FcRn Blockers (Rystiggo, Vyvgart, & Vyvgart Hytrulo) (for Indiana Only)
Clinical coverage policy for administration of FcRn-blocking drugs (Rystiggo, Vyvgart, Vyvgart Hytrulo) for specified indications in Indiana; defines medical necessity, initial and continuation criteria, dosing windows, and prescribing requirements.
Added J9256 to the list of applicable HCPCS codes.
Removed C9305 from the list of applicable HCPCS codes.
Coverage Criteria for FcRn-blocking Therapies
inv-01: Rystiggo (rozanolixizumab-noli) — Myasthenia Gravis — Covered when ALL of the following are met
Covered when ALL of the following are met
inv-02: Rystiggo — Continuation of Therapy — Covered when ALL of the following are met
Covered when ALL of the following are met
inv-03: Vyvgart / Vyvgart Hytrulo — Myasthenia Gravis — Covered when ALL of the following are met
Covered when ALL of the following are met
inv-04: Vyvgart / Vyvgart Hytrulo — Continuation of Therapy — Covered when ALL of the following are met
Covered when ALL of the following are met
inv-05: Vyvgart Hytrulo — CIDP — Covered when ALL of the following are met
Covered when ALL of the following are met
inv-06: Vyvgart Hytrulo — CIDP Continuation — Covered when ALL of the following are met
Covered when ALL of the following are met
inv-07: Initial coverage criteria — gMG (AChR+) — Covered when ALL of the following are met for generalized myasthenia gravis (gMG) with AChR antibodies:
Covered when ALL of the following are met for generalized myasthenia gravis (gMG) with AChR antibodies:
gMG AChR+ coverage
- Disease severity and baseline measures: MG-ADL and/or QMG scores consistent with trial enrollment (e.g., MG-ADL >=5 in efgartigimod Study 1; MG-ADL >=3 with >=3 non-ocular points in rozanolixizumab study)MG-ADL >=5 (efgartigimod) OR MG-ADL >=3 with >=3 non-ocular points (rozanolixizumab)
Use trial inclusion thresholds to support medical necessity
- Stable background therapy: On stable dose of MG therapy prior to treatment (AChE inhibitors, steroids, or non-steroidal immunosuppressive therapies)stable dosing prior to screening as per trials
Trials required stability of background therapies
- Laboratory requirement: Serum IgG at or above trial-specified minimum (e.g., >=6 g/L for efgartigimod studies; >=5.5 g/L for rozanolixizumab)IgG >= 6 g/L or >=5.5 g/L depending on agent
Reported in trial enrollment criteria
inv-08: Initial coverage criteria — gMG (MuSK+) — Covered when ALL of the following are met for generalized myasthenia gravis (gMG) with MuSK antibodies for rozanolixizumab:
Covered when ALL of the following are met for generalized myasthenia gravis (gMG) with MuSK antibodies for rozanolixizumab:
gMG MuSK+ coverage
- Disease activity: MG-ADL total score at least 3 with at least 3 points from non-ocular symptomsMG-ADL >=3 with >=3 non-ocular points
Per rozanolixizumab study inclusion
- Stable background therapy: On stable MG therapy (AChE inhibitors, steroids, or NSISTs) prior to screeningstable dosing
Per trial requirements
- Laboratory requirement: Serum IgG >=5.5 g/LIgG >=5.5 g/L
Per rozanolixizumab trial inclusion
inv-09: Initial coverage criteria — CIDP — Covered when ALL of the following are met for CIDP:
Covered when ALL of the following are met for CIDP:
CIDP coverage
- Clinical pattern: Typical CIDP or CIDP variants with progressive or relapsing symmetric proximal and distal weakness and sensory involvement over >=8 weeks; absent or reduced reflexes (or variant definitions per guideline)symptom duration >=8 weeks
Per EAN/PNS diagnostic criteria
- Electrodiagnostics: Electrodiagnostic evidence supportive of demyelination as defined by listed criteria (e.g., motor distal latency prolongation >=50% above ULN in two nerves, reduction of motor conduction velocity >=30% below LLN in two nerves, prolongation/absence of F-waves, motor conduction block, temporal dispersion, distal CMAP duration prolongation, etc.)meets at least one strongly supportive parameter or equivalent per guideline
See detailed electrodiagnostic criteria in policy text
Use of FcRn-blocking agents covered by this policy must not be combined with a complement inhibitor, another FcRn blocker, or administration of immune globulin for the same indication. The policy explicitly disallows co-administration of Rystiggo, Vyvgart, or Vyvgart Hytrulo with complement inhibitors (for example, eculizumab, ravulizumab, or zilucoplan), with another FcRn blocker, or with immune globulin in the covered indications.
FDA marketing approval is informational only; FDA approval alone is not a basis for coverage. Coverage under this policy is subject to applicable federal, state, and contractual benefit plan terms, which may differ from the policy statements herein.
Continuation authorizations require documentation that the patient has achieved and maintained the expected clinical response. For generalized myasthenia gravis this includes documentation of at least a 2-point improvement in MG-ADL from pre-treatment baseline and a reduction in signs and symptoms; for CIDP continuation requires objective evidence of positive clinical response on a recognized scale (e.g., Rankin, Modified Rankin, MRC). Failure to demonstrate the required improvement or need for escalation/addition of baseline immunosuppressive therapy or rescue therapy while on treatment will be considered treatment failure and may lead to denial of continued coverage.
A reminder of coverage governance: while FDA approvals for the FcRn-blocking agents are described for informational purposes, FDA approval alone does not guarantee coverage. Coverage decisions must conform to applicable federal, state, and contractual benefit plan requirements that govern reimbursement.
Applicable Codes and Key Measures
| G61.81 | Chronic inflammatory demyelinating polyneuritis |
| G70.00 | Myasthenia gravis without (acute) exacerbation |
| G70.01 | Myasthenia gravis with (acute) exacerbation |
| J9256 | Added to applicable HCPCS codes |
| C9305 | Removed from applicable HCPCS codes |
Provider Actions, Documentation, and Authorization
Prior Authorization Required
Prior authorization is required for covered FcRn‑blocking therapies. Submit a prior authorization request with medical records demonstrating the specified initial‑therapy criteria (diagnosis, antibody status, MG‑ADL/MGFA as applicable, prior therapy failures) as described in the policy. Applicable HCPCS codes have been updated for this policy.
- Applicable HCPCS updates (effective 01/01/2026): Added J9256; Removed C9305
- Prior authorization required for Vyvgart, Vyvgart Hytrulo, Rystiggo, and other covered FcRn‑blocking therapies per policy criteria
Failure to Submit Supporting Medical Records May Result in Denial
Submission of supporting medical records is required. Failure to provide the requested documentation may result in delay or denial of the request.
- Examples of required documentation: chart notes, laboratory results (e.g., antibody status, IgG), electrodiagnostic testing (for CIDP), MG‑ADL and MGFA documentation, history of prior therapies and responses, prior authorization forms
- Denial risk if records do not confirm required elements (diagnosis, antibody positivity where required, baseline scores, prior therapy trials/failures)
Prior Trials and Failures Required
Policy requires documentation of prior trials and failures (or contraindication/intolerance) of specified therapies before authorization of FcRn‑blocking agents for initial therapy.
- gMG: History of failure of at least two immunosuppressive agents over ≥12 months, OR failure of ≥1 immunosuppressive therapy plus ≥4 courses of plasmapheresis/IVIG over ≥12 months without control
- CIDP: Trial and failure (≥2 months) of corticosteroids AND trial and failure (≥3 months) of IVIG (or intolerance/contraindication to IVIG with dose escalation documented) as specified in policy
Step Therapy (Informational)
Step‑therapy information (informational): No single mandatory step sequence is imposed by this policy beyond the required prior trials/failures described above. Patients on stable background therapy (AChE inhibitors, steroids, or NSISTs) may be eligible; step‑therapy expectations are defined by the clinical criteria (trials/failures) rather than a formal step program.
- Patients must generally be on stable doses of baseline MG therapies prior to initiation (e.g., AChE inhibitors, steroids, NSISTs) as noted in clinical trial eligibility and policy criteria
- Policy does not require a separate administrative step‑therapy program beyond the documented clinical trials/failures and stability requirements
Background on FcRn-blocking Therapies
Background: FcRn blockers are biologic agents that bind the neonatal Fc receptor (FcRn) and thereby reduce circulating IgG levels. By lowering pathogenic IgG and autoantibody concentrations, these agents can reduce disease activity in antibody-mediated disorders such as generalized myasthenia gravis and chronic inflammatory demyelinating polyneuropathy.
Definitions and Key Terms
Policy Revision History and Changes
Annual HCPCS update: added J9256 and removed C9305 from the list of applicable HCPCS codes.
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.