ModifiedAnthemPolicy CC-0246

Rystiggo (rozanolixizumab-noli) — Coverage Criteria for generalized myasthenia gravis

Clinical criteria governing prior authorization, quantity limits, and continuation requirements for Rystiggo (rozanolixizumab-noli) when used to treat adults with antibody-positive generalized myasthenia gravis.

Policy Summary

PayerAnthem

PolicyRystiggo (rozanolixizumab-noli) — Coverage Criteria for generalized myasthenia gravis

Policy CodePolicy CC-0246

Change TypeRevised — coding, exclusions, and quantity limits

Effective Date

Next Review Date

Key ActionObtain prior authorization with required clinical documentation and use HCPCS J9333 for billing.

SourceLink

POLICY UPDATE CHANGES

Added nipocalimab to the combination exclusion list.

Updated quantity limits to include new vial sizes and removed weight-based dosing limit.

Added ICD-10 Procedure XW013TB to coding effective 10/1/25.

18+minimum age

MG-ADL ≥3minimum symptom score

≥2-pointcontinuation response

6 wkscycle length

≤840 mg

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Coverage Criteria for Rystiggo (rozanolixizumab-noli)

Initial Therapy

Initial requests for Rystiggo may be approved if ALL of the following are met:

Initial approval criteria

Age: Individual is 18 years of age or older
Diagnosis: Individual has a diagnosis of generalized myasthenia gravis (gMG)
Antibody status: Documentation of either a positive serologic test for anti-acetylcholine receptor antibodies (AchR-Ab+) OR a positive serologic test for anti-MuSK antibodies
Rystiggo is approved for AchR- or MuSK-positive gMG
Disease severity: MGFA Clinical Classification Class II to IVa disease
Symptom burden: MG-ADL score of at least 3 or higherMG-ADL ≥ 3
Prior therapy (compound condition)
- A. Acetylcholinesterase inhibitor requirement: Either trial and inadequate response or intolerance to an acetylcholinesterase inhibitor; OR the individual is on a stable dose of an acetylcholinesterase inhibitor; OR has a contraindication to acetylcholinesterase inhibitors
- B. Immunosuppressive therapy requirement: Either trial and inadequate response or intolerance to one or more immunosuppressive agents (including systemic corticosteroids or non-steroidal immunosuppressants); OR the individual is on a stable dose of one or more immunosuppressive agents; OR has a contraindication to systemic corticosteroids and non-steroidal immunosuppressants

Continuation Therapy

Requests for continued use may be approved if ALL of the following are met:

Continuation approval criteria

Prior clinical response: Individual has experienced prior clinical response to rozanolixizumab-noli defined by reduction in signs or symptoms that impact daily function AND documentation of at least a 2-point reduction in MG-ADL total score from pre-treatment baselineMG-ADL reduction ≥2 points
Need for continued therapy: Individual requires continued treatment to maintain response or to regain clinically meaningful response

Requests for Rystiggo (rozanolixizumab-noli) will not be approved when used in combination with other specified long-term or targeted therapies. Specifically, combination use with maintenance immunoglobulin treatment, eculizumab, efgartigimod alfa, nipocalimab, ravulizumab, rituximab, or zilucoplan is excluded from coverage and should not be submitted for concurrent approval. This combination exclusion was updated during the annual review to add nipocalimab to the list of agents not permitted for concurrent use.

Requests that do not meet the specified initial or continuation criteria described in this policy are not medically necessary and will not be approved. In addition, requests for Rystiggo for any indications or combinations outside the criteria set forth (including the combination exclusions) are not approved. Continuation requests must document prior clinical response and meet the policy’s continuation requirements to be considered for renewal.

Coding and Clinical Metrics

Prior Authorization

Prior Authorization Required

Provider action: Prior authorization required. Include HCPCS code J9333 when submitting claims for rozanolixizumab-noli (Rystiggo). Prior authorization must document diagnosis, MG-ADL baseline score, prior therapies and trial/intolerance to acetylcholinesterase inhibitors as applicable.

Prior authorization required; include HCPCS J9333 on requests and claims.
Documentation must include diagnosis, MG-ADL baseline and response, antibody status, MGFA class, prior therapy trials/intolerance.

Step Therapy

Step Therapy Requirements

Step therapy requirements: For initial approval, member must have trial and inadequate response or intolerance to an acetylcholinesterase inhibitor unless the member is already on a stable dose or has a contraindication. Ensure documentation of trial, response, stability, or contraindication is included with the authorization request.

Initial therapy requires trial and inadequate response or intolerance to an acetylcholinesterase inhibitor, OR documentation member is on a stable dose, OR documentation of contraindication to acetylcholinesterase inhibitors.

Provider Requirements, Documentation, and Exclusions

Step Therapy

Step therapy: prior trials required

A trial and inadequate response or intolerance to an acetylcholinesterase inhibitor and to one or more immunosuppressive agents is required prior to approval unless the member is on a stable dose or has a contraindication.

Documentation Required

Required clinical documentation for initial and continuation requests

Provide documentation of generalized myasthenia gravis diagnosis, antibody positivity (AchR-Ab+ or MuSK+), MGFA Clinical Class II–IVa, and baseline MG-ADL score ≥3; for continuation include documentation of prior clinical response and at least a 2-point reduction in MG-ADL from pre-treatment baseline.

Denial Risk

Do not combine Rystiggo with listed agents

Background

Generalized myasthenia gravis (gMG) is an autoimmune neuromuscular disorder caused by pathogenic IgG autoantibodies directed at components of the neuromuscular junction, producing fluctuating skeletal muscle weakness and symptoms such as dyspnea, dysphagia, diplopia, dysarthria, and ptosis. Rystiggo (rozanolixizumab-noli) is an FcRn inhibitor — a monoclonal antibody that binds the neonatal Fc receptor to reduce circulating IgG levels — and is approved for adults with anti‑AChR or anti‑MuSK antibody–positive gMG. Clinical evidence includes randomized placebo‑controlled data showing statistically significant improvement in MG‑ADL score after a 6‑week weekly dosing period. The MG‑ADL score is used to measure symptom impact, and a reduction of ≥2 points from pre‑treatment baseline is considered a clinically meaningful improvement.

Definitions and Clinical Measures

inv-14: FcRn inhibitor — definition of class/mechanism

Class definitionMonoclonal antibody that binds the neonatal Fc receptor (FcRn) to reduce circulating IgG levels

Representative agent in policyRystiggo (rozanolixizumab-noli)

Therapeutic effectLowers pathogenic IgG autoantibodies implicated in generalized myasthenia gravis

Administration noteRystiggo is administered subcutaneously via an infusion pump by a healthcare professional

inv-15: MG-ADL — definition of Myasthenia Gravis Activities of Daily Living score and clinical threshold

DefinitionMyasthenia Gravis Activities of Daily Living (MG-ADL) total score — a patient-reported measure of symptom impact on daily function

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