CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Imaavy (nipocalimab) IV — Clinical coverage criteria for generalized myasthenia gravis

Clinical coverage criteria for Imaavy (nipocalimab-aahu) IV for treatment of generalized myasthenia gravis (gMG) in members aged 12 years and older across Medicaid, Commercial, and Medicare lines.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyImaavy (nipocalimab) IV — Clinical coverage criteria for gMG

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date11/01/2025

Next Review DateN/A

Key ActionObtain prior authorization with documentation of Ab+ gMG, baseline MG-ADL ≥6, neurologist involvement, and required prior-therapy or biologic escalation evidence.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥12Minimum age for coverage

MG-ADL ≥6Baseline severity threshold

6 moInitial authorization length

30→15 mg/kg q2wkFDA dosing (init→maint)

J9256HCPCS code

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Coverage Criteria for Imaavy (nipocalimab)

Initial Therapy / Medical Necessity

Covered when ALL of the following are met:

Universal criteria: Member is at least 12 years of age; prescribed by, or in consultation with, a neurologist; member will NOT be using the requested agent in combination with other immunomodulatory biologic therapies; and the member does NOT have any FDA labeled contraindications to the requested agent.

Diagnosis and objective baseline: Submission of medical records to support the diagnosis of generalized myasthenia gravis (gMG); MGFA Clinical Classification II–IVb; positive serologic test for anti-AChR or anti-MuSK antibodies; baseline neurological examination documenting objective signs of weakness and fatiguability (e.g., QMG); and baseline MG-ADL total score ≥6.

Prior/conventional therapy requirements: Member meets at least one of the following: inadequate response to at least ONE conventional MG agent (corticosteroids, azathioprine, cyclosporine, mycophenolate mofetil, tacrolimus, methotrexate, cyclophosphamide); OR intolerance/hypersensitivity to ONE conventional agent; OR FDA labeled contraindication to ALL conventional agents; OR requirement for chronic IVIG; OR requirement for chronic plasmapheresis/plasma exchange.

Biologic escalation requirements (adults): For adult anti-AChR Ab+ gMG: inadequate response or contraindication to inebilizumab (Uplizna) and efgartigimod (Vyvgart) or efgartigimod + hyaluronidase (Vyvgart Hytrulo). For adult anti-MuSK Ab+ gMG: inadequate response or contraindication to inebilizumab (Uplizna) and rozanolixizumab (Rystiggo). For adult anti-AChR Ab+ members who require a maintenance dose every 2 weeks >1200 mg (2 vials): inadequate response or contraindication to rozanolixizumab (Rystiggo) or eculizumab (Soliris). Prescribed dose must be provided and consistent with FDA labeling based on documented weight.

Renewal Criteria

Renewal covered when ALL of the following are met:

Prior approval and provider: Member was previously approved for the requested agent through the plan's Medical Drug Review; prescribed by, or in consultation with, a neurologist; member will NOT be using the requested agent in combination with other immunomodulatory biologic therapies; member does NOT have any FDA labeled contraindications; and prescribed dose is provided and in accordance with FDA-approved labeling based on current documented weight.

Clinical response: Member has had an improvement of at least 2 points from baseline in the MG-ADL total score sustained for at least 4 weeks AND improvement in muscle strength testing with fatigue maneuvers on neurologic examination compared to baseline (may substitute a ≥3-point improvement in QMG sustained for ≥4 weeks if available).

Use of Imaavy (nipocalimab) in combination with other immunomodulatory biologic therapies is expressly excluded. Examples of disallowed concurrent agents include Rystiggo (rozanolixizumab), Vyvgart (efgartigimod), Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase), Soliris/Epysqli/Bkemv (eculizumab), Ultomiris (ravulizumab), Uplizna (inebilizumab), Zilbrysq (zilucoplan), among others. Requests documenting concurrent use of any of these immunomodulatory biologics may be denied.

Treatment with Imaavy is not covered unless all required clinical and administrative conditions are met. The member must be ≥12 years of age, the prescription must be by or in consultation with a neurologist, and the member must not be receiving Imaavy in combination with other immunomodulatory biologic therapies. Documented positive serology for anti-AChR or anti-MuSK antibodies (Ab+ gMG) and supportive medical records (e.g., chart notes, labs, baseline neurological exam) are required.

Baseline disease severity must meet an MG-ADL total score of ≥6, and adult members must satisfy the applicable prior therapy/biologic escalation requirements (for example, inadequate response or contraindication to specified conventional agents or to other biologics as outlined for anti-AChR and anti-MuSK subgroups). Failure to meet the age, neurologist involvement, Ab+ serology, baseline MG-ADL threshold, or the specified prior therapy/biologic escalation rules renders treatment not medically necessary.

Provider Requirements and Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for the requested agent. Authorization requires the member be at least 12 years of age, the request be prescribed by or in consultation with a neurologist, documentation supporting a diagnosis of generalized myasthenia gravis (including serologic testing, baseline neurologic exam and MG-ADL/QMG scores), evidence of prior inadequate response/intolerance/contraindication to specified conventional and biologic therapies as applicable, and other criteria as detailed in the medical necessity criteria.

Age ≥ 12 years
Prescribed by or in consultation with a neurologist
Submission of medical records to support gMG diagnosis (e.g., chart notes, laboratory values, MG-ADL, QMG, baseline neurologic exam)
Positive anti-AChR or anti-MuSK serology as applicable
Baseline MG-ADL total score ≥ 6 and objective signs of neurological weakness/fatiguability
Documentation of prior inadequate response, intolerance, or contraindication to specified conventional agents (or need for chronic IVIG/plasmapheresis) OR prior inadequate response/contraindication to prior biologics when required (see step-therapy requirements)
Prescribed dose consistent with FDA labeling and current documented weight

Step Therapy

Step Therapy / Prior Biologic Requirements

Step therapy / prior biologic requirements apply for adult members depending on antibody status and dosing needs. For anti-AChR Ab+ gMG in adults, prior inadequate response or contraindication to Uplizna (inebilizumab) and Vyvgart (efgartigimod) or Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase) is required. For anti-MuSK Ab+ gMG in adults, prior inadequate response or contraindication to Uplizna (inebilizumab) and Rystiggo (rozanolixizumab) is required. For adult anti-AChR Ab+ gMG members who require maintenance dosing every 2 weeks using >1200 mg (2 vials), prior inadequate response or contraindication to Rystiggo (rozanolixizumab) or eculizumab is required.

Adults with anti-AChR Ab+ gMG: inadequate response or contraindication to inebilizumab and efgartigimod (or efgartigimod + hyaluronidase)
Adults with anti-MuSK Ab+ gMG: inadequate response or contraindication to inebilizumab and rozanolixizumab
Adults anti-AChR Ab+ gMG requiring >1200 mg maintenance every 2 weeks: inadequate response or contraindication to rozanolixizumab or eculizumab

Documentation Required

Documentation Requirement

Submission of supporting medical records is required to demonstrate diagnosis, baseline severity, prior treatments, and response. Include chart notes, laboratory values (serology), baseline MG-ADL and QMG scores, and documentation of prior therapies tried or contraindications/intolerances.

Chart notes documenting diagnosis and neurologic exam (fatigability/strength testing)
Laboratory confirmation of anti-AChR or anti-MuSK antibodies
Baseline and follow-up MG-ADL and/or QMG scores
Documentation of prior conventional and biologic therapies tried, intolerances, contraindications, or use of chronic IVIG/plasmapheresis

Documentation Required

Renewal Documentation

For renewal, the member must have prior approval through the plan's Medical Drug Review process and demonstrate clinical improvement: at least a 2-point reduction from baseline in MG-ADL sustained ≥ 4 weeks OR a ≥ 3-point improvement in QMG sustained ≥ 4 weeks, plus improvement in muscle strength testing on neurologic exam. Renewal also requires continued prescribing by/with a neurologist and adherence to dosing per FDA labeling.

Previous approval via the plan's Medical Drug Review
Prescribed by or in consultation with a neurologist
No concurrent use with other immunomodulatory biologic therapies
At least a 2-point reduction in MG-ADL sustained for ≥ 4 weeks OR ≥ 3-point reduction in QMG sustained for ≥ 4 weeks
Documentation of improved muscle strength with fatigue maneuvers compared to baseline

Denial Risk

Combination Therapy Prohibition

Use of the requested agent in combination with other immunomodulatory biologic therapies is prohibited. Concurrent administration with agents such as rozanolixizumab, efgartigimod (including Vyvgart Hytrulo), eculizumab, ravulizumab, inebilizumab, zilucoplan, and other similar immunomodulatory biologics is not allowed.

Combination therapy with Rystiggo (rozanolixizumab) is prohibited
Combination therapy with Vyvgart (efgartigimod) or Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase) is prohibited
Combination therapy with Soliris/Epiginna/Bkemv (eculizumab) or Ultomiris (ravulizumab) is prohibited
Combination therapy with Uplizna (inebilizumab) is prohibited
Combination therapy with Zilbrysq (zilucoplan) or other immunomodulatory biologics is prohibited

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

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

OpenPayer

Imaavy (nipocalimab) IV — Clinical coverage criteria for generalized myasthenia gravis

Coverage Criteria for Imaavy (nipocalimab)

Coding, Dosing, and Units

Provider Requirements and Authorization

Background

Definitions and Scales