ModifiedCentenePolicy CP PHAR.555

Efgartigimod Alfa-fcab, Efgartigimod/Hyaluronidase-qvfc (Vyvgart; Vyvgart Hytrulo)

Defines medical necessity and prior authorization requirements for efgartigimod alfa-fcab (Vyvgart) and efgartigimod alfa/hyaluronidase-qvfc (Vyvgart Hytrulo) for Centene lines of business including Commercial, HIM, and Medicaid; applies to prescribers and reviewers evaluating coverage for gMG and CIDP.

Policy Summary

PayerCentene

PolicyEfgartigimod Alfa-fcab, Efgartigimod/Hyaluronidase-qvfc (Vyvgart; Vyvgart Hytrulo)

Policy CodePolicy CP PHAR.555

Change TypeMultiple: added Vyvgart Hytrulo and CIDP indicationrevised prior therapy requirementadded HCPCS codes and concurrent therapy exclusions

Effective DateDec 17, 2021

Next Review DateN/A

Key ActionSubmit prior authorization with documentation that the member meets the listed initial or continued therapy criteria, including current weight and required prior therapy trials.

SourceLink

POLICY UPDATE CHANGES

Vyvgart Hytrulo added to policy and a CIDP indication was added for Vyvgart Hytrulo.

Requirement for trial of two non-steroidal immunosuppressants was revised to a trial of at least one.

New HCPCS codes J9332 and J93347 were added for efgartigimod products.

Added exclusions for concurrent therapy with certain agents including Bkemv, Epysqli, Zilbrysq, and FcRn antagonists; for CIDP also excluded concurrent complement inhibitors.

Revised requirement for a 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 purposes.

Added HCPCS codes J9332 and J93347 to the policy.

Vyvgart Hytrulo (subcutaneous) formulation and prefilled syringe formulation were added to the policy.

Updated exclusions to add concurrent therapy prohibitions with specific agents (Bkemv, Epysqli, Zilbrysq) and FcRn antagonists; for CIDP added exclusion for concurrent complement inhibitor or FcRn antagonist.

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

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J9332, J93347HCPCS codes added

gMG, CIDPIndications covered

6 monthsCommercial approval duration

MG-ADL >=5Baseline severity threshold

>=1Required prior trial

50 daysMinimum retreat interval

Coverage Criteria

Initial Therapy - gMG

Initial Approval — Generalized Myasthenia Gravis (must meet all):

gMG Initial: Member has diagnosis of generalized myasthenia gravis; prescribed by or in consultation with a neurologist; age >= 18 years; baseline MG-ADL score >= 5; greater than 50% of the baseline MG-ADL score is due to non-ocular symptoms; positive anti-AChR serology; MGFA clinical classification Class II–IV; documented failure of a cholinesterase inhibitor unless contraindicated; documented failure of a corticosteroid unless contraindicated; documented failure of at least one immunosuppressive therapy unless contraindicated; agent is not prescribed concurrently with a complement inhibitor or another FcRn antagonist; dosing limits: Vyvgart IV does not exceed 10 mg/kg (max 1,200 mg per infusion for members >= 120 kg) IV once weekly x4 weeks per 8-week cycle OR Vyvgart Hytrulo SC does not exceed 1,008 mg (vial) / 1,000 mg (syringe) once weekly x4 weeks per 8-week cycle; for Vyvgart requests document current weight for dose calculation.

Initial Therapy - CIDP

Initial Approval — CIDP (Vyvgart Hytrulo only, must meet all):

CIDP Initial: Request is for Vyvgart Hytrulo; member has diagnosis of chronic inflammatory demyelinating polyneuropathy (CIDP) with diagnosis confirmed by electrodiagnostic testing; prescribed by or in consultation with a neurologist or neuromuscular specialist; disease progressive or relapsing for >= 2 months; age >= 18 years; clinical features consistent with typical CIDP (progressive or relapsing symmetric proximal and distal weakness with sensory involvement of >= 2 limbs OR defined CIDP variants) and absence of excluded alternative diagnoses (e.g., Lyme, diphtheria/toxin exposure, hereditary demyelinating neuropathy, multifocal motor neuropathy, POEMS, certain gammopathies); documented failure of at least one immune globulin therapy unless contraindicated; Vyvgart Hytrulo is not prescribed concurrently with immune globulin therapy, a complement inhibitor, or another FcRn antagonist; dose does not exceed 1,008 mg (vial) / 1,000 mg (syringe) SC once weekly x4 weeks per 8-week cycle.

Continuation Therapy - gMG

Continued Therapy — Generalized Myasthenia Gravis (must meet one of the following):

gMG Continued: a) Member is currently receiving the medication via a Centene benefit OR member previously met initial approval criteria and is continuing therapy; AND member is responding positively to therapy as evidenced by a >= 2-point reduction in total MG-ADL score; OR b) continuity of care provisions apply for the member's state/product. Additional requirements: agent is not prescribed concurrently with a complement inhibitor or another FcRn antagonist; for Vyvgart requests document current weight. If request is for a dose increase, new dose must not exceed the stated maximums for IV or SC formulations.

Continuation Therapy - CIDP

Continued Therapy — CIDP (must meet one of the following):

CIDP Continued: a) Member is currently receiving the medication via a Centene benefit OR member previously met initial approval criteria; OR b) continuity of care provisions apply for the member's state/product. Member must demonstrate improvement or stabilization on a CIDP disability/impairment scale or symptom improvement in affected limbs. Vyvgart Hytrulo must not be prescribed concurrently with immune globulin therapy, a complement inhibitor, or another FcRn antagonist. If request is for a dose increase, new dose must not exceed 1,008 mg (vial) / 1,000 mg (syringe) SC once weekly for the initial 4-week cycle.

Other Indications / Off-label

Other diagnoses/indications:

Other Indications: For uses not specified in this policy, follow the applicable formulary/non-formulary and off-label use policies for the relevant line of business (refer to Centene policies CP.CPA.190, HIM.PA.33, CP.PMN.255, CP.PMN.16, CP.CPA.09, HIM.PA.154, CP.PMN.53 as appropriate). If a recent label change within the last 6 months is not yet reflected in this policy, refer to the specified policies above.

Coverage Criteria (partial extract)

Covered when ALL relevant indication-specific criteria are met per policy sections (partial content in this window):

gMG indication dosing: Initial regimen: Vyvgart IV 10 mg/kg once weekly x4 weeks; subsequent cycles based on clinical evaluation; do not start a subsequent cycle sooner than 50 days from the start of the prior treatment cycle; maximum 10 mg/kg/week (1,200 mg for members >= 120 kg).50 days

MG-ADL responder criteria and cycle retreatment based on MG-ADL score described elsewhere in policy

Vyvgart Hytrulo gMG dosing: SC regimen: Prefilled syringe 1,000 mg efgartigimod alfa + 10,000 units hyaluronidase or vial 1,008 mg efgartigimod alfa + 11,200 units once weekly x4 weeks; subsequent cycles based on clinical evaluation; safety not established for initiating subsequent cycles sooner than 50 days from the start of the previous cycle; maximum per week equals syringe or vial strength.50 days

Prefilled syringe and vial formulations available

Vyvgart Hytrulo CIDP dosing:

Initial and Continuation Therapy Criteria

Covered when ALL of the following are met

Core prerequisites: Member has an FDA-approved indication for efgartigimod (Vyvgart) or Vyvgart Hytrulo (including gMG and CIDP as applicable); documentation includes the member's current weight for dosing calculations; prior trial of at least one non-steroidal immunosuppressant therapy documented when applicable; age and diagnostic/severity criteria per indication are documented.at least 1 trial

Per updated FDA labeling and policy revisions; exact diagnostic and severity criteria are in the indication-specific sections.

Exclusions at initiation/continuation: No concurrent use with specified excluded agents including complement inhibitors and FcRn antagonists (and specific agents added in updates: Bkemv, Epysqli, Zilbrysq); concurrent use with certain agents (e.g., Soliris, Ultomiris) explicitly prohibited per prior updates; concurrent therapy exclusions for CIDP include complement inhibitors or FcRn antagonists.none

Policy updated to add these exclusions (1Q2025)

The policy excludes concurrent use of Vyvgart Hytrulo with immune globulin therapy, complement inhibitors (for example Soliris/Ultomiris), or another FcRn antagonist. Requests that include any of these agents at the time of initiation or continuation should be considered non-compliant with the concurrent‑use rules and may be denied.

Use of efgartigimod products for off‑label indications not specified in this policy is subject to the applicable Centene off‑label and formulary policies. Refer to CP.CPA.09, HIM.PA.154, or CP.PMN.53 (as applicable by line of business) for documentation and evidence requirements; absent sufficient support per those policies, coverage for non‑FDA indications is not authorized.

The policy explicitly prohibits concurrent therapy with listed agents. Historically this included Soliris and Ultomiris; the 1Q2025 update added exclusions for concurrent use with agents such as Bkemv, Epigslist (Epigslist/Epigslist‑class agents listed in the update), Zilbrysq, and other specified FcRn antagonists. For CIDP indications, concurrent use with complement inhibitors or FcRn antagonists is also excluded. Any request proposing simultaneous administration with these agents should be reviewed as an exclusion.

Requests for diagnoses, ages, or dosing regimens that are not listed in the policy sections will be evaluated against the off‑label and formulary policies referenced in this document. If the requested use is not specifically listed in section III, approval will only be considered when the criteria of the applicable off‑label or non‑formulary policy are met and all required supporting documentation is provided.

Treatments or indications that are not addressed by FDA labeling and that lack sufficient evidence as defined by the Centene off‑label use policies will be considered not medically necessary. Requests for such uses should follow the referenced off‑label evaluation pathways; absent adequate supportive evidence and documentation, coverage will not be authorized.

Concurrent use of Vyvgart or Vyvgart Hytrulo with the specified excluded agents (including complement inhibitors and FcRn antagonists listed in the policy updates) is treated as not medically necessary and is a basis for denial of the request. Ensure medication histories document absence of these prohibited concurrent therapies prior to approving initiation or continuation.

Coding

HCPCS CodesHCPCS

J9332	Injection_efgartigimod alfa-fcab 2mg
J9334	Injection,efgartigimod alfa, 2 mg and hyaluronidase-qvfc
J93347	Injection, efgartigimod alfa/hyaluronidase (added 10/27/23)

Covered HCPCS CodesHCPCSCovered

J9332	HCPCS code added to policy
J93347	HCPCS code added to policy

inv-16: MG-ADL baseline

MG-ADL baseline threshold>= 5 (baseline MG-ADL score)

Responder definitionClinically meaningful response = >= 2-point decrease in total MG-ADL score

Non-ocular symptom requirement>50% of baseline MG-ADL score must be due to non-ocular symptoms

inv-17: Age for gMG and CIDP

Minimum age>= 18 years for generalized myasthenia gravis and for CIDP

Prescriber requirementPrescribed by or in consultation with a neurologist or neuromuscular specialist as applicable

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Providers must submit a prior authorization request and supporting clinical documentation demonstrating that the member meets all applicable initial or continuation therapy criteria in this policy.

Prior authorization required for Vyvgart (efgartigimod alfa‑fcab) and Vyvgart Hytrulo (efgartigimod alfa/hyaluronidase) prior to initiation or continuation of therapy.
Requests lacking documentation that the member meets all approval criteria may be denied.

Billing Rule

Prior Authorization & Billing Codes

Include applicable HCPCS billing codes on the prior authorization and claim submissions to facilitate processing.

Definitions

inv-33: Efgartigimod alfa-fcab / Efgartigimod alfa/hyaluronidase-qvfc

Efgartigimod alfa-fcab (Vyvgart)A neonatal Fc receptor (FcRn) antagonist for IV administration (Vyvgart dosing: 10 mg/kg IV once weekly x4 weeks for initial cycle)

Efgartigimod alfa/hyaluronidase-qvfc (Vyvgart Hytrulo)Combination of efgartigimod alfa and hyaluronidase for subcutaneous administration (prefilled syringe: 1,000 mg + 10,000 units; vial: 1,008 mg + 11,200 units; dosing once weekly x4 weeks for initial cycle)

Mechanism/formulation noteEfgartigimod alfa is an FcRn antagonist; Hytrulo includes hyaluronidase to permit SC delivery

inv-34: MG-ADL — Myasthenia Gravis-Activities of Daily Living scale

MG-ADL scaleAn 8-item patient-reported instrument measuring function in domains related to myasthenia gravis (each item scored 0-3)

Clinically meaningful change

Background

Efgartigimod products act as FcRn antagonists. Vyvgart Hytrulo combines efgartigimod alfa with hyaluronidase to enable subcutaneous administration. Vyvgart (efgartigimod alfa‑fcab) and Vyvgart Hytrulo are FDA‑approved for generalized myasthenia gravis in adults who are anti‑AChR antibody positive; Vyvgart Hytrulo also has an FDA‑approved indication for chronic inflammatory demyelinating polyneuropathy (CIDP) in adults. Providers must document current patient weight for dose calculation and follow the dosing limits specified in the policy (IV and SC strengths per labeling).

Policy Summary

PayerCentene

PolicyEfgartigimod Alfa-fcab, Efgartigimod/Hyaluronidase-qvfc (Vyvgart; Vyvgart Hytrulo)

Policy CodePolicy CP PHAR.555

Change TypeMultiple: added Vyvgart Hytrulo and CIDP indicationrevised prior therapy requirementadded HCPCS codes and concurrent therapy exclusions

Effective DateDec 17, 2021

Next Review DateN/A

Key ActionSubmit prior authorization with documentation that the member meets the listed initial or continued therapy criteria, including current weight and required prior therapy trials.

SourceLink

On This Page

SC regimen for CIDP: Syringe 1,000 mg/10,000 units or vial 1,008 mg/11,200 units once weekly x4 weeks; dosing/cycle rules similar to gMG; Vyvgart Hytrulo has an added CIDP indication per policy updates.

CIDP-specific diagnostic criteria and supportive scales referenced in appendices

Prior therapy requirement: Document trial of at least one non-steroidal immunosuppressant (revised from two) and other prior therapy trials as applicable per therapeutic alternatives appendix.trial >=1 agent

Therapeutic alternatives listed in Appendix B

Concurrent therapy exclusions: No concurrent use with specified agents (historically Soliris or Ultomiris and, per 1Q2025 updates, additional exclusions including Bkemv, Epysqli, Zilbrysq, and FcRn antagonists); for CIDP also exclude concurrent complement inhibitors or FcRn antagonists.N/A

Concurrent therapy exclusions added in 1Q2025 review

FDA indication population

Indications specified apply to adult patients who are anti-AChR antibody positive for gMG; CIDP indication applies to adults for Vyvgart Hytrulo

inv-18: Minimum interval between cycles

Minimum interval between cyclesNo subsequent cycle should be initiated sooner than 50 days from the start of the previous treatment cycle

Cycle retreatment basisSubsequent cycles are based on clinical evaluation and MG-ADL response (e.g., if MG-ADL rises to >=5 or loss of clinically meaningful improvement)

Safety statementSafety not established for initiating subsequent cycles sooner than 50 days from prior cycle start

HCPCS: J9332 — Injection, efgartigimod alfa‑fcab, 2 mg.

HCPCS: J9334 (or J93347 as applicable per billing guidance) — Injection, efgartigimod alfa and hyaluronidase (Vyvgart Hytrulo) — verify current code set before submission.

Denial Risk

Off‑Label Indication Denial Risk

Off‑label or non‑FDA approved indications that are not addressed in this policy may be denied. If the requested use is not listed in the policy and criterion 1 of the Other Diagnoses/Indications section does not apply, follow the applicable off‑label use policy.

Commercial: CP.CPA.09
Health insurance marketplace: HIM.PA.154
Medicaid: CP.PMN.53

Documentation Required

Required Supporting Documentation

Provide complete supporting clinical documentation with the prior authorization request to demonstrate the member meets the approval criteria.

Office chart notes documenting diagnosis, neurologist consultation, and clinical status (e.g., MG‑ADL and MGFA classification for gMG).
Relevant laboratory results, including serologic testing for anti‑AChR antibodies when applicable.
Documentation of prior therapy trials and reasons for failure or contraindication (see Appendix B for therapeutic alternatives).
For Vyvgart requests: member’s current weight (kg) for dose calculation.

Step Therapy

Prior Therapy Requirements & Step Therapy

Requests must include documentation of required prior therapy trials as specified in the approval criteria; insufficient prior therapy documentation may result in denial.

For generalized myasthenia gravis (gMG): documented failure (or contraindication/intolerance) of a cholinesterase inhibitor, a corticosteroid, and at least one immunosuppressive therapy before approval.
Policy requires trials of prior therapies per the approval criteria with documented agents, dates, and durations (see Appendix B for specifics).
Step‑therapy requirement: trial of at least one non‑steroidal immunosuppressant therapy is required prior to approval unless contraindicated.

A 2-point decrease in total MG-ADL score is considered a clinically meaningful response

Use in retreatment decisionsPhase 3 ADAPT used MG-ADL response (>=2-point improvement) and MG-ADL >=5 threshold to guide retreatment timing

inv-35: CIDP diagnostic supportive criteria

Supportive criteria when EDx insufficientIf electrodiagnostic studies do not meet minimal criteria for CIDP, at least 2 additional supportive criteria may be required

Examples of supportive criteriaResponse to standard CIDP treatments, cerebrospinal fluid analysis, nerve imaging, or nerve biopsy

Reference guidanceDiagnostic criteria for CIDP variants refer to 2021 EAN/PNS CIDP guideline; not all variants allow using 2 supportive criteria

inv-36: Chronic inflammatory demyelinating polyneuropathy

DefinitionChronic inflammatory demyelinating polyneuropathy (CIDP) includes typical CIDP and CIDP variants characterized by clinical and electrodiagnostic phenotypes

Common clinical featuresTypical CIDP presents with symmetric proximal and distal weakness and sensory involvement of >=2 limbs; variants have specific phenotypes

Standard treatmentsImmune globulins, corticosteroids, and plasma exchange are recommended treatments for disabling CIDP symptoms