CurrentBlue Cross Blue Shield - North CarolinaPolicy N/A

Neonatal Fc Receptor (FcRn) Blockers “Notification” (PDF) Opens in a New Tab.

Defines medical necessity criteria, site-of-care rules, dosing/HCPCS codes, duration, and continuation requirements for FcRn blocker products (efgartigimod alfa-fcab, efgartigimod alfa and hyaluronidase-qvfc, nipocalimab-aahu, rozanolixizumab-noli) for generalized myasthenia gravis (gMG) and CIDP where applicable.

Policy Summary

PayerBlue Cross Blue Shield - North Carolina

PolicyNeonatal Fc Receptor (FcRn) Blockers “Notification” (PDF) Opens in a New Tab.

Policy CodePolicy N/A

Change TypeConsolidation and criteria additions/clarifications

Effective DateJan 1, 2026

Next Review DateDec 31, 2026

Key ActionProvider must submit medical record documentation of serologic test results, severity scores, prior therapy trials/intolerances, electrodiagnostic findings for CIDP, and site-of-care justification; prior authorization applies.

SourceLink

POLICY UPDATE CHANGES

Consolidated Vyvgart, Vyvgart Hytrulo, Imaavy, and Rystiggo policies into a single Neonatal Fc Receptor (FcRn) Blockers policy.

For Vyvgart and Vyvgart Hytrulo, added requirement to use self-administered Vyvgart Hytrulo unless certain criteria are met.

For Imaavy (patients ≥18 yrs), added requirement to trial Vyvgart/Vyvgart Hytrulo or Rystiggo plus trial of Ultomiris for anti-AChR antibody positive patients, OR trial of Rystiggo for anti-MuSK antibody positive patients.

Updated CIDP electrodiagnostic requirements to align with guidelines.

Added Site of Care medical necessity criteria outlining when inpatient or outpatient hospital administration is appropriate.

Restricted Products Covered

2Indications Covered (gMG, CIDP)

180Initial Approval Duration (days)

365Continuation Approval Duration (days)

Coverage Summary

This policy covers Neonatal Fc Receptor (FcRn) blocker products — Vyvgart (efgartigimod alfa-fcab), Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc), Imaavy (nipocalimab-aahu), and Rystiggo (rozanolixizumab-noli) — for their FDA-labeled indications: generalized myasthenia gravis (gMG) (product-specific age and serology requirements) and, where applicable, chronic inflammatory demyelinating polyneuropathy (CIDP) for Vyvgart Hytrulo. Coverage is restricted but allowed with criteria (covered_with_criteria), requiring documentation of diagnosis, product-specific serology and severity scoring, prior therapy trials or documented intolerance/contraindication, specialist involvement, and adherence to Site of Care rules and dosing/HCPCS limits.

Policy key facts

Effective date2026-01-01

Last review2025-11-01

Next review2026-12-31

Initial approval duration180 days (6 months)

Continuation approval duration365 days (1 year)

Restricted Products Covered4

Medical Necessity Criteria

Initial Criteria for Approval - gMG (generalized myasthenia gravis)

The restricted product(s) may be considered medically necessary when the following criteria are met:

ALL of the following

Age
- Patient is 18 years of age or older
- If request is for nipocalimab (Imaavy), patient is 12 years of age or older
Serology (product-specific)
- If request is for efgartigimod alfa (Vyvgart, Vyvgart Hytrulo): positive serological test for anti-acetylcholine receptor (AChR) antibodies [medical record documentation required]

Provider Actions & Site-of-Care Requirements

Prior Authorization

Prior authorization required with documentation

Prior authorization required. Provider must submit medical record documentation including: serologic test results (product-specific antibody testing per policy), Myasthenia Gravis Foundation of America (MGFA) clinical class, MG-ADL score or comparable standardized severity rating, documentation of prior therapy trials or documented intolerances/contraindications (conventional MG agents, IVIG/plasmapheresis when applicable), electrodiagnostic findings for CIDP when applicable (specified demyelination criteria), and documentation that self-administration of Vyvgart Hytrulo is not feasible when requesting a healthcare-administered formulation. Prior authorization applies to all restricted products listed below.

Serologic test results (anti‑AChR and/or anti‑MuSK per product-specific requirements)
MGFA clinical classification
MG-ADL total score or comparable validated MG severity score
Documentation of prior therapy trials, intolerances, or FDA‑labeled contraindications (conventional agents, IVIG, plasmapheresis as applicable)
Electrodiagnostic findings meeting CIDP demyelination criteria (motor distal latency, conduction velocity, F‑wave, conduction block, temporal dispersion, CMAP duration with nerve‑count thresholds)
Documentation that self-administration of Vyvgart Hytrulo is not feasible (physical/cognitive limitation and lack of caregiver/support)

Coding

Vyvgart (efgartigimod alfa-fcab) HCPCSHCPCSCovered

J9332

efgartigimod alfa-fcab, per label (IV infusion)

Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) HCPCSHCPCSCovered

J9334

efgartigimod alfa and hyaluronidase-qvfc, per label (SC injection)

Imaavy (nipocalimab-aahu) HCPCS / miscellaneousmixedCovered

C9305	nipocalimab-aahu, per label (IV infusion) - primary HCPCS listed
J3490	Unclassified biologics/meds - may be used per policy for nipocalimab
J3590	Unclassified biologics/meds - may be used per policy for nipocalimab

Rystiggo (rozanolixizumab-noli) HCPCSHCPCSCovered

J9333

rozanolixizumab-noli, per label (SC infusion)

Background & Evidence

The policy consolidates prior individual FcRn blocker policies into one Corporate Medical Policy effective January 1, 2026, with notification provided 11/1/2025. It references FDA-labeled indications for each product and incorporates product-specific age and antibody requirements. Specialist involvement (e.g., neurologist) is required for prescribing or consultation. Disease severity must be documented using MGFA class and MG-ADL or comparable standardized rating scales with product-specific MG-ADL thresholds. Serologic confirmation (anti-AChR and/or anti-MuSK as specified by product) is required. Prior therapy requirements mandate trials of conventional MG agents or documented intolerance/contraindication, and for CIDP updated electrodiagnostic demyelination criteria with nerve-count thresholds are required. Site-of-care rules justify inpatient or outpatient hospital administration only when Site of Care Medical Necessity Criteria (e.g., severe prior adverse event, increased risk conditions, inability to adhere, new-to-therapy or re-initiation scenarios, or formulation change) are met.

Evidence

Key referencesFDA package inserts; Vivacity-MG3; MycarinG; ADAPT; International consensus guidance; EAN/PNS CIDP guideline

New to therapy: defined as the initial injection or infusion OR less than 3 months since initial injection or infusion.

Re-initiation of therapy: defined as either the first injection/infusion after 6 months of no injections or infusions for drugs with approved dosing interval <6 months, OR the first injection/infusion after a gap of ≥1 month outside the approved dosing interval for drugs requiring every 6 months dosing.

Thresholds & Assessment Metrics

Clinical thresholds

Vyvgart / Vyvgart Hytrulo MG-ADL threshold>= 5

Imaavy MG-ADL threshold>= 6

Rystiggo MG-ADL threshold>= 3 with >=3 non-ocular points

CIDP electrodiagnostic requirementAt least ONE demyelination criterion among specified list (e.g., motor distal latency prolongation in >=2 motor nerves; reduction of motor conduction velocity in >=2 motor nerves; prolongation/absence of F-waves in >=2 motor nerves; partial motor conduction block in >=2 motor nerves; abnormal temporal dispersion in >=2 motor nerves; distal CMAP duration prolongation in >=1 motor nerve plus another criterion). See policy for full nerve-count thresholds.

For continuation of therapy in gMG, the patient must have demonstrated clinical benefit with the requested agent as documented in the medical record — for example, improved MG-ADL total score, improved quantitative myasthenia gravis total score, or an improved score on another comparable validated standardized rating scale.

Revision History

2025-11-01policy_notification

Policy notification issued on 11/1/2025 announcing forthcoming consolidated Neonatal Fc Receptor (FcRn) Blockers policy effective 1/1/2026 consolidating Vyvgart, Vyvgart Hytrulo, Imaavy, and Rystiggo policies.

2026-01-01policy_effectiveLatest

Corporate medical policy effective 1/1/2026: consolidated FcRn Blockers policy issued establishing coverage criteria, HCPCS/Coding, durations, and requirements for Vyvgart, Vyvgart Hytrulo, Imaavy, and Rystiggo.

2025-11-01administration_requirement_added

Policy Summary

PayerBlue Cross Blue Shield - North Carolina

PolicyNeonatal Fc Receptor (FcRn) Blockers “Notification” (PDF) Opens in a New Tab.

Policy CodePolicy N/A

Change TypeConsolidation and criteria additions/clarifications

Effective DateJan 1, 2026

Next Review DateDec 31, 2026

SourceLink

On This Page

If request is for nipocalimab (Imaavy) or rozanolixizumab (Rystiggo): positive serological test for anti-AChR antibodies OR anti-muscle-specific tyrosine kinase (MuSK) antibodies [medical record documentation required]

MGFA / Severity: Patient has a Myasthenia Gravis Foundation of America (MGFA) clinical classification class of II to IVb, or comparable standardized rating scale

MG-ADL or comparable severity score (product-specific)

If request is for efgartigimod alfa (Vyvgart, Vyvgart Hytrulo): MG-ADL total score of 5 or higher>= 5
If request is for nipocalimab (Imaavy): MG-ADL total score of 6 or higher>= 6
If request is for rozanolixizumab (Rystiggo): MG-ADL total score of 3 or higher AND at least 3 points are from non-ocular symptomsMG-ADL >= 3 with >=3 non-ocular points

Medications exacerbating MG

Prescriber has assessed current medications and discontinued any medications known to exacerbate myasthenia gravis (e.g., beta blockers, procainamide, quinidine, magnesium, anti-PD-1 monoclonal antibodies, hydroxychloroquine, aminoglycosides)
Prescriber has provided clinical rationale indicating that discontinuation of the offending agent is not clinically appropriate [medical record documentation required]

Prior/concomitant therapy for gMG

Tried and had an inadequate response to at least ONE conventional agent used for MG (corticosteroids, azathioprine, cyclosporine, mycophenolate mofetil, tacrolimus, methotrexate, cyclophosphamide) [medical record documentation required]
Intolerance or hypersensitivity to ONE conventional agent used for MG [medical record documentation required]
FDA labeled contraindication to ALL conventional agents used for MG [medical record documentation required]
Required chronic IVIG (at least every 3 months over 12 months without symptom control) [medical record documentation required]
Required chronic plasmapheresis/plasma exchange (at least every 3 months over 12 months without symptom control) [medical record documentation required]

Product sequencing and restrictions (product-specific)

If request is for efgartigimod alfa (Vyvgart, Vyvgart Hytrulo) or rozanolixizumab (Rystiggo): allowed
If request is for nipocalimab (Imaavy) AND patient is ≥ 18 years
- Anti-AChR pathway
  - Trial or intolerance to efgartigimod/rozanolixizumab
    Patient has tried and had an inadequate response to ONE of: efgartigimod alfa (Vyvgart, Vyvgart Hytrulo) OR rozanolixizumab (Rystiggo) [medical record documentation required]
    Patient has intolerance, FDA labeled contraindication, or hypersensitivity to both efgartigimod alfa AND rozanolixizumab [medical record documentation required]
  - Trial or intolerance to Ultomiris
    Patient has tried and had an inadequate response to ravulizumab (Ultomiris) [medical record documentation required]
    Patient has an intolerance, FDA labeled contraindication, or hypersensitivity to ravulizumab (Ultomiris) [medical record documentation required]
- Anti-MuSK pathway
  - Patient has tried and had an inadequate response to rozanolixizumab (Rystiggo) [medical record documentation required]
  - Patient has an intolerance, FDA labeled contraindication, or hypersensitivity to rozanolixizumab (Rystiggo) [medical record documentation required]

General safeguards

Patient will NOT be using the requested agent in combination with other immunotherapy or complement inhibitors used to treat the requested indication (examples listed: eculizumab products, efgartigimod alfa, immunoglobulins, nipocalimab, ravulizumab, rozanolixizumab, zilucoplan)
Prescriber is a specialist in the area of the patient's diagnosis (e.g., neurologist) or has consulted with a specialist
Requested quantity does NOT exceed the maximum units allowed for the duration of approval (see HCPCS/dosing table)
For injection/infusion in inpatient/outpatient hospital setting, Site of Care Criteria applies (see Site of Care Medical Necessity Criteria)

Initial Criteria for Approval - CIDP (chronic inflammatory demyelinating polyneuropathy)

Specific to efgartigimod alfa and hyaluronidase-qvfc (Vyvgart Hytrulo)

ALL of the following

Diagnosis of CIDP
Product: Request is for efgartigimod alfa and hyaluronidase-qvfc (Vyvgart Hytrulo)
Age: Patient is 18 years of age or older
Duration of symptoms: Progressive or relapsing and remitting symptoms present for at least 2 months>= 2 months
Distribution: Progressive or relapsing motor sensory impairment of more than one limb
Electrodiagnostic criteria: Electrodiagnostic findings indicating demyelination with at least ONE of the following [medical record documentation required]: motor distal latency prolongation in ≥2 motor nerves; OR reduction of motor conduction velocity in ≥2 motor nerves; OR prolongation of F-wave latency in ≥2 motor nerves; OR absence of F-waves in ≥2 motor nerves plus at least one other demyelination criterion in ≥1 other nerve; OR partial motor conduction block in ≥2 motor nerves (or in 1 nerve plus at least one other demyelination criterion in ≥1 other nerve); OR abnormal temporal dispersion in ≥2 motor nerves; OR distal CMAP duration prolongation in ≥1 motor nerve plus at least one other demyelination criterion in ≥1 other nerveAt least one listed demyelination criterion with nerve-count thresholds
Prior therapy for CIDP
- Tried and had an inadequate response to immunoglobulin (IV or SC) OR plasma exchange therapy for at least 3 months [medical record documentation required]>= 3 months
- Intolerance or hypersensitivity to immunoglobulin OR plasma exchange therapy [medical record documentation required]
- FDA labeled contraindication to immunoglobulin AND plasma exchange therapy [medical record documentation required]
Specialist: Prescriber is a specialist in the area of the patient's diagnosis or has consulted with a specialist
Quantity limits: Requested quantity does NOT exceed the maximum units allowed for the duration of approval (see HCPCS/dosing table)
Site of Care: For injection/infusion in inpatient/outpatient hospital setting, Site of Care Criteria applies (see Site of Care Medical Necessity Criteria)

Special criteria for administration of IV/SC formulations (physical/cognitive limitation)

Applies when request is for IV/healthcare-administered product in place of self-administered Vyvgart Hytrulo

ALL of the following

Applicability: If request is for efgartigimod alfa-fcab (Vyvgart) or efgartigimod alfa and hyaluronidase-qvfc (Vyvgart Hytrulo), patient has a physical or cognitive limitation making self-administered Vyvgart Hytrulo unsafe or not feasible
Inability to self-administer the medication [medical record documentation required]
Lack of support: Lack of caregiver or support system for assistance with administration of self-administered products [medical record documentation required]

Continuation Criteria for Approval

Requirements for ongoing coverage after initial approval

ALL of the following

gMG continuation-specific
- Eligibility path
  - Patient was approved through Blue Cross NC initial criteria for approval
  - Patient would have met initial criteria for approval at the time they started therapy
- Clinical benefit for gMG: For gMG: patient has demonstrated clinical benefit with the requested agent (e.g., improved MG-ADL, improved quantitative myasthenia gravis total score, or comparable standardized rating scale) [medical record documentation required]
- Imaavy sequencing for continuation: If request is for nipocalimab (Imaavy) and patient is ≥18 yrs: sequencing requirements apply including trial of efgartigimod alfa OR rozanolixizumab or intolerance to both, AND trial or intolerance to ravulizumab (Ultomiris), OR for anti-MuSK pathway trial/intolerance to rozanolixizumab
CIDP continuation
- CIDP clinical benefit: For CIDP: request is for efgartigimod alfa and hyaluronidase-qvfc (Vyvgart Hytrulo) AND patient has demonstrated clinical benefit (e.g., improved or stabilized upper and/or lower limb function, improved symptoms) [medical record documentation required]
General continuation requirements
- Combination therapy prohibition: Patient will NOT be using the requested agent in combination with other immunotherapy or complement inhibitors used to treat the requested indication
- Physical/cognitive limitation for Vyvgart formulations: If the request is for Vyvgart or Vyvgart Hytrulo, patient meets the physical/cognitive limitation criteria for healthcare-administered formulation if applicable (see special criteria)
- Specialist involvement: Prescriber is a specialist in the area of the patient's diagnosis or has consulted with a specialist
- Quantity limits: Requested quantity does NOT exceed the maximum units allowed for the duration of approval (see HCPCS/dosing table)

Site of Care Medical Necessity Criteria

Conditions under which administration in inpatient or outpatient hospital setting is allowed

ANY of the following

Inpatient administration: Injection or infusion may be given in inpatient setting if above medical necessity criteria are met AND inpatient admission is NOT for the sole purpose of administering the injection or infusion
Outpatient hospital administration
- Severe adverse event history: History of a severe adverse event following the injection/infusion of the requested medication (e.g., anaphylaxis, seizure, thromboembolism, MI, renal failure)
- Increased risk conditions: Conditions that increase risk for severe adverse event (e.g., unstable renal function, cardiopulmonary conditions, unstable vascular access)
- Mild adverse events not managed: History of mild adverse events not successfully managed through mild pre-medication (e.g., diphenhydramine, acetaminophen, steroids, fluids)
- Adherence inability: Inability to physically and cognitively adhere to treatment schedule and regimen complexity
- New to therapy (initial injection/infusion OR <3 months since initial injection/infusion)
- Re-initiation of therapy
  - Re-initiation rule 1: First injection/infusion after 6 months of no injections/infusions for drugs with approved dosing interval <6 months
  - Re-initiation rule 2: First injection/infusion after ≥1-month gap in therapy outside of approved dosing interval for drugs requiring every 6 months dosing
- Formulation change: Requirement of a change in the requested restricted product formulation
Fallback to home/office: If Site of Care criteria are not met, injection/infusion will be administered in home-based infusion or physician office setting with or without supervision by a certified healthcare professional

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refined_at

Documentation Required

Document clinical benefit for continuation

For continuation approvals, providers must document that the patient has demonstrated clinical benefit with the requested agent using validated MG or CIDP scales (for gMG examples include improved or stabilized MG-ADL total score, quantitative myasthenia gravis total score, or another comparable standardized rating scale; for CIDP examples include improved or stabilized upper/lower limb function or symptoms). Continued specialist involvement (prescriber is a specialist or has consulted a specialist) must also be documented.

Documented improvement or stabilization on validated MG/CIDP scales (e.g., MG-ADL, QMG, limb function measures)
Ongoing care by specialist or documented specialist consultation

Billing Rule

Quantity limits and maximum units

Quantity limits apply. Providers must ensure the requested quantity does not exceed the maximum units allowed for the duration of approval. Refer to the policy HCPCS/dosing table for Initial and Continuation maximum units by product when submitting requests.

Vyvgart (J9332) — Maximum Units: Initial and Continuation listed in policy dosing table
Vyvgart Hytrulo (J9334) — Maximum Units: Initial and Continuation listed (gMG and CIDP values specified in policy)
Imaavy (C9305, J3490, J3590) — Maximum Units: Initial and Continuation listed in policy dosing table
Rystiggo (J9333) — Maximum Units: Initial and Continuation listed in policy dosing table

Documentation Required

Site of care justification for hospital administration

When requesting inpatient or outpatient hospital administration, providers must document that one of the Site of Care criteria is met. Acceptable justifications include: inpatient admission not solely for administration; history of a severe adverse event to the medication; conditions increasing risk for severe adverse events; history of mild adverse events not controlled with pre‑medication; inability to physically or cognitively adhere to the regimen; new to therapy or re‑initiation criteria per policy; or requirement to change formulation. If Site of Care criteria are not met, administration should occur in home infusion or physician office settings.

Inpatient admission not solely for administering the drug
History of severe adverse event (e.g., anaphylaxis, seizure, thromboembolism, MI, renal failure)
Conditions increasing risk for severe adverse events (e.g., unstable renal function, cardiopulmonary disease, unstable vascular access)
History of mild adverse events not managed with pre‑medication
Inability to adhere physically or cognitively to treatment schedule
New to therapy or re‑initiation as defined in policy
Need to change the restricted product formulation

Added requirement that Vyvgart Hytrulo be used as the self-administered formulation unless patient demonstrates inability to self-administer and lack of caregiver/support; healthcare-administered Vyvgart/Vyvgart Hytrulo allowed only when both inability to self-administer and lack of caregiver/support are documented.

2025-11-01sequencing_requirement_addedLatest

For Imaavy (nipocalimab) in patients ≥18 years, added sequencing requirements: anti-AChR positive patients must trial Vyvgart/Vyvgart Hytrulo or Rystiggo plus trial of ravulizumab (Ultomiris) (or document intolerance/contraindication), and anti-MuSK positive patients must trial Rystiggo (or document intolerance/contraindication).

2025-11-01electrodiagnostic_clarificationLatest

CIDP electrodiagnostic criteria clarified/updated to enumerate demyelination findings (motor distal latency prolongation, reduction of motor conduction velocity, F-wave prolongation or absence, partial motor conduction block, temporal dispersion, distal CMAP duration prolongation) with specified nerve-count thresholds.

2025-11-01site_of_care_criteria_addedLatest

Added Site-of-Care medical necessity criteria defining when inpatient or outpatient hospital administration is appropriate (e.g., severe adverse event history, increased risk conditions, inability to adhere, new-to-therapy or re-initiation definitions, or formulation change); otherwise administration to occur in home or physician office.

Site of Care: For injection/infusion in inpatient/outpatient hospital setting, Site of Care Criteria applies