FcRn Blockers (for Ohio Only)
This Ohio-only UnitedHealthcare medical benefit drug policy governs coverage and authorization criteria for FcRn blocker therapies (Imaavy, Rystiggo, Vyvgart, Vyvgart Hytrulo) administered by a healthcare professional, and affects providers requesting medical benefit coverage for these agents for Ohio members.
Added Imaavy (nipocalimab-aahu) for intravenous (IV) route to the list of drug products administered by a healthcare professional.
Replaced Rystiggo IV route entry with Rystiggo for subcutaneous (SC) route in the list of applicable products.
Imaavy (nipocalimab-aahu) added as proven and medically necessary for CIDP and/or gMG under specified criteria (detailed initial and continuation criteria for gMG included).
Revised lists of drug products that must not be given in combination with Vyvgart, Vyvgart Hytrulo, or Rystiggo to add CD19-directed cytolytic antibody (e.g., Uplizna) and to include Imaavy in FcRn blocker lists.
Replaced HCPCS code C9305 with J9256 in Applicable Codes.
Coverage and Medical Necessity Criteria
Imaavy — Initial Therapy
Covered when ALL of the following are met
Imaavy initial
- Patient has not failed a previous course of Imaavy therapy.
- Diagnosis of generalized myasthenia gravis (gMG).
- Serology: Positive serologic test for anti-AChR antibodies OR positive serologic test for anti-MuSK antibodies.
- MGFA Clinical Classification II, III, or IV at initiation of therapy.
- MG-ADL total score >= 5 at initiation of therapy.
Prior treatment (AChR vs MuSK)
- If anti-AChR antibody positive: History of failure of at least two immunosuppressive agents over >=12 months OR history of failure of at least one immunosuppressive therapy plus four or more courses of plasmapheresis/plasma exchange and/or immune globulin over >=12 months without symptom control.
- If anti-MuSK antibody positive: History of failure of at least one immunosuppressive agent over >=12 months.
- Patient is not receiving Imaavy in combination with any of the following: a CD19-directed cytolytic antibody (e.g., Uplizna/inebilizumab); a complement inhibitor (e.g., eculizumab, ravulizumab, zilucoplan); an FcRn blocker (e.g., Rystiggo, Vyvgart, Vyvgart Hytrulo); or immune globulin (e.g., Hizentra, Privigen, Gammagard).
- Imaavy is dosed according to 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.
Imaavy continuation
- Improvement and/or maintenance of at least a 2-point improvement (reduction) in the MG-ADL score from pre-treatment baseline.
- Reduction in signs and symptoms of myasthenia gravis.
- Maintenance, reduction, or discontinuation of baseline immunosuppressive therapy (Note: add-on, dose escalation of IST, or additional rescue therapy from baseline while on Imaavy is considered treatment failure).
- Patient is not receiving Imaavy in combination with a CD19-directed cytolytic antibody, a complement inhibitor, another FcRn blocker, or immune globulin.
- Imaavy is dosed according to U.S. FDA labeled dosing for gMG.
- Prescribed by, or in consultation with, a neurologist.
- Reauthorization will be for no more than 12 months.
Imaavy — Continuation Therapy
Covered when ALL of the following are met
Imaavy continuation
- Improvement and/or maintenance of at least a 2-point improvement (reduction) in the MG-ADL score from pre-treatment baseline.
- Reduction in signs and symptoms of myasthenia gravis.
- Maintenance, reduction, or discontinuation of dose(s) of baseline immunosuppressive therapy prior to starting Imaavy (Note: add-on, dose escalation of IST, or additional rescue therapy from baseline while on Imaavy therapy will be considered treatment failure).
- Patient is not receiving Imaavy in combination with any of the following: a CD19-directed cytolytic antibody (e.g., Uplizna/inebilizumab); a complement inhibitor (e.g., eculizumab, ravulizumab, zilucoplan); an FcRn blocker (e.g., Rystiggo, Vyvgart, Vyvgart Hytrulo); or immune globulin (e.g., Hizentra, Privigen, Gammagard).
- Imaavy is dosed according to U.S. FDA labeled dosing for gMG.
- Prescribed by, or in consultation with, a neurologist.
- Reauthorization will be for no more than 12 months.
Vyvgart / Vyvgart Hytrulo — Initial Therapy
Covered when ALL of the following are met
Vyvgart / Vyvgart Hytrulo initial
- Patient has not failed a previous course of Vyvgart or Vyvgart Hytrulo therapy.
- Diagnosis of generalized myasthenia gravis (gMG).
- Positive serologic test for anti-AChR antibodies.
- MGFA Clinical Classification II, III, or IV at initiation of therapy.
- MG-ADL total score >= 5 at initiation of therapy.
- Prior treatment requirement: History of failure of at least two immunosuppressive agents over >=12 months OR history of failure of at least one immunosuppressive therapy plus four or more courses of plasmapheresis/plasma exchange and/or immune globulin over >=12 months without symptom control.
- Patient is not receiving Vyvgart or Vyvgart Hytrulo in combination with a CD19-directed cytolytic antibody, a complement inhibitor, another FcRn blocker, or immune globulin.
- Vyvgart or Vyvgart Hytrulo is dosed according to 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.
Vyvgart / Vyvgart Hytrulo — Continuation Therapy
Covered when ALL of the following are met
Vyvgart / Vyvgart Hytrulo continuation
- Improvement and/or maintenance of at least a 2-point improvement (reduction) in the MG-ADL score from pre-treatment baseline.
- Reduction in signs and symptoms of myasthenia gravis.
- Maintenance, reduction, or discontinuation of dose(s) of baseline immunosuppressive therapy prior to starting Vyvgart or Vyvgart Hytrulo (Note: add-on, dose escalation of IST, or additional rescue therapy from baseline while on therapy will be considered treatment failure).
- Patient is not receiving Vyvgart or Vyvgart Hytrulo in combination with a CD19-directed cytolytic antibody, a complement inhibitor, another FcRn blocker, or immune globulin.
- Vyvgart or Vyvgart Hytrulo is dosed according to U.S. FDA labeled dosing for gMG.
- Prescribed by or in consultation with a neurologist.
- Reauthorization will be for no more than 12 months.
Rystiggo — Initial Therapy
Covered when ALL of the following are met
Rystiggo initial
- Patient has not failed a previous course of Rystiggo therapy.
- Diagnosis of generalized myasthenia gravis (gMG).
- Serology: Positive serologic test for anti-AChR antibodies OR positive serologic test for anti-MuSK antibodies.
- MGFA Clinical Classification II, III, or IV at initiation of therapy.
- MG-ADL total score >= 5 at initiation of therapy.
- If AChR-positive prior treatment: History of failure of at least two immunosuppressive agents over >=12 months OR history of failure of at least one immunosuppressive therapy plus four or more courses of plasmapheresis/plasma exchange and/or immune globulin over >=12 months without symptom control.
- Patient is not receiving Rystiggo in combination with a CD19-directed cytolytic antibody, a complement inhibitor, another FcRn blocker, or immune globulin.
- Patient will be given Rystiggo no sooner than 63 days from the start of the previous treatment cycle.
- Rystiggo is dosed according to 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.
Rystiggo — Continuation Therapy
Covered when ALL of the following are met
Rystiggo continuation
- Improvement and/or maintenance of at least a 2-point improvement (reduction) in the MG-ADL score from pre-treatment baseline.
- Reduction in signs and symptoms of myasthenia gravis.
- Maintenance, reduction, or discontinuation of dose(s) of baseline immunosuppressive therapy prior to starting Rystiggo (Note: add-on, dose escalation of IST, or additional rescue therapy from baseline while on Rystiggo therapy will be considered treatment failure).
- Patient is not receiving Rystiggo in combination with a CD19-directed cytolytic antibody, a complement inhibitor, another FcRn blocker, or immune globulin.
- Patient is not being given Rystiggo sooner than 63 days from the start of the previous treatment cycle.
- Rystiggo is dosed according to U.S. FDA labeled dosing for gMG.
- Prescribed by, or in consultation with, a neurologist.
- Reauthorization will be for no more than 12 months.
Vyvgart Hytrulo — CIDP (partial)
Covered when ALL of the following are met
Rystiggo — Continuation Therapy
Covered when ALL of the following are met for continuation of Rystiggo:
Vyvgart Hytrulo — Continuation Therapy (CIDP)
Covered when ALL of the following are met for continuation of Vyvgart Hytrulo:
CIDP: Typical
Clinical diagnostic criteria for CIDP
Per 2021 EAN/PNS guidance as cited in policy.
CIDP: Variants
CIDP variants (any one of the following qualifies as a variant, otherwise same as typical CIDP):
Tendon reflexes may be normal in unaffected limbs.
Electrodiagnostic: Strongly and Weakly Supportive Criteria
Electrodiagnostic criteria supportive of demyelination
Any nerve meeting any criteria (a-g) counts.
Imaavy Initial Therapy (gMG)
Imaavy (nipocalimab) is considered proven and medically necessary for generalized myasthenia gravis when ALL of the following are met:
Concomitant agents explicitly prohibited list provided.
Imaavy Continuation
Continuation (reauthorization) criteria for Imaavy
Rescue therapy or worsening while on Imaavy considered failure.
Concomitant use of other immune-targeted agents is prohibited with FcRn blocker therapies listed in this policy. Specifically, patients must not receive a CD19-directed cytolytic antibody (e.g., Uplizna/inebilizumab), a complement inhibitor (e.g., eculizumab, ravulizumab, zilucoplan), another FcRn blocker (examples include Rystiggo/rozanolixizumab-noli, Vyvgart/efgartigimod alfa-fcab, Vyvgart Hytrulo/efgartigimod alfa and hyaluronidase-qvfc, or Imaavy/nipocalimab-aahu), or an immune globulin product (e.g., Hizentra, Privigen, Gammagard) concurrently when the policy specifies such a restriction.
The policy explicitly prohibits use of the FcRn blockers in combination with listed agents when specified by the individual drug criteria. Prohibited combinations include a CD19-directed cytolytic antibody (e.g., Uplizna/inebilizumab), a complement inhibitor (e.g., eculizumab, ravulizumab, zilucoplan), another FcRn blocker (examples across the policy include Imaavy, Rystiggo, Vyvgart, Vyvgart Hytrulo), and immune globulin products (e.g., Hizentra, Privigen, Gammagard). These combination prohibitions appear in the initial and continuation sections for Imaavy, Vyvgart/Vyvgart Hytrulo, and Rystiggo and must be documented as absent for approval.
The policy repeatedly names specific classes that cannot be given concurrently with FcRn blockers: CD19-directed cytolytic antibodies (for example, Uplizna/inebilizumab), complement inhibitors (for example, eculizumab, ravulizumab, zilucoplan), and other FcRn blockers (including Imaavy, Rystiggo, Vyvgart, Vyvgart Hytrulo). Concurrent administration of these agents is treated as noncompliance with the coverage criteria and will preclude meeting the drug-specific initial or continuation requirements.
For continuation (reauthorization) of FcRn blockers, the policy requires objective evidence of clinical benefit. Continuation of therapy is considered not medically necessary if medical records do not demonstrate at least a 2-point improvement in the MG-ADL total score from the pre-treatment baseline, if there is clinical worsening that requires add-on or escalation of baseline immunosuppressive therapy, or if additional rescue therapies are needed compared to baseline. The policy further notes that add-on or increased dosing of baseline IST or rescue treatment while on therapy is considered treatment failure.
Rystiggo (rozanolixizumab-noli) has a specified minimum interval requirement: a patient must not receive Rystiggo sooner than 63 days from the start of the previous treatment cycle. Administration of Rystiggo earlier than this interval or use in prohibited combinations (see prohibited agents) will not meet continuation criteria and is considered noncompliant with the policy.
Summary of Imaavy-specific combination and continuation restrictions: Imaavy (nipocalimab-aahu) must not be given concurrently with a CD19-directed cytolytic antibody (e.g., Uplizna/inebilizumab), a complement inhibitor (e.g., eculizumab, ravulizumab, zilucoplan), another FcRn blocker (e.g., Rystiggo, Vyvgart, Vyvgart Hytrulo), or an immune globulin product (e.g., Hizentra, Privigen, Gammagard). For continuation, documentation must show a ≥ 2-point improvement in MG-ADL, reduction in signs/symptoms, and no requirement for escalation/additional rescue therapy; receiving Imaavy in prohibited combinations or failing to meet the continuation response criteria will be considered treatment failure and not medically necessary.
Covered HCPCS codes listed in the policy for reference are: J9256 (Injection, nipocalimab-aahu, 3 mg), J9332 (Injection, efgartigimod alfa-fcab, 2 mg), J9333 (Injection, rozanolixizumab-noli, 1 mg), and J9334 (Injection, efgartigimod alfa, 2 mg and hyaluronidase-qvfc).
Diagnosis codes referenced in the policy include: G61.81 (Chronic inflammatory demyelinating polyneuritis), G70.00 (Myasthenia gravis without acute exacerbation), and G70.01 (Myasthenia gravis with acute exacerbation).
Billing and Diagnosis Codes
| G61.81 | Chronic inflammatory demyelinating polyneuritis. |
| G70.00 | Myasthenia gravis without (acute) exacerbation. |
| G70.01 | Myasthenia gravis with (acute) exacerbation. |
| J9256 | Specified Applicable Codes replacement for prior C9305 |
Prior Authorization, Documentation, and Step Therapy
Prior authorization — submit medical records and clinical status
Prior authorization is required for initiation of FcRn blocker therapy; submit medical records confirming diagnosis of generalized myasthenia gravis or CIDP, antibody/serologic status, MGFA class II–IV (for gMG), MG-ADL total score ≥5 at initiation (for gMG), prior immunosuppressive therapy history as specified per agent, and that the drug is prescribed by or in consultation with a neurologist. Initial approvals are limited to no more than 12 months.
- Include chart notes, laboratory values, serologic test results (anti-AChR or anti-MuSK) when applicable.
- Document prior therapy trials/failures or contraindications per agent-specific criteria.
- Indicate neurologist prescribing or consultation.
Prior authorization — document prior therapy trials or contraindications
Prior authorization requests must include evidence of diagnosis and prior therapy trials, failures, or documented contraindications (e.g., corticosteroids, IVIG/SCIG, or immunosuppressants) as specified for the requested agent; authorizations (initial and reauthorization) are limited to no more than 12 months.
- For CIDP, show trial and failure (or contraindication/intolerance) to corticosteroids and to immune globulin unless alternative criteria apply.
- For gMG agents, document prior immunosuppressive agent failures or specified plasmapheresis/IVIG courses per agent criteria.
Imaavy prior authorization — required documentation and criteria
For Imaavy (nipocalimab), prior authorization requires submission of medical records confirming diagnosis of gMG, positive anti-AChR or anti-MuSK serology, MGFA clinical class II–IV at initiation, MG-ADL total score ≥5 at initiation, prior therapy history per the agent-specific step therapy rules, exclusion of prohibited concomitant agents, neurologist prescribing/consultation, and dosing per FDA labeling; initial and reauthorization approvals are limited to ≤12 months.
- If AChR-positive: document failure of ≥2 immunosuppressive agents over ≥12 months OR failure of ≥1 immunosuppressive therapy plus ≥4 courses of plasmapheresis/IVIG over ≥12 months.
- If MuSK-positive: document failure of ≥1 immunosuppressive agent over ≥12 months.
- Document patient is not receiving prohibited concomitant therapies (CD19-directed cytolytic antibody, complement inhibitor, another FcRn blocker, or immune globulin).
Step therapy — Vyvgart / Vyvgart Hytrulo prior treatment requirements
Vyvgart and Vyvgart Hytrulo require step-therapy documentation: history of failure of at least two immunosuppressive agents over the course of at least 12 months, or the alternative pathway of failure of one immunosuppressive therapy plus multiple courses of plasmapheresis/IVIG as specified in the policy.
- Document specific immunosuppressive agents tried and durations (total ≥12 months).
- If using the alternative pathway, document ≥4 courses of plasmapheresis/plasma exchange and/or immune globulin over ≥12 months without symptom control.
Required prior therapy — Vyvgart Hytrulo for CIDP
For Vyvgart Hytrulo use in CIDP, prior authorization must document trial and failure (or contraindication/intolerance) to corticosteroids and trial and failure to immune globulin (IVIG/SCIG) after the specified durations, or both the alternative conditions (failure of an immunosuppressive agent over ≥12 months or contraindication to immune globulins).
- Show trial and failure after at least 2 months for corticosteroids.
- Show trial and failure after at least 3 months for immune globulin, or document contraindication to all immune globulins.
- Indicate patient is not receiving Vyvgart Hytrulo in combination with immune globulin.
Step therapy — Imaavy prior treatment requirements for AChR-positive gMG
Before initiating Imaavy for AChR-positive gMG, document failure of at least two immunosuppressive agents over at least 12 months, or alternatively failure of one immunosuppressive agent plus four or more courses of plasmapheresis/IVIG over 12 months, per the policy's step therapy requirements.
- Provide dates, agents, doses, and reasons for discontinuation or failure.
- If using plasmapheresis/IVIG pathway, list dates and number of courses (≥4 over ≥12 months).
Documentation — medical records, scores, and prior therapy history required
Submit complete medical records for initial and continuation requests, including chart notes, laboratory values, serologic test results, baseline and on-treatment MG-ADL scores, documented prior therapies and durations, and objective measures of response (e.g., MRC, Rankin) for CIDP continuation.
- For gMG: include MG-ADL baseline score (≥5 at initiation) and subsequent MG-ADL scores to document ≥2-point improvement for continuation.
- For CIDP: include electrodiagnostic findings and objective clinical scale scores for continuation.
Denial risk — missing initiation criteria documentation
Denial risk exists if required initiation documentation is missing: absent serologic testing (anti-AChR or anti-MuSK), missing MGFA class II–IV, MG-ADL <5 at initiation (for gMG), or lack of documented prior therapy failures per agent-specific step therapy rules.
- Ensure serology results and MGFA classification are clearly documented in chart notes.
- Document prior immunosuppressive therapy trials with durations and outcomes to avoid denial.
Combination therapy and timing restrictions — prohibited combinations and intervals
Use in combination with prohibited agents (CD19-directed cytolytic antibodies, complement inhibitors, other FcRn blockers including Imaavy, or immune globulin) or administering agents outside timing restrictions (e.g., Rystiggo given sooner than 63 days from prior cycle) may result in denial of authorization.
- Do not administer Rystiggo sooner than 63 days from the start of the previous treatment cycle.
- Do not give Vyvgart, Vyvgart Hytrulo, or Imaavy concurrently with listed prohibited agents.
Continuation denial triggers — insufficient response or treatment failure
Continuation/reauthorization may be denied if records do not show at least a 2-point improvement in MG-ADL from pre-treatment baseline, if there is clinical worsening or need for added rescue therapy or escalation of baseline immunosuppressive therapy while on treatment, or if the patient is receiving the agent in prohibited combinations.
- For Imaavy and other FcRn blockers, document reduction in signs/symptoms and maintenance/reduction/discontinuation of baseline IST; add-on or escalation is treatment failure.
- For Rystiggo, absence of ≥2-point MG-ADL improvement or administration sooner than 63 days are continuation denial triggers.
Key Definitions and Clinical Scales
Background and Clinical Evidence
FcRn blockers are therapies that reduce circulating pathogenic IgG by targeting the neonatal Fc receptor. In this policy, FcRn blockers (including efgartigimod formulations, rozanolixizumab, and nipocalimab/Imaavy) are addressed for treatment of generalized myasthenia gravis (gMG) with specified serologic and severity requirements, and Vyvgart Hytrulo is also addressed for chronic inflammatory demyelinating polyneuropathy (CIDP). Coverage is tied to documented disease severity (MGFA class II–IV and MG-ADL ≥5 at initiation for gMG), prior therapy history, and evidence of clinical response for continuation.
Policy Revision History
Added Imaavy (nipocalimab-aahu) for IV administration and added Imaavy as a proven and medically necessary therapy for gMG with specified initial and continuation criteria; replaced Rystiggo IV route entry with Rystiggo SC in the list of products administered by a healthcare professional.
Revised prohibited combination lists for Vyvgart, Vyvgart Hytrulo, and Rystiggo to add CD19-directed cytolytic antibodies (e.g., Uplizna) and to include Imaavy among listed FcRn blockers; updated coverage criteria for Vyvgart/Vyvgart Hytrulo accordingly.
Replaced applicable HCPCS code C9305 with J9256 in the Applicable Codes section.
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