Does J9333 require prior authorization?

Yes, J9333 requires prior authorization (high confidence). At least one active policy explicitly requires prior authorization.

What is the Medicare reimbursement rate for J9333?

Medicare facility rate: N/A. Non-facility rate: N/A. Work RVU: 0.00.

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`J9333`, Injection, rozanolixizumab-noli, 1 mg

HCPCS/CPT

Prior Authorization

Prior Auth Required

At least one active policy explicitly requires 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, etc.) confirming all of the following:  Patient has not failed a previous course of Imaavy therapy; and  Diagnosis of generalized myasthenia gravis (gMG); and  One of the following: – Positive serologic test for anti-AChR antibodies; or – Positive serologic test for anti-MuSK antibodies and  Patient has a Myasthenia Gravis Foundation of America (MGFA) Clinical Classification of class II, III, or IV at initiation of therapy; and  Patient has a Myasthenia Gravis Activities of Daily Living scale (MG-ADL) total score ≥ 5 at initiation of therapy
Submission of medical records (e.g., chart notes, laboratory values, etc.) confirming all of the following:  Patient has not failed a previous course of Imaavy therapy; and  Diagnosis of generalized myasthenia gravis (gMG); and  One of the following: – Positive serologic test for anti-AChR antibodies; or – Positive serologic test for anti-MuSK antibodies and  Patient has a Myasthenia Gravis Foundation of America (MGFA) Clinical Classification of class II, III, or IV at initiation of therapy; and  Patient has a Myasthenia Gravis Activities of Daily Living scale (MG-ADL) total score ≥ 5 at initiation of therapy and o One of the following (For Medicare reviews, refer to the CMS section.*): – History of failure of at least two immunosuppressive agents over the course of at least 12 months (e.g., azathioprine, corticosteroids, cyclosporine, methotrexate, mycophenolate, etc.); or – Patient has a history of failure of at least one immunosuppressive therapy and has required four or more courses of plasmapheresis/plasma exchanges and/or immune globulin over the course of at least 12 months without symptom control or  If anti-muscle-specific tyrosine kinase (MuSK) antibody positive: – History of failure of at least one immunosuppressive agent over the course of at least 12 months (e.g., azathioprine, corticosteroids, cyclosporine, methotrexate, mycophenolate, etc.) and o Patient is not receiving Imaavy in combination with any of the following:  A CD19-directed cytolytic antibody [e.g., Uplizna (inebilizumab)]; and  A complement inhibitor [e.g., eculizumab, Ultomiris (ravulizumab), Zilbrysq (zilucoplan)]; and  An FcRn blocker [e.g., Rystiggo (rozanolixizumab-noli), Vyvgart (efgartigimod alfa-fcab), Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc)]; and  An immune globulin (e.g., Hizentra, Privigen, Gammagard) and o Imaavy is dosed according to the US FDA labeled dosing for gMG; and o Prescribed by, or in consultation with, a neurologist; and o Initial authorization will be for no more than 12 months

Key Coverage Criteria

This policy addresses only the determination of medical necessity for the hospital outpatient setting for infusion and injectable therapy; the medical necessity of the pharmacologic or biologic medication itself may be reviewed separately.
Requests for select medications intended for administration in a hospital outpatient setting will be directed to a preferred alternative site of care (non-hospital affiliated outpatient facility or home).
Rozanolixizumab-noli is medically necessary for generalized myasthenia gravis (gMG) in adults who are anti-AChR or anti-MuSK antibody positive, aged 18+, MGFA class II–IVa, MG-ADL ≥3 with ≥3 non-ocular points, IgG ≥5.5 g/L, and failure/intolerance to at least one acetylcholinesterase inhibitor or immunosuppressive therapy as specified.
Imaavy is proven for the treatment of generalized myasthenia gravis in patients who are anti-acetylcholine receptor (AChR) antibody positive or antimuscle-specific tyrosine kinase (MuSK) antibody positive. Imaavy is medically necessary for the treatment of generalized myasthenia gravis in patients who are anti-AChR antibody positive or anti-MuSK antibody positive when all of the following criteria are met:
Imaavy is proven for the treatment of generalized myasthenia gravis in patients who are anti-acetylcholine receptor (AChR) antibody positive or antimuscle-specific tyrosine kinase (MuSK) antibody positive. Imaavy is medically necessary for the treatment of generalized myasthenia gravis in patients who are anti-AChR antibody positive or anti-MuSK antibody positive when all of the following criteria are met: Initial Therapy
Rystiggo is proven for the treatment of generalized myasthenia gravis in patients who are anti-acetylcholine receptor (AChR) antibody positive or antimuscle-specific tyrosine kinase (MuSK) antibody positive. Rystiggo is medically necessary for the treatment of generalized myasthenia gravis in patients who are anti-AChR antibody positive or anti-MuSK antibody positive when all of the following criteria are met: Initial Therapy

20 Active Policies

ARKBLUE-ROZANOLIXIZUMAB-NOLI-E-G-RYSTIGGO-DA2CC0ABA0, Rozanolixizumab-noli (e.g., Rystiggo)

FLORIDA_BLUE-FLBLUE-RYSTIGGO-BE1ACECA09, Rystiggo

BCBSLA-00865-9D91B9C91A, 00865 rozanolixizumab-noli (Rystiggo)

BCBSM-2177386-1B07278B14, RYSTIGGO (ROZANOLIXIZUMAB-NOLI)

HEALTHPARTNERS-CC-ENTRY-252184, Neonatal Fc receptor antagonists (Vyvgart, Vyvgart Hytrulo, Rystiggo, Imaavy)

MULTI

POINT32HEALTH-MDMNG-13696, Rystiggo (rozanolixizumab-noll)

MULTI

POINT32HEALTH-MDMNG-13686, Rystiggo (rozanolixizumab-noli)

MULTI

BCBSNE-X-131-5053ACE7BD, ULTOMIRIS, PIASKY, UPLIZNA, EMPAVELI, PIASKY,RYSTIGGO, IMAAVY

MODA-RYSTIGGO-DE87B0BC10, Rystiggo (rozanolixizumab-noli)

HEALTHNET_OR-HNOR-ROZANOLIXIZUMAB-NOLI-RYSTIGGO-CP-PHAR-648-680F938B6A, Rozanolixizumab-noli (Rystiggo); CP.PHAR.648

IBX-MEDICARE-ADVANTAGE-MA08-164A-3AF58A9B5C, Rozanolixizumab-noli (Rystiggo)

IBX-COMMERCIAL-08-02-08A-30C0D4B936, Rozanolixizumab-noli (Rystiggo)

BCBSNM-ADM1001.034, Specialty Medication Administration Site of Care

BCBSOK-RX501.161, Rozanolixixumab-noli

BCBSOK-ADM1001.034, Specialty Medication Administration Site of Care

UMR-POL-UMR-fcrn-blockers, FcRn Blockers

UMR-POL-UMR-provider-administered-drugs-soc, Provider Administered Drugs – Site of Care

AMERIHEALTH-COMMERCIAL-08-02-08A-E8FD46D972, Rozanolixizumab-noli (Rystiggo)

SUREST-POL-SUREST-fcrn-blockers, FcRn Blockers

AMERIHEALTH-MEDICARE-ADVANTAGE-MA08-164A-3697DB9DBA, Rozanolixizumab-noli (Rystiggo)

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Ask Backwork about documentation requirements, denial risks, or coverage in your state.

Ask Backwork about J9333 Sign up free

J9333, Injection, rozanolixizumab-noli, 1 mg

HCPCS/CPT

Prior Authorization

Prior Auth Required

At least one active policy explicitly requires 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, etc.) confirming all of the following:  Patient has not failed a previous course of Imaavy therapy; and  Diagnosis of generalized myasthenia gravis (gMG); and  One of the following: – Positive serologic test for anti-AChR antibodies; or – Positive serologic test for anti-MuSK antibodies and  Patient has a Myasthenia Gravis Foundation of America (MGFA) Clinical Classification of class II, III, or IV at initiation of therapy; and  Patient has a Myasthenia Gravis Activities of Daily Living scale (MG-ADL) total score ≥ 5 at initiation of therapy
Submission of medical records (e.g., chart notes, laboratory values, etc.) confirming all of the following:  Patient has not failed a previous course of Imaavy therapy; and  Diagnosis of generalized myasthenia gravis (gMG); and  One of the following: – Positive serologic test for anti-AChR antibodies; or – Positive serologic test for anti-MuSK antibodies and  Patient has a Myasthenia Gravis Foundation of America (MGFA) Clinical Classification of class II, III, or IV at initiation of therapy; and  Patient has a Myasthenia Gravis Activities of Daily Living scale (MG-ADL) total score ≥ 5 at initiation of therapy and o One of the following (For Medicare reviews, refer to the CMS section.*): – History of failure of at least two immunosuppressive agents over the course of at least 12 months (e.g., azathioprine, corticosteroids, cyclosporine, methotrexate, mycophenolate, etc.); or – Patient has a history of failure of at least one immunosuppressive therapy and has required four or more courses of plasmapheresis/plasma exchanges and/or immune globulin over the course of at least 12 months without symptom control or  If anti-muscle-specific tyrosine kinase (MuSK) antibody positive: – History of failure of at least one immunosuppressive agent over the course of at least 12 months (e.g., azathioprine, corticosteroids, cyclosporine, methotrexate, mycophenolate, etc.) and o Patient is not receiving Imaavy in combination with any of the following:  A CD19-directed cytolytic antibody [e.g., Uplizna (inebilizumab)]; and  A complement inhibitor [e.g., eculizumab, Ultomiris (ravulizumab), Zilbrysq (zilucoplan)]; and  An FcRn blocker [e.g., Rystiggo (rozanolixizumab-noli), Vyvgart (efgartigimod alfa-fcab), Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc)]; and  An immune globulin (e.g., Hizentra, Privigen, Gammagard) and o Imaavy is dosed according to the US FDA labeled dosing for gMG; and o Prescribed by, or in consultation with, a neurologist; and o Initial authorization will be for no more than 12 months

Key Coverage Criteria

This policy addresses only the determination of medical necessity for the hospital outpatient setting for infusion and injectable therapy; the medical necessity of the pharmacologic or biologic medication itself may be reviewed separately.
Requests for select medications intended for administration in a hospital outpatient setting will be directed to a preferred alternative site of care (non-hospital affiliated outpatient facility or home).
Rozanolixizumab-noli is medically necessary for generalized myasthenia gravis (gMG) in adults who are anti-AChR or anti-MuSK antibody positive, aged 18+, MGFA class II–IVa, MG-ADL ≥3 with ≥3 non-ocular points, IgG ≥5.5 g/L, and failure/intolerance to at least one acetylcholinesterase inhibitor or immunosuppressive therapy as specified.
Imaavy is proven for the treatment of generalized myasthenia gravis in patients who are anti-acetylcholine receptor (AChR) antibody positive or antimuscle-specific tyrosine kinase (MuSK) antibody positive. Imaavy is medically necessary for the treatment of generalized myasthenia gravis in patients who are anti-AChR antibody positive or anti-MuSK antibody positive when all of the following criteria are met:
Imaavy is proven for the treatment of generalized myasthenia gravis in patients who are anti-acetylcholine receptor (AChR) antibody positive or antimuscle-specific tyrosine kinase (MuSK) antibody positive. Imaavy is medically necessary for the treatment of generalized myasthenia gravis in patients who are anti-AChR antibody positive or anti-MuSK antibody positive when all of the following criteria are met: Initial Therapy
Rystiggo is proven for the treatment of generalized myasthenia gravis in patients who are anti-acetylcholine receptor (AChR) antibody positive or antimuscle-specific tyrosine kinase (MuSK) antibody positive. Rystiggo is medically necessary for the treatment of generalized myasthenia gravis in patients who are anti-AChR antibody positive or anti-MuSK antibody positive when all of the following criteria are met: Initial Therapy

20 Active Policies

ARKBLUE-ROZANOLIXIZUMAB-NOLI-E-G-RYSTIGGO-DA2CC0ABA0, Rozanolixizumab-noli (e.g., Rystiggo)

FLORIDA_BLUE-FLBLUE-RYSTIGGO-BE1ACECA09, Rystiggo

BCBSLA-00865-9D91B9C91A, 00865 rozanolixizumab-noli (Rystiggo)

BCBSM-2177386-1B07278B14, RYSTIGGO (ROZANOLIXIZUMAB-NOLI)

HEALTHPARTNERS-CC-ENTRY-252184, Neonatal Fc receptor antagonists (Vyvgart, Vyvgart Hytrulo, Rystiggo, Imaavy)

MULTI

POINT32HEALTH-MDMNG-13696, Rystiggo (rozanolixizumab-noll)

MULTI

POINT32HEALTH-MDMNG-13686, Rystiggo (rozanolixizumab-noli)

MULTI

BCBSNE-X-131-5053ACE7BD, ULTOMIRIS, PIASKY, UPLIZNA, EMPAVELI, PIASKY,RYSTIGGO, IMAAVY

MODA-RYSTIGGO-DE87B0BC10, Rystiggo (rozanolixizumab-noli)

HEALTHNET_OR-HNOR-ROZANOLIXIZUMAB-NOLI-RYSTIGGO-CP-PHAR-648-680F938B6A, Rozanolixizumab-noli (Rystiggo); CP.PHAR.648

IBX-MEDICARE-ADVANTAGE-MA08-164A-3AF58A9B5C, Rozanolixizumab-noli (Rystiggo)

IBX-COMMERCIAL-08-02-08A-30C0D4B936, Rozanolixizumab-noli (Rystiggo)

BCBSNM-ADM1001.034, Specialty Medication Administration Site of Care

BCBSOK-RX501.161, Rozanolixixumab-noli

BCBSOK-ADM1001.034, Specialty Medication Administration Site of Care

UMR-POL-UMR-fcrn-blockers, FcRn Blockers

UMR-POL-UMR-provider-administered-drugs-soc, Provider Administered Drugs – Site of Care

AMERIHEALTH-COMMERCIAL-08-02-08A-E8FD46D972, Rozanolixizumab-noli (Rystiggo)

SUREST-POL-SUREST-fcrn-blockers, FcRn Blockers

AMERIHEALTH-MEDICARE-ADVANTAGE-MA08-164A-3697DB9DBA, Rozanolixizumab-noli (Rystiggo)

Have a follow-up question?

Ask Backwork about documentation requirements, denial risks, or coverage in your state.

Ask Backwork about J9333 Sign up free

`J9333`, Injection, rozanolixizumab-noli, 1 mg

Prior Authorization

Medicare Pricing

Documentation Required

Key Coverage Criteria

20 Active Policies

Related Codes

Have a follow-up question?

`J9333`, Injection, rozanolixizumab-noli, 1 mg

Prior Authorization

Medicare Pricing

Documentation Required

Key Coverage Criteria

20 Active Policies

Related Codes

Have a follow-up question?

J9333, Injection, rozanolixizumab-noli, 1 mg

Prior Authorization

Medicare Pricing

Documentation Required

Key Coverage Criteria

20 Active Policies

Related Codes

Have a follow-up question?

J9333, Injection, rozanolixizumab-noli, 1 mg

Prior Authorization

Medicare Pricing

Documentation Required

Key Coverage Criteria

20 Active Policies

Related Codes

Have a follow-up question?

`J9333`, Injection, rozanolixizumab-noli, 1 mg

`J9333`, Injection, rozanolixizumab-noli, 1 mg