ModifiedUnitedHealthcarePolicy CSOH2026D00111.E

Medical Benefit Drug Policy

Ohio-only UnitedHealthcare medical benefit drug policy governing medical-administered FcRn blocking agents Rystiggo (rozanolixizumab-noli), Vyvgart (efgartigimod alfa-fcab IV), and Vyvgart Hytrulo (efgartigimod alfa + hyaluronidase SC vial) with coverage criteria for generalized myasthenia gravis and CIDP, continuation criteria, and applicable HCPCS/J-codes.

Policy Summary

PayerUnitedHealthcare

PolicyMedical Benefit Drug Policy

Policy CodePolicy CSOH2026D00111.E

Change TypeTiming criteria added; HCPCS code added; clinical evidence updated

Effective DateJan 1, 2026

Next Review Date

Key ActionSubmit medical records (chart notes, labs) documenting diagnostic, treatment history, and response criteria for initial and continuation authorizations; authorizations limited to no more than 12 months.

POLICY UPDATE CHANGES

Added timing criterion requiring Rystiggo be given no sooner than 63 days from the start of the previous treatment cycle (initial and continuation).

Clarified Vyvgart and Vyvgart Hytrulo timing criterion to specify no sooner than 50 days from the start of the previous treatment cycle and added continuation timing requirement.

Added HCPCS code C9305 to applicable codes list.

Updated clinical evidence and references to reflect current information.

3Drugs covered (medical benefit formulations)

2Indications with criteria (gMG, CIDP)

Maximum initial/renewal authorization months

Coverage summary

This Ohio-only UnitedHealthcare medical benefit drug policy (effective 2026-01-01, policy number CSOH2026D00111.E) covers FcRn blocking agents administered by a healthcare professional with a coverage stance of covered_with_criteria. The medical-benefit formulations included are: Vyvgart IV (efgartigimod alfa-fcab), Vyvgart Hytrulo SC vial (efgartigimod alfa + hyaluronidase-qvfc), and Rystiggo SC (rozanolixizumab-noli) (see covered products list).

Note: the Vyvgart Hytrulo prefilled syringe (self-administered SC product) is obtained under the pharmacy benefit and is excluded from this medical benefit drug policy.

Key thresholds and timing

MG-ADL at initiation≥ 5

MG-ADL improvement for continuation≥ 2-point improvement from pre-treatment baseline

Vyvgart / Vyvgart Hytrulo minimum intervalNo sooner than 50 days from the start of the previous treatment cycle

Rystiggo minimum intervalNo sooner than 63 days from the start of the previous treatment cycle

Maximum initial/renewal authorization months12

gMG — Initial therapy (Vyvgart / Vyvgart Hytrulo)

Myasthenia Gravis - Vyvgart and Vyvgart Hytrulo

Proven and medically necessary when ALL of the following are met:

Initial Therapy

Submission of medical records (e.g., chart notes, laboratory values, etc.) confirming criteria
Patient has not failed a previous course of Vyvgart therapy
Patient has not failed a previous course of Vyvgart Hytrulo therapy
Diagnosis of generalized myasthenia gravis (gMG)

gMG — Continuation therapy (Vyvgart / Vyvgart Hytrulo)

Continuation of Therapy

ALL of the following

Patient has previously been treated with Vyvgart or Vyvgart Hytrulo;
- ALL of the following
  - Improvement and/or maintenance of at least a 2-point improvement (reduction in score) in the MG-ADL score from pre-treatment baseline>= 2
  - Reduction in signs and symptoms of myasthenia gravis;

gMG — Initial therapy (Rystiggo)

Myasthenia Gravis - Rystiggo

Proven and medically necessary when ALL of the following are met:

Initial Therapy

Documentation: Submission of medical records (e.g., chart notes, laboratory values, etc.) confirming criteria
Prior treatment: Patient has not failed a previous course of Rystiggo therapy
Diagnosis of generalized myasthenia gravis (gMG)
ONE of the following serologies

gMG — Continuation therapy (Rystiggo)

Myasthenia Gravis - Rystiggo

Proven and medically necessary when ALL of the following are met:

Continuation of Therapy

Prior treatment: Patient has previously been treated with Rystiggo
Documentation: Submission of medical records (e.g., chart notes, laboratory tests) demonstrating all of the following
MG-ADL improvement: Improvement and/or maintenance of at least a 2 point improvement (reduction in score) in the MG-ADL score from pre-treatment baselineMG-ADL improvement ≥ 2 points

CIDP — Vyvgart Hytrulo (Initial & Continuation)

CIDP - Vyvgart Hytrulo

Medically necessary when ALL of the following are met:

Initial Therapy

Prior treatment: Patient has not failed a previous course of Vyvgart Hytrulo therapy
Diagnosis
- Duration: Progressive symptoms present for at least 2 months
- Pattern: Symptomatic polyradiculoneuropathy as indicated by progressive or relapsing motor or sensory impairment of more than one limb

Applicable codes

HCPCS/J-codes referenced (medical benefit injectable products)HCPCS

J9332	Injection, efgartigimod alfa-fcab, 2 mg
J9333	Injection, rozanolixizumab-noli, 1 mg
J9334	Injection, efgartigimod alfa, 2 mg and hyaluronidase-qvfc
C9305	Injection, nipocalimab-aahu, 3 mg

ICD-10 diagnosis codes referencedICD-10

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

Billing Rule

Use appropriate HCPCS/J-code; inclusion does not guarantee reimbursement

Report the applicable HCPCS/J-code for the administered product per administration (codes such as J9332, J9333, J9334, C9305). Inclusion of a code in this policy does not guarantee reimbursement; billing should follow code reporting per administration.

Provider actions and documentation

Prior Authorization

Prior authorization required for initial and continuation therapy (≤12 months)

Prior authorization is required for initial and continuation therapy. Submission of medical records confirming the required diagnostic, treatment history, and response is required. Initial authorizations and reauthorizations will be for no more than 12 months.

Documentation Required

Clinical documentation required (MGFA, MG-ADL baseline/changes, prior therapies, electrodiagnostics, neurologist involvement)

Required clinical documentation includes MGFA clinical classification, MG-ADL score at baseline and documented changes (including ≥2-point improvement for continuation), prior immunosuppressive therapy trials, prior IVIG/PLEX courses, electrodiagnostic evidence for CIDP per EFNS/PNS criteria, and that the prescription was made by or in consultation with a neurologist.

Clinical evidence highlights

67.7%Vyvgart MG-ADL responder rate (efgartigimod) vs placebo 67.7% vs 29.7% (p<0.0001)

63.1%Vyvgart QMG responder rate vs placebo 63.1% vs 14.1% (p<0.0001)

-3.4Rystiggo (rozanolixizumab) MG-ADL change at day 43: -3.4 vs -0.8 (p<0.001)

0.394Vyvgart Hytrulo CIDP time-to-deterioration HR 0.394 (95% CI 0.253–0.614; p<0.0001)

Clinical evidence and supporting information were updated in this revision (see Summary of Changes). Key trial endpoints referenced in the updated Clinical Evidence include: Vyvgart (efgartigimod alfa-fcab) MG-ADL responder rate advantage (67.7% vs 29.7%, p < 0.0001), Vyvgart QMG responder rate (63.1% vs 14.1%, p < 0.0001), Rystiggo (rozanolixizumab-noli) MG-ADL change at day 43 (-3.4 vs -0.8, p < 0.001), and Vyvgart Hytrulo CIDP hazard ratio for time to deterioration (HR 0.394, 95% CI: 0.253–0.614; p < 0.0001).

More detailed supporting information and full references are provided in the archived and updated Supporting Information and Clinical Evidence sections as noted in the changes entry.

Definitions

MG-ADL: The Myasthenia Gravis Activities of Daily Living scale is an 8-item instrument with a total score ranging from 0 to 24; higher scores indicate greater impairment. Clinically meaningful change is commonly considered a 2-point reduction for responder definitions used in trials.

MGFA: The Myasthenia Gravis Foundation of America Clinical Classification (MGFA) is used to describe clinical severity (classes II–IV are referenced in criteria for initiation of therapy).

CIDP EFNS/PNS: Electrodiagnostic criteria per the European Federation of Neurological Societies/Peripheral Nerve Society (EFNS/PNS) define demyelinating features (e.g., motor distal latency prolongation, reduced motor conduction velocity, prolonged F-wave latency, absent F-waves, conduction block, abnormal temporal dispersion, distal CMAP duration increase) required to support a diagnosis of definite CIDP.

Background: This policy covers FcRn blockers that reduce circulating IgG, specifically efgartigimod alfa-fcab (Vyvgart IV), efgartigimod alfa + hyaluronidase (Vyvgart Hytrulo SC vial), and rozanolixizumab-noli (Rystiggo SC).

As noted in the Coverage Rationale, the Vyvgart Hytrulo prefilled syringe is a self-administered subcutaneous product obtained under the pharmacy benefit and is not covered under this medical benefit policy.

Revision history

01/01/2026revisedLatest

Added timing criterion requiring Rystiggo be given no sooner than 63 days from the start of the previous treatment cycle (applies to both initial therapy and continuation of therapy for Rystiggo).

01/01/2026revisedLatest

Clarified Vyvgart and Vyvgart Hytrulo timing criterion to specify no sooner than 50 days from the start of the previous treatment cycle and added continuation timing requirement (replaced prior phrasing referencing '50 days after each treatment cycle').

01/01/2026

Policy Summary

PayerUnitedHealthcare

PolicyMedical Benefit Drug Policy

Policy CodePolicy CSOH2026D00111.E

Change TypeTiming criteria added; HCPCS code added; clinical evidence updated

Effective DateJan 1, 2026

Next Review Date

On This Page

Positive serologic test for anti-AChR antibodies

MGFA class: Patient has a Myasthenia Gravis Foundation of America (MGFA) Clinical Classification of class II, III, or IV at initiation of therapy

MGADL: Patient has a Myasthenia Gravis Activities of Daily Living scale (MGADL) total score ≥ 5 at initiation of therapyMGADL ≥ 5

ONE of the following

History of failure of at least two immunosuppressive agents over the course of at least 12 months (e.g., azathioprine, corticosteroids, cyclosporine, methotrexate, mycophenolate, etc.)
Patient has a history of failure of at least one immunosuppressive therapy and has required four or more courses of plasmapheresis/plasma exchanges and/or immune globulin over the course of at least 12 months without symptom control

Exclusions: Patient is not receiving Vyvgart or Vyvgart Hytrulo in combination with a complement inhibitor (e.g., eculizumab, ravulizumab/Ultomiris, zilucoplan/Zilbrysq)

Exclusions: Patient is not receiving Vyvgart or Vyvgart Hytrulo in combination with another FcRn blocker (e.g., Rystiggo/rozanolixizumab-noli)

Exclusions: Patient is not receiving Vyvgart or Vyvgart Hytrulo in combination with an immune globulin

Timing: Patient will be given Vyvgart or Vyvgart Hytrulo no sooner than 50 days from the start of the previous treatment cycleNo sooner than 50 days from start of previous treatment cycle

New/clarified timing criterion

Dosing: Vyvgart or Vyvgart Hytrulo is dosed according to the U.S. FDA labeled dosing for gMG

Prescriber: Prescribed by or in consultation with a neurologist

Authorization: Initial authorization will be for no more than 12 months≤ 12 months

Maintenance, reduction, or discontinuation of dose(s) of baseline immunosuppressive therapy (IST) prior to starting Vyvgart or Vyvgart Hytrulo (Note: Add-on therapy, dose escalation of baseline IST, or additional rescue therapy from baseline to treat myasthenia gravis or exacerbation of symptoms while on Vyvgart or Vyvgart Hytrulo therapy will be considered treatment failure.)

Patient is not receiving Vyvgart or Vyvgart Hytrulo in combination with a complement inhibitor (e.g., eculizumab or Ultomiris [ravulizumab], Zilbrysq [zilucoplan]);

Patient is not receiving Vyvgart or Vyvgart Hytrulo in combination with another FcRn blocker (e.g., Rystiggo [rozanolixizumab-noli]);

Patient is not receiving Vyvgart or Vyvgart Hytrulo in combination with an immune globulin;

Patient will be given Vyvgart or Vyvgart Hytrulo no sooner than 50 days from the start of the previous treatment cycle;

Operational timing: no sooner than 50 days from start of prior cycle.

Vyvgart or Vyvgart Hytrulo 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<= 12 months

Prior Authorization

Prior Authorization Required

Prior authorization required for initial and continuation therapy. Submit medical records (e.g., chart notes, laboratory values, MG-ADL scores) supporting the clinical criteria. Initial and reauthorization requests will be approved for no more than 12 months.

Submit chart notes, clinic progress notes, MG-ADL scores (pre- and on-treatment), and relevant laboratory values.
Initial and reauthorization approvals limited to a maximum of 12 months.

Denial Risk

Combination Therapy Exclusions — Potential Denial Risk

Claims may be denied if used in excluded combinations. Vyvgart or Vyvgart Hytrulo must not be used concurrently with complement inhibitors, other FcRn blockers, or immune globulin as specified in the criteria.

Combination with complement inhibitors (e.g., eculizumab, ravulizumab, zilucoplan) — not allowed.
Combination with other FcRn blockers (e.g., rozanolixizumab) — not allowed.
Combination with immune globulin (IVIG or SCIG) — not allowed.

Positive serologic test for anti-AChR antibodies

Positive serologic test for anti-MuSK antibodies

MGFA class: Patient has a Myasthenia Gravis Foundation of America (MGFA) Clinical Classification of class II, III, or IV at initiation of therapy

MGADL: Patient has a Myasthenia Gravis Activities of Daily Living scale (MGADL) total score ≥ 5 at initiation of therapyMGADL ≥ 5

ONE of the following based on serology

AChR positive: If anti-AChR antibody positive: History of failure of at least two immunosuppressive agents over the course of at least 12 months; or failure of at least one immunosuppressive therapy plus four or more courses of plasmapheresis/plasma exchanges and/or immune globulin over 12 months without symptom control
MuSK positive: If anti-MuSK antibody positive: History of failure of at least one immunosuppressive agent over the course of at least 12 months

Exclusions: Patient is not receiving Rystiggo in combination with a complement inhibitor (e.g., eculizumab, ravulizumab/Ultomiris, zilucoplan/Zilbrysq)

Exclusions: Patient is not receiving Rystiggo in combination with another FcRn blocker (e.g., Vyvgart, Vyvgart Hytrulo)

Exclusions: Patient is not receiving Rystiggo in combination with an immune globulin

Timing: Patient will be given Rystiggo no sooner than 63 days from the start of the previous treatment cycleNo sooner than 63 days from start of previous treatment cycle

New timing criterion added

Dosing: Rystiggo is dosed according to the US FDA labeled dosing for gMG

Prescriber: Prescribed by, or in consultation with, a neurologist

Authorization: Initial authorization will be for no more than 12 months≤ 12 months

Clinical response: Reduction in signs and symptoms of myasthenia gravis

Treatment failure note: Note: Add-on, dose escalation of IST, or additional rescue therapy from baseline while on therapy is considered treatment failure

Baseline IST: Maintenance, reduction, or discontinuation of dose(s) of baseline immunosuppressive therapy (IST) prior to starting Rystiggo

Exclusions: Patient is not receiving Rystiggo in combination with a complement inhibitor (e.g., eculizumab, ravulizumab/Ultomiris, zilucoplan/Zilbrysq)

Exclusions: Patient is not receiving Rystiggo in combination with another FcRn blocker (e.g., Vyvgart, Vyvgart Hytrulo)

Exclusions: Patient is not receiving Rystiggo in combination with an immune globulin

Timing: Patient is not being given Rystiggo sooner than 63 days from the start of the previous treatment cycleNo sooner than 63 days from start of previous treatment cycle

Continuation timing requirement

Dosing: Rystiggo is dosed according to the US FDA labeled dosing for gMG

Prescriber: Prescribed by, or in consultation with, a neurologist

Authorization: Reauthorization will be for no more than 12 months≤ 12 months

Prior Authorization

Continuation authorization requires documented response (MG-ADL ≥2) and is limited to ≤12 months

Continuation authorizations require submission of medical records showing clinical response, including improvement or maintenance of at least a 2-point improvement in the MG-ADL score from pre-treatment baseline. Reauthorization will be for no more than 12 months.

Electrodiagnostic findings (consistent with EFNS/PNS guidelines for definite CIDP) indicating the presence of at least one of the following: 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; abnormal temporal dispersion in at least 2 nerves; distal CMAP duration increase in at least 1 nerve

Corticosteroids: Trial and failure (after a trial of at least two months), contraindication, or intolerance to corticosteroids

ONE of the following for immune globulin

IVIG failure: Trial and failure (after a trial of at least three months) to an immune globulin (IVIG or SCIG)
Intolerance/dose escalation: Both: Intolerance to all immune globulins (IVIG or SCIG) AND dose has been adjusted or escalated to the maximally allowable and/or tolerated dose
Contraindication to all immune globulins (IVIG or SCIG)

Exclusions: Patient is not receiving Vyvgart Hytrulo in combination with an immune globulin

Dosing: Vyvgart Hytrulo is dosed according to the U.S. FDA labeled dosing for CIDP

Prescriber: Prescribed by, or in consultation with, a neurologist

Authorization: Initial authorization will be for no more than 12 months≤ 12 months

Continuation of Therapy

Prior treatment: Patient has previously been treated with Vyvgart Hytrulo
Response documentation: Documentation of positive clinical response to therapy as measured by an objective scale (e.g., Rankin, Modified Rankin, Medical Research Council (MRC) scale)
Exclusions: Patient is not receiving Vyvgart Hytrulo in combination with an immune globulin
Dosing: Vyvgart Hytrulo is dosed according to the US FDA labeled dosing for CIDP
Prescriber: Prescribed by, or in consultation with, a neurologist
Authorization: Reauthorization will be for no more than 12 months≤ 12 months

Documentation Required

CIDP documentation requirements (electrodiagnostics, prior IVIG/PLEX, objective response scales)

Required clinical documentation for CIDP includes: electrodiagnostic findings consistent with EFNS/PNS criteria for definite CIDP (e.g., motor distal latency prolongation in 2 nerves; reduction of motor conduction velocity in 2 nerves; prolongation or absence of F‑wave latency; partial motor conduction block; abnormal temporal dispersion; distal CMAP duration increase), history of prior IVIG or PLEX courses (including trials, failures, contraindications or intolerances), and objective measures of response on an objective scale (e.g., Rankin, Modified Rankin, Medical Research Council [MRC] scale).

Denial Risk

Denial risk for prohibited combination therapies

Claims may be denied if the therapy is used in prohibited combinations. The policy specifies exclusion of use in combination with complement inhibitors, other FcRn blockers, or immune globulin; use in such combinations may result in denial per the criteria.

Added HCPCS code C9305 to applicable codes list.

01/01/2026revisedLatest

Updated clinical evidence and references sections to reflect current information; previous policy version archived.