Neurology - Vyvgart Hytrulo - (IP0574)

Coverage Summary

Scope: Cigna coverage policy defining prior authorization, approval criteria, dosing, durations, documentation requirements, and exclusions for Vyvgart Hytrulo for CIDP and generalized myasthenia gravis (gMG) in adults.

Coverage stance: covered_with_criteria; prior authorization is required and approvals are provided for specified durations per indication (e.g., 3 months for CIDP initial, 1 year for continuing CIDP; 6 months for gMG initial, 1 year for continuing gMG).

FDA-Approved Indications: CIDP (Chronic Inflammatory Demyelinating Polyneuropathy) – treatment in adults; gMG (generalized myasthenia gravis) – treatment of adults who are anti-acetylcholine receptor antibody-positive (AChR).

Product description: Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) is available as a single-use vial (1,008 mg efgartigimod alfa / 11,200 units hyaluronidase) and a single-use prefilled syringe (1,000 mg efgartigimod alfa / 10,000 units hyaluronidase) for subcutaneous administration.

Effective / last review dates: Policy effective date 05/01/2026; last review 01/15/2026.

Policy snapshot

Policy numberIP0574

Effective date2026-05-01

Last review2026-01-15

Coverage stanceCovered with criteria (prior authorization required)

Required HCPCS codeJ9334 (Injection, efgartigimod alfa, 2 mg and hyaluronidase-qvfc)

Required code count / specific code1 required HCPCS code: J9334

Initial Therapy Criteria

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) - FDA-Approved Indications

Approve for the duration noted below if the patient meets ONE of the following (A or B):

A) Initial Therapy (Approve for 3 months)

Patient is ≥ 18 years of age
Diagnosis of CIDP was supported by electrodiagnostic studies
iii. ONE of
- a): Patient has a contraindication to intravenous or subcutaneous immune globulin
  Examples of intravenous or subcutaneous immune globulin include: Gammagard Liquid, Gammaked, Gamunex-C, Panzyga, Privigen, Hizentra, and HyQvia.
- b) BOTH of

Continuation Therapy Criteria

Dosing (per indication) & Quantity Constraints

Dosing (per indication)

Approve ONE of the following dosing presentations:

ANY of the following

CIDP dosing: CIDP: One single-dose vial (1,008 mg efgartigimod alfa and 11,200 units hyaluronidase) or one prefilled syringe (1,000 mg efgartigimod alfa and 10,000 units hyaluronidase) administered as a subcutaneous injection once weekly
gMG dosing: gMG: One single-dose vial (1,008 mg efgartigimod alfa and 11,200 units hyaluronidase) or one prefilled syringe (1,000 mg efgartigimod alfa and 10,000 units hyaluronidase) administered as a subcutaneous injection once weekly for 4 weeks; subsequent treatment cycles administered based on clinical evaluation

Unproven / Exclusions

Denial Risk

Concomitant Use — Not Medically Necessary

Concomitant use of Vyvgart Hytrulo with another neonatal Fc receptor blocker, a complement inhibitor, a rituximab product, or Uplizna (inebilizumab-cdon) is considered not medically necessary. The policy explicitly added Uplizna to the list of products for which concomitant use is not covered in recent revisions.

Applicable Codes

Considered Medically Necessary (HCPCS)HCPCSCovered

J9334

Injection, efgartigimod alfa, 2 mg and hyaluronidase-qvfc

Removed / Not to be used (previously listed)mixedNot Covered

C9399	Previously listed, removed from coding
J3490	Previously listed, removed from coding
J3590	Previously listed, removed from coding

Coding change: J9334 (Injection, efgartigimod alfa, 2 mg and hyaluronidase-qvfc) was added to the policy coding effective 1/1/2024, and previously listed miscellaneous codes C9399, J3490, and J3590 were removed.

Provider Actions & Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for benefit coverage of Vyvgart Hytrulo. Approvals are provided for the durations specified in the criteria: CIDP initial therapy — 3 months; CIDP continuing therapy — 1 year; gMG initial therapy — 6 months; gMG continuing therapy — 1 year.

Affected code: J9334

Documentation Required

Documentation is required where noted in the criteria. Required documentation may include evidence of anti-AChR antibody positivity for gMG, electrodiagnostic support for CIDP, documentation of prior immune globulin therapy and intolerance or inadequate response, and supporting records such as chart notes, laboratory tests, claims records, and prescription receipts. All documentation must include patient-specific identifying information.

Clinical Evidence

HR 0.394CIDP trial: time to deterioration HR (95% CI: 0.253–0.614; P < 0.0001)

67.7% vs 29.7%gMG IV trial responder rate: Vyvgart IV responders 67.7% vs placebo 29.7% (P < 0.0001)

Background evidence: For CIDP, pivotal evidence came from a two-stage trial with an open-label responder-identification phase followed by a randomized, double-blind, placebo-controlled withdrawal period (responder-withdrawal design) that demonstrated a statistically significant delay in time to clinical deterioration (HR 0.394; 95% CI 0.253–0.614; P < 0.0001).

For gMG, the ADAPT-SC study showed non-inferiority of the subcutaneous Vyvgart Hytrulo formulation to the intravenous Vyvgart formulation; prior IV trials demonstrated substantial MG-ADL responder rates for Vyvgart IV versus placebo (67.7% vs 29.7%, P < 0.0001).

Available presentations include a healthcare-administered vial and a patient- or caregiver-administered prefilled syringe for subcutaneous injection, and for gMG the initial regimen is weekly for 4 weeks with subsequent treatment cycles administered based on clinical evaluation.

Background & Definitions

Vyvgart Hytrulo is a neonatal Fc receptor blocker indicated for CIDP and anti-AChR antibody-positive generalized myasthenia gravis (gMG) in adults. It is available as single-use vials (1,008 mg efgartigimod alfa / 11,200 units hyaluronidase) for administration by a healthcare professional and single-use prefilled syringes (1,000 mg efgartigimod alfa / 10,000 units hyaluronidase) that may be self- or caregiver-administered after instruction.

Trial design highlights: The CIDP program used a two-stage design with an open-label responder-identification phase (Stage A) followed by a randomized, double-blind, placebo-controlled withdrawal period (Stage B). The gMG clinical development included a trial demonstrating non-inferiority of the subcutaneous formulation to the intravenous formulation (ADAPT-SC) and prior IV randomized, double-blind, placebo-controlled evidence showing a robust MG-ADL responder rate for Vyvgart IV.

Term	Definition
CIDP
Chronic inflammatory demyelinating polyneuropathy; peripheral nervous system disorder diagnosed with clinical and electrodiagnostic criteria.
MG-ADL
Myasthenia Gravis Activities of Daily Living, an 8-item patient-reported measure; higher score indicates greater impairment.

Revision History

2024-10-15coding_update

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

2024-10-15policy_addition

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) condition and approval criteria were added to the policy, including initial and continuing therapy pathways and associated documentation/examples for IV/SC immune globulin.

2024-10-15dosing_change

Prefilled syringe presentation dosing information for Vyvgart Hytrulo was added to the dosing section (vial and prefilled syringe dosing specified for CIDP and gMG).

Generalized Myasthenia Gravis (gMG) - FDA-Approved Indications

Approve if the patient meets ONE of the following (A or B):

A) Initial Therapy (Approve for 6 months)

Patient is ≥ 18 years of age
Patient has confirmed anti-acetylcholine receptor antibody-positive generalized myasthenia gravis
[documentation required]
iii. BOTH of
- a): Myasthenia Gravis Foundation of America classification of II to IV
- b): Myasthenia Gravis Activities of Daily Living (MGADL) score of ≥ 5MG-ADL ≥ 5
iv. ONE of
- a): Patient received or is currently receiving pyridostigmine
- b): Patient has had inadequate efficacy, a contraindication, or significant intolerance to pyridostigmine
Patient has evidence of unresolved symptoms of generalized myasthenia gravis (examples: difficulty swallowing, difficulty breathing, or functional disability resulting in discontinuation of physical activity)
The medication is being prescribed by or in consultation with a neurologist

B) Patient is Currently Receiving Vyvgart Hytrulo (or Vyvgart Intravenous) (Approve for 1 year)

Patient is ≥ 18 years of age
According to the prescriber, patient is continuing to derive benefit from Vyvgart Hytrulo (or Vyvgart Intravenous)
Examples of derived benefit include reductions in exacerbations of myasthenia gravis; improvements in speech, swallowing, mobility, and respiratory function.
The medication is being prescribed by or in consultation with a neurologist