UnitedHealthcare FcRn Blockers Coverage Update

Coverage Criteria

inv-01: Rystiggo — Initial Therapy — ALL of the following

Covered when ALL of the following are met for Rystiggo:

Rystiggo initial therapy general requirements: Submission of medical records confirming patient has not failed previous 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; prescribed by or in consultation with a neurologist; initial authorization ≤ 12 months

See subsequent nodes for antibody-specific prior therapy requirements

Antibody status-specific prior therapy (AChR): If anti-AChR antibody positive then either history of failure of ≥2 immunosuppressive agents over ≥12 months OR failure of ≥1 immunosuppressive therapy plus ≥4 courses of plasmapheresis/plasma exchange and/or immune globulin over ≥12 months without symptom control

Antibody status-specific prior therapy (MuSK): If anti-MuSK antibody positive then history of failure of ≥1 immunosuppressive agent over ≥12 months

Prohibitions and dosing: Patient is not receiving Rystiggo in combination with a complement inhibitor, another FcRn blocker, or immune globulin; Rystiggo is dosed according to the 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

inv-02: Rystiggo — Continuation Therapy — ALL of the following

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

Rystiggo continuation criteria: 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; reduction in signs and symptoms of myasthenia gravis; maintenance, reduction, or discontinuation of baseline immunosuppressive therapy (add-on, dose escalation, or additional rescue therapy from baseline will be considered treatment failure)≥2-point MG-ADL improvement maintained

Documentation required; reauthorization ≤ 12 months

Prohibitions and dosing for continuation: Patient is not receiving Rystiggo in combination with a complement inhibitor, another FcRn blocker, or immune globulin; Rystiggo is dosed according to the U.S. FDA labeled dosing for gMG; prescribed by or in consultation with a neurologist

Reauthorization will be for no more than 12 months

inv-03: Vyvgart/Vyvgart Hytrulo — gMG Initial and Continuation — ALL of the following

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

Vyvgart/Vyvgart Hytrulo initial therapy general requirements: Submission of medical records confirming patient has not failed previous Vyvgart or Vyvgart Hytrulo; diagnosis of generalized myasthenia gravis (gMG); positive anti-AChR serology; MGFA Clinical Classification class II–IV at initiation; MG-ADL total score ≥ 5 at initiation; history of failure of ≥2 immunosuppressive agents over ≥12 months OR failure of ≥1 immunosuppressive therapy plus ≥4 courses of plasmapheresis/plasma exchange and/or immune globulin over ≥12 months without symptom control; patient will be given Vyvgart or Vyvgart Hytrulo no sooner than 50 days after each treatment cycle; not receiving prohibited combinations; dosed per U.S. FDA label; prescribed by or in consultation with a neurologist; initial authorization ≤ 12 monthsMG-ADL ≥5 at initiation

Vyvgart/Vyvgart Hytrulo continuation criteria: 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; reduction in signs and symptoms of myasthenia gravis; maintenance, reduction, or discontinuation of baseline immunosuppressive therapy (add-on, dose escalation, or additional rescue therapy from baseline will be considered treatment failure); not receiving prohibited combinations; dosed per U.S. FDA label; prescribed by or in consultation with a neurologist; reauthorization ≤ 12 months

inv-04: Vyvgart Hytrulo — CIDP Initial and Continuation — ALL of the following

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

CIDP diagnosis requirements: Diagnosis of CIDP (typical or listed variants) with documented definite or probable CIDP per EFNS/PNS (2010) or EAN/PNS (2021) criteria; electrodiagnostic testing confirming at least two motor nerve abnormalities OR electrodiagnostic allows only possible CIDP with one motor nerve abnormality plus supportive features (e.g., objective response to immunomodulatory agents, imaging, CSF, nerve biopsy); immunological testing excludes other neuropathies; prescribed by or in consultation with a neurologist; initial authorization ≤ 12 monthsmeets EFNS/PNS or EAN/PNS criteria

See supportive diagnostic features and immunological testing requirements

CIDP prior therapy requirements: Trial and failure (after trial ≥2 months), contraindication, or intolerance to corticosteroids; trial and failure (after trial ≥3 months), contraindication, or intolerance to immune globulin with dose maximized/tolerated and objective response assessments not met (I-RODS, INCAT for disability; grip strength, MRC sum score, or mISS for impairment); patient is not receiving Vyvgart Hytrulo in combination with immune globulin; Vyvgart Hytrulo is dosed according to U.S. FDA labeled dosing for CIDP

Objective assessments must demonstrate lack of response before approval

inv-05: Medical necessity/coverage criteria derived from pivotal trials — trial-derived enrollment criteria

Covered when ALL of the following trial-derived criteria are met (evidence-based enrollment criteria from pivotal studies):

AChR+ gMG (efgartigimod IV/SC)

Severity and functional impairment: MG-ADL total score meeting trial thresholds (e.g., ≥5 for enrollment); MG-ADL responder defined as ≥2-point reduction for ≥4 consecutive weeksMG-ADL ≥5 at screening as used in Study 1
Clinical response rates observed: 67.7% vs 29.7% MG-ADL responders (efgartigimod vs placebo)
Concurrent therapy: On a stable dose of MG therapy prior to screening (AChE inhibitors, steroids, or NSISTs)stable dose prior to screening
Trial required stability of background therapies

The policy excludes use of any FcRn blocker in combination with certain other immunomodulatory agents. Specifically, a patient must not receive the requested FcRn blocker in combination with a complement inhibitor (for example, eculizumab, ravulizumab/Ultomiris, or zilucoplan/Zilbrysq), another FcRn blocker (e.g., Vyvgart, Vyvgart Hytrulo, or Rystiggo as applicable), or immune globulin (IVIG or SCIG). Clinical documentation showing concomitant use of any of these agents would be inconsistent with the policy and may result in denial. The policy also requires dosing to follow the U.S. FDA labeled dosing and that treatment be prescribed by or in consultation with a neurologist.

FDA approval and prescribing information are summarized in the policy for informational context only. FDA approval alone is not a basis for coverage; coverage decisions are determined by the policy clinical criteria and supporting documentation rather than by regulatory approval status alone.

Providers must verify the governing benefit plan terms before relying on this policy. Federal, state, or contractual coverage requirements may differ from UnitedHealthcare standard plan guidance and, in the event of conflict, those governing requirements will take precedence. The policy therefore instructs checking applicable federal, state, or contractual rules prior to using this guidance.

When required prior therapy trials have not been met, the policy does not support coverage. For generalized myasthenia gravis this includes documented failure of specified prior immunosuppressive therapies (number and duration vary by antibody status) or inadequate courses of plasmapheresis/IVIG where required by the criteria. For CIDP, the policy requires trial and failure (or contraindication/intolerance) of corticosteroids and immune globulin with objective assessments documented (e.g., I-RODS, INCAT, grip strength, MRC sum score, or mISS) before Vyvgart Hytrulo is considered. Absence of these documented prior therapy trials or objective response assessments would not meet the policy’s medical necessity criteria.

Within the extracted sections of this policy there are no explicit statements labeling specific situations as “not medically necessary.” Instead, the document emphasizes that FDA approval is informational and that coverage is determined by meeting the policy’s medical necessity criteria and submission of supporting medical records.

The policy extract does not list explicit conditions coded as "not medically necessary." Providers are reminded to consult the full benefit terms and the policy’s clinical criteria when assessing whether a request meets coverage requirements.

Coding

Applicable HCPCS and ICD-10 Codesmixed

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

Codes mentionedmixed

N/A	No explicit procedure, diagnosis, or billing codes listed in this section.

inv-14: MG-ADL score at initiation — threshold

MG-ADL threshold at initiationMG-ADL total score ≥ 5

MGFA clinical class requiredMGFA class II, III, or IV at initiation

Prescribing constraintPrescribed by or in consultation with a neurologist

inv-15: MG-ADL improvement for continuation — 2-point improvement requirement

Required MG-ADL improvement for continuationImprovement and/or maintenance of at least a 2-point improvement (reduction) in MG-ADL from pre-treatment baseline

Clinical evidence of benefitReduction in signs and symptoms of myasthenia gravis must be documented

Provider Actions & Authorization

Prior Authorization

Prior Authorization Required

Prior authorization required — submit supporting medical records demonstrating clinical criteria. Prior authorization is required for initial and continuation therapy. Submit chart notes, laboratory values, serologic status (anti‑AChR and/or anti‑MuSK as applicable), MGFA clinical class, baseline and follow-up MG‑ADL (and other scale scores for CIDP such as aINCAT, I‑RODS, INCAT, MRC, grip strength) and documentation of prior treatment trials, dosing, and response.

Initial and continuation authorizations: up to 12 months
Include baseline severity scores (MG‑ADL, QMG) and objective response data for continuation (≥2‑point MG‑ADL improvement for gMG; objective CIDP scale improvement per policy)

Prior Authorization

Prior Authorization Expectations

Prior authorization expectations — clinical trial inclusion criteria and trial prerequisites often reflect required documentation. For gMG, expect documentation of antibody positive status (AChR or MuSK as applicable), MGFA class II–IV, MG‑ADL thresholds, and stable doses of background MG therapies prior to initiation. For CIDP, expect EFNS/PNS diagnostic confirmation, electrodiagnostic evidence, and documented trial/failure or intolerance to corticosteroids and IVIG/SCIG with objective response assessments.

Background

Efgartigimod (Vyvgart; Vyvgart Hytrulo when combined with hyaluronidase) and rozanolixizumab (Rystiggo) are neonatal Fc receptor (FcRn) blockers. These agents reduce circulating IgG, including pathogenic autoantibodies implicated in immune-mediated neuromuscular diseases. Vyvgart is available as an IV formulation (efgartigimod alfa-fcab) and as a subcutaneous combination with hyaluronidase (Vyvgart Hytrulo: efgartigimod alfa plus hyaluronidase), while Rystiggo (rozanolixizumab-noli) is an alternative FcRn-targeting therapy. Clinical trials cited in the policy demonstrated efficacy in generalized myasthenia gravis using functional outcome measures such as the MG-ADL score, and the CIDP evidence for Vyvgart Hytrulo derived from a responder/withdrawal study design.

Definitions

inv-30: MG-ADL responder definition — ≥2 point reduction for at least 4 consecutive weeks within cycle

MG-ADL responder definition (trial-aligned)≥2 point reduction in total MG-ADL score from baseline for at least 4 consecutive weeks within the treatment cycle

Timing constraintFirst reduction must occur no later than 1 week after the last infusion of the cycle (as used in efgartigimod study)

Score range contextMG-ADL total score ranges 0–24; higher scores indicate greater impairment

inv-31: MG-ADL responder — restated trial-aligned definition and timing

Restated MG-ADL responder definitionA patient with a ≥2 point reduction in total MG-ADL score for at least 4 consecutive weeks, with the first reduction occurring no later than 1 week after the last infusion of the cycle

Clinical rationale

OpenPayer

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

Coverage Criteria

Coding

Provider Actions & Authorization

Background

Definitions