CurrentCignaPolicy IP0575

Neurology - Rystiggo

Policy governs prior authorization, coverage criteria, dosing, and coding for Rystiggo (rozanolixizumab-noli) for treatment of generalized myasthenia gravis in adults under Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyNeurology - Rystiggo (Rystiggo; rozanolixizumab-noli) coverage criteria

Policy CodePolicy IP0575

Change TypeCoding and title updatesexclusions expandeddocumentation clarifications

Effective DateAug 15, 2025

Next Review DateN/A

Key ActionObtain prior authorization and document antibody-positive status, MG-ADL score, prior pyridostigmine trial (or contraindication), and dosing to support approval.

SourceLink

POLICY UPDATE CHANGES

Policy title updated from 'Rozanolixizumab' to 'Neurology - Rystiggo' and coding updated (removed C9399, J3490, J3590; added J9333).

Conditions Not Recommended for Approval updated to add Imaavy as an example neonatal Fc receptor blocker and biosimilars to Soliris added to complement inhibitor examples.

Documentation requirements were added throughout the policy.

18 wksprimary efficacy trial duration

6 injtreatment cycle length

≥18minimum age

J9333primary HCPCS

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Coverage Criteria for Rystiggo (rozanolixizumab-noli)

Initial Therapy — Approve for 6 months if the patient meets ALL of the following

Approve for 6 months if the patient meets ALL of the following

Initial Therapy criteria: Patient is ≥ 18 years of age; AND patient has confirmed anti-acetylcholine receptor (anti-AChR) antibody-positive generalized myasthenia gravis OR confirmed anti-muscle-specific tyrosine kinase (anti-MuSK) antibody-positive generalized myasthenia gravis (documentation required); AND MGFA class II to IV AND MG-ADL score ≥ 3 for non-ocular symptoms; AND patient received or is currently receiving pyridostigmine OR has had inadequate efficacy, a contraindication, or significant intolerance to pyridostigmine; AND patient has evidence of unresolved symptoms of generalized myasthenia gravis (examples: difficulty swallowing, difficulty breathing, or a functional disability such as impaired mobility, double vision, or impaired speech) ; AND treatment cycles are no more frequent than every 63 days from the start of the previous treatment cycle; AND medication is prescribed by or in consultation with a neurologist.MG-ADL >= 3

Documentation required for antibody status and clinical scores.

Continuation Therapy — Approve for 1 year if the patient meets ALL of the following

Approve for 1 year if the patient meets ALL of the following

Continuation Therapy criteria: Patient is ≥ 18 years of age; AND prescriber attests patient is continuing to derive benefit from Rystiggo (examples: reductions in MG exacerbations; improvements in speech, swallowing, mobility, or respiratory function); AND treatment cycles are no more frequent than every 63 days from the start of the previous treatment cycle; AND medication is prescribed by or in consultation with a neurologist.

Benefit should be documented by prescriber statement and supporting clinical evidence.

Dosing — Dosing. Approve if BOTH of the following are met

Dosing. Approve if BOTH of the following are met

Dosing: Patient meets ONE of the following dosing tiers: (i) < 50 kg: 420 mg administered by subcutaneous infusion once weekly for 6 weeks; OR (ii) 50 kg to < 100 kg: 560 mg administered by subcutaneous infusion once weekly for 6 weeks; OR (iii) ≥ 100 kg: 840 mg administered by subcutaneous infusion once weekly for 6 weeks; AND treatment cycles are no more frequent than every 63 days from the start of the previous treatment cycle.

Administer SC infusion at a rate up to 20 mL/h. Subsequent cycles based on clinical evaluation; safety of initiating cycles sooner than 63 days has not been established.

Rystiggo (rozanolixizumab-noli) is considered not medically necessary for any use other than the listed indication. This includes, but is not limited to, concomitant administration with another neonatal Fc receptor blocker, a complement inhibitor, or a rituximab product. Examples cited in the policy include neonatal Fc receptor blockers such as Imaavy, Vyvgart, and Vyvgart Hytrulo, and complement inhibitors such as eculizumab (Soliris) and its biosimilars, Ultomiris, and Zilbrysq.

Concomitant use of Rystiggo with another neonatal Fc receptor blocker, a complement inhibitor, or a rituximab product is considered not medically necessary due to lack of evidence supporting combined therapy. The policy specifically lists examples of neonatal Fc receptor blockers (Imaavy, Vyvgart, Vyvgart Hytrulo) and complement inhibitors (eculizumab/Soliris and biosimilars, Ultomiris, Zilbrysq) to illustrate the exclusion.

Billing and Coding

Considered Medically Necessary CodesHCPCSCovered

J9333

Injection, rozanolixizumab-noli, 1 mg

Removed/Deprecated Codesmixed

C9399	Removed - unlisted drug/biological
J3490	Removed - unclassified drugs
J3590	Removed - unclassified biologics

inv-08: Treatment cycle frequency — key threshold

Treatment cycle frequencyTreatment cycles must be no more frequent than every 63 days from the start of the previous treatment cycle.

RationaleSafety of initiating subsequent cycles sooner than 63 days has not been established.

Applies toInitial, continuation, and dosing criteria for Rystiggo treatment cycles per policy.

Provider Actions & Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for Rystiggo. Approval is recommended when documented criteria and dosing in the policy are met. All approvals are provided for the duration noted in the policy. Requests for doses outside the established dosing will be reviewed case-by-case by a clinician. Rystiggo must be prescribed by or in consultation with a physician who specializes in the condition being treated. Documentation is required where noted in the criteria (e.g., antibody status, MG-ADL score, MGFA class, prior therapies).

Prior authorization required for Rystiggo
Approvals provided for specified durations; 1 month = 30 days
Dose requests outside policy dosing reviewed case-by-case
Prescriber requirement: neurologist or specialist (or in consultation)

Step Therapy

Provider Actions — Prior Trial Requirement

Policy requires a prior trial of pyridostigmine before approval for initial therapy OR documentation that pyridostigmine had inadequate efficacy, a contraindication, or significant intolerance. For initial therapy approvals, patient must also meet age, antibody status, MGFA class, MG-ADL score, evidence of unresolved symptoms, treatment cycle frequency limits, and prescriber specialty as detailed in the policy.

Background

Myasthenia gravis is an autoimmune neuromuscular disorder characterized by fluctuating skeletal muscle weakness caused by pathogenic IgG autoantibodies (for example, against the acetylcholine receptor or MuSK). Rystiggo is a neonatal Fc receptor blocker indicated for adults with antibody-positive generalized myasthenia gravis and acts by reducing pathogenic IgG antibody levels. Clinical trial data cited in the policy demonstrated statistically significant improvement in patient-reported functional measures (MG-ADL) versus placebo.

Definitions and Clinical Measures

inv-14: MG-ADL — definition

MG-ADL definitionPatient-reported measure assessing the impact of generalized myasthenia gravis on eight signs/symptoms; each sign/symptom is scored 0–3 (4-point scale).

Score interpretationHigher total MG-ADL score indicates greater impairment in daily function.

Trial eligibility useClinical trial and policy eligibility required MG-ADL ≥ 3 with at least 3 points from non-ocular symptoms.

inv-15: MGFA class — policy reference

MGFA classification referencedMyasthenia Gravis Foundation of America (MGFA) clinical classification is used to categorize disease severity.

Operational classes for eligibilityPolicy references MGFA classes II to IVa for eligibility in the pivotal trial and operational use in criteria.