CurrentBlue Cross Blue Shield - IowaPolicy N/A

Rystiggo (rozanolixizumab-noli) — Prior Authorization and Coverage Criteria for Generalized Myasthenia Gravis

Policy governs prior authorization, coverage criteria, documentation, dosing limits, and billing for Rystiggo in adult patients with antibody-positive generalized myasthenia gravis for Wellmark Blue Cross and Blue Shield members.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyRystiggo (rozanolixizumab-noli) — Prior Authorization and Coverage Criteria for gMG

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization; initial approval may be granted for 6 months when all coverage criteria and documentation are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 moInitial authorization duration

12 moReauthorization duration

>=5Minimum MG-ADL

J9333HCPCS

Coverage Criteria for Rystiggo (rozanolixizumab-noli)

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Initial therapy for generalized myasthenia gravis (gMG)

Authorization of 6 months may be granted when ALL of the following are met:

Antibody positive: Member is anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive

Disease classification: Member has Myasthenia Gravis Foundation of America (MGFA) clinical classification II to IV

Symptom severity: Member has a MG activities of daily living (MG-ADL) total score of 5 or more>=5

Prior therapy: Member had an inadequate response with two or more conventional therapies (e.g., pyridostigmine, corticosteroids, immunosuppressants such as azathioprine, cyclosporine, mycophenolate) OR required chronic treatment with plasmapheresis, plasma exchange (PE) or intravenous immunoglobulin (IVIG) in addition to immunosuppressant therapy

Concomitant therapy stability: Member is on a stable dose of at least one of: acetylcholinesterase inhibitors (e.g., pyridostigmine), steroids (>=1 month), or nonsteroidal immunosuppressive therapy (NSIST) (>=6 months)

Members who do not meet the specified coverage requirements are not eligible for authorization of Rystiggo. Specifically, coverage is restricted to adults with antibody-positive generalized myasthenia gravis who meet all of the following: documented anti-AChR or anti-MuSK antibody positivity; MGFA clinical classification II–IV; an MG-ADL total score of ≥ 5 is required for consideration (members with scores below this threshold do not meet severity requirements); an inadequate response to two or more conventional therapies or need for chronic plasmapheresis/PE or IVIG plus immunosuppressant therapy; and stability on at least one concomitant therapy (acetylcholinesterase inhibitor, steroids for ≥1 month, or a nonsteroidal immunosuppressant for ≥6 months).

Provider Requirements and Authorization Process

Prior Authorization

Prior Authorization Required

Prior authorization is required for initial treatment. Initial approval may be granted for up to 6 months when ALL clinical criteria are met. Reauthorization may be granted for up to 12 months when there is documentation of continued clinical benefit and no unacceptable toxicity or disease progression while on therapy.

Initial authorization: up to 6 months when criteria for generalized myasthenia gravis (gMG) are satisfied
Reauthorization: up to 12 months when member demonstrates positive response (e.g., improvement in MG-ADL or QMG scores) and no unacceptable toxicity or disease progression

Step Therapy

Prior Therapy Requirement

For initial therapy, the member must have had an inadequate response to two or more conventional therapies OR required chronic plasmapheresis/plasma exchange (PE) or IVIG in addition to immunosuppressant therapy.

Examples of conventional therapies: pyridostigmine, corticosteroids, immunosuppressants (e.g., azathioprine, cyclosporine, mycophenolate mofetil)
Chronic PE/plasmapheresis or IVIG counts as meeting the prior therapy requirement when ongoing need is documented

Documentation Required

Required Documentation

Submission of the following documentation is required to initiate review: For initial requests, provide chart notes, medical records, or claims history documenting antibody test results, MGFA classification, MG-ADL score, details of prior therapies, and history of plasmapheresis/PE or IVIG if applicable. For continuation requests, provide chart notes or medical records documenting positive clinical response to therapy.

Initial requests must include: positive AChR or MuSK antibody test; MGFA clinical classification (II–IV); MG-ADL total score (≥5); documentation of use of AChE inhibitor, steroids, NSIST, and/or IVIG where applicable; prior chronic plasmapheresis/PE if applicable
Continuation requests must include: documentation of clinical improvement (e.g., MG-ADL or QMG compared to baseline) and absence of unacceptable toxicity or disease progression

Denial Risk

Not Medically Necessary if Criteria Not Met

Rystiggo (rozanolixizumab-noli) is considered not medically necessary and will be denied when the member does not meet the specified clinical criteria for generalized myasthenia gravis, including antibody positivity, MGFA class II–IV, MG-ADL ≥5, prior therapy requirements, and being on a stable dose of at least one supportive therapy.

Denial will be issued if member is not AChR- or MuSK-antibody positive
Denial will be issued if MGFA classification is outside II–IV or MG-ADL score is <5
Denial will be issued if prior therapy requirement (inadequate response to ≥2 conventional therapies or need for chronic PE/IVIG) is not documented
Denial will be issued if required documentation (initial or continuation) is not provided

Definitions and Scores

gMG indication — treatment indication definition

Indication statementTreatment of generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive

PopulationAdult patients with gMG who test positive for AChR or MuSK antibodies

Coverage linkageAntibody positivity is a required criterion for initial 6-month authorization

MG-ADL — definition and policy threshold

DefinitionMG-ADL (Myasthenia Gravis Activities of Daily Living) score quantifies functional impact of myasthenia gravis and is required documentation for prior authorization

Policy thresholdPolicy requires a MG-ADL total score of 5 or more for initial coverage consideration

Documentation requirementInitial requests must include MG-ADL score in chart notes or medical records

OpenPayer

Rystiggo (rozanolixizumab-noli) — Prior Authorization and Coverage Criteria for Generalized Myasthenia Gravis

Coverage Criteria for Rystiggo (rozanolixizumab-noli)

Coding and Scoring

Provider Requirements and Authorization Process

Background

Definitions and Scores