CurrentEmblemHealthPolicy MG.MM.PH.390

Rystiggo (rozanolixizumab-noli) subcutaneous injection

Coverage criteria and utilization management for Rystiggo (rozanolixizumab-noli) for treatment of generalized myasthenia gravis in adults, describing authorization, dosing, limitations, and coding for EmblemHealth and ConnectiCare members.

Policy Summary

PayerEmblemHealth

PolicyRystiggo (rozanolixizumab-noli) subcutaneous injection

Policy CodePolicy MG.MM.PH.390

Change TypeDosing, eligibility threshold, and renewal/exclusion updates

Effective Date

Next Review Date

Key ActionObtain prior authorization; initial approval is 6 months with possible 1-year renewal and submit clinical evidence including antibody status and MG-ADL score.

SourceLink

POLICY UPDATE CHANGES

Updated dosing limits.

Initial MG-ADL score threshold changed from >5 to ≥3 for non-ocular symptoms.

Added renewal criteria, limitations and exclusions.

6 weeksTypical induction dosing duration (weekly doses)

63 daysMinimum interval before subsequent treatment cycles

6 monthsInitial authorization period

1 yearRenewal authorization duration

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Coverage Criteria for Rystiggo (rozanolixizumab-noli)

Initial therapy

Covered when ALL of the following are met

Age and diagnosis: Patient is >= 18 years of age AND has confirmed anti-acetylcholine receptor (AChR) antibody positive generalized myasthenia gravis OR anti-muscle-specific tyrosine kinase (MuSK) antibody positive myasthenia gravis.

Severity and timing: Myasthenia Gravis Foundation of America (MGFA) classification II to IV AND treatment cycles are no more frequent than 63 days from the start of the previous treatment cycle.

Symptom and prior therapy: (1) MG-ADL score >= 3 for non-ocular symptoms AND patient received or is currently receiving pyridostigmine OR (2) patient has evidence of unresolved symptoms of generalized myasthenia gravis (examples: difficulty swallowing, difficulty breathing, functional disability) AND has inadequate efficacy, contraindication, or significant intolerance to pyridostigmine.

Prescriber: Medication is prescribed by, or in consultation with, a neurologist.

Continuation/Renewal

Renewal/Continuation

Continued benefit: Patient is continuing to derive benefit from Rystiggo according to the prescriber (examples: reductions in MG exacerbations; improvements in speech, swallowing, mobility, respiratory function).

Authorization duration: Initial approval 6 months; continuation approval duration is 1 year.

Requests for Rystiggo that propose concomitant administration with another neonatal Fc receptor (FcRn) blocker (for example, Vyvgart or Vyvgart Hytrulo), a complement inhibitor (for example, Soliris, Ultomiris, or Zilbrysq), or a rituximab product raise safety and efficacy concerns and are explicitly addressed by the policy. Such concurrent use is a stated limitation and may be reviewed for medical necessity; in most cases these combinations are excluded from coverage because the policy does not support overlapping mechanisms that target FcRn or complement pathways alongside Rystiggo.

The prescribing clinician should document the rationale when proposing any non‑standard combination therapy; absent compelling, documentable justification and supporting clinical evidence, requests for concomitant administration with these agents are likely to be denied.

The policy excludes concurrent use of Rystiggo with other specified FcRn blockers, complement inhibitors, or rituximab products. Because these agents have overlapping or interacting mechanisms of action, the policy treats their combined use as unsupported; therefore, prior authorization requests that indicate active concurrent therapy with these products will be evaluated against this exclusion and may be denied as not medically necessary.

Providers submitting requests should avoid proposing simultaneous therapy with the listed agents. If clinicians believe concurrent therapy is clinically required, they must supply clear, contemporaneous documentation demonstrating why alternative, sequential, or single‑agent approaches are unsuitable for the member.

Billing and Coding

Applicable Procedure CodesHCPCSCovered

J9333

Injection, rozanolixizumab-noli 1 mg

Applicable NDCsNDC

50474-0980-79	Rystiggo 140mg/2mL
50474-0981-83	Rystiggo 420mg/3mL
50474-0982-84	Rystiggo 560mg/4mL
50474-0983-86	Rystiggo 840mg/6mL

ICD-10 DiagnosesICD-10Covered

G70.00	Myasthenia gravis without (acute) exacerbation
G70.01	Myasthenia gravis with (acute) exacerbation
G70.2	Congenital and developmental myasthenia

MG-ADL score (non-ocular symptoms)

MG-ADL threshold (non-ocular symptoms)>= 3

ContextApplies to MG-ADL score for non-ocular symptoms as part of initial eligibility for Rystiggo

Related requirementPatient must have received or currently receiving pyridostigmine OR have unresolved gMG symptoms with inadequate efficacy, contraindication, or intolerance to pyridostigmine

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization and Duration

Prior authorization is required for initial and continuation therapy. Initial approvals will be provided for 6 months; continuation (renewal) approvals may be provided for 1 year. Treatment cycles must be no more frequent than 63 days from the start of the previous treatment cycle.

Initial authorization duration: 6 months
Renewal/continuation duration: 1 year
Treatment cycle frequency: no more frequent than every 63 days

Documentation Required

Pyridostigmine Trial or Exception

Requests must document a trial of pyridostigmine or provide clinical rationale for why a pyridostigmine trial is not appropriate (for example, intolerance, contraindication, or evidence of unresolved symptoms despite therapy). The prescriber should indicate whether the patient received or is currently receiving pyridostigmine.

Document trial of pyridostigmine OR provide reasoned exception (intolerance, contraindication, or persistent symptoms despite use)

Background

Rystiggo (rozanolixizumab‑noli) is indicated for the treatment of generalized myasthenia gravis in adults who are anti‑AChR or anti‑MuSK antibody positive. It is a subcutaneously administered monoclonal antibody that targets the neonatal Fc receptor (FcRn) to reduce pathogenic IgG levels, with typical treatment delivered in weight‑based weekly dosing cycles.

Because Rystiggo acts via FcRn blockade, the policy explicitly excludes its concomitant use with other FcRn blockers and with certain complement inhibitors or rituximab products due to overlapping mechanisms and potential safety or efficacy concerns.

Definitions

Indication — generalized myasthenia gravis (gMG)

IndicationTreatment of generalized myasthenia gravis (gMG) in adult patients who are anti‑AChR or anti‑MuSK antibody positive

Age requirementAdults (>= 18 years)

Antibody statusConfirmed anti‑acetylcholine receptor (AChR) OR anti‑muscle‑specific tyrosine kinase (MuSK) antibody positive

Severity considerationsMGFA classification II to IV considered in eligibility assessment