ModifiedUnitedHealthcarePolicy CS2026D00111Q

FcRn blockers (Imaavy, Rystiggo, Vyvgart, Vyvgart Hytrulo) for generalized myasthenia gravis and CIDP

Medical Benefit Drug Policy governing coverage and medical necessity criteria for FcRn blocker products administered by healthcare professionals (Imaavy, Rystiggo, Vyvgart, Vyvgart Hytrulo) for generalized myasthenia gravis (gMG) and Vyvgart Hytrulo for CIDP; applies to UnitedHealthcare members except where state-specific exceptions are noted.

Policy Summary

PayerUnitedHealthcare

PolicyFcRn blockers (Imaavy, Rystiggo, Vyvgart, Vyvgart Hytrulo) for generalized myasthenia gravis and CIDP

Policy CodePolicy CS2026D00111Q

Change TypeMaterial revisions and additions

Effective DateApr 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of diagnosis, antibody status, baseline and on-treatment MG-ADL scores, prior therapy history, and neurologist involvement; initial and reauthorization approvals limited to no more than 12 months.

SourceLink

POLICY UPDATE CHANGES

Imaavy (nipocalimab-aahu) was added for intravenous (IV) administration and included as a proven and medically necessary treatment for generalized myasthenia gravis when specified criteria are met.

List of products that must not be co-administered with Rystiggo was updated to add CD19-directed cytolytic antibodies and to include Imaavy among FcRn blockers.

Coverage rationale updated to indicate Vyvgart Hytrulo has an additional FDA indication for CIDP.

Added 'a CD19-directed cytolytic antibody [e.g., Uplizna (inebilizumab)]' to the list of drug products the patient must not be receiving in combination with Rystiggo/Imaavy.

Replaced the example list for 'another FcRn blocker' to include Imaavy (nipocalimab-aahu) among FcRn blocker examples.

Specified that reauthorization will be for no more than 12 months and that Imaavy is dosed per the U.S. FDA labeled dosing for gMG.

Examples of FcRn blockers and immune globulin products in policy history were revised to add Imaavy and name Hizentra, Privigen, and Gammagard.

Removed criterion requiring the patient is not being given Vyvgart or Vyvgart Hytrulo sooner than 50 days from the start of the previous treatment cycle.

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4FcRn blocker products listed

>=5MG-ADL required at initiation

≥2MG-ADL improvement for continuation

12 monthsMax authorization duration

CD19New contraindicated drug class

Coverage Criteria for FcRn Blockers (gMG, CIDP)

Initial Therapy

Covered when ALL of the following are met for Imaavy initial therapy:

Imaavy initial therapy: Patient has not failed a previous course of Imaavy; diagnosis of generalized myasthenia gravis (gMG); positive serologic test for anti-AChR or anti‑MuSK antibodies; MGFA Clinical Classification class II, III, or IV at initiation; MG-ADL total score ≥ 5 at initiation; not receiving prohibited concomitant therapies (CD19-directed cytolytic antibody, complement inhibitor, another FcRn blocker, or immune globulin); Imaavy is dosed according to U.S. FDA labeled dosing for gMG; prescribed by, or in consultation with, a neurologist; initial authorization will be for no more than 12 months.

Prior therapy requirements (if anti-AChR antibody positive): History of failure of at least two immunosuppressive agents over the course of at least 12 months OR history of failure of at least one immunosuppressive therapy plus four or more courses of plasmapheresis/plasma exchange and/or immune globulin over at least 12 months.

Applies if anti-AChR antibody positive

Prior therapy requirement (if anti-MuSK antibody positive): History of failure of at least one immunosuppressive agent over the course of at least 12 months.

Applies if anti-MuSK antibody positive

Continuation Therapy

Covered when ALL of the following are met for continuation of Imaavy:

Imaavy continuation: Patient has previously been treated with Imaavy; submission of medical records demonstrating improvement and/or maintenance of at least a 2‑point improvement in MG-ADL from pre‑treatment baseline and reduction in signs and symptoms of myasthenia gravis; maintenance, reduction, or discontinuation of baseline immunosuppressive therapy doses prior to starting Imaavy (add‑on, dose escalation, or additional rescue therapy compared with baseline while on Imaavy is considered treatment failure); patient is not receiving prohibited concomitant therapies (CD19-directed cytolytic antibody, complement inhibitor, another FcRn blocker, or immune globulin); Imaavy is dosed according to U.S. FDA labeled dosing for gMG; prescribed by, or in consultation with, a neurologist; reauthorization will be for no more than 12 months.MG-ADL >=2-point improvement

Continuation requires objective clinical improvement and maintenance/reduction of baseline IST.

Initial Therapy

Covered when ALL of the following are met for Rystiggo initial therapy:

Rystiggo initial therapy: Patient has not failed a previous course of Rystiggo; diagnosis of generalized myasthenia gravis (gMG); positive serologic test for anti-AChR or anti‑MuSK antibodies; MGFA Clinical Classification class II, III, or IV at initiation; MG-ADL total score ≥ 5 at initiation; prior therapy requirements per antibody status (if anti‑AChR: failure of ≥2 immunosuppressive agents over ≥12 months OR failure of ≥1 plus ≥4 courses of plasmapheresis/IVIG over ≥12 months; if anti‑MuSK: failure of ≥1 immunosuppressive agent over ≥12 months); patient is not receiving prohibited concomitant therapies (CD19-directed cytolytic antibody, complement inhibitor, another FcRn blocker, or immune globulin); Rystiggo will be given no sooner than 63 days from the start of the previous treatment cycle; Rystiggo is dosed according to U.S. FDA labeled dosing for gMG; prescribed by, or in consultation with, a neurologist; initial authorization will be for no more than 12 months.

Continuation Therapy

Covered when ALL of the following are met for Rystiggo continuation:

Rystiggo continuation: Patient has previously been treated with Rystiggo; submission of medical records demonstrating improvement and/or maintenance of at least a 2‑point improvement in MG-ADL from pre‑treatment baseline and reduction in signs and symptoms of myasthenia gravis; maintenance, reduction, or discontinuation of baseline immunosuppressive therapy doses prior to starting Rystiggo (add‑on, dose escalation, or additional rescue therapy compared with baseline while on Rystiggo is considered treatment failure); patient is not receiving prohibited concomitant therapies (CD19-directed cytolytic antibody, complement inhibitor, another FcRn blocker, or immune globulin); Rystiggo is not given sooner than 63 days from the start of the previous treatment cycle; Rystiggo is dosed according to U.S. FDA labeled dosing for gMG; prescribed by, or in consultation with, a neurologist; reauthorization will be for no more than 12 months.MG-ADL >=2-point improvement

Initial Therapy

Covered when ALL of the following are met for Vyvgart or Vyvgart Hytrulo initial therapy:

Vyvgart / Vyvgart Hytrulo initial therapy: Patient has not failed a previous course of Vyvgart or Vyvgart Hytrulo; diagnosis of generalized myasthenia gravis (gMG); positive serologic test for anti‑AChR antibodies; MGFA Clinical Classification class II, III, or IV at initiation; MG-ADL total score ≥ 5 at initiation; prior therapy requirement: history of failure of at least two immunosuppressive agents over ≥12 months OR failure of ≥1 immunosuppressive therapy plus ≥4 courses of plasmapheresis/IVIG over ≥12 months; patient is not receiving prohibited concomitant therapies (CD19-directed cytolytic antibody, complement inhibitor, another FcRn blocker, or immune globulin); drug is dosed according to U.S. FDA labeled dosing for gMG; prescribed by, or in consultation with, a neurologist; initial authorization will be for no more than 12 months.

Applies to anti‑AChR antibody–positive patients.

Continuation Therapy

Covered when ALL of the following are met for Vyvgart or Vyvgart Hytrulo continuation:

Vyvgart / Vyvgart Hytrulo continuation: Patient has previously been treated with Vyvgart or Vyvgart Hytrulo; submission of medical records demonstrating improvement and/or maintenance of at least a 2‑point improvement in MG-ADL from pre‑treatment baseline and reduction in signs and symptoms of myasthenia gravis; maintenance, reduction, or discontinuation of baseline immunosuppressive therapy doses prior to starting Vyvgart/Vyvgart Hytrulo (add‑on, dose escalation, or additional rescue therapy compared with baseline while on Vyvgart/Vyvgart Hytrulo is considered treatment failure); patient is not receiving prohibited concomitant therapies (CD19-directed cytolytic antibody, complement inhibitor, another FcRn blocker, or immune globulin); drug is dosed according to U.S. FDA labeled dosing for gMG; prescribed by, or in consultation with, a neurologist; reauthorization will be for no more than 12 months.MG-ADL >=2-point improvement

CIDP

Covered when ALL of the following are met for Vyvgart Hytrulo for CIDP:

Vyvgart Hytrulo CIDP: Patient has not failed a previous course of Vyvgart Hytrulo; diagnosis of chronic inflammatory demyelinating polyneuropathy (CIDP) confirmed by progressive symptoms for at least 2 months and symptomatic polyradiculoneuropathy with progressive or relapsing motor or sensory impairment of more than one limb; electrodiagnostic findings consistent with EFNS/PNS guidelines showing at least one specified demyelinating parameter; patient is not receiving Vyvgart Hytrulo in combination with an immune globulin; Vyvgart Hytrulo is dosed according to U.S. FDA labeled dosing for CIDP; prescribed by, or in consultation with, a neurologist; initial authorization will be for no more than 12 months.symptoms >=2 months

Electrodiagnostic detail provided in CIDP criteria.

Continuation therapy — Vyvgart / Vyvgart Hytrulo for gMG