ModifiedUnitedHealthcarePolicy CS2026D00111R

FcRn blocker therapies for generalized myasthenia gravis and CIDP

Medically necessary coverage criteria and authorization requirements for IV and SC FcRn-blocking drugs (Imaavy, Rystiggo, Vyvgart, Vyvgart Hytrulo) administered by a healthcare professional, and Vyvgart Hytrulo for CIDP; applies to UnitedHealthcare members except where state-specific exceptions noted.

Policy Summary

PayerUnitedHealthcare

PolicyFcRn blocker therapies for generalized myasthenia gravis and CIDP

Policy CodePolicy CS2026D00111R

Change TypeMaterial clinical addition (FDA indication) and operational update

Effective DateMay 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with medical records documenting diagnosis, serologic status, prior therapies and objective response (e.g., MG-ADL scores) for initial and continuation requests.

SourceLink

POLICY UPDATE CHANGES

Vyvgart Hytrulo (efgartigimod alfa + hyaluronidase) is indicated for treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP).

Replaced instruction to refer to the state's Medicaid clinical policy with reference link to the Medical Benefit Drug Policy titled Denied Drug Codes - Pharmacy Benefit Drugs (for Arizona Only) Supporting Information.

4drugs referenced

>=5min MG-ADL at initiation

2-pointMG-ADL improvement for continuation

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221CIDP study randomized N

Coverage Criteria for FcRn-Blocking Therapies

Coverage for efgartigimod alfa + hyaluronidase in CIDP

Coverage for efgartigimod alfa + hyaluronidase (Vyvgart Hytrulo) in chronic inflammatory demyelinating polyneuropathy (CIDP).

ALL of the following

Patient has not failed a previous course of Vyvgart Hytrulo therapy.
- ALL of the following
  - Progressive symptoms present for at least 2 months.
  - Symptomatic polyradiculoneuropathy indicated by progressive or relapsing motor or sensory impairment of more than one limb.
  - Electrodiagnostic findings consistent with EFNS/PNS guidelines for definite CIDP demonstrating at least one of: Motor distal latency prolongation in 2 nerves; reduction of motor conduction velocity in 2 nerves; prolongation of F-wave latency in 2 nerves; absence of F-waves in at least 1 nerve; partial motor conduction block of at least 1 motor nerve; or abnormal temporal dispersion in at least 2 nerves.
OR documentation that the patient has a contraindication to all immune globulins (intravenous or subcutaneous).
Patient is not receiving Vyvgart Hytrulo in combination with an immune globulin.
Vyvgart Hytrulo is dosed according to the 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.

Applicable Codes and Measurement Thresholds

Applicable Codesmixed

J9256	Injection, nipocalimab-aahu, 3 mg.
J9332	Injection, efgartigimod alfa-fcab, 2 mg.
J9333	Injection, rozanolixizumab-noli, 1 mg.
J9334	Injection, efgartigimod alfa, 2 mg and hyaluronidase-qvfc
G61.81	Chronic inflammatory demyelinating polyneuritis.
G70.00	Myasthenia gravis without (acute) exacerbation.
G70.01	Myasthenia gravis with (acute) exacerbation.

Referenced Products and Indicationsmixed

Vyvgart (efgartigimod alfa)	Prescribing information referenced (FDA-approved product for gMG)
Vyvgart Hytrulo (efgartigimod alfa + hyaluronidase)	Prescribing information referenced (FDA-approved for gMG and CIDP)
Rystiggo	Neonatal Fc receptor blocker (FDA indication for gMG)
Imaavy	Neonatal Fc receptor blocker (FDA indication for gMG)

inv-17: MG-ADL total score at initiation — threshold

MG-ADL total score required at initiation>= 5 total score on the Myasthenia Gravis Activities of Daily Living (MG-ADL)

MGFA clinical class requiredMyasthenia Gravis Foundation of America (MGFA) Clinical Classification II–IV at initiation

Prescriber requirementPrescribed by, or in consultation with, a neurologist

inv-18: MG-ADL improvement for continuation — threshold

MG-ADL improvement required for continuation>= 2-point improvement (reduction) in MG-ADL from pre-treatment baseline

Clinical sign/symptom requirementDocumentation of reduction in signs and symptoms of myasthenia gravis

Prior Authorization, Documentation, and Submission Requirements

Prior Authorization

Prior Authorization Required — Submit Complete Medical Records

Prior authorization is required. Submit complete medical records (chart notes, labs, prior therapy documentation) with the initial request. Failure to submit required records (including documentation confirming diagnosis, baseline measures such as MG-ADL and MGFA class, prior therapy history, or objective baseline CIDP measures) may result in denial or delay of the request.

Required records include: diagnosis confirmation, baseline MG-ADL score, MGFA classification, prior immunosuppressive therapy history, prior IVIG/SCIG or plasmapheresis courses, electrodiagnostic testing for CIDP when applicable, and objective response measures for continuation requests.

Prior Authorization

AChR/MuSK Prior Therapy Requirements

For myasthenia gravis (AChR-positive) initial requests, documentation must show failure of at least two immunosuppressive agents over ≥12 months OR failure of at least one immunosuppressive agent plus ≥4 courses of plasmapheresis and/or immune globulin over ≥12 months. For MuSK-positive patients, documentation must show failure of at least one immunosuppressive agent over ≥12 months.

Background and Scope

This policy covers intravenous and subcutaneous neonatal Fc receptor (FcRn)–blocking monoclonal therapies indicated for generalized myasthenia gravis (gMG) and, for Vyvgart Hytrulo, for chronic inflammatory demyelinating polyneuropathy (CIDP). It applies when treatment is prescribed by or in consultation with a neurologist and when required documentation (diagnosis, serologic status, prior therapy history, and objective clinical scores) is submitted for prior authorization. The CIDP coverage discussion references guideline-based diagnostic criteria and clinical trial evidence showing benefit for efgartigimod alfa plus hyaluronidase in identified responders.

Definitions and Clinical Thresholds

inv-37: MG-ADL score definition and policy thresholds

MG-ADL initiation threshold>= 5 total MG-ADL score required to initiate FcRn blocker therapy for gMG

MGFA class at initiationMGFA Clinical Classification II–IV required at initiation

Documentation neededSubmission of medical records (chart notes, labs, MG-ADL scores) confirming baseline MG-ADL >=5 and MGFA class

inv-38: MGFA Clinical Classification requirement at initiation

Required MGFA class at initiationMyasthenia Gravis Foundation of America (MGFA) Clinical Classification II, III, or IV

Use purposeUsed as an eligibility criterion for initiating FcRn blocker therapy for generalized myasthenia gravis

Policy Revision History

2026-05-01operational updateLatest

Policy operationalized an Arizona-specific change and archived prior policy version CS2026D00111Q; administrative references updated per state guidance.

FDA indication added

FDA indication statement added noting Vyvgart Hytrulo (efgartigimod alfa + hyaluronidase) is indicated for treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP).

clinical evidence referenced

Policy Summary

PayerUnitedHealthcare

PolicyFcRn blocker therapies for generalized myasthenia gravis and CIDP

Policy CodePolicy CS2026D00111R

Change TypeMaterial clinical addition (FDA indication) and operational update

Effective DateMay 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with medical records documenting diagnosis, serologic status, prior therapies and objective response (e.g., MG-ADL scores) for initial and continuation requests.

SourceLink

On This Page

Immunosuppressive therapy statusMaintenance, reduction, or discontinuation (not escalation) of baseline IST prior to starting therapy

inv-19: MG-ADL responder threshold (sustained reduction requirement)

MG-ADL responder definition>= 2-point reduction in total MG-ADL score from baseline sustained for >= 4 consecutive weeks (first reduction no later than 1 week after last infusion of the cycle)

Scale rangeMG-ADL total score ranges 0–24; higher scores indicate greater impairment

Clinical rationaleA 2-point change balances sensitivity (77%) and specificity (82%) as a clinically meaningful threshold

inv-20: QMG responder threshold

QMG responder definition>= 3-point reduction in total QMG score from baseline sustained for >= 4 consecutive weeks (first reduction no later than 1 week after last infusion of the cycle)

QMG scale rangeQMG total score ranges 0–39; higher scores indicate more severe weakness

Assessment typeQMG is a 13-item clinician-assessed measure of muscle weakness

inv-21: Electrodiagnostic thresholds for CIDP demyelination

Electrodiagnostic requirement (examples)At least one demyelinating abnormality per EFNS/PNS/EAN-PNS criteria (e.g., motor distal latency prolongation >=50% above ULN in 2 nerves; motor conduction velocity reduction >=30% below LLN in 2 nerves; F-wave latency prolongation >=20% above ULN in 2 nerves)

Additional supportive criteriaAbsence of F‑waves in 2 nerves + >=1 other demyelinating parameter in >=1 other nerve, partial motor conduction block (>=30% reduction) in >=1 motor nerve, or abnormal temporal dispersion (>30% duration increase in >=2 nerves)

LFF numeric thresholdsLow frequency fatigue (LFF) timing examples: LFF 2 Hz median >8.4 ms, ulnar >9.6 ms, peroneal >8.8 ms, tibial >9.2 ms; LFF 20 Hz median >7.4 ms, ulnar >7.8 ms, peroneal >8.1 ms, tibial >8.0 ms

Denial Risk

Concomitant Therapy Exclusions — Combination Use Not Allowed

Vyvgart and Vyvgart Hytrulo must NOT be used in combination with excluded agents. Document that the patient is not receiving these agents in combination: CD19-directed cytolytic antibodies (e.g., inebilizumab), complement inhibitors (e.g., eculizumab, ravulizumab, zilucoplan), other FcRn blockers (e.g., nipocalimab, rozanolixizumab), or immune globulins (IVIG/SCIG). Requests showing concomitant use with these agents are not supported.

Documentation Required

CIDP Initial Therapy — Required Diagnostic and Electrodiagnostic Documentation

For CIDP initial therapy requests, submit documentation that all of the following are met: progressive symptoms ≥2 months; symptomatic polyradiculoneuropathy affecting more than one limb (progressive or relapsing motor or sensory impairment); and supportive electrodiagnostic findings consistent with EFNS/PNS criteria (examples include motor distal latency prolongation in ≥2 nerves, reduced motor conduction velocity in ≥2 nerves, prolonged or absent F-waves, partial motor conduction block, abnormal temporal dispersion, or distal CMAP duration increase). If therapy is sought because of contraindication to immune globulins, document the contraindication.

Documentation Required

CIDP Continuation — Objective Response Required

CIDP continuation requests must include objective documentation of positive clinical response (e.g., aINCAT, Rankin/modified Rankin, MRC scale) and show that the patient is not receiving Vyvgart Hytrulo in combination with immune globulin. Also document dosing per FDA labeling and that the prescriber is or consulted with a neurologist. Reauthorization will be for no more than 12 months.

Documentation Required

Clinical Trial Enrollment and Diagnostic Criteria — Document Per EFNS/PNS or EAN/PNS Guidelines

Clinical trial enrollment or study-derived diagnoses must be supported by documentation meeting EFNS/PNS (2010) or the 2021 EAN/PNS guideline criteria for definite/probable CIDP. Document study stage, diagnostic criteria used, and objective response measures when relying on trial data.

DocumentationMGFA classification must be documented in submitted medical records for authorization

inv-39: MG-ADL responder definition (sustained ≥2 point reduction)

Responder thresholdMG-ADL responder = >= 2-point reduction in total MG-ADL score from baseline sustained for >= 4 consecutive weeks

Timing requirementFirst reduction must occur no later than 1 week after last infusion of the cycle

Clinical interpretation2-point threshold chosen as balance of sensitivity and specificity in validation studies

inv-40: QMG responder definition (sustained ≥3 point reduction)

Responder thresholdQMG responder = >= 3-point reduction in total QMG score from baseline sustained for >= 4 consecutive weeks

Timing requirementFirst reduction must occur no later than 1 week after last infusion of the cycle

Scale detailsQMG is a 13-item clinician-assessed measure; total score range 0–39

inv-41: Typical CIDP — definition per guideline

Typical CIDP clinical definitionProgressive or relapsing, symmetric, proximal and distal muscle weakness of upper and lower limbs with sensory involvement of at least two limbs, developing over at least 8 weeks, and absent or reduced tendon reflexes in all limbs

Diagnostic contextDefined by EAN/PNS 2021 guideline as the clinical core of CIDP diagnostic criteria

Use in policyTypical CIDP clinical features inform eligibility for Vyvgart Hytrulo when combined with electrodiagnostic support

inv-42: CIDP variants — listed variant patterns

Listed CIDP variantsDistal CIDP; Multifocal CIDP; Focal CIDP; Motor CIDP; Sensory CIDP

Variant characteristicsVariant presents with the specified pattern (e.g., distal predominantly lower limb involvement for distal CIDP) but otherwise follow typical CIDP diagnostic elements; tendon reflexes may be normal in unaffected limbs

Policy implicationRecognition of variants supports diagnosis per EAN/PNS 2021 and may affect electrodiagnostic interpretation

Randomized withdrawal trial evidence for efgartigimod alfa + hyaluronidase in CIDP (HR 0.394 for time to clinical deterioration) referenced to support CIDP coverage considerations.