CurrentCareSourcePolicy N/A

Rystiggo (rozanolixizumab-noli) prior authorization for generalized myasthenia gravis

Defines medical benefit coverage, prior-authorization requirements, dosing limits, and renewal criteria for Rystiggo in adults with seropositive generalized myasthenia gravis for CareSource Arkansas PASSE members.

Policy Summary

PayerCareSource

PolicyRystiggo (rozanolixizumab-noli) prior authorization for generalized myasthenia gravis

Policy CodePolicy N/A

Change TypeNew policyrevised steroid trial duration

Effective DateOct 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization with documentation of seropositive AChR or MuSK antibodies and required prior therapy trials.

SourceLink

POLICY UPDATE CHANGES

New policy for Rystiggo created.

Changed steroid trial duration from 3 months to 4 weeks.

>=18minimum age for coverage

6 moinitial approval duration

12 more-authorization duration

18 vialsquantity limit

>=63 daysmin interval between cycles

Policy Summary

PayerCareSource

PolicyRystiggo (rozanolixizumab-noli) prior authorization for generalized myasthenia gravis

Policy CodePolicy N/A

Change TypeNew policyrevised steroid trial duration

Effective DateOct 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization with documentation of seropositive AChR or MuSK antibodies and required prior therapy trials.

SourceLink

On This Page

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Coverage Criteria for Rystiggo

inv-01: Initial Therapy

Covered when ALL of the following are met for initial authorization:

Initial Authorization: 1) Member is at least 18 years of age; AND 2) Medication is prescribed by or in consultation with a neurologist; AND 3) Lab result documents seropositivity for AChR or MuSK antibodies; AND 4) Member has a documented diagnosis of MGFA class II-IV myasthenia gravis; AND 5) Member has tried and failed at least 1 conventional therapy: pyridostigmine; corticosteroid for at least 4 weeks; non-steroid immunosuppressant (e.g., azathioprine) for at least 6 months; AND 6) Dosing follows specified per-body-weight vial/volume limits and does not exceed QL of 18 vials per 42 days.

If all requirements met, approve for 6 months

inv-02: Continuation Therapy

Reauthorization covered when ALL of the following are met:

Reauthorization: 1) Treatment cycles are prescribed at least 63 days apart; AND 2) Chart notes document clinically meaningful improvement in symptom severity and daily functioning compared to pre-treatment baseline (e.g., improved MG-ADL or QMG scores).

If all requirements met, approve for additional 12 months

Use of Rystiggo for indications not explicitly listed in this policy is considered not medically necessary. Providers seeking coverage for diagnoses or clinical situations outside the scope of this document should refer to the plan’s Off‑Label policy for guidance on non‑covered indications and the process for exception requests.

CareSource considers Rystiggo (rozanolixizumab‑noli) not medically necessary for the treatment of any condition that is not specified in this policy. Requests for use outside the covered indication(s) will be denied unless an exception is granted per the Off‑Label policy.

Coding and Treatment Intervals

Covered HCPCS/NDC/CPT not listed explicitlymixed

No codes listed

treatment cycle interval

Minimum interval between treatment cycles>= 63 days between cycles

Cycle scheduleOne cycle = subcutaneous infusion once weekly for 6 weeks

Approval linkageSubsequent cycles must be based on clinical evaluation and meet the minimum spacing requirement

Provider Requirements, Documentation, and Denial Triggers

Prior Authorization

Prior Authorization Required

Prior authorization required — Rystiggo (rozanolixizumab‑noli) is a medical benefit and requires prior authorization. Medication must be prescribed by or in consultation with a neurologist for adults (member age ≥ 18). Approval is time‑limited and contingent on meeting the criteria below.

Applies to Rystiggo (rozanolixizumab‑noli) when billed as a medical infusion/administration service.
Member age ≥ 18 required.
Prescription must be by or in consultation with a neurologist.

Step Therapy

Required Prior Therapies

Required prior therapies — for initial authorization the member must have tried and failed specified conventional therapies before Rystiggo is approved.

Pyridostigmine (acetylcholinesterase inhibitor) — trial documented and inadequate control.
Corticosteroid therapy for at least 4 weeks.

Clinical Background

Myasthenia gravis (MG) is an antibody‑mediated autoimmune disorder affecting the neuromuscular junction and causing fluctuating skeletal muscle weakness and fatigability. This policy addresses use of Rystiggo in adults with seropositive generalized myasthenia gravis (anti‑AChR or anti‑MuSK antibody positive) and requires documentation of disease severity and response to prior therapies as part of the authorization process.

Key Definitions

MGFA class II-IV

MGFA Class IIMild weakness affecting muscles other than ocular muscles; may also have ocular weakness at any level

MGFA Class IIIModerate weakness affecting muscles other than ocular muscles; may also have ocular weakness at any level

MGFA Class IVSevere weakness affecting muscles other than ocular muscles; may also have ocular weakness at any level

Initial Therapy — Authorization and Dosing Limits

inv-13: Initial therapy

Initial authorization criteria and dosing limits

Initial therapy nodes: Adult (>=18 years) with seropositive generalized myasthenia gravis (MGFA II-IV) prescribed by or in consultation with a neurologist; prior failure of conventional therapies: pyridostigmine; corticosteroid for at least 4 weeks; non-steroid immunosuppressant (e.g., azathioprine) for at least 6 months; administered as subcutaneous infusion once weekly for 6 weeks as one cycle; dosing per body weight with vial/volume limits and quantity limit of 18 vials per 42 days.QL: 18 vials per 42 days

If met, approve for 6 months

Reauthorization / Continuation Criteria

inv-14: Reauthorization

Reauthorization requirements

Reauthorization nodes: Treatment cycles >=63 days apart AND documentation of clinically meaningful improvement versus pre-treatment baseline (e.g., improved MG-ADL or QMG scores).

Approve for 12 months if met

Step Therapy Requirements

Required prior therapy	Minimum duration / notes
Pyridostigmine
Trial of pyridostigmine (no specific minimum duration stated in policy)
Corticosteroid
At least 4 weeks
Non‑steroid immunosuppressant (e.g., azathioprine)
At least 6 months

Quantity Limits and Dosing

Rystiggo (rozanolixizumab-noli) — quantity limits

Quantity limit18 vials per 42 days

Per-cycle dosingDose and volume based on patient body weight per policy dosing table

Administration frequencySubcutaneous infusion once weekly for 6 weeks per treatment cycle

Administration and Site-of-Care

Note

Infusion center administration and cycle spacing

Administer as subcutaneous infusion once weekly for 6 weeks as one treatment cycle; subsequent cycles must be based on clinical evaluation and prescribed at least 63 days apart.