CurrentEmblemHealthPolicy MG.MMPH.440

Imaavy (nipocalimab-aahu) Intravenous

Clinical coverage and prior authorization criteria for Imaavy (nipocalimab-aahu) IV for treatment of generalized myasthenia gravis in eligible EmblemHealth members, including initial and renewal authorizations, dosing limits, and coding. Applies to providers requesting coverage/preauthorization from EmblemHealth/ConnectiCare.

Policy Summary

PayerEmblemHealth

PolicyImaavy (nipocalimab-aahu) Intravenous

Policy CodePolicy MG.MMPH.440

Change TypeNew policy

Effective DateAug 7, 2025

Next Review DateAug 7, 2025

Key ActionObtain prior authorization and submit clinical evidence supporting diagnosis, antibody status, baseline MG-ADL/QMG scores, prior therapies, and thymectomy status as applicable.

SourceLink

POLICY UPDATE CHANGES

New policy authored establishing coverage and criteria for Imaavy (nipocalimab) for generalized myasthenia gravis.

12+minimum patient age

6 moinitial PA validity

12 morenewal PA validity

3600→1800 q2wdosing schedule

≥3MG-ADL baseline

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Coverage Criteria for Imaavy (nipocalimab)

Initial Therapy Criteria

Covered when ALL of the following are met:

Universal criteria: Patient is at least 12 years of age; patient is up to date with all vaccinations in accordance with current vaccination guidelines prior to initiating therapy.

gMG-specific criteria: Patient has generalized myasthenia gravis with MGFA Clinical Classification II–IV; patient is seropositive for anti‑AChR or anti‑MuSK antibodies; physician has documented objective signs of neurological weakness and fatiguability on a baseline neurological exam (e.g., QMG); patient has a baseline MG‑ADL total score of at least 3; patient required at least one acute or chronic treatment with plasmapheresis/PE or IVIG in addition to immunosuppressant therapy; thymectomy is required only for AChR‑positive patients with thymoma or for non‑thymomatous AChR‑positive patients age ≤50 years; patient had an inadequate response to prior therapy as defined below.MG-ADL >= 3

Prior treatment requirements differ by antibody status: for MuSK disease, a minimum 1‑year trial of immunosuppressive therapy (e.g., corticosteroids, azathioprine, mycophenolate) plus rituximab; for AChR‑positive disease, a minimum 1‑year trial of concurrent oral corticosteroid plus another immunosuppressant (e.g., azathioprine, cyclosporine, mycophenolate).

Continuation/Renewal Criteria

Renewal is allowed when ALL of the following are met:

Continued eligibility: Patient continues to meet the universal and indication‑specific initial criteria and has absence of unacceptable toxicity from the drug (examples: infection, severe hypersensitivity such as anaphylaxis or angioedema).

Clinical response: Either at least a 1‑point reduction from baseline in MG‑ADL total score OR at least a 1‑point improvement from baseline in QMG total score (QMG may be used if available).>=1 point improvement

The thymectomy requirement in the initial coverage criteria is not universally required for all patients. It applies only to AChR‑positive patients who have a thymoma or to non‑thymomatous AChR‑positive patients who are 50 years of age or younger. Providers should only document thymectomy status when this applies to the member’s antibody and thymic pathology; patients who are MuSK‑positive or AChR‑negative are not subject to this thymectomy requirement.

Requests that do not meet the policy’s defined eligibility criteria are excluded from coverage. Specifically, Imaavy is for members who are at least 12 years of age, who are seropositive for anti‑AChR or anti‑MuSK antibodies, and who have generalized disease of MGFA Class II–IV. Members with a baseline MG‑ADL total score below 3 do not meet the baseline severity threshold. Prior therapy requirements must also be met: MuSK disease requires a minimum one‑year trial of immunosuppressive therapy plus rituximab, while AChR‑positive disease requires at least one year of concurrent oral corticosteroid plus another immunosuppressant. Additionally, members must have required at least one acute or chronic course of plasmapheresis/PE or IVIG in addition to immunosuppressant therapy. For renewals, lack of clinical improvement (no ≥1‑point reduction in MG‑ADL or no ≥1‑point QMG improvement) or presence of unacceptable toxicity (for example, infection or severe hypersensitivity) would preclude continued coverage.

Coding: Procedure, NDC, and Diagnosis Codes

Applicable Procedure CodesHCPCS

J3590

Unclassified biologics

Applicable NDCsNDC

157894-0800-XX	Imaavy 300 mg/1.62 mL solution in single-dose vial
157894-0801-XX	Imaavy 1,200 mg/6.5 mL solution in a single-dose vial

ICD-10 DiagnosesICD-10

G70.00	Myasthenia gravis without (acute) exacerbation
G70.01	Myasthenia gravis with (acute) exacerbation

MG-ADL baseline

Required baseline MG-ADL>= 3 (MG-ADL total score at baseline)

PurposeBaseline MG-ADL used to document disease burden and determine eligibility for initial therapy

Measurement timingScore must be recorded on baseline neurological assessment prior to initiating therapy

Provider Actions, Prior Authorization and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Imaavy (initial and renewal). Initial PA validity will be provided for 6 months. Renewals may be approved every 12 months thereafter.

Prior authorization required before initiation of therapy
Initial prior authorization valid for 6 months
Subsequent prior authorization renewals may be authorized every 12 months

Documentation Required

Documentation Requirement — Submit Complete Clinical Evidence

The treating provider must submit complete clinical documentation demonstrating that the member meets all clinical criteria. Failure to submit the required evidence will prevent proper review and may result in denial of the request.

Include all requested records with the PA submission

Definitions and Clinical Classifications

Imaavy (nipocalimab) — key facts

Drug class / mechanismNeonatal Fc receptor (FcRn) blocker that reduces pathogenic IgG autoantibodies

IndicationTreatment of generalized myasthenia gravis (gMG) in patients who are anti-AChR or anti-MuSK antibody positive

Minimum patient age12 years and older

MGFA Clinical Classification (Classes I–V)

Class IOcular muscle weakness only; all other muscle strength normal

Class II (IIa / IIb)Mild weakness affecting muscles other than ocular; IIa predominates limb/axial; IIb predominates oropharyngeal/respiratory

Background

Imaavy (nipocalimab) is a neonatal Fc receptor (FcRn) blocker indicated for the treatment of generalized myasthenia gravis in adults and in pediatric patients aged 12 years and older who are anti‑AChR or anti‑MuSK antibody positive. The mechanism of action reduces pathogenic circulating autoantibodies by inhibiting FcRn‑mediated IgG recycling, with the therapeutic goal of improving muscle strength and daily function in patients with gMG. When requesting coverage, document antibody status, baseline MG‑ADL and neurologic exam findings, prior immunosuppressive and rescue (plasmapheresis/IVIG) treatments, and thymectomy status when applicable.

Revision History

2025-08-07Policy CreatedLatest

New EmblemHealth clinical policy MG.MMPH.440 created establishing coverage and prior authorization criteria for Imaavy (nipocalimab) for generalized myasthenia gravis.

Policy Summary

PayerEmblemHealth

PolicyImaavy (nipocalimab-aahu) Intravenous

Policy CodePolicy MG.MMPH.440

Change TypeNew policy

Effective DateAug 7, 2025

Next Review DateAug 7, 2025

Key ActionObtain prior authorization and submit clinical evidence supporting diagnosis, antibody status, baseline MG-ADL/QMG scores, prior therapies, and thymectomy status as applicable.

SourceLink

On This Page

Incomplete documentation may result in denial or delay

Step Therapy

Prior Therapy Requirements

Prior therapy requirements must be documented and supported by medical records demonstrating inadequate response or intolerance as specified below.

For MuSK-positive disease: documentation of a minimum 1-year trial of immunosuppressive therapy (e.g., corticosteroids, azathioprine, mycophenolate) and trial of rituximab with inadequate response or intolerance.
For AChR-positive disease: documentation of a minimum 1-year trial of concurrent oral corticosteroid plus another immunosuppressive agent (e.g., azathioprine, cyclosporine, mycophenolate) with inadequate response or intolerance.
Documentation of at least one acute or chronic treatment with plasmapheresis/plasma exchange (PE) or intravenous immunoglobulin (IVIG) in addition to immunosuppressant therapy

Documentation Required

Required Clinical Documentation

Required clinical documentation to accompany the PA request: diagnosis confirmation and objective assessments, antibody testing results, prior treatment records, and baseline disease severity measures. Without these items EmblemHealth will be unable to properly review the request.

Diagnosis: documentation of generalized myasthenia gravis and Myasthenia Gravis Foundation of America (MGFA) Clinical Classification (Class II–IV)
Antibody testing: positive serologic test result for anti‑AChR or anti‑MuSK antibodies
Surgical history: documentation of thymectomy when applicable (AChR+ with thymoma or non‑thymomatous patients ≤50 years)
Baseline neurological exam: objective signs of weakness and fatigability (e.g., QMG score)
Baseline disease severity: MG‑Activities of Daily Living (MG‑ADL) total score (must be ≥3)
Prior therapy records: detailed documentation of immunosuppressive therapy trials (agents, doses, durations) and response or intolerance
Acute/chronic treatments: records showing at least one course of plasmapheresis/plasma exchange (PE) or IVIG in addition to immunosuppressant therapy
Vaccination status: documentation that patient is up to date with vaccinations per current guidelines

Class III (IIIa / IIIb)

Moderate weakness affecting muscles other than ocular; IIIa predominates limb/axial; IIIb predominates oropharyngeal/respiratory

Class IV (IVa / IVb)Severe weakness affecting muscles other than ocular; IVa predominates limb/axial; IVb predominates oropharyngeal/respiratory

Class VIntubation with or without mechanical ventilation (except routine postoperative), indicates most severe disease