CurrentAmeriHealth Caritas VIP CarePolicy MA08.164a

Rozanolixizumab-noli (Rystiggo) Coverage for Generalized Myasthenia Gravis

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This policy governs medical-benefit coverage and medical-necessity requirements for rozanolixizumab-noli (Rystiggo) in adults with generalized myasthenia gravis. Coverage is subject to the member’s Evidence of Coverage, benefit contract, applicable Medicare guidance, and the clinical criteria in this policy.

Policy Summary

PayerAmeriHealth Caritas VIP Care

PolicyRozanolixizumab-noli (Rystiggo) Coverage for Generalized Myasthenia Gravis

Policy CodePolicy MA08.164a

Change TypeAdministrative annual review

Effective DateMay 7, 2024

Next Review DateN/A

Key ActionSubmit documentation confirming antibody-positive generalized myasthenia gravis, required severity scores, prior-treatment history, and dosing criteria for authorization.

SourceLink

POLICY UPDATE CHANGES

The policy was reissued on September 18, 2026 as part of the Company's annual review process.

Adults 18+Covered population

MGFA II–IVaDisease classification

MG-ADL ≥3; QMG ≥11Severity scores

6 weekly doses

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CurrentAmeriHealth Caritas VIP CarePolicy MA08.164a

Rozanolixizumab-noli (Rystiggo) Coverage for Generalized Myasthenia Gravis

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Policy Summary

PayerAmeriHealth Caritas VIP Care

PolicyRozanolixizumab-noli (Rystiggo) Coverage for Generalized Myasthenia Gravis

Policy CodePolicy MA08.164a

Change TypeAdministrative annual review

Effective DateMay 7, 2024

Next Review DateN/A

Key ActionSubmit documentation confirming antibody-positive generalized myasthenia gravis, required severity scores, prior-treatment history, and dosing criteria for authorization.

SourceLink

POLICY UPDATE CHANGES

The policy was reissued on September 18, 2026 as part of the Company's annual review process.

Adults 18+Covered population

MGFA II–IVaDisease classification

MG-ADL ≥3; QMG ≥11Severity scores

6 weekly doses

≥63 daysNext-cycle interval

420/560/840 mgDose options

Coverage Criteria

Initial Therapy Criteria

Covered when all of the following criteria are met:

Initial therapy criteria

Adult with generalized myasthenia gravis
- Age: The individual is 18 years of age or older≥18 years
- Diagnosis and severity
  - Diagnosis: Documented generalized myasthenia gravis based on the individual's history and supported by previous evaluations
  - Autoantibodies: Confirmed positive record of autoantibodies against the acetylcholine receptor (AChR) or muscle-specific kinase (MuSK)
  - MGFA classification: Myasthenia Gravis Foundation of America (MGFA) Class II, III, or IVaMGFA Class II, III, or IVa
  - Disease severity scores: MG-ADL score of at least 3, with at least 3 points from non-ocular symptoms, and a QMG score of at least 11MG-ADL ≥3, including ≥3 non-ocular points; QMG ≥11
ONE of the following prior-treatment pathways
- Standard-of-care therapy: History of inadequate response or intolerance to an acetylcholinesterase inhibitor or corticosteroidExamples include pyridostigmine or prednisone
- Rescue therapy: Use of immunoglobulin (IVIg) or plasma exchange (PLEX) as rescue therapyIVIg or PLEX
Combination restriction: Rozanolixizumab-noli (Rystiggo) is not being administered in combination with eculizumab, ravulizumab, or efgartigimod alfa-fcabNo concurrent combination therapy
Dosing and frequency: Rozanolixizumab-noli (Rystiggo) is administered once weekly for six weeks, with each subsequent treatment cycle initiated no sooner than 63 days from the start of the previous cycle<50 kg: 420 mg; 50 to <100 kg: 560 mg; ≥100 kg: 840 mg

Continuation Therapy Criteria

Continuation coverage requires all of the following requirements:

Continuation therapy criteria

Positive clinical response: Medical records demonstrate a positive clinical response from baselineExample: two-point reduction in the MG-ADL total score
Submit medical records documenting the response.
Treatment-cycle spacing: The subsequent treatment cycle is initiated no sooner than 63 days from the start of the previous treatment cycle≥63 days
The safety of initiating subsequent cycles sooner than 63 days has not been established.

Concurrent treatment exclusion: Coverage does not include rozanolixizumab-noli (Rystiggo) when it is administered concurrently with eculizumab, ravulizumab, or efgartigimod alfa-fcab.

Pediatric use: The safety and effectiveness of rozanolixizumab-noli (Rystiggo) have not been established in the pediatric population.

Coding and Clinical Measures

CPT Procedure Code Number(s)CPT

N/A

ICD - 10 Procedure Code Number(s)ICD-10

N/A

ICD - 10 Diagnosis Code Number(s)ICD-10

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

HCPCS Level II Code Number(s)HCPCS

J9333

Injection, rozanolixizumab-noli, 1 mg

Revenue Code Number(s)Revenue

N/A

MG-ADL threshold

MeasureMG-ADL (Myasthenia Gravis Activities of Daily Living)

Minimum total scoreAt least 3 points

Non-ocular symptom pointsAt least 3 points from non-ocular symptoms

QMG threshold

MeasureQuantitative Myasthenia Gravis (QMG) score

Minimum scoreAt least 11

Provider Actions and Authorization Requirements

Prior Authorization

Clinical Authorization Required

Prior authorization is required for Rystiggo (rozanolixizumab-noli). Coverage is available for adults with antibody-positive generalized myasthenia gravis only when all initial clinical, treatment-history, combination-therapy, dosing, and frequency requirements are satisfied.

Submit documentation supporting each initial coverage criterion before treatment is authorized.

Documentation Required

Initial Clinical Documentation

Initial authorization requires records confirming the diagnosis and prior evaluations, positive AChR or MuSK autoantibody testing, MGFA class II, III, or IVa disease, and the required MG-ADL and QMG scores.

Patient is at least 18 years of age.
MG-ADL score is at least 3, with at least 3 points from non-ocular symptoms.

Clinical Background

Myasthenia gravis is a chronic autoimmune neuromuscular disease that causes fluctuating skeletal-muscle weakness. Manifestations may involve the ocular, facial, bulbar, respiratory, neck, and limb muscles.

Clinical Definitions

MGFA Class II

ClassificationMGFA Class II

SeverityMild weakness affecting muscles other than ocular muscles

Ocular involvementMay also have ocular muscle weakness of any severity

MGFA Class III

ClassificationMGFA Class III

SeverityModerate weakness affecting muscles other than ocular muscles

Ocular involvementMay also have ocular muscle weakness of any severity

Initial Therapy Criteria

Initial therapy requires all of the following clinical eligibility, prior-treatment, combination-therapy, and dosing criteria:

Initial Rystiggo therapy criteria

Clinical eligibility
- Age: The individual is 18 years of age or older≥18 years
- Generalized myasthenia gravis diagnosis: Documented diagnosis of generalized myasthenia gravis based on the individual's history and supported by previous evaluations
- Antibody status: Confirmed positive record of autoantibodies against the acetylcholine receptor (AChR) or muscle-specific kinase (MuSK)

Continuation Criteria

Continuation Therapy Criteria

Continuation requires documented positive clinical response and appropriate treatment-cycle spacing:

Continuation therapy criteria

Positive clinical response: Medical records demonstrate a positive clinical response from baselineExample: two-point reduction in the MG-ADL total score
Appropriate treatment-cycle spacing: Each subsequent treatment cycle is initiated no sooner than 63 days from the start of the previous treatment cycle≥63 days
The safety of initiating subsequent cycles sooner than 63 days has not been established.

Step Therapy

Step	Requirement
1	History of inadequate response or intolerance to an acetylcholinesterase inhibitor or corticosteroid, or use of IVIg or plasma exchange as rescue therapy.

Quantity and Dosing Limits

Rystiggo quantity limit

DrugRozanolixizumab-noli (Rystiggo)

Quantity limitOne dose once weekly

Treatment courseSix weeks

Rystiggo weight-based dosing

Body weight less than 50 kg420 mg per dose

Body weight 50 kg to less than 100 kg560 mg per dose

Body weight 100 kg or greater840 mg per dose

Policy Summary

PayerAmeriHealth Caritas VIP Care

PolicyRozanolixizumab-noli (Rystiggo) Coverage for Generalized Myasthenia Gravis

Policy CodePolicy MA08.164a

Change TypeAdministrative annual review

Effective DateMay 7, 2024

Next Review DateN/A

Key ActionSubmit documentation confirming antibody-positive generalized myasthenia gravis, required severity scores, prior-treatment history, and dosing criteria for authorization.

SourceLink

On This Page

Policy applicationRequired with the MG-ADL threshold for initial coverage

QMG score is at least 11.

Step Therapy

Failure or Intolerance of Prior Therapy

Document a history of inadequate response or intolerance to at least one qualifying standard-of-care or rescue therapy before initial coverage.

Standard-of-care therapy, such as an acetylcholinesterase inhibitor (for example, pyridostigmine) or a corticosteroid (for example, prednisone).
Intravenous immunoglobulin (IVIg) or plasma exchange (PLEX) used as rescue therapy.

Denial Risk

Prohibited Combination Therapy

Rystiggo is not covered when administered in combination with eculizumab (Soliris), ravulizumab (Ultomiris), or efgartigimod alfa-fcab (Vyvgart).

Document that the individual is not receiving any of these prohibited combination therapies.

Billing Rule

Dosing and Early Repeat-Cycle Rule

Administer Rystiggo once weekly for six weeks using the weight-based dose. A subsequent treatment cycle must not begin sooner than 63 days after the start of the previous cycle; safety of earlier initiation has not been established.

Body weight less than 50 kg: 420 mg once weekly for six weeks.
Body weight 50 kg to less than 100 kg: 560 mg once weekly for six weeks.
Body weight 100 kg or more: 840 mg once weekly for six weeks.

Documentation Required

Continuation Response Documentation

For continuation coverage, submit medical records demonstrating a positive clinical response from baseline, such as a two-point reduction in the MG-ADL total score.

Continuation documentation must support clinical improvement from baseline.
Do not request a subsequent cycle without response documentation.

Denial Risk

Unapproved or Unsupported Use

Uses of Rystiggo other than the policy-supported treatment of generalized myasthenia gravis are considered experimental or investigational and are not covered, unless supported as an accepted off-label use under the Company's medical policy for off-label coverage of prescription drugs and biologics.

Coverage is limited to the supported adult gMG indication and criteria.

Denial Risk

Insufficient Response Documentation

Continuation coverage requires medical records demonstrating a positive clinical response from baseline. Requests without sufficient response documentation may be denied.

Examples of supporting evidence include a two-point reduction in the MG-ADL total score.

MGFA Class IVa

ClassificationMGFA Class IVa

SeveritySevere weakness affecting muscles other than ocular muscles

Predominant involvementPredominantly affects limb, axial muscles, or both, with lesser involvement of oropharyngeal muscles; ocular weakness of any severity may also occur

MG-ADL

ProfileMyasthenia Gravis Activities of Daily Living (MG-ADL) profile

Activities assessedTalking, chewing, swallowing, breathing, ability to brush, ability to arise, double vision, and eyelid droop

ScoringEach item is scored from 0 to 3

QMG

Measure13-item direct physician assessment scoring system for myasthenia gravis severity

Item scoringEach item is scored from 0 to 3, with 3 representing the most severe impairment

Total score range0 to 39

Disease classification: MGFA Class II, III, or IVaMGFA Class II, III, or IVa

Disease severity: MG-ADL score of at least 3, with at least 3 points from non-ocular symptoms, and QMG score of at least 11MG-ADL ≥3, including ≥3 non-ocular points; QMG ≥11

ONE of the following prior-treatment pathways

Standard-of-care therapy: History of inadequate response or intolerance to an acetylcholinesterase inhibitor or corticosteroidExamples include pyridostigmine or prednisone
Rescue therapy: Use of immunoglobulin (IVIg) or plasma exchange (PLEX) as rescue therapyIVIg or PLEX

No prohibited combination therapy: The individual is not receiving rozanolixizumab-noli (Rystiggo) in combination with eculizumab, ravulizumab, or efgartigimod alfa-fcabNo concurrent combination therapy

Dose and schedule: Rozanolixizumab-noli (Rystiggo) is administered once weekly for six weeks, with each subsequent treatment cycle initiated no sooner than 63 days from the start of the previous cycle<50 kg: 420 mg; 50 to <100 kg: 560 mg; ≥100 kg: 840 mg

Rystiggo treatment-cycle spacing

Cycle intervalEach subsequent treatment cycle begins no sooner than 63 days from the start of the previous cycle

Minimum interval63 days

Safety noteThe safety of initiating subsequent cycles sooner than 63 days has not been established