Currentculinary health fundPolicy N/A

Imaavy (nipocalimab) — Utilization Management Medical Policy

Defines prior authorization, coverage criteria, dosing, and conditions not recommended for approval for Imaavy IV infusion for adults and pediatric patients ≥12 years with antibody-positive generalized myasthenia gravis.

Policy Summary

Payerculinary health fund

PolicyImaavy (nipocalimab) — Utilization Management Medical Policy

Policy CodePolicy N/A

Change TypeOperational revision — added explicit noncoverage for inebilizumab

Effective DateMay 14, 2025

Next Review DateMay 14, 2025

Key ActionSubmit prior authorization with neurologist documentation, MG-ADL score, antibody positivity, prior pyridostigmine use (or intolerance), and dosing per policy.

SourceLink

POLICY UPDATE CHANGES

The Conditions Not Recommended for Approval section was revised to add 'Uplizna ® (inebilizumab-cdon intravenous infusion)' to the list of agents not to be used concomitantly with Imaavy.

≥12minimum age for approved use

30→15 mg/kg q2wFDA dosing regimen

n=196pivotal trial size

6 mo / 1 yrauthorization durations

concomitant biologics

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Coverage and Medical Necessity Criteria

FDA-Approved Indication

Covered when the following criteria are met

Indication

Initial Therapy (approve 6 months): Patient is ≥ 12 years of age; AND if patient is ≥ 18 years of age, patient meets BOTH: MGFA class II–IV AND MG-ADL score ≥ 6; AND patient has confirmed anti-AChR OR anti-MuSK antibody-positive generalized myasthenia gravis; AND patient previously received or is currently receiving pyridostigmine OR has had inadequate efficacy, a contraindication, or significant intolerance to pyridostigmine; AND patient has evidence of unresolved symptoms of generalized myasthenia gravis (examples: difficulty swallowing, difficulty breathing, or functional disability such as double vision, impaired speech, or impaired mobility); AND the medication is being prescribed by or in consultation with a neurologist.
All listed subcriteria (i–vi) required
Currently Receiving Imaavy (approve 1 year): Patient is ≥ 12 years of age; AND according to the prescriber, patient is continuing to derive benefit from Imaavy (examples: reduced exacerbations; improvements in speech, swallowing, mobility, or respiratory function); AND the medication is being prescribed by or in consultation with a neurologist.
All listed subcriteria (i–iii) required

Requests for concomitant administration of Imaavy with certain other biologic therapies are not recommended. Specifically, concurrent use with another neonatal Fc receptor (FcRn) blocker, a complement inhibitor, a rituximab product, or Uplizna (inebilizumab-cdon) is listed under conditions not recommended for approval. The policy notes there is no evidence to support combined use of Imaavy with these agents and gives representative examples of FcRn blockers (e.g., Rystiggo, Vyvgart) and complement inhibitors (e.g., Soliris, Ultomiris, Zilbrysq).

Coverage for Imaavy is not recommended for clinical situations that are not explicitly described in the Recommended Authorization Criteria. The policy states that requests falling outside those listed approval criteria will not be recommended for approval and that the criteria will be updated as new published data become available.

Billing and Coding

Document codesmixed

N/A	No specific CPT/HCPCS/ICD-10 codes listed in document

inv-06: MG-ADL score — required threshold value to qualify

Required numeric thresholdMG-ADL total score ≥ 6 for adult initial therapy (patients ≥ 18 years)

Applies toAdults (age ≥ 18) as part of initial-therapy criteria; patient must also meet other initial criteria (age ≥12, antibody positive, prior pyridostigmine use or documented intolerance/inefficacy, unresolved symptoms, neurology prescriber)

Purpose in policyUsed as part of the Initial Therapy approval pathway to establish symptom burden warranting 6-month authorization

Prescriber Requirements and Authorization Actions

Prior Authorization

Prior Authorization and Approval Durations

Prior Authorization Required. Prior authorization is recommended for coverage of Imaavy. Approvals are time-limited as noted: initial therapy approvals are for 6 months; continuation (currently receiving) approvals are for 1 year. Requests for doses outside the documented dosing will be reviewed case-by-case by a clinician. Because of specialized evaluation and monitoring, Imaavy must be prescribed by or in consultation with a neurologist.

Initial therapy approval duration: 6 months (1 month = 30 days).
Continuation therapy approval duration: 1 year.
Dosing exceptions considered case-by-case by Medical Director or Pharmacist.

Step Therapy

Prior Symptomatic Therapy Expectation

Prior symptomatic therapy expectation: patients must have previously received or be currently receiving pyridostigmine, OR have documented inadequate efficacy, contraindication, or significant intolerance to pyridostigmine. This requirement applies to initial therapy requests.

Clinical Background

Myasthenia gravis (MG) is an autoimmune neuromuscular disorder caused by pathogenic IgG autoantibodies directed at components of the neuromuscular junction (for example, AChR, MuSK, or LRP4). The disease is characterized by fluctuating skeletal muscle weakness that typically worsens with activity and improves with rest, and it commonly affects ocular, bulbar, limb, neck, and respiratory muscles. Imaavy is a neonatal Fc receptor blocker indicated for antibody-positive generalized myasthenia gravis in patients aged ≥ 12 years, and its mechanism—blocking the neonatal Fc receptor—reduces circulating pathogenic IgG antibodies implicated in disease pathophysiology.

Definitions and Scoring

inv-12: generalized myasthenia gravis (gMG) — disease definition/key characteristics

DefinitionAutoimmune neuromuscular disease caused by pathogenic IgG autoantibodies against neuromuscular junction components (AChR, MuSK, LRP4) resulting in fluctuating skeletal muscle weakness

Typical clinical featuresWeakness that worsens with activity and improves with rest; commonly affects ocular, bulbar (speech/swallow), limb, neck, and respiratory muscles

Antibody statusMost patients are anti‑AChR antibody–positive (~85%); 5–8% are anti‑MuSK antibody–positive

inv-13: MG-ADL score — definition of the Myasthenia Gravis Activities of Daily Living score and its use/threshold in the policy

What the MG-ADL measuresMyasthenia Gravis Activities of Daily Living (MG-ADL) total score used to assess symptom burden and functional impact in gMG

Policy use and threshold

Documentation Required

Required Prescriber and Clinical Documentation

Documentation and prescriber requirements. Approval requires that Imaavy be prescribed by or in consultation with a neurologist. For initial therapy, include documentation of diagnosis, MGFA class (if adult), MG-ADL score (if adult), antibody status (anti-AChR or anti-MuSK), evidence of unresolved symptoms, prior pyridostigmine use or documented intolerance/contraindication, and planned dosing. For continuation therapy, include the prescriber’s statement that the patient is continuing to derive clinical benefit (examples: reduced exacerbations; improvements in speech, swallowing, mobility, or respiratory function) and confirmation of ongoing neurologist involvement.

Prescriber: neurologist or consultation with neurologist required.
Initial therapy documentation: patient age, MGFA class II–IV (if ≥18), MG-ADL ≥6 (if ≥18), antibody status, prior pyridostigmine use or documentation of intolerance/contraindication, evidence of unresolved symptoms (e.g., difficulty swallowing/breathing, functional disability), and planned dosing (initial and maintenance).
Continuation therapy documentation: patient age, statement of continued clinical benefit with examples, and confirmation of neurologist prescribing/consultation.