CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Rystiggo (rozanolixizumab-noli) (Subcutaneous) — Coverage Criteria

Coverage criteria, dosing, and authorization rules for Rystiggo (rozanolixizumab-noli) for adults with antibody-positive generalized myasthenia gravis; applies to Neighborhood Health Plan of Rhode Island lines of business including Medicaid, Commercial, and Medicare-Medicaid Plan (MMP).

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyRystiggo (rozanolixizumab-noli) (Subcutaneous) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateAug 1, 2024

Next Review DateMay 8, 2024

Key ActionObtain prior authorization with submission of medical records documenting diagnosis, antibody status, MGFA class II–IV, baseline MG-ADL ≥3, and prior therapy history.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

16 weeksinitial authorization period

6 doses / 63 daystreatment schedule in initial cycle

J9333HCPCS code

G70.0, G70.00, G70.01covered diagnosis ICD-10 codes

P&T-reviewedPolicy reviewed by P&T

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.

Coverage Criteria for Rystiggo (rozanolixizumab-noli)

Initial Approval Criteria

Covered when ALL of the following are met:

Age: Patient is at least 18 years of age

Diagnosis and testing: Submission of medical records to support the diagnosis of generalized myasthenia gravis (gMG); positive serologic test for anti-AChR or anti-MuSK antibodies

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

Disease severity: MGFA Clinical Classification of Class II to IV disease

Baseline assessments: Physician-assessed objective signs of neurological weakness and fatiguability on baseline neurologic exam (e.g., QMG); baseline MG-ADL total score ≥3MG-ADL ≥3

QMG may be used as the objective exam

Prior therapy - AChR+: For AChR-positive disease: inadequate response after a minimum 1-year trial of concurrent use of two or more immunosuppressive therapies (for example, corticosteroid plus azathioprine, cyclosporine, or mycophenolate)

Prior therapy - MuSK+: For MuSK-positive disease: minimum 1-year trial with immunosuppressive therapy (e.g., corticosteroids, azathioprine, mycophenolate) and rituximab

Rescue therapy requirement: Patient required at least one acute or chronic treatment with plasmapheresis/plasma exchange (PE) or IVIG in addition to immunosuppressant therapy

Concomitant biologics: Will not be used in combination with other immunomodulatory biologic therapies (examples: rituximab, eculizumab, ravulizumab, pegcetacoplan, satralizumab, inebilizumab, efgartigimod, zilucoplan)

Vaccination and infection: Will not be administered with live-attenuated or live vaccines during treatment; patient does not have an active infection

IgG deficiency: Patient does not have an IgG deficiency necessitating supplementation with IgG

Renewal Criteria

Renewal covered when ALL of the following are met:

Continued eligibility: Patient continues to meet universal and indication-specific criteria

Toxicity: Absence of unacceptable toxicity from the drug (examples: infection, severe hypersensitivity, aseptic meningitis)

Clinical response: Improvement of at least 1-point from baseline in MG-ADL total score (or ≥1-point improvement in QMG if available) and improvement in muscle strength testing with fatigue maneuvers compared to baselineMG-ADL improvement ≥1

QMG may substitute for MG-ADL when available

Ongoing need: Patient requires continuous treatment after an initial beneficial response due to new or worsening disease activity; a minimum of 63 days must have elapsed from the start of the previous treatment cycle

General coverage criteria for Rystiggo

Covered when use meets the following plan criteria:

Primary coverage requirements: Use aligns with FDA-approved labeling and/or relevant clinical literature; prescriber provides information for individual consideration; use of cost-effective alternatives considered first when appropriate. For INTEGRITY (Medicare-Medicaid Plan) members, these criteria apply only in the absence of an applicable NCD or LCD.

Neighborhood will review requests individually based on submitted prescriber information

Use of Rystiggo in combination with other immunomodulatory biologic therapies is prohibited. The policy explicitly states Rystiggo "will not be used in combination with other immunomodulatory biologic therapies" and lists examples including rituximab, eculizumab, ravulizumab, pegcetacoplan, satralizumab, inebilizumab, efgartigimod, and zilucoplan.

For members enrolled in the Medicare‑Medicaid Plan (INTEGRITY), these plan coverage criteria apply only when there is no applicable National Coverage Determination (NCD) or Local Coverage Determination (LCD). The policy states Neighborhood will give individual consideration to each request and that INTEGRITY members are exempt from the policy criteria when an applicable NCD/LCD exists.

Requests for Rystiggo are considered not medically necessary when the patient does not meet the policy's specified diagnostic, serologic, disease‑classification, baseline assessment, or prior‑therapy requirements. Specifically, documentation must support a diagnosis of generalized myasthenia gravis, positive anti‑AChR or anti‑MuSK serology, MGFA Class II–IV disease, a baseline MG‑ADL total score ≥3 with objective neurologic examination (e.g., QMG), and the appropriate prior therapy trials (e.g., one‑year immunosuppressive regimens and, depending on antibody status, rituximab or documented plasmapheresis/IVIG use) as described in the policy.

Use that is inconsistent with FDA‑approved labeling or the relevant clinical literature, or that lacks sufficient prescriber‑submitted justification, may be considered not medically necessary. The plan requires prescribers to submit clinical information to justify use per FDA labeling or the literature so the plan can give individual consideration; requests that do not justify the FDA‑approved indication or meet the plan's coverage criteria may be denied.

Coding and Billing

Covered HCPCS CodesHCPCSCovered

J9333

Injection, rozanolixizumab-noli, 1 mg; 1 billable unit = 1 mg

NDCNDC

50474-0980-xx

Rystiggo 280mg/2mL solution in a single-dose vial

Covered Diagnosis CodesICD-10Covered

G70.0	Myasthenia gravis
G70.00	Myasthenia gravis without (acute) exacerbation
G70.01	Myasthenia gravis with (acute) exacerbation

Medicare Part B Covered Diagnosis Codesmixed

Medicare Part B Covered Diagnosis Codes

N/A

Medicare Part B Administrative Contractor Jurisdictionsmixed

MAC jurisdiction listings

Administrative contractor jurisdictions and contractors listed by state groups (e.g., CA, HI, NV = Noridian; NC = Palmetto GBA; NY, CT, MA, RI, VT, ME, NH = NGS; etc.)

Infusion pump rate — administration details (Rystiggo)

Administration routeSubcutaneous via infusion pump

Allowed pump infusion rateUp to 20 mL/hour

Frequency for initial cycleOnce weekly for 6 weeks

Weight-based dosing volumes<50 kg: 3 mL; 50 to <100 kg: 4 mL; ≥100 kg: 6 mL

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Initial authorization will be provided for 16 weeks. Coverage may be renewed every 6 months thereafter; renewal requires documentation of clinical benefit (see Renewal Criteria).

Initial approval period: 16 weeks
Renewal interval: every 6 months (must meet renewal criteria)

Step Therapy

Step Therapy Intention

Step therapy may be applied to ensure use of more cost-effective options when appropriate. Members who have received this medication within the prior 365 days are exempt from Step Therapy requirements (MMP exemption).

Members with prior use within 365 days: no step therapy required
All other members: step therapy may be required per plan implementation

Background and Context

Rystiggo (rozanolixizumab‑noli) is a neonatal Fc receptor (FcRn) blocker approved for treatment of adult patients with generalized myasthenia gravis who are anti‑AChR or anti‑MuSK antibody positive. Generalized myasthenia gravis is characterized by weakness and fatigability of ocular, bulbar, limb, and respiratory muscles; approval was based on randomized clinical trial data demonstrating improvement in MG‑ADL scores compared with placebo. Neighborhood reviewed Rystiggo through its Pharmacy & Therapeutics Committee and adopted coverage criteria to align use with the FDA label and relevant literature.

Definitions and Clinical Terms

Rystiggo (rozanolixizumab-noli) — definition and indication

Drug name (generic)Rozanolixizumab-noli

Brand nameRystiggo

Mechanism of actionNeonatal Fc receptor (FcRn) blocker

IndicationTreatment of generalized myasthenia gravis (gMG) in adults who are anti-AChR or anti-MuSK antibody positive

Common adverse effectsHeadache, increased risk of infection, diarrhea, pyrexia, hypersensitivity reactions, nausea

MGFA Clinical Classification and coverage requirement

What it is

Policy Revision History

2024-08-01Policy effective date

Policy effective date established for Rystiggo (rozanolixizumab-noli).

2024-05-08Last review

Policy last reviewed (document-level last_review date).

2024-05-08Next review

Next scheduled policy review date (document-level next_review).