CurrentSecurity Health Plan of Wisconsin, Inc.Policy SHP-P0797

Imaavy (nipocalimab-aahu) (Intravenous)

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This policy governs prior authorization, medical necessity, dosing, renewal, and billing requirements for intravenous Imaavy used for generalized myasthenia gravis or another FDA-labeled indication. It applies to providers requesting coverage through Security Health Plan of Wisconsin.

Policy Summary

PayerSecurity Health Plan of Wisconsin, Inc.

PolicyImaavy (nipocalimab-aahu) (Intravenous)

Policy CodePolicy SHP-P0797

Change TypeNo material change

Effective DateJan 1, 2026

Last ReviewSep 4, 2025

Next Review DateN/A

Key ActionSubmit supporting clinical documentation with every prior authorization request for Imaavy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsInitial authorization

12 monthsRenewal interval

30 mg/kgInitial gMG dose

15 mg/kg q2 weeksMaintenance schedule

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CurrentSecurity Health Plan of Wisconsin, Inc.Policy SHP-P0797

Imaavy (nipocalimab-aahu) (Intravenous)

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Policy Summary

PayerSecurity Health Plan of Wisconsin, Inc.

PolicyImaavy (nipocalimab-aahu) (Intravenous)

Policy CodePolicy SHP-P0797

Change TypeNo material change

Effective DateJan 1, 2026

Last ReviewSep 4, 2025

Next Review DateN/A

Key ActionSubmit supporting clinical documentation with every prior authorization request for Imaavy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsInitial authorization

12 monthsRenewal interval

30 mg/kgInitial gMG dose

15 mg/kg q2 weeksMaintenance schedule

2Covered diagnosis codes

Medical Necessity and Coverage Requirements

Concurrent use is excluded. Imaavy will not be approved when used with Soliris (eculizumab), Bkemv (eculizumab-aeeb), Epysqli (eculizumab-aagh), Ultomiris (ravulizumab-cwvz), Vyvgart (efgartigimod), Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc), Zilbrysq (zilucoplan), or Rystiggo (rozanolixizumab-noli).

FDA-labeled contraindications are excluded. Coverage is not approved when the patient has an FDA-labeled contraindication to Imaavy.

Excessive dosing or quantity is excluded. The requested dose and quantity must remain within the FDA-labeled dosing for the applicable indication; requests exceeding that dosing are not approved.

Billing Codes and Dosing Parameters

HCPCS CodesHCPCS

J9256	Injection, nipocalimab-aahu, 3 mg; 1 billable unit = 3 mg (Effective 01/01/2026)
J3590	Unclassified biologics (Discontinue use on 01/01/2026)
C9305	Injection, nipocalimab-aahu, 3 mg; 1 billable unit = 3 mg (Discontinue use on 01/01/2026)

NDC(s)NDC

57894-0800-xx	Imaavy 300 mg/1.62 mL solution in a single-dose vial
57894-0801-xx	Imaavy 1,200 mg/6.5 mL solution in a single-dose vial

Covered Diagnosis CodesICD-10Covered

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

Initial Maximum Billable Units

Initial limit1,200 billable units

Billing basisHCPCS unit

TimingInitially, per dose and over time

Maintenance Maximum Billable Units

Maintenance limit600 billable units

FrequencyEvery two weeks thereafter

Billing basisHCPCS unit

MGFA Clinical Classification

Classification systemMyasthenia Gravis Foundation of America (MGFA) clinical classification

Required rangeClass II-IVb

Clinical useRequired for generalized myasthenia gravis coverage

MG-ADL Total Score

AssessmentMyasthenia Gravis Activities of Daily Living (MG-ADL) total score

Required minimumAt least 6 (≥ 6)

Clinical useRequired for generalized myasthenia gravis coverage

Initial gMG Dose

Dose30 mg/kg

AdministrationOnce by intravenous infusion

Infusion durationOver at least 30 minutes

Maintenance gMG Dose

Dose15 mg/kg

AdministrationBy intravenous infusion over at least 15 minutes

Dosing intervalEvery two weeks, beginning two weeks after the initial dose

Authorization, Documentation, and Denial Risks

Prior Authorization

Prior Authorization and Authorization Duration

Prior authorization is required. Submit each request through the plan’s Medical Drug Review process with supporting clinical documentation. Initial authorization is valid for 6 months; renewal authorization may be granted every 12 months thereafter.

Initial authorization duration: 6 months.
Renewal duration: 12 months thereafter.

Step Therapy

Conventional Therapy History Required

Document the patient’s treatment history before requesting Imaavy for gMG. The policy requires evidence of an inadequate response, intolerance, or hypersensitivity to at least one conventional agent, unless an alternate qualifying pathway applies.

Inadequate response to at least one conventional agent; or
Intolerance or hypersensitivity to at least one conventional agent; or

Therapy Overview

Imaavy (nipocalimab-aahu) is an intravenous therapy addressed by this policy for generalized myasthenia gravis and other FDA-labeled indications. For generalized myasthenia gravis, coverage focuses on clinically significant disease supported by qualifying antibody serology, MGFA clinical class II-IVb, and an MG-ADL total score of at least 6, together with assessment of medications that may exacerbate the disease and the patient's conventional treatment history.

Clinical Definitions

MGFA Clinical Classification

TermMyasthenia Gravis Foundation of America (MGFA) clinical classification

Required rangeClass II-IVb

PurposeIdentifies the required disease-severity classification for generalized myasthenia gravis coverage

MG-ADL

TermMyasthenia Gravis Activities of Daily Living (MG-ADL)

Required scoreTotal score of at least 6 (≥ 6)

PurposeMeasures the required functional burden for generalized myasthenia gravis coverage

Policy Summary

PayerSecurity Health Plan of Wisconsin, Inc.

PolicyImaavy (nipocalimab-aahu) (Intravenous)

Policy CodePolicy SHP-P0797

Change TypeNo material change

Effective DateJan 1, 2026

Last ReviewSep 4, 2025

Next Review DateN/A

Key ActionSubmit supporting clinical documentation with every prior authorization request for Imaavy.

SourceLink

On This Page

An FDA-labeled contraindication to all conventional agents; or

The patient required chronic intravenous immunoglobulin (IVIG); or

The patient required chronic plasmapheresis/plasma exchange.

Step Therapy

Qualifying Conventional Agents

The policy recognizes the following conventional agents used for the treatment of myasthenia gravis:

Corticosteroids
Azathioprine
Cyclosporine
Mycophenolate mofetil
Tacrolimus
Methotrexate
Cyclophosphamide

Documentation Required

Required Clinical Records

Submit supporting clinical documentation with every authorization request, including records establishing diagnosis, treatment history, and medical necessity. Documentation may be submitted by direct upload through the PA web portal or by fax.

Medical records and chart notes
Laboratory results and confirmatory diagnostics
Diagnosis documentation
Step-therapy documentation
Clinical markers, including genetic and mutational testing, when applicable
Medical-necessity documentation supporting initiation

Documentation Required

gMG Diagnostic and Severity Documentation

For gMG requests, provide medical records documenting the required serology, MGFA classification, and disease severity.

Diagnosis of generalized Myasthenia Gravis (gMG)
Positive serological test for anti-AChR antibodies or anti-MuSK antibodies
Myasthenia Gravis Foundation of America (MGFA) clinical classification II-IVb
MG-Activities of Daily Living total score ≥ 6

Documentation Required

Medication and Treatment-History Documentation

Document medication review and the patient’s response or inability to tolerate conventional therapy. Current medications must be assessed for agents that may exacerbate myasthenia gravis.

Document whether medications known to exacerbate myasthenia gravis were discontinued, or why discontinuation is not clinically appropriate.
Examples include beta blockers, procainamide, quinidine, magnesium, anti-programmed death receptor-1 monoclonal antibodies, hydroxychloroquine, and aminoglycosides.
Provide the prior agent, treatment response, intolerance, hypersensitivity, contraindication, or qualifying chronic IVIG/plasmapheresis history, as applicable.

Documentation Required

Renewal Documentation

For renewal, document continued eligibility and clinical benefit under the plan’s criteria. The prescriber must remain appropriately involved in the patient’s care.

Prior approval for the requested agent through the plan’s Medical Drug Review process
Clinical benefit with the requested agent
Prescriber is a specialist in the diagnosis area, such as a neurologist, or has consulted with one
No combination use with the prohibited therapies listed in the policy
No FDA-labeled contraindication to the requested agent
Requested dose remains within FDA-labeled dosing for the indication

Denial Risk

Missing Supporting Documentation May Result in Denial

Failure to submit the medical records and supporting evidence may result in denial because the plan cannot establish medical necessity in accordance with the policy guidelines.

Submit records at the time of the request for review.
Include documentation supporting diagnosis, step therapy, clinical markers when applicable, and all applicable medical-necessity criteria.

Denial Risk

Failure to Meet gMG Clinical Criteria

A request may be denied when the patient does not meet the policy’s gMG clinical requirements or when the submitted records do not establish them.

No documented gMG diagnosis, or no qualifying positive anti-AChR or anti-MuSK serology
MGFA classification outside class II-IVb or not documented
MG-Activities of Daily Living total score below 6 or not documented
Required medication assessment or discontinuation rationale is absent
Required conventional-therapy failure, intolerance, hypersensitivity, contraindication, chronic IVIG, or chronic plasmapheresis criterion is not met
If an alternate FDA-labeled indication is requested, the patient’s age must be within labeling or supported for use at that age and indication

Denial Risk

Contraindication, Prohibited Combination, or Excessive Dose

Approval or renewal may be denied when the request conflicts with safety, combination-therapy, or dosing requirements.

The requested agent must not be used with Soliris (eculizumab), Bkemv (eculizumab-aeeb), Epysqli (eculizumab-aagh), Ultomiris (ravulizumab-cwvz), Vyvgart (efgartigimod), Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc), Zilbrysq (zilucoplan), or Rystiggo (rozanolixizumab-noli).
The patient must not have an FDA-labeled contraindication to the requested agent.
The requested quantity or dose must be within FDA-labeled dosing for the requested indication.

Denial Risk

Failure to Qualify for Renewal

Renewal may be denied when the patient was not previously approved through the plan’s Medical Drug Review process or when continued clinical benefit is not demonstrated. Patients without prior plan approval require initial evaluation review.

Document prior plan approval for the requested agent.
Provide evidence of clinical benefit with ongoing treatment.
Continue to document specialist prescribing or specialist consultation and compliance with combination, contraindication, and dosing requirements.

Generalized Myasthenia Gravis (gMG)

SerologyPositive anti-acetylcholine receptor (anti-AChR) antibodies or positive anti-muscle-specific kinase (anti-MuSK) antibodies

Disease severityMGFA clinical classification class II-IVb and MG-ADL total score of at least 6

Medication assessmentCurrent medications must be assessed, including medications known to exacerbate myasthenia gravis

Treatment historyThe policy requires an inadequate response, intolerance or hypersensitivity, or contraindication involving a conventional agent; chronic IVIG or chronic plasmapheresis/plasma exchange also qualifies