CurrentCareSourcePolicy N/A

PHARMACY POLICY STATEMENT Arkansas PASSE

Defines prior-authorization medical-benefit coverage criteria, dosing, initial and reauthorization requirements, and non-covered indications for Imaavy (nipocalimab-aahu) for treatment of generalized myasthenia gravis in patients aged ≥12 years within the Arkansas PASSE pharmacy policy.

Policy Summary

PayerCareSource

PolicyPHARMACY POLICY STATEMENT Arkansas PASSE

Policy CodePolicy N/A

Change TypeNew policy (added)

Effective DateOct 1, 2025

Next Review Date

Key ActionPrior authorization is required for Imaavy; submit documentation showing age ≥12, neurologist prescribing/consultation, MGFA class II-IV diagnosis, seropositivity for AChR or MuSK antibodies, and prior therapy trials with durations.

SourceLink

POLICY UPDATE CHANGES

New policy for Imaavy created

1Covered Indication (gMG AChR/MuSK positive)

12Minimum age (years)

6mInitial approval duration

12mReauthorization duration

Coverage Summary

Imaavy (nipocalimab-aahu) is covered with prior-authorization medical-benefit criteria for the treatment of generalized myasthenia gravis in patients aged ≥12 years who are seropositive for AChR or MuSK antibodies; this coverage follows the Arkansas PASSE pharmacy policy requiring PA documentation (age, neurologist prescribing/consultation, MGFA class II–IV diagnosis, antibody seropositivity, and prior therapy trials) and specifies dosing and approval durations.

Key thresholds and policy stats

Age>= 12 years

Corticosteroid trial>= 4 weeks

Non-steroid immunosuppressant trial>= 6 months

Initial approval duration6 months

Reauthorization duration12 months

Initial dosing30 mg/kg IV once

Maintenance dosing15 mg/kg IV every 2 weeks (start 2 weeks after initial)

Covered indication count1 (gMG AChR/MuSK positive)

Provider Actions & Requirements

Prior Authorization

Prior authorization required

Submit prior authorization with documentation showing member is ≥12 years old, medication prescribed by or in consultation with a neurologist, documented MGFA class II–IV myasthenia gravis, laboratory evidence of AChR or MuSK antibody seropositivity, and documentation of prior therapy trials with durations (see documentation callouts for specifics).

Documentation Required

Document antibody seropositivity

Attach laboratory result(s) in the chart notes demonstrating seropositivity for either anti‑AChR or anti‑MuSK antibodies (lab report or equivalent result required as part of the prior authorization submission).

Documentation Required

Document prior therapy failures/trials

Include documentation of prior trials and/or failures: trial of pyridostigmine, and trial of at least one conventional therapy defined as either a corticosteroid for ≥4 weeks or a non‑steroid immunosuppressant (e.g., azathioprine) for ≥6 months. Specify durations and clinical response in the chart notes.

Documentation Required

Document clinical improvement for reauthorization

For reauthorization, provide chart notes documenting clinically meaningful improvement in symptom severity and daily functioning compared with the pre‑treatment baseline (examples include improved MG‑ADL or QMG scores); these notes must be included in the reauthorization request.

Billing Rule

Dosing schedule must be followed

Imaavy dosing: initial IV 30 mg/kg once, then begin maintenance two weeks after the initial dose with 15 mg/kg IV every two weeks. Initial approvals are for 6 months; if reauthorization criteria are met, approval duration is 12 months.

Background & Definitions

Imaavy is a neonatal Fc receptor blocker indicated for generalized myasthenia gravis in patients ≥12 years who are AChR- or MuSK-antibody positive. Standard first-line therapy for MG includes pyridostigmine (an acetylcholinesterase inhibitor) with addition of immunosuppressive treatment such as corticosteroids (e.g., prednisone) and/or non-steroid immunosuppressants (e.g., azathioprine) when control is inadequate.

MGFA clinical classification used in the policy: Class II–IV defined as Class II = mild weakness affecting muscles other than ocular; Class III = moderate weakness affecting muscles other than ocular; Class IV = severe weakness affecting muscles other than ocular. Expanded descriptions are provided in the policy appendix.

Revision History

2025-05-06material_changeLatest

Policy created 05/06/2025 and effective 10/01/2025 establishing prior authorization criteria and dosing for Imaavy (nipocalimab-aahu). Detail: New policy for Imaavy created; establishes PA requirements (age ≥12, neurologist prescribing/consultation, MGFA class II-IV diagnosis, seropositivity for AChR or MuSK antibodies, prior therapy trials), initial dosing 30 mg/kg IV once with maintenance 15 mg/kg IV every two weeks starting two weeks after initial dose, initial approval duration 6 months, reauthorization criteria and 12-month renewal.

2025-10-01effective_date

Policy effective date: 10/01/2025 (establishes when the new PA criteria and dosing become effective).

Policy Summary

PayerCareSource

PolicyPHARMACY POLICY STATEMENT Arkansas PASSE

Policy CodePolicy N/A

Change TypeNew policy (added)

Effective DateOct 1, 2025

Next Review Date

SourceLink

On This Page

Medical benefit	Imaavy (nipocalimab-aahu) = Medical
Prior_Authorization Required	Prior authorization required for Imaavy

OpenPayer

PHARMACY POLICY STATEMENT Arkansas PASSE

Coverage Summary

Initial Therapy — Medical Necessity Criteria

Continuation / Reauthorization Criteria

Not Medically Necessary / Exclusions

Provider Actions & Requirements

Applicable Codes & Benefit

Clinical Evidence & References

Background & Definitions

Revision History