ModifiedCignaPolicy IP0574

Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) coverage

This Cigna coverage policy governs prior authorization, medical necessity criteria, dosing, and coding for Vyvgart Hytrulo subcutaneous injections for adults with CIDP or anti-AChR positive generalized myasthenia gravis.

Policy Summary

PayerCigna

PolicyVyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) coverage

Policy CodePolicy IP0574

Change TypeCoding and criteria revisionsdosing interval removaladded 'currently receiving' criterion

Effective DateJan 15, 2025

Next Review DateN/A

Key ActionObtain prior authorization and submit claims using HCPCS J9334 when the patient meets the policy criteria.

SourceLink

POLICY UPDATE CHANGES

Moved the restriction 'treatment cycles are no more frequent than every 50 days from the start of the previous treatment cycle' from the dosing section into Generalized Myasthenia Gravis criteria, and later removed that requirement following prescribing information updates.

Added criterion 'Patient is Currently Receiving Vyvgart Hytrulo (or Vyvgart Intravenous [efgartigimod alfa- fcab intravenous infusion])' for Generalized Myasthenia Gravis.

Updated coding: removed C9399, J3490, J3590 and added J9334 (effective 1/1/2024).

Added documentation instructions and dosing information for the Vyvgart Hytrulo prefilled syringe.

2FDA-approved indications covered

≥18Minimum age

3m CIDP / 6m gMGInitial authorization

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AnnualPolicy revision cadence

NCApplicable state listed

Coverage Criteria for Vyvgart Hytrulo

CIDP Coverage Criteria

Vyvgart Hytrulo is medically necessary for CIDP when ONE of the following is met:

CIDP - initial therapy: Initial Therapy: Approve for 3 months if ALL of (i) patient is >= 18 years of age; AND (ii) diagnosis of CIDP is supported by electrodiagnostic studies; AND (iii) patient meets ONE of the following: (a) has a contraindication to intravenous or subcutaneous immune globulin (examples include Gammagard Liquid, Gammaked, Gamunex-C, Panzyga, Privigen, Hizentra, and HyQvia); OR (b) has previously received IV or SC immune globulin and had inadequate efficacy or significant intolerance; AND (iv) the medication is prescribed by or in consultation with a neurologist.>= 18 years

Initial therapy path

CIDP - current therapy: Patient is Currently Receiving Vyvgart Hytrulo: Approve for 1 year if ALL of (i) patient is >= 18 years of age; AND (ii) according to the prescriber, the patient has a clinically significant improvement in neurologic symptoms (examples include improved or stabilized nerve conduction study results or improved strength and sensation on exam); AND (iii) the medication is prescribed by or in consultation with a neurologist.>= 18 years

Continuation criteria

Generalized Myasthenia Gravis (anti-AChR positive) Coverage Criteria

Vyvgart Hytrulo is medically necessary for generalized myasthenia gravis when ONE of the following is met:

gMG - initial therapy: Initial Therapy: Approve for 6 months if ALL of (i) patient is >= 18 years of age; AND (ii) patient has confirmed anti-acetylcholine receptor (anti-AChR) antibody-positive generalized myasthenia gravis [documentation required]; AND (iii) patient meets BOTH of the following: (a) Myasthenia Gravis Foundation of America (MGFA) classification II to IV; AND (b) MG-ADL score >= 5; AND (iv) patient meets ONE of the following: (a) received or is currently receiving pyridostigmine; OR (b) has had inadequate efficacy, a contraindication, or significant intolerance to pyridostigmine; AND (v) patient has evidence of unresolved symptoms of gMG (examples include difficulty swallowing, difficulty breathing, or functional disability such as double vision, impaired speech, or impaired mobility); AND (vi) the medication is being prescribed by or in consultation with a neurologist.MG-ADL >= 5; MGFA II-IV

Initial therapy path

gMG - current therapy: Patient is Currently Receiving Vyvgart Hytrulo (or Vyvgart Intravenous): Approve for 1 year if ALL of (i) patient is >= 18 years of age; AND (ii) according to the prescriber, the patient is continuing to derive benefit from Vyvgart Hytrulo (examples of derived benefit include reductions in exacerbations and improvements in speech, swallowing, mobility, and respiratory function); AND (iii) the medication is being prescribed by or in consultation with a neurologist.

Therapy-specific criteria (summary of revisions)

Policy includes distinct criteria sets for Generalized Myasthenia Gravis and CIDP; revisions moved and removed certain dosing interval requirements and added current-therapy language.

Generalized Myasthenia Gravis - historical dosing interval: Treatment cycles are no more frequent than every 50 days from the start of the previous treatment cycle (this requirement was moved into GRMG criteria and later removed per prescribing information).50 days

Requirement moved then removed; subsequent cycles are based on clinical evaluation

Generalized Myasthenia Gravis - currently receiving added: Added criterion: Patient is currently receiving Vyvgart Hytrulo (or Vyvgart Intravenous [efgartigimod alfa intravenous infusion]) as an approval pathway for ongoing therapy.

Supports 1-year continuation approval

CIDP - updates for patients currently receiving: CIDP continuation criteria were updated to add/clarify that patients currently receiving Vyvgart Hytrulo must be >= 18 years of age and that the medication be prescribed by or in consultation with a neurologist.

Vyvgart Hytrulo for any use not specifically listed in this policy is not medically necessary. This includes use outside the FDA‑approved indications and any other unlisted indications where supporting evidence is not available.

Concomitant use of Vyvgart Hytrulo with another neonatal Fc receptor blocker, a complement inhibitor, or a rituximab product is listed under Conditions Not Covered and is considered not medically necessary; examples of neonatal Fc receptor blockers (e.g., Imaavy, Rystiggo, Vyvgart intravenous) and complement inhibitors (e.g., Soliris and biosimilars, Ultomiris, Zilbrysq) are provided in the policy notes.

The policy states there is no evidence to support concomitant administration of Vyvgart Hytrulo with another neonatal Fc receptor blocker, a complement inhibitor, or a rituximab product; such concomitant use is therefore considered not medically necessary.

Specific conditions and concomitant‑use scenarios are collected under the policy section titled Conditions Not Covered. The policy provides illustrative examples and was updated to add Imaavy among neonatal Fc receptor blocker examples and to note biosimilars to Soliris among complement inhibitors.

Coding and Code Updates

Considered Medically Necessary when criteria metHCPCSCovered

J9334

Injection, efgartigimod alfa, 2 mg and hyaluronidase-qvfc

Considered Medically Necessary / Coding updatesHCPCSCovered

J9334	Injection, efgartigimod alfa, 2 mg and hyaluronidase-qvfc
C9399	Removed (previously listed) — unspecified HCPCS code
J3490	Removed (previously listed) — unclassified drugs
J3590	Removed (previously listed) — unclassified biologics

inv-10: MG-ADL score — required threshold value

MG-ADL score>= 5

MGFA classification requiredMGFA class II-IV (both required for initial gMG therapy)

DocumentationMG-ADL score must be documented as part of initial therapy criteria

inv-11: Minimum age for therapy — adult use threshold

Minimum age for Vyvgart Hytrulo therapy>= 18 years

Applies to CIDP initial and continuation criteriaPatient must be >=18 years for CIDP initial therapy and for patients currently receiving Vyvgart Hytrulo

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior Authorization is required for Vyvgart Hytrulo. Approval is recommended when the patient meets the policy clinical criteria and dosing. Requests for doses outside the established dosing in this policy will be reviewed on a case-by-case basis by a clinician. Approvals are provided for the duration specified in the policy. Prescriptions must be by or in consultation with a physician who specializes in the condition being treated. Documentation is required where noted in the criteria (e.g., anti-AChR antibody confirmation, electrodiagnostic studies for CIDP).

Prior authorization required for Vyvgart Hytrulo
Approvals follow criteria and dosing in this policy; exceptions reviewed case-by-case
Prescriber: specialist or in consultation with specialist
Documentation required where noted in criteria

Background

Vyvgart Hytrulo is a combination product of efgartigimod alfa and hyaluronidase‑qvfc formulated for subcutaneous administration and is approved for two adult indications: chronic inflammatory demyelinating polyneuropathy (CIDP) and anti‑AChR antibody‑positive generalized myasthenia gravis (gMG). CIDP is a chronic demyelinating peripheral neuropathy diagnosed by clinical and electrodiagnostic criteria, and gMG is an autoimmune neuromuscular disease characterized by fluctuating skeletal muscle weakness associated with anti‑acetylcholine receptor antibodies.

Definitions and Product Details

inv-22: Vyvgart Hytrulo — product description, formulation, presentation details

Active ingredientsEfgartigimod alfa and hyaluronidase-qvfc combination product

PresentationsSingle-use vial: 1,008 mg efgartigimod alfa / 11,200 units hyaluronidase; Single-use prefilled syringe: 1,000 mg efgartigimod alfa / 10,000 units hyaluronidase

Route and administrationSubcutaneous use; vial intended for administration with a winged infusion set by a healthcare professional; prefilled syringe may be self-administered or caregiver-administered after instruction

inv-23: CIDP — definition of chronic inflammatory demyelinating polyneuropathy

DefinitionChronic inflammatory demyelinating polyneuropathy (CIDP) is a chronic peripheral nervous system disorder with progressive motor and sensory dysfunction over >8 weeks; diagnosis requires electrodiagnostic evidence of demyelination

Policy Summary

PayerCigna

PolicyVyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) coverage

Policy CodePolicy IP0574

Change TypeCoding and criteria revisionsdosing interval removaladded 'currently receiving' criterion

Effective DateJan 15, 2025

Next Review DateN/A

Key ActionObtain prior authorization and submit claims using HCPCS J9334 when the patient meets the policy criteria.

SourceLink

On This Page

Continuation criteria

Added in revision to align with dosing and prescriber requirements

Applies to gMG initial and continuation criteriaPatient must be >=18 years for gMG initial therapy and for patients currently receiving Vyvgart Hytrulo

inv-12: Treatment cycle interval (historical) — previously required no more frequent than every 50 days; requirement removed per prescribing information

Historical interval requirementPreviously required treatment cycles no more frequent than every 50 days from the start of the previous treatment cycle

Policy changeThis 50-day requirement was moved into gMG criteria during revision and later removed per prescribing information

Current guidanceSubsequent treatment cycles are administered based on clinical evaluation (50-day restriction removed)

Billing Rule

Prior Authorization and Coding

Prior authorization is required and claims must be billed using HCPCS code J9334 when criteria are met. Deleted or ineffective codes and use of codes other than J9334 may not be eligible for reimbursement. Claims submitted without covered diagnosis or procedure codes listed in the policy will be denied as not covered.

Use HCPCS J9334: Injection, efgartigimod alfa, 2 mg and hyaluronidase-qvfc
Deleted/ineffective codes or other codes may be ineligible for reimbursement
Claims lacking covered diagnosis/procedure codes will be denied

Step Therapy

Required Prior or Contraindicated Therapies

For initial therapy of CIDP, patient must have contraindication to IV/SC immune globulin or prior IV/SC immune globulin with inadequate efficacy or significant intolerance. Examples of IV/SC immune globulin include Gammagard Liquid, Gammaked, Gamunex-C, Panzyga, Privigen, Hizentra, and HyQvia. For generalized myasthenia gravis, patients should have received or tried pyridostigmine unless contraindicated or intolerant. These prior or contraindicated therapies must be documented.

CIDP initial therapy requires contraindication to IV/SC immune globulin OR prior IV/SC immune globulin with inadequate efficacy or significant intolerance
Examples of IV/SC immune globulin: Gammagard Liquid; Gammaked; Gamunex-C; Panzyga; Privigen; Hizentra; HyQvia
Myasthenia gravis: prior use of pyridostigmine or documented contraindication/intolerance

Documentation Required

Documentation Required for Clinical Criteria

Documentation must be provided where noted in the criteria for the requested indication (examples: chart notes, lab tests, electrodiagnostic study results, claims records). Specific documentation expectations include confirmation of anti-acetylcholine receptor antibody–positive generalized myasthenia gravis and electrodiagnostic support for CIDP. All documentation must include patient-specific identifying information.

Anti-AChR antibody confirmation required for generalized myasthenia gravis [documentation required]
Electrodiagnostic studies required to support CIDP diagnosis
Chart notes, labs, and other records acceptable; must include patient identifiers

Note

Provider-Actions Note

Operational note: documentation instructions were added to the policy. Providers should include the specified documentation with prior authorization requests to avoid delays or denials. For patients currently receiving Vyvgart Hytrulo, updated criteria (e.g., age ≥ 18 and neurologist prescription/consultation) apply per revision history.

Follow documentation instructions in policy when submitting prior authorization requests
Current-treatment continuation criteria updated (e.g., CIDP and MG continuation requirements)

Denial Risk

Coding and Documentation Noncompliance

Claims submitted for services not accompanied by covered diagnosis or procedure codes in this policy will be denied. Services billed with codes other than J9334 (or with deleted/ineffective codes) may not be eligible for reimbursement.

Claims without covered diagnosis/procedure codes will be denied as not covered
Use J9334 for reimbursable billing; deleted/ineffective codes may be ineligible

Symmetric proximal and distal muscle weakness, numbness, fatigue, gait difficulties, falls, fine motor impairment, and paresthesia

Diagnostic supportElectrodiagnostic studies (nerve conduction) are required; supportive criteria can include CSF protein, nerve imaging/pathology, and response to treatment

inv-24: gMG (anti-AChR antibody-positive) — definition of generalized myasthenia gravis with anti-AChR antibodies

DefinitionGeneralized myasthenia gravis (gMG) anti-AChR antibody-positive: an autoimmune neuromuscular disease in adults confirmed by presence of anti-acetylcholine receptor antibodies, characterized by fluctuating skeletal muscle weakness affecting daily activities

Prevalence of antibody positivityApproximately 85% of patients with myasthenia gravis are anti-AChR antibody-positive

Clinical features required for therapyFor initial Vyvgart Hytrulo therapy, MGFA class II–IV and MG-ADL score >=5 are required (documentation required for anti-AChR antibody status)

inv-25: Chronic inflammatory demyelinating polyneuropathy (CIDP) — alternate naming and note added in revisions

Alternate namesAlso referred to as chronic relapsing polyneuropathy or chronic inflammatory demyelinating polyradiculoneuropathy

Policy noteA note adding these alternate names was included in the CIDP criteria revisions

RelevanceAlternate terminology appears in the CIDP FDA-approved indications and revision details