Loading...

UnitedHealthcare FcRn Blocker Coverage Update | OpenPayer

ModifiedUnitedHealthcarePolicy N/A

FcRn Blockers (Rystiggo, Vyvgart, Vyvgart Hytrulo) — Medical Benefit Drug Policy

Medical Benefit Drug Policy governing clinical coverage and prior authorization criteria for FcRn blocking agents (rozanolixizumab, efgartigimod alfa formulations) for treatment of generalized myasthenia gravis and CIDP where specified; applies to UnitedHealthcare commercial lines except where state-specific guidance overrides.

Policy Summary

PayerUnitedHealthcare

PolicyFcRn Blockers (Rystiggo, Vyvgart, Vyvgart Hytrulo) — Medical Benefit Drug Policy

Policy CodePolicy N/A

Change TypeMaterial: added CIDP indicationadded Rystiggo for AChR and MuSKclarified FcRn agent indications

Effective DateSep 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization with supporting medical records including antibody status and baseline MG-ADL/QMG scores; approvals limited to ≤12 months.

SourceLink

POLICY UPDATE CHANGES

Added Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase) indication for CIDP in adults.

Added Rystiggo (rozanolixizumab-noli) FDA indication for gMG including anti-AChR and anti-MuSK antibody positive patients.

Clarified that Vyvgarte and Vyvgart Hytrulo are FcRn blockers indicated for AChR antibody positive gMG in adults.

3drug products referenced

3 codeslisted HCPCS drug codes

≥5MG-ADL minimum

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria for FcRn Blocker Therapies

Rystiggo (rozanolixizumab) — Initial Therapy

Covered when ALL of the following are met

Rystiggo initial therapy for gMG: Diagnosis of generalized myasthenia gravis; positive serologic test for anti-AChR or anti-MuSK antibodies; Myasthenia Gravis Foundation of America (MGFA) clinical classification II–IV at initiation; MG-ADL total score ≥5 at initiation; patient has not failed a previous course of Rystiggo; history of failure of at least two immunosuppressive agents over ≥12 months OR (if AChR positive) failure of ≥1 immunosuppressive therapy plus ≥4 courses of plasmapheresis and/or IVIG over ≥12 months OR (if MuSK positive) failure of ≥1 immunosuppressive agent over ≥12 months; patient is not receiving Rystiggo in combination with a complement inhibitor, another FcRn blocker, or immune globulin; Rystiggo is dosed according to U.S. FDA labeling; prescribed by or in consultation with a neurologist; initial authorization ≤12 monthsMG-ADL ≥5

See policy documentation requirements for supporting medical records (diagnosis, antibody status, MG-ADL, prior therapy history).

Rystiggo — Continuation of Therapy

Covered when ALL of the following are met

Rystiggo continuation: Patient has previously been treated with Rystiggo; improvement and/or maintenance of at least a 2-point improvement (reduction) in MG-ADL from pre-treatment baseline; maintenance, reduction, or discontinuation of baseline immunosuppressive therapy (no add-on or dose escalation of IST or additional rescue therapy while on Rystiggo); reduction in signs and symptoms of myasthenia gravis; patient is not receiving Rystiggo in combination with a complement inhibitor, another FcRn blocker, or immune globulin; Rystiggo is dosed according to U.S. FDA labeling; prescribed by or in consultation with a neurologist; reauthorization ≤12 months≥2-point MG-ADL improvement

Add-on or escalation of IST or need for additional rescue therapy while on Rystiggo is considered treatment failure and not supportive of continuation.

Vyvgart / Vyvgart Hytrulo — Initial Therapy (gMG, AChR+)

Covered when ALL of the following are met

Vyvgart / Vyvgart Hytrulo initial therapy for gMG: Diagnosis of generalized myasthenia gravis; positive anti-AChR serology; patient has not failed a previous course of Vyvgart or Vyvgart Hytrulo; history of failure of at least two immunosuppressive agents over ≥12 months OR failure of ≥1 immunosuppressive therapy plus ≥4 courses of plasmapheresis and/or IVIG over ≥12 months; dosing no sooner than 50 days after each treatment cycle; patient is not receiving Vyvgart or Vyvgart Hytrulo in combination with another FcRn blocker, a complement inhibitor, or immune globulin; prescribed by or in consultation with a neurologist; initial authorization ≤12 monthsN/A

Applies to AChR-antibody positive patients only; dosing interval requirement per labeling.

Vyvgart / Vyvgart Hytrulo — Continuation of Therapy (gMG)

Covered when ALL of the following are met

Vyvgart continuation for gMG: Patient has previously been treated with Vyvgart or Vyvgart Hytrulo; improvement and/or maintenance of at least a 2-point improvement (reduction) in MG-ADL from pre-treatment baseline; maintenance, reduction, or discontinuation of baseline immunosuppressive therapy (no dose escalation or additional rescue therapy while on Vyvgart); reduction in signs and symptoms of myasthenia gravis; patient is not receiving Vyvgart or Vyvgart Hytrulo in combination with another FcRn blocker, a complement inhibitor, or immune globulin; Vyvgart or Vyvgart Hytrulo is dosed according to U.S. FDA labeling; prescribed by or in consultation with a neurologist; reauthorization ≤12 months≥2-point MG-ADL improvement

Add dose escalation of IST or need for additional rescue therapy while on treatment is considered treatment failure.

Vyvgart Hytrulo — Initial Therapy (CIDP)

Covered when ALL of the following are met

Vyvgart Hytrulo initial therapy for CIDP: Diagnosis of chronic inflammatory demyelinating polyneuropathy (CIDP) with typical CIDP or recognized variant (multifocal, distal, focal, motor, sensory); electrodiagnostic confirmation of at least two motor nerve abnormalities OR possible CIDP with two supporting features (imaging, objective response to immunomodulators, CSF, nerve biopsy) and exclusion of other neuropathies by immunologic testing; trial and failure (after at least 2 months), contraindication, or intolerance to corticosteroids AND IVIG/SCIG with dose optimized and failure to obtain objective response defined by disability or impairment scales; Vyvgart Hytrulo is dosed according to U.S. FDA labeling for CIDP; patient is not receiving Vyvgart Hytrulo in combination with immune globulin; prescribed by or in consultation with a neurologist; initial authorization ≤12 monthsInstrument-specific objective assessment thresholds (e.g., INCAT decrease ≥2; I-RODS increase 2–4 centile points; grip increase ≥10%; mISS decrease ≥2; MRC sum score increase 2–4)

Objective response failure thresholds and required testing per EFNS/PNS guidance and policy details.

Vyvgart Hytrulo — Continuation of Therapy (CIDP)

Covered when ALL of the following are met

Vyvgart Hytrulo continuation for CIDP: Patient has previously been treated with Vyvgart Hytrulo; documentation of positive clinical response to therapy measured by objective scales (e.g., INCAT, modified Rankin, MRC sum score); patient is not receiving Vyvgart Hytrulo in combination with immune globulin; Vyvgart Hytrulo is dosed according to U.S. FDA labeling for CIDP; prescribed by or in consultation with a neurologist; reauthorization ≤12 monthsDocumented objective clinical improvement

Initial authorization will be for no more than 12 months; objective scales must be used to document response.

Initial therapy — gMG (efgartigimod)

Covered when ALL of the following are met (for efgartigimod products in gMG):

gMG efgartigimod initial coverage: 1) Adult patient with diagnosis of generalized myasthenia gravis; 2) Positive anti-AChR antibody test; 3) Baseline MG-ADL and/or QMG documented; 4) On a stable dose of MG therapy (AChE inhibitors, steroids, or NSISTs) prior to treatment; 5) Serum IgG at or above study-specified minimum (≈6 g/L).

Based on Study 1 inclusion criteria and FDA labeling for intravenous and subcutaneous efgartigimod formulations.

Initial therapy — gMG (rozanolixizumab)

Covered when ALL of the following are met (for rozanolixizumab in gMG):

gMG rozanolixizumab initial coverage: 1) Adult patient with diagnosis of generalized myasthenia gravis; 2) Positive anti-AChR or anti-MuSK antibody test; 3) MG-ADL total score ≥3 with at least 3 non-ocular points; 4) Serum IgG ≥5.5 g/L; 5) On a stable dose of MG therapy (AChE inhibitors, steroids, or NSISTs) prior to screening.

Based on Study 1 rozanolixizumab inclusion criteria and FDA labeling; efficacy measured by change in MG-ADL at day 43.

Initial/continuation therapy — CIDP (Vyvgart Hytrulo)

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

CIDP efgartigimod+hyaluronidase coverage: 1) Adult patient with documented definite or probable CIDP by EFNS/PNS (2010) or EAN/PNS (2021) criteria; 2) History of progressive or relapsing CIDP; 3) Prior identification as a responder during an open-label period may be required per study-based evidence; 4) Monitoring plan for clinical deterioration (e.g., aINCAT/INCAT) established and in use.

Based on the two-stage responder-enriched randomized withdrawal CIDP study and FDA labeling for Vyvgart Hytrulo.

Use of FcRn blocking agents in combination with other systemic immune-modulating therapies is explicitly excluded. Specifically, patients must not receive these products in combination with a complement inhibitor (for example, eculizumab, ravulizumab, or zilucoplan), another FcRn blocker (for example, Rystiggo, Vyvgart, or Vyvgart Hytrulo), or with immune globulin (IVIG/SCIG/plasmapheresis used concurrently). This exclusion applies across all listed indications and is a required element of coverage determination.

FDA approval and labeling information is provided for context but is informational only. Coverage decisions require assessment against applicable federal, state, and contractual benefit terms and may exclude uses outside of FDA-labeled indications; accordingly, FDA approval alone does not guarantee coverage.

Continuation approvals require demonstration of objective clinical benefit and absence of treatment escalation. For generalized myasthenia gravis, continuation criteria include documentation of prior treatment with the same FcRn agent and an improvement and/or maintenance of at least a 2-point reduction in MG-ADL from pretreatment baseline sustained as specified. Escalation or addition of baseline immunosuppressive therapy, or need for additional rescue therapy while on treatment, is considered treatment failure and does not meet continuation criteria.

Use of these agents for indications not supported by FDA labeling or when clinical documentation is incomplete may be considered not medically necessary. Requests lacking documented antibody status (AChR or MuSK where required), baseline objective disease measures (e.g., MG-ADL, QMG, INCAT/I-RODS for CIDP), or other study-like baseline data referenced in the policy may be denied per plan rules and contractual requirements.

Coding and Measurement Definitions

Drug HCPCS CodesHCPCS

J9332	Injection , efgartigimod alfa-fcab , 2 mg.
J9333	Injection, rozanolixizumab-noli; 1 mg.
J9334	Injection, efgartigimod alfa , 2 mg and hyaluronidase-qvfc

Diagnosis ICD-10 CodesICD-10

G61.81	Chronic inflammatory demyelinating polyneuritis
G70.00	Myasthenia gravis without (acute) exacerbation.
G70.01	Myasthenia gravis with (acute) exacerbation

inv-16: MG-ADL — ≥5 for inclusion / baseline consideration

MG-ADL baseline thresholdMG-ADL total score ≥5 for study inclusion / baseline consideration

MGFA class requirementMyasthenia Gravis Foundation of America (MGFA) clinical classification II–IV at initiation

Stable background therapyOn a stable dose of MG therapy (AChE inhibitors, steroids, or NSISTs) prior to treatment

inv-17: MG-ADL responder threshold — >= 2 point reduction for ≥4 consecutive weeks

MG-ADL responder definition≥2-point reduction in MG-ADL total score from baseline sustained for at least 4 consecutive weeks

Timing of first reduction

Prior Authorization and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Submit supporting medical records (chart notes, laboratory values, electrodiagnostic testing, MG-ADL and/or QMG scores, antibody test results, prior treatment history) that demonstrate the diagnostic and clinical criteria listed below. Initial authorizations will be for no more than 12 months; reauthorizations (continuation of therapy) will also be for no more than 12 months when continuation criteria are met.

Requests must reference FDA-approved indications and be consistent with the specific product formulation (e.g., IV vs SC dosing and labeled indications).
Initial authorization and reauthorization durations: up to 12 months.

Denial Risk

Documentation-based Denials

Failure to submit medical records confirming the required documentation will result in denial. Required documentation must be included with the prior authorization request and should clearly support the diagnosis, antibody status, baseline disease severity, prior therapy history, and response to therapy for continuation requests.

Background on FcRn Blockers

FcRn blockers (including efgartigimod alfa formulations and rozanolixizumab) act by binding the neonatal Fc receptor (FcRn) and reducing circulating IgG levels, thereby lowering pathogenic autoantibody concentrations. Efgartigimod alfa formulations may be coformulated with hyaluronidase to enable subcutaneous delivery and increased tissue permeability. These mechanisms underlie the clinical trial–measured benefits (for example, improvements in MG-ADL and QMG scores) observed with these agents in generalized myasthenia gravis and in study designs for CIDP.

Definitions and Response Criteria

inv-29: MG-ADL responder — A patient achieving a ≥2-point reduction in MG-ADL total score from pre-treatment baseline sustained for at least 4 consecutive weeks, wi...

MG-ADL responder — core definitionA patient achieving a ≥2-point reduction in MG-ADL total score from pre-treatment baseline sustained for at least 4 consecutive weeks

Trial-timing requirementFirst reduction must occur no later than the week after the last infusion of the cycle as used in pivotal trials

PurposeEndpoint used to define clinical response in pivotal gMG trials and for continuation decisions

inv-30: Typical CIDP diagnosis support — Electrodiagnostic confirmation of ≥2 motor nerve abnormalities or possible CIDP with supporting evidence (imaging, CSF, response to immun...

Electrodiagnostic confirmationElectrodiagnostic testing confirming at least two motor nerve abnormalities supports a typical CIDP diagnosis