J9333 — Injection, rozanolixizumab-noli, 1 mg
HCPCS/CPT
Prior Authorization
No Prior Auth Required
Code is covered without prior authorization (high confidence)
Medicare Pricing
Work RVU
0.00
Facility
N/A
Non-Facility
N/A
Documentation Required
- Submission of medical records (e.g., chart notes, laboratory values) confirming the required diagnostic and clinical criteria for initial therapy (drug-specific): diagnosis of gMG or CIDP as applicable, antibody test results (anti-AChR and/or anti-MuSK), MGFA Clinical Classification, MG-ADL total score at initiation.
- For initial gMG therapy (Rystiggo): documentation that patient has not failed a previous course of Rystiggo therapy; positive serologic test for anti-AChR OR anti-MuSK antibodies; MGFA class II–IV at initiation; MG-ADL total score ≥ 5 at initiation; prior immunosuppressive therapy history (number and duration of agents failed) or history of required plasmapheresis/IVIG courses if applicable.
- For initial gMG therapy (Vyvgart/Vyvgart Hytrulo): documentation that patient has not failed a previous course of Vyvgart or Vyvgart Hytrulo; positive serologic test for anti-AChR antibodies; MGFA class II–IV at initiation; MG-ADL total score ≥ 5 at initiation; prior immunosuppressive therapy history (number and duration of agents failed) or history of required plasmapheresis/IVIG courses if applicable.
Key Coverage Criteria
- Rystiggo (rozanolixizumab-noli) intravenous: Medically necessary for the treatment of generalized myasthenia gravis (gMG) in patients who are anti-acetylcholine receptor (AChR) antibody positive or anti-muscle-specific tyrosine kinase (MuSK) antibody positive when all Rystiggo coverage criteria are met (see limitations/documentation).
- Vyvgart (efgartigimod alfa-fcab) intravenous: Medically necessary for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-AChR antibody positive when all Vyvgart coverage criteria are met (see limitations/documentation).
- Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) vial subcutaneous (medical benefit): Medically necessary for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-AChR antibody positive when all Vyvgart/Vyvgart Hytrulo coverage criteria are met (see limitations/documentation).
- Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for self-administered subcutaneous injection: Generally obtained under the pharmacy benefit (not medical benefit) unless member's benefit plan specifies otherwise; exception for UnitedHealthcare of California delegated provider groups (medical benefit prior authorization may apply).
- Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for chronic inflammatory demyelinating polyneuropathy (CIDP): Medically necessary for treatment of CIDP when all CIDP-specific coverage criteria are met (progressive symptoms ≥2 months, symptomatic polyradiculoneuropathy affecting >1 limb, required electrodiagnostic findings per EFNS/PNS, prior trials/failures/intolerance/contraindications to corticosteroids and immunoglobulin as specified, etc.).
- Authorization of hospital outpatient facility infusion services (place of service codes 19 and 22) for specialty medications and IVIG/SCIG when outpatient hospital facility-based administration is medically necessary and the member meets at least one of the criteria below.
14 Active Policies
UHC-POL-fcrn-blockers — FcRn Blockers (Rystiggo, Vyvgart, & Vyvgart Hytrulo)
UHC-POL-provider-administered-drugs-soc — Provider Administered Drugs – Site of Care
UMR-POL-UMR-fcrn-blockers — FcRn Blockers (Rystiggo, Vyvgart, & Vyvgart Hytrulo)
UMR-POL-UMR-provider-administered-drugs-soc — Provider Administered Drugs – Site of Care
SUREST-POL-SUREST-fcrn-blockers
Related Codes
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