CurrentCignaPolicy IP0743

Imaavy (nipocalimab) for generalized myasthenia gravis

Defines Cigna coverage and prior authorization requirements for intravenous Imaavy (nipocalimab-aahu) for treatment of anti-AChR or anti-MuSK antibody-positive generalized myasthenia gravis in patients ≥12 years.

Policy Summary

PayerCigna

PolicyImaavy (nipocalimab) for generalized myasthenia gravis

Policy CodePolicy IP0743

Change TypeNew policyHCPCS code added

Effective DateDec 15, 2025

Next Review Date

Key ActionObtain prior authorization and submit required documentation (including antibody confirmation) to support coverage for Imaavy.

SourceLink

POLICY UPDATE CHANGES

Added HCPCS code J9256 (Injection, nipocalimab-aahu, 3 mg) effective 1/1/2026.

New coverage policy created for Imaavy with FDA-approved indication, criteria, and dosing.

Specified approval durations: 6 months for initial therapy and 1 year for patients currently receiving Imaavy.

J9256HCPCS code added for nipocalimab (3 mg)

≥12Minimum age for coverage

6 moInitial approval duration

q2wMaintenance dosing interval

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Coverage Criteria for Imaavy (nipocalimab)

FDA-Approved Indication - Generalized Myasthenia Gravis

Approve when ONE of the following (A or B) is met:

A or B: A) Initial Therapy OR B) Patient is Currently Receiving Imaavy

A) Initial Therapy: Approve for 6 months if ALL of (i) through (vi) are met

Initial Therapy - components: i. Patient is ≥ 12 years of age; AND ii. If patient is ≥ 18 years, BOTH: (a) Myasthenia Gravis Foundation of America class II-IV AND (b) MG-ADL score ≥ 6; AND iii. ONE of: confirmed anti-acetylcholine receptor antibody-positive OR confirmed anti-muscle-specific tyrosine kinase antibody-positive (documentation required); AND iv. ONE of: previously received or currently receiving pyridostigmine OR inadequate efficacy/contraindication/intolerance to pyridostigmine; AND v. Evidence of unresolved symptoms of generalized myasthenia gravis (examples: difficulty swallowing, difficulty breathing, functional disability such as double vision or impaired mobility); AND vi. Prescribed by or in consultation with a neurologist

Documentation required for antibody confirmation and other items as noted

B) Currently Receiving Imaavy: Approve for 1 year if ALL of (i)-(iii) are met

Currently Receiving - components: i. Patient is ≥ 12 years of age; AND ii. Prescriber states patient is continuing to derive benefit from Imaavy (examples: reduced exacerbations; improvements in speech, swallowing, mobility, respiratory function); AND iii. Prescribed by or in consultation with a neurologist

Imaavy (nipocalimab) is not considered medically necessary for uses other than the FDA‑approved indication for generalized myasthenia gravis. This includes situations where Imaavy would be used in combination with another agent class listed below or for any other unapproved indication; such concomitant use and other non‑FDA‑approved uses are excluded from coverage.

Concomitant use of Imaavy with another neonatal Fc receptor blocker (for example, Rystiggo/rozanolixizumab or Vyvgart/efgartigimod), a complement inhibitor (for example, eculizumab, ravulizumab, or zilucoplan), or any rituximab product is specifically listed as not medically necessary. The policy notes there is no evidence supporting combined use of Imaavy with these agents and provides representative drug examples for each class.

Coding and Billing Information

Considered Medically Necessary when criteria metHCPCSCovered

J9256

Injection, nipocalimab-aahu, 3 mg (Code effective 1/1/2026)

inv-05: MG-ADL — eligibility threshold

MG-ADL threshold for adult initial therapyMG-ADL (Myasthenia Gravis Activities of Daily Living) score ≥ 6

Use in trial contextThreshold derived from pivotal trial (Vivacity-MG3) where enrolled adults had MG-ADL ≥ 6 at baseline

Role in policy eligibilityRequired for patients ≥18 years as part of the Initial Therapy criteria (MGFA II–IV plus MG-ADL ≥ 6)

Measurement purposeQuantifies symptom burden and is used as a baseline eligibility metric for initiating Imaavy

Provider Actions, Documentation & Prior Authorization

Prior Authorization

Prior Authorization Required

Prior Authorization is required for Imaavy. Requests must include supporting documentation as specified below. Approvals are for the duration indicated in the policy (months = 30 days). Imaavy must be prescribed by or in consultation with a physician who specializes in the condition being treated (e.g., neurologist for generalized myasthenia gravis).

Prior authorization required for Imaavy (see Criteria and Dosing).
Approval durations: initial approvals and continuation approvals per policy; extensions allowed if criteria continue to be met.
Requests for doses outside policy dosing considered case-by-case by a clinician.

Step Therapy

PROVIDER ACTION — Prior/Current Use of Pyridostigmine

The policy requires documentation of prior use of, or current use of, pyridostigmine OR documentation demonstrating inadequate efficacy, contraindication, or significant intolerance to pyridostigmine for Initial Therapy eligibility. Ensure the submitted prior therapy information clearly addresses these requirements.

Background

Myasthenia gravis is an autoimmune neuromuscular disorder characterized by fluctuating skeletal muscle weakness due to pathogenic IgG autoantibodies directed against components of the neuromuscular junction (most commonly anti‑acetylcholine receptor and less commonly anti‑MuSK). Clinically, patients experience activity‑worsened weakness that can affect ocular, bulbar, limb and respiratory muscles; assessment tools such as the MG‑ADL score quantify symptom burden and were used in the pivotal trial supporting Imaavy's efficacy.

Definitions and Scales

inv-11: Generalized Myasthenia Gravis (gMG)

DefinitionGeneralized Myasthenia Gravis (gMG) is an autoimmune disorder causing fluctuating skeletal muscle weakness due to pathogenic autoantibodies leading to impaired neuromuscular transmission; hallmark is activity-worsened weakness

Antibody-mediated subtypesCommon pathogenic antibodies include anti-acetylcholine receptor (anti-AChR), anti-muscle-specific tyrosine kinase (anti-MuSK), and less commonly anti-LRP4

Clinical features / examplesSymptoms include difficulty swallowing, difficulty breathing, double vision, impaired mobility, speech problems, and other activity-worsened functional deficits

inv-12: MG-ADL score — description and use

What it isThe MG-ADL (Myasthenia Gravis Activities of Daily Living) score is a patient-reported measure that quantifies symptom burden across daily activities affected by gMG