CurrentViva HealthPolicy IC-P0797

Imaavy (nipocalimab-aahu) intravenous for generalized myasthenia gravis (gMG)

Clinical coverage and prior authorization criteria for intravenous Imaavy (nipocalimab-aahu) for treatment of generalized myasthenia gravis and other FDA-labeled indications; defines initial and renewal approval criteria, dosing, limits, and billing codes. Applies to Viva Health medical benefit drug management.

Policy Summary

PayerViva Health

PolicyImaavy (nipocalimab-aahu) intravenous for generalized myasthenia gravis (gMG)

Policy CodePolicy IC-P0797

Change TypeNo material changes

Effective Date06/05/2025

Next Review Date

Key ActionSubmit prior authorization with documentation of diagnosis, serologic antibody test results, MGFA class, MG-ADL score, medication history and prior therapies to support approval.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6Initial prior authorization duration

12Renewal prior authorization duration

1200→600Maximum billable units / dosing frequency

J9256,C9305,J3590HCPCS codes listed

Medical Necessity Criteria for Imaavy (nipocalimab-aahu)

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Initial Approval Criteria

Target agent(s) will be approved when ALL of the following are met:

Diagnosis or other FDA indication

Generalized Myasthenia Gravis (gMG)
- The patient has a diagnosis of generalized Myasthenia Gravis (gMG)
- ANY of the following
  - Positive serological test for anti-AChR antibodies
  - Positive serological test for anti-MuSK antibodies
- MGFA clinical classification class II-IVb
- MG-Activities of Daily Living (MG-ADL) total score >= 6>= 6
- ANY of the following
  - Medications known to exacerbate myasthenia gravis have been discontinued (examples: beta blockers, procainamide, quinidine, magnesium, anti-programmed death receptor-1 monoclonal antibodies, hydroxychloroquine, aminoglycosides)
  - Discontinuation of the offending agent is NOT clinically appropriate
- ANY of the following
  - Inadequate response to at least ONE conventional agent used for MG (examples: corticosteroids, azathioprine, cyclosporine, mycophenolate mofetil, tacrolimus, methotrexate, cyclophosphamide)
  - Intolerance or hypersensitivity to ONE conventional agent used for MG (same examples)
  - FDA labeled contraindication to ALL conventional agents used for MG (same examples)
  - Patient required chronic IVIG
  - Patient required chronic plasmapheresis/plasma exchange
The patient has another FDA labeled indication for the requested agent and route of administration

If FDA labeled indication

Patient's age is within FDA labeling for the requested indication
There is support for using the requested agent for the patient's age for the requested indication

ALL of the following

The prescriber is a specialist in the area of the patient's diagnosis (e.g., neurologist), or the prescriber has consulted with such a specialist
The patient will NOT be using the requested agent in combination 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 does NOT have any FDA labeled contraindications to the requested agent
The requested quantity (dose) is within FDA labeled dosing for the requested indication

Renewal Criteria

Target agent(s) will be approved when ALL of the following are met:

ALL of the following

Patient has been previously approved for the requested agent through the plan's Medical Drug Review process
Patient has had clinical benefit with the requested agent
The prescriber is a specialist in the area of the patient's diagnosis (e.g., neurologist), or the prescriber has consulted with such a specialist
The patient will NOT be using the requested agent in combination 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)

Billing and Coding

HCPCS / Billing codesHCPCSCovered

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)

Covered ICD-10 Diagnosis CodesICD-10Covered

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

NDCsNDC

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

What Providers Must Do

Prior Authorization

Prior authorization required

Prior authorization is required for Imaavy (nipocalimab-aahu). Initial authorizations are provided for 6 months and renewals may be approved every 12 months. Initial review requires documentation of the diagnosis, relevant serologic antibody testing, Myasthenia Gravis Foundation of America (MGFA) clinical classification, MG-ADL score, and medication history/prior therapies.

J9256
C9305
J3590

Documentation Required

Required clinical documentation

Medical records must include serologic antibody test results (anti‑AChR or anti‑MuSK) and documentation of inadequate response, intolerance/hypersensitivity, or FDA‑labeled contraindication to conventional MG agents — or documentation that the patient required chronic IVIG or chronic plasmapheresis. Document the patient's MGFA clinical class and MG‑ADL total score.

Denial Risk

Concomitant therapy exclusion

Authorization will be denied if the patient is to be treated concurrently with specified complement inhibitors or FcRn‑targeting agents.

Soliris (eculizumab)
Bkemv (eculizumab‑aeeb)
Epysqli (eculizumab‑aagh)
Ultomiris (ravulizumab‑cwvz)
Vyvgart (efgartigimod)
Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase‑qvfc)
Zilbrysq (zilucoplan)
Rystiggo (rozanolixizumab‑noli)

Imaavy dosing for generalized myasthenia gravis (gMG) uses an intravenous schedule with an initial dose of 30 mg/kg IV administered once over at least 30 minutes, followed by a maintenance dose of 15 mg/kg IV given two weeks after the initial dose over at least 15 minutes, and continuing the 15 mg/kg maintenance infusion every two weeks thereafter.

Clinical and Administrative Background

The policy limits dosing by billable HCPCS units to a maximum of 1200 billable units for the initial administration and 600 billable units every two weeks thereafter.

Prior authorization durations are 6 months for initial approval and 12 months for each renewal.

Defined Terms

Definitions

MGFAMyasthenia Gravis Foundation of America clinical classification.

MG-ADLMyasthenia Gravis Activities of Daily Living score; functional assessment used to quantify symptom burden.

MGFA class requirementPolicy requires MGFA clinical classification class II-IVb for gMG initial approval.

Quick Reference Metrics

6 monthsInitial prior authorization duration

12 monthsRenewal prior authorization duration

1200 → 600 q2wMaximum billable units: 1200 units initially then 600 units every 2 weeks

J9256, C9305, J3590HCPCS codes listed (C9305/J3590 discontinued 01/01/2026)