CurrentBlue Cross Blue Shield - IowaPolicy N/A

Rystiggo (rozanolixizumab-noli) — coverage criteria for generalized myasthenia gravis

Policy governs medical necessity and authorization criteria for Rystiggo (rozanolixizumab-noli) in adults with generalized myasthenia gravis who are AChR- or MuSK-antibody positive. It applies to Wellmark/Blue Cross and Blue Shield members per their contract benefits.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyRystiggo (rozanolixizumab-noli) — coverage criteria for generalized myasthenia gravis

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization for Rystiggo with documentation of positive AChR or MuSK antibody, MGFA class II–IV, MG-ADL ≥5, and prior inadequate response to conventional therapies.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 moinitial authorization duration

6 mocontinuation authorization duration

≥5MG-ADL threshold

II–IVMGFA class required

J9333HCPCS

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Coverage Criteria for Rystiggo (rozanolixizumab-noli)

inv-01: Initial Therapy

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

Initial Approval for gMG: Member is anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive

Initial Approval for gMG: Member has Myasthenia Gravis Foundation of America (MGFA) clinical classification II to IV

Initial Approval for gMG: Member has a Myasthenia Gravis Activities of Daily Living (MG-ADL) total score of 5 or more>= 5

Initial Approval for gMG: Member is on a stable dose of at least one of the following: acetylcholinesterase inhibitors (e.g., pyridostigmine), steroids (at least 1 month of treatment), or nonsteroidal immunosuppressive therapy (NSIST) (at least 6 months; e.g., azathioprine, mycophenolate mofetil)

Initial Approval for gMG: Member had an inadequate response to two or more conventional therapies (e.g., pyridostigmine, corticosteroids, immunosuppressants such as azathioprine, cyclosporine, mycophenolate) OR required chronic plasmapheresis/plasma exchange (PE) or IVIG in addition to immunosuppressant therapy

Authorization duration 6 months

inv-02: Continuation Therapy

Authorization of 6 months may be granted for continued treatment when the following is met:

Continuation Approval: No evidence of unacceptable toxicity or disease progression while on the current regimen compared to baseline in Quantitative Myasthenia Gravis (QMG) total score

Authorization duration 6 months

This policy is applied according to the member’s contract benefits in effect at the time services are rendered. Benefit determinations (including exclusions, limitations, or exceptions) may vary by contract and must be verified for each member. This medical policy may not apply to the Federal Employee Program (FEP); benefits for FEP members are determined by the Federal Employee Program.

Rystiggo (rozanolixizumab-noli) is considered not medically necessary for members who do not meet the coverage criteria set forth in this policy.

Coding and Clinical Thresholds

Covered HCPCS CodesHCPCSCovered

J9333

injection, rozanolixizumab-noli; mg (effective 1/1/24)

inv-06: MG-ADL total score — threshold value for eligibility

MG-ADL total score threshold>= 5

Use for eligibilityMG-ADL total score of 5 or more is required for initial approval

Documented on requestMG-ADL must be provided in initial documentation (chart notes/medical records)

Provider Requirements and Authorization Actions

Prior Authorization

Prior Authorization Required

Prior authorization is required for Rystiggo (rozanolixizumab-noli). Authorization may be granted for up to 6 months when all initial approval criteria are met.

Prior authorization duration: up to 6 months when initial criteria satisfied

Denial Risk

Denial for Unmet Criteria

Rystiggo is considered not medically necessary and will be denied when the member does not meet the specified clinical and treatment criteria for generalized myasthenia gravis (gMG).

Denial applies when member is antibody-negative, MGFA class outside II–IV, MG‑ADL score <5, lacks required prior therapies, or when required documentation is not provided

Background

Rystiggo (rozanolixizumab-noli) is indicated for the treatment of generalized myasthenia gravis (gMG) in adults who are anti‑acetylcholine receptor (AChR) or anti‑muscle‑specific tyrosine kinase (MuSK) antibody positive. Coverage under this policy aligns with the FDA‑approved indication and requires documentation of antibody positivity, clinical classification by the Myasthenia Gravis Foundation of America (MGFA) within class II–IV, and an MG‑ADL total score meeting the policy threshold of MG‑ADL ≥ 5 for initial authorization.

Definitions and Clinical Scales

inv-12: FDA-Approved Indication — treatment indication for gMG in adults who are anti-AChR or anti-MuSK antibody positive

FDA‑approved indicationTreatment of generalized myasthenia gravis (gMG) in adult patients who are anti‑acetylcholine receptor (AChR) or anti‑muscle‑specific tyrosine kinase (MuSK) antibody positive

Patient populationAdults with gMG who are AChR‑ or MuSK‑antibody positive

Alignment with coverage intentCoverage criteria align with the FDA‑approved indication requiring antibody positivity

inv-13: MG-ADL — Myasthenia Gravis Activities of Daily Living score; threshold >=5 used for eligibility

MG-ADL definitionMyasthenia Gravis Activities of Daily Living (MG‑ADL) score — total score used to assess functional status

Required score for coverage