CurrentCignaPolicy IP0743

Imaavy (nipocalimab-aahu) for generalized myasthenia gravis

Cigna coverage policy governing prior authorization, dosing, indications, and exclusions for intravenous Imaavy for treatment of generalized myasthenia gravis in patients aged ≥12 years under Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyImaavy (nipocalimab-aahu) for generalized myasthenia gravis

Policy CodePolicy IP0743

Change TypeCoding additioncoverage clarification

Effective DateMay 1, 2026

Next Review Date

Key ActionObtain prior authorization; approvals are recommended when the patient meets the listed criteria (initial approvals for 6 months; continuation approvals for 1 year).

SourceLink

POLICY UPDATE CHANGES

Added HCPCS code J9256 (Injection, nipocalimab-aahu, 3 mg) to Coding Information.

Conditions Not Covered section revised to add Uplizna (inebilizumab-cdon) to the list of agents that should not be used concomitantly with Imaavy.

Expanded documentation statement to explicitly include prescription receipts and require patient-specific identifying information.

≥12minimum age for FDA-approved indication

30 mg/kginitial dosing

15 mg/kg q2wmaintenance dosing

J9256

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Coverage Criteria for Imaavy (nipocalimab-aahu)

FDA-Approved Indication (Generalized Myasthenia Gravis)

Approve for the FDA-approved indication of generalized myasthenia gravis when the following criteria are met.

FDA-Approved Indication: Patient meets ONE of Initial Therapy (A) or Currently Receiving Imaavy (B).

A) Initial Therapy - approve for 6 months

A.i Age: Patient is >= 12 years of age.
A.ii Adult severity: If patient is >= 18 years of age, patient must meet BOTH: a) Myasthenia Gravis Foundation of America classification of II to IV; AND b) Myasthenia Gravis Activities of Daily Living (MGADL) score >= 6.MGADL >= 6
A.iii Antibody status: Patient has confirmed anti-acetylcholine receptor (anti-AChR) antibody-positive generalized MG OR confirmed anti-muscle-specific tyrosine kinase (anti-MuSK) antibody-positive generalized MG (documentation required).
A.iv Prior pyridostigmine requirement: Patient previously received or is currently receiving pyridostigmine OR has had inadequate efficacy, a contraindication, or significant intolerance to pyridostigmine.
A.v Unresolved symptoms: Patient has evidence of unresolved symptoms of generalized myasthenia gravis (examples: difficulty swallowing, difficulty breathing, or functional disability limiting activity).
A.vi Prescriber specialty: Medication is being prescribed by or in consultation with a neurologist.

B) Patient is Currently Receiving Imaavy - approve for 1 year

B.i Age: Patient is >= 12 years of age.
B.ii Derived benefit: According to the prescriber, patient is continuing to derive benefit from Imaavy (examples: reduced exacerbations; improvements in speech, swallowing, mobility, respiratory function).
B.iii Prescriber specialty: Medication is being prescribed by or in consultation with a neurologist.

Dosing

Approve dosing as documented below.

Dosing: Initial therapy: single IV infusion 30 mg/kg administered over at least 30 minutes; then maintenance 15 mg/kg IV starting 2 weeks after the initial dose and every 2 weeks thereafter. For patients currently on Imaavy, approve maintenance 15 mg/kg IV every 2 weeks.

Initial infusion administered over at least 30 minutes; maintenance infusions administered over at least 15 minutes.

Imaavy (nipocalimab-aahu) is not medically necessary for uses outside its FDA-approved indication of generalized myasthenia gravis. This includes any other diagnoses, indications, or clinical scenarios not explicitly covered by the FDA-approved indication and the policy’s coverage criteria. Such uses are listed under the Conditions Not Covered section and will be updated if new evidence becomes available.

Concomitant administration of Imaavy with the following agents is considered not medically necessary and is excluded from coverage: another neonatal Fc receptor (FcRn) blocker (for example, Rystiggo, Vyvgart, or Vyvgart Hytrulo), a complement inhibitor (for example, eculizumab, ravulizumab, or zilucoplan), a rituximab product, or Uplizna (inebilizumab-cdon). The policy states there is no evidence to support concomitant use of Imaavy with these agents.

Coding Information

Considered medically necessary HCPCSHCPCSCovered

J9256

Injection, nipocalimab-aahu, 3 mg

MGADL score — required score threshold for consideration

MGADL score thresholdMGADL score of >= 6 is required for adult patients (>= 18 years) as part of initial therapy criteria.

Context of useUsed to define suboptimal response to current stable standard-of-care therapy in the clinical trial and required for initial approval in adults.

Authorization implicationMeets one component of the adult severity requirement to qualify for a 6-month initial approval when combined with MGFA II–IV and other criteria.

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for benefit coverage of Imaavy. Approvals for initial therapy are typically 6 months; approvals for patients currently receiving Imaavy are typically 1 year. All approvals are provided for the duration noted in the policy (months = 30 days each). Requests for doses outside the dosing documented in the policy will be considered case-by-case by a clinician. Imaavy must be prescribed by or in consultation with a neurologist (or physician who specializes in the condition).

Initial approvals: 6 months (see Initial Therapy criteria)
Continuation approvals: 1 year for patients currently receiving Imaavy who continue to derive benefit
Off-label or non-standard dosing will be reviewed case-by-case by a clinician

Documentation Required

Required Documentation

Documentation is required where noted in the criteria as [documentation required]. Documentation may include, but is not limited to, chart notes, laboratory tests, medical test results, claims records, and prescription receipts. All documentation must include patient-specific identifying information.

Background

Myasthenia gravis (MG) is an autoimmune neuromuscular disorder caused by pathogenic IgG autoantibodies that impair neuromuscular transmission, commonly directed against the acetylcholine receptor (anti-AChR) or muscle-specific tyrosine kinase (anti-MuSK). Patients with generalized myasthenia gravis (gMG) experience fluctuating, fatigable weakness affecting ocular, bulbar, limb, neck, and respiratory muscles; symptoms typically worsen with activity and improve with rest. Imaavy is indicated for treatment of antibody-positive gMG in patients aged ≥ 12 years under the FDA-approved indication described in this policy.

Definitions

gMG — definition of generalized myasthenia gravis

DefinitionGeneralized myasthenia gravis (gMG): chronic autoimmune neuromuscular disease causing weakness in skeletal muscles that worsens with activity and improves with rest; can affect ocular, bulbar, limb, neck, and respiratory muscles.

PathophysiologyCaused by pathogenic immunoglobulin G (IgG) autoantibodies against neuromuscular junction components (commonly AChR and MuSK).

Age indicationImaavy is indicated for gMG in adults and pediatric patients aged >= 12 years who are antibody-positive.

Antibody-positive gMG — definition for anti-AChR and anti-MuSK antibody-positive disease

Antibody typesAnti-acetylcholine receptor (anti-AChR) and anti-muscle-specific tyrosine kinase (anti-MuSK) immunoglobulin G autoantibodies.

Diagnostic role