies sufficient documentation of efficacy and safety consistent with the applicable Centene off‑label use policies (e.g., CP.CPA.09 for commercial, HIM.PA.154 for marketplace, CP.PMN.53 for Medicaid) or unless evidence of coverage documents indicate coverage.

Contraindications include serious hypersensitivity to efgartigimod alfa products or any excipients; for Vyvgart Hytrulo specifically, serious hypersensitivity to hyaluronidase is a contraindication. Concurrent use is excluded with certain therapies — for example, complement inhibitors and other FcRn antagonists — and the policy updates have expanded specific concurrent‑therapy exclusions over time.

When state Medicaid coverage provisions conflict with this clinical policy, the state Medicaid coverage provisions take precedence for Medicaid members; refer to the applicable state Medicaid manual for specifics.

Use of the drug for non‑FDA indications is not authorized under this policy unless the request includes sufficient off‑label documentation demonstrating efficacy and safety per the applicable off‑label use policies or unless evidence of coverage documents provide for the requested use.

Off‑label requests that do not include the required supporting documentation (clinical records, literature or evidence consistent with Centene off‑label policies) or that lack required prior treatments/diagnostic confirmation as specified in the criteria will be considered not authorized and may be denied.

Coding and Key Metrics

Coding notesmixed

NDC / HCPCS not listed

Document does not list specific billing codes in this section.

Covered HCPCS CodesHCPCSCovered

J9332

Injection, efgartigimod alfa-fcab, 2 mg.

Covered HCPCS CodesHCPCSCovered

J9334

Injection, efgartigimod alfa, 2 mg and hyaluronidase-qvfc

inv-15: MG-ADL baseline — Required baseline severity for gMG (>= 5)

Required baseline MG-ADLMG-ADL score ≥ 5 at baseline

Age requirementMember aged ≥ 18 years

MG-ADL non-ocular symptom requirement>50% of baseline MG-ADL score attributable to non-ocular symptoms

inv-16: MG-ADL response — Response threshold (>= 2-point reduction)

Response threshold>= 2-point reduction in total MG-ADL score

Clinical meaningfulnessA 2-point decrease in MG-ADL is considered clinically meaningful

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Determined by Health Plan

Prior authorization is required. The Health Plan determines prior authorization requirements and makes final coverage decisions in accordance with the member's benefit plan and applicable administrative policies.

Prior authorization required for initial approval for generalized myasthenia gravis (gMG) and for chronic inflammatory demyelinating polyneuropathy (CIDP).
Prior authorization required for HCPCS-coded products Vyvgart (J9332) and Vyvgart Hytrulo (J9334).

Documentation Required

Documentation Required; Insufficient or Off‑Label Requests May Be Denied

Requests must include supporting clinical documentation showing the member meets all approval criteria. Incomplete documentation or requests for non-covered or non‑FDA indications that lack sufficient off‑label justification may be denied.

Provider must submit office chart notes, diagnostic test results, labs, MG‑ADL scores, MGFA classification, serologic testing results, electrodiagnostic testing (for CIDP), and any other relevant clinical information.

Background and Drug Information

Efgartigimod alfa‑fcab (Vyvgart) is a neonatal Fc receptor (FcRn) antagonist that reduces circulating pathogenic IgG. Vyvgart is supplied for intravenous administration; dosing for generalized myasthenia gravis is 10 mg/kg IV once weekly for the first 4 weeks with subsequent cycles guided by clinical response. Vyvgart Hytrulo combines efgartigimod alfa with hyaluronidase to enable subcutaneous delivery and is available in syringe and vial formulations; the Hytrulo subcutaneous induction dosing is approximately 1,000–1,008 mg SC once weekly for 4 weeks depending on formulation, with subsequent cycles based on clinical evaluation.

Definitions and Abbreviations

inv-32: FcRn — Neonatal Fc receptor; target mechanism of efgartigimod alfa

TermNeonatal Fc receptor (FcRn)

MechanismFcRn is the target mechanism of efgartigimod alfa (FcRn antagonist)

Acronym referenceFcRn defined in Appendix A (abbreviation/acronym key)

inv-33: gMG — Generalized myasthenia gravis; requires anti-AChR antibody positive status

TermGeneralized myasthenia gravis (gMG)

FDA indication requirementVyvgart and Vyvgart Hytrulo indicated for gMG in adult patients who are anti-AChR antibody positive

Policy diagnostic requirement

Policy Revision History

2022-01-04criteria_revision

Revised prior trial requirement from two non‑steroidal immunosuppressant therapies to at least one and added requirement to document member's current weight for dose calculation.

2022-06-30coding_addition

Added HCPCS code J9332 for efgartigimod alfa-fcab (Vyvgart).

2022-08-09concurrent_therapy_update

Updated concurrent use exclusions to include Ultomiris (a complement inhibitor).

Policy Summary

PayerCentene

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

Policy CodePolicy CP.PHAR.555

Change TypeRevised, Added, Clarified

Effective DateDec 17, 2021

Next Review Date

Key ActionSubmit prior authorization with documentation showing member meets criteria and include current weight for Vyvgart dosing.

SourceLink

On This Page

CIDP Hytrulo dosing:

Vyvgart Hytrulo SC for CIDP: Prefilled syringe — 1,000 mg/10,000 units once weekly; Vial — 1,008 mg/11,200 units once weekly. Subsequent treatment based on CIDP‑specific clinical evaluation and validated disability/impairment scales (e.g., INCAT, I‑RODS).

Use CIDP disability/impairment scales to assess response

For CIDP, policy language uses 'insufficient response' to prior immune globulin therapy rather than 'failure'.

Prior therapy requirement: For gMG, a prior trial of at least one non‑steroidal immunosuppressant therapy is required (policy revised from two to one trial). For CIDP, insufficient response to at least one immune globulin therapy is required unless contraindicated. Document prior therapies and responses.Document trial and response; step therapy exceptions (e.g., Illinois HIM) may apply

Providers must include supporting documentation such as office notes and prior treatment records.

Contraindications and exclusions: Contraindicated in patients with serious hypersensitivity to efgartigimod alfa products or any excipients; Vyvgart Hytrulo is contraindicated in those with serious hypersensitivity to hyaluronidase. Concurrent use with certain agents (immune globulins, complement inhibitors, other FcRn antagonists) is excluded as specified in the policy and updates.N/A

See Appendix C for full contraindication listing and policy revision history for specific agent exclusions.

Continuation requirementContinuation approval requires documentation of ≥2-point MG-ADL improvement or other positive clinical response

inv-17: Maximum dose (Vyvgart) — 10 mg/kg/week (1,200 mg per infusion for members ≥ 120 kg)

Maximum IV dose (Vyvgart)10 mg/kg per week (maximum 1,200 mg per infusion for members weighing ≥ 120 kg)

Induction regimen10 mg/kg IV once weekly for the first 4 weeks (subsequent cycles per clinical evaluation)

Weight documentationFor Vyvgart requests, documentation of member's current weight (kg) is required for dose calculation

inv-18: Maximum dose (Vyvgart Hytrulo syringe) — 1,000 mg efgartigimod alfa and 10,000 units hyaluronidase per week

Maximum SC dose (Hytrulo syringe)1,000 mg efgartigimod alfa and 10,000 units hyaluronidase once weekly

Vial alternative dosingVial formulation: 1,008 mg efgartigimod alfa and 11,200 units hyaluronidase once weekly

Induction regimenOnce weekly SC injections for the first 4 weeks; subsequent cycles based on clinical evaluation

Documentation must include the member's current weight (kg) for Vyvgart dose calculation purposes.

Off‑label (non‑FDA) indications will not be authorized unless sufficient documentation of efficacy and safety is provided per applicable off‑label policies (CP.CPA.09 for Commercial, HIM.PA.154 for HIM, CP.PMN.53 for Medicaid).

Step Therapy

Step Therapy / Prior Treatment Requirements

Step therapy and prior treatment requirements must be met unless clinically contraindicated or state continuity/legislation (e.g., IL HB 5395 for Illinois HIM) supersedes the requirement.

For gMG: failure of a cholinesterase inhibitor and failure of a corticosteroid are required unless contraindicated or adverse effects are experienced.
For gMG: requirement revised to at least one trial of a non‑steroidal immunosuppressive therapy (reduced from two trials) unless contraindicated.
For CIDP (Vyvgart Hytrulo): insufficient response to at least one immune globulin therapy is required unless contraindicated or adverse effects are experienced.
For CIDP: failure of corticosteroid therapy for non‑pure motor symptoms is required unless contraindicated.

Policy requires positive anti-AChR serology for gMG indication

inv-34: MG-ADL — 8-item patient-reported scale; 2-point decrease is clinically meaningful

InstrumentMG-ADL: 8-item patient-reported scale (0–3 per item) measuring functional domains in myasthenia gravis

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

Use in trialsPhase 3 ADAPT trial used MG-ADL response (≥2-point improvement) to guide subsequent treatment cycles

inv-35: CIDP — Chronic inflammatory demyelinating polyradiculoneuropathy; diagnostic criteria reference

TermChronic inflammatory demyelinating polyradiculoneuropathy (CIDP)

Diagnostic criteriaDiagnosis may require electrodiagnostic testing; if electrodiagnostics are insufficient, ≥2 supportive criteria (e.g., CSF, imaging, biopsy, response to treatment) may be used per 2021 EAN/PNS CIDP guideline

Exclusion of other causesOther causes (e.g., POEMS, osteosclerotic myeloma, lumbosacral radiculoplexus neuropathy) must be excluded

inv-36: Health Plan — Definition of 'Health Plan' for policy applicability

Definition'Health Plan' means a health plan that has adopted this clinical policy and that is operated or administered, in whole or in part, by Centene Management Company, LLC, or any of such health plan's affiliates

ApplicabilityPolicy guidance is provided to assist coverage decisions but does not constitute a contract or guarantee of payment

Plan-level authorityCoverage decisions are subject to all terms, conditions, exclusions, and limitations of the member's coverage documents and applicable Health Plan-level administrative policies

2022-08-23continuation_criteria_update

Added continuation therapy restriction prohibiting concurrent use with Soliris or Ultomiris and applied template changes to continuation and other sections.

2023-06-27product_addition

Added Vyvgart Hytrulo to the policy (RT4) expanding formulations covered under the policy.

2023-10-27coding_addition

Added HCPCS code J9334 for Vyvgart Hytrulo (efgartigimod alfa with hyaluronidase).

2024-11-20concurrent_therapy_update

Expanded concurrent therapy exclusions for gMG to include Bkemv, Epysqli, Zilbrysq, and an FcRn antagonist; for CIDP added exclusion for complement inhibitors or FcRn antagonists.

2025-04-23formulation_update

Updated policy to include the new Vyvgart Hytrulo prefilled syringe formulation.

2025-10-23criteria_clarificationLatest

Clarified that immunosuppressive therapy for gMG should be non‑steroidal; changed CIDP prior immune globulin language from 'failure' to 'insufficient response'; clarified that gMG response criterion (>=2‑point MG‑ADL reduction) may be greater than 2 points; added Imaavy to concurrent therapy exclusions.