Prior Authorization Required

Prior authorization is required for Uplizna (inebilizumab-cdon) for generalized myasthenia gravis (gMG). Initial and reauthorization approvals will be for no more than 12 months. Uplizna must be dosed according to the U.S. FDA labeled dosing and administered no sooner than two weeks after the first initial dose and every 6 months thereafter for subsequent infusions for gMG. For NMOSD and IgG4‑RD indications, initial and reauthorization will be for no more than 12 months and dosing must follow the U.S. FDA labeled regimens.

• Initial and reauthorization: ≤ 12 months
• gMG dosing interval: no sooner than 2 weeks after first initial dose, then every 6 months
• NMOSD/IgG4‑RD: U.S. FDA labeled dosing

gMG Prior Authorization Documentation

For generalized myasthenia gravis (gMG), the following must be included with the prior authorization submission: positive serologic test results for anti‑AChR or anti‑MuSK antibodies; documentation of MGFA Clinical Classification (class II, III, or IV) at initiation; baseline Myasthenia Gravis Activities of Daily Living (MG‑ADL) total score ≥ 5; and prior therapy history consistent with serostatus-based requirements. Prescriptions must be by, or in consultation with, a neurologist.

• Serologic test results: anti‑AChR or anti‑MuSK
• MGFA class documentation: II, III, or IV at initiation
• MG‑ADL score: baseline ≥ 5
• Prescriber: neurologist (or consult)

Required Supporting Medical Records

Required clinical documentation for gMG prior authorization includes chart notes and laboratory reports showing diagnosis, serostatus, MGFA class, baseline and follow‑up MG‑ADL scores, and a detailed prior treatment history (agents, doses, dates, and response). Failure to submit complete records is grounds for denial or delay.

• Chart notes confirming gMG diagnosis and that patient has not previously failed Uplizna
• Serologic test results (anti‑AChR or anti‑MuSK)
• MGFA classification and MG‑ADL baseline score (≥ 5)
• Detailed prior therapy history: immunosuppressive agents, IVIG/PLEX courses, rituximab/glucocorticoid trials, dates, and outcomes

Documentation Insufficiency — Denial Risk

Denial risk increases when required documentation is missing or incomplete. Absent items that commonly trigger denials include: missing serology, no MGFA or MG‑ADL documentation, lack of prior therapy details (agents, duration, response), and no specialist-consult or neurologist attestation.

• Missing serologic confirmation (anti‑AChR or anti‑MuSK)
• No MGFA class or MG‑ADL baseline score
• Incomplete prior therapy history (agents, duration, outcomes)
• No documentation of specialist involvement

Prior Therapy Requirements by Serostatus

Prior therapy requirements differ by serostatus for gMG: anti‑AChR antibody positive patients must have either (a) history of failure of at least two immunosuppressive agents over ≥ 12 months (e.g., azathioprine, corticosteroids, cyclosporine, methotrexate, mycophenolate), or (b) history of failure of at least one immunosuppressive therapy plus ≥ 4 courses of plasmapheresis/plasma exchange and/or immune globulin over ≥ 12 months without symptom control. Anti‑MuSK antibody positive patients must have history of failure of at least one immunosuppressive agent over ≥ 12 months.

• Anti‑AChR positive: ≥2 immunosuppressive agent failures over ≥12 months OR ≥1 immunosuppressive failure plus ≥4 courses of PLEX/IVIG over ≥12 months
• Anti‑MuSK positive: ≥1 immunosuppressive agent failure over ≥12 months

Prior Rituximab (or Glucocorticoid) Requirement

For NMOSD and IgG4‑RD indications, a history of rituximab failure, intolerance, or contraindication must be documented prior to approval unless clinical criteria specify otherwise. If rituximab was not tolerated or is contraindicated, documentation must include provider attestation that the same intolerance or severe adverse event would not be expected with Uplizna.

• NMOSD: history of rituximab failure OR intolerance/contraindication with attestation
• IgG4‑RD: history of failure/contraindication/intolerance to glucocorticoids AND rituximab failure or documented intolerance/contraindication with attestation

Concurrent Therapy and Dosing Interval Conflicts

Uplizna must not be administered in combination with certain therapies for the same indication. For gMG, concurrent use with complement inhibitors (e.g., eculizumab, ravulizumab, zilucoplan), FcRn blockers (e.g., nipocalimab, rozanolixizumab, efgartigimod), or immune globulin (IVIG/SCIG) is prohibited. For NMOSD and IgG4‑RD, do not combine with disease‑modifying therapies for the same condition (e.g., rituximab, complement inhibitors, anti‑IL6 agents). Infusions given sooner than the allowable interval (e.g., <6 months for gMG maintenance or < labeled interval for other indications) may result in denial.

• Prohibited concurrent therapies for gMG: complement inhibitors, FcRn blockers, immune globulin
• Prohibited concurrent therapies for NMOSD/IgG4‑RD: disease‑modifying therapies for the same indication (e.g., rituximab, complement inhibitors, anti‑IL6)
• Dosing interval conflict: administering Uplizna sooner than allowed (gMG: <6 months after prior cycle) can cause denial