Does J9332 require prior authorization?

Yes, J9332 requires prior authorization (high confidence). At least one active policy explicitly requires prior authorization.

What is the Medicare reimbursement rate for J9332?

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

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`J9332`, Injection, efgartigimod alfa-fcab, 2mg

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

Medically necessary for CIDP in adults (age >=18) after prior failure or contraindication to IVIg and corticosteroids.
MG: adults (>=18) eligible if anti-AChR positive, MGFA II-IV, MG-ADL ≥5, and inadequate response/intolerance/contraindication to acetylcholinesterase inhibitor plus at least one immunosuppressive therapy.
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).
CIDP coverage criteria: efgartigimod alfa and hyaluronidase-qvfc (Vyvgart Hytrulo) may be considered medically necessary to treat CIDP after failure of or contraindication to immunoglobulin and corticosteroids.
MG coverage criteria: adults with generalized MG must meet all listed criteria (AChR antibody positive, MGFA Class II-IV, MG-ADL ≥5, and prior inadequate response/intolerance to an acetylcholinesterase inhibitor plus at least one immunosuppressive therapy).

20 Active Policies

ARKBLUE-EFGARTIGIMOD-E-G-VYVGART-6803ED4803, Efgartigimod (e.g., Vyvgart)

FLORIDA_BLUE-FLBLUE-EFGARTIGIMOD-ALFA-VYVGARTTM-AND-VYVGART-HYTRULO-EFGARTIGIMOD-6C34B6B051, efgartigimod alfa -Vyvgart and Vyvgart Hytrulo (efgartigimod alfa/hyaluronidase-qvfc)

BCBSLA-00790-C708843DC8, 00790 efgartigimod alfa (Vyvgart), efgartigimod alfa and hyaluronidase- human (Vyvgart Hytrulo)

POINT32HEALTH-MDMNG-14321, Vyvgart (efgartigimod alfa-fcab) and Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc)

MULTI

POINT32HEALTH-MDMNG-14331, Vyvgart (efgartigimod alfa-fcab), Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc)

MULTI

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

MULTI

BCBSND-EFGARTIGIMOD-VYVGART-ME-B7A0447123, Efgartigimod Vyvgart ME

BCBSNE-X-187-F0D284E7A7, VYVGART (PREAUTHORIZATION REQUIRED)

MODA-VYVGART-E2BEFBB978, Vyvgart (efgartigimod alfa-fcab)

HEALTHNET_OR-HNOR-EFGARTIGIMOD-ALFA-FCAB-EFGARTIGIMOD-HYALURONIDASE-QVFC-V-E3B73D871F, Efgartigimod Alfa-fcab, Efgartigimod/Hyaluronidase-qvfc (Vyvgart, Vyvgart Hytrulo); CP.PHAR.555

IBX-MEDICARE-ADVANTAGE-MA08-142E-424A2C53FC, Efgartigimod alfa-fcab (Vyvgart) and efgartigimod-alfa and hyaluronidase-qvfc (Vyvgart Hytrulo)

IBX-COMMERCIAL-08-01-84E-D9E65D41BF, Efgartigimod alfa - fcab (Vyvgart)

BCBSNM-RX501.141, Efgartigimod alfa-fcab or Efgartigimod alfa and hyaluronidase-qvfc

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

BCBSOK-RX501.141, Efgartigimod alfa-fcab or Efgartigimod alfa and hyaluronidase-qvfc

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-08-01-84E-F14DB9FA96, Efgartigimod alfa - fcab (Vyvgart)

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

Have a follow-up question?

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

Ask Backwork about J9332 Sign up free

J9332, Injection, efgartigimod alfa-fcab, 2mg

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

Medically necessary for CIDP in adults (age >=18) after prior failure or contraindication to IVIg and corticosteroids.
MG: adults (>=18) eligible if anti-AChR positive, MGFA II-IV, MG-ADL ≥5, and inadequate response/intolerance/contraindication to acetylcholinesterase inhibitor plus at least one immunosuppressive therapy.
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).
CIDP coverage criteria: efgartigimod alfa and hyaluronidase-qvfc (Vyvgart Hytrulo) may be considered medically necessary to treat CIDP after failure of or contraindication to immunoglobulin and corticosteroids.
MG coverage criteria: adults with generalized MG must meet all listed criteria (AChR antibody positive, MGFA Class II-IV, MG-ADL ≥5, and prior inadequate response/intolerance to an acetylcholinesterase inhibitor plus at least one immunosuppressive therapy).

20 Active Policies

ARKBLUE-EFGARTIGIMOD-E-G-VYVGART-6803ED4803, Efgartigimod (e.g., Vyvgart)

FLORIDA_BLUE-FLBLUE-EFGARTIGIMOD-ALFA-VYVGARTTM-AND-VYVGART-HYTRULO-EFGARTIGIMOD-6C34B6B051, efgartigimod alfa -Vyvgart and Vyvgart Hytrulo (efgartigimod alfa/hyaluronidase-qvfc)

BCBSLA-00790-C708843DC8, 00790 efgartigimod alfa (Vyvgart), efgartigimod alfa and hyaluronidase- human (Vyvgart Hytrulo)

POINT32HEALTH-MDMNG-14321, Vyvgart (efgartigimod alfa-fcab) and Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc)

MULTI

POINT32HEALTH-MDMNG-14331, Vyvgart (efgartigimod alfa-fcab), Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc)

MULTI

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

MULTI

BCBSND-EFGARTIGIMOD-VYVGART-ME-B7A0447123, Efgartigimod Vyvgart ME

BCBSNE-X-187-F0D284E7A7, VYVGART (PREAUTHORIZATION REQUIRED)

MODA-VYVGART-E2BEFBB978, Vyvgart (efgartigimod alfa-fcab)

HEALTHNET_OR-HNOR-EFGARTIGIMOD-ALFA-FCAB-EFGARTIGIMOD-HYALURONIDASE-QVFC-V-E3B73D871F, Efgartigimod Alfa-fcab, Efgartigimod/Hyaluronidase-qvfc (Vyvgart, Vyvgart Hytrulo); CP.PHAR.555

IBX-MEDICARE-ADVANTAGE-MA08-142E-424A2C53FC, Efgartigimod alfa-fcab (Vyvgart) and efgartigimod-alfa and hyaluronidase-qvfc (Vyvgart Hytrulo)

IBX-COMMERCIAL-08-01-84E-D9E65D41BF, Efgartigimod alfa - fcab (Vyvgart)

BCBSNM-RX501.141, Efgartigimod alfa-fcab or Efgartigimod alfa and hyaluronidase-qvfc

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

BCBSOK-RX501.141, Efgartigimod alfa-fcab or Efgartigimod alfa and hyaluronidase-qvfc

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-08-01-84E-F14DB9FA96, Efgartigimod alfa - fcab (Vyvgart)

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

Have a follow-up question?

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

Ask Backwork about J9332 Sign up free

`J9332`, Injection, efgartigimod alfa-fcab, 2mg

Prior Authorization

Medicare Pricing

Documentation Required

Key Coverage Criteria

20 Active Policies

Related Codes

Have a follow-up question?

`J9332`, Injection, efgartigimod alfa-fcab, 2mg

Prior Authorization

Medicare Pricing

Documentation Required

Key Coverage Criteria

20 Active Policies

Related Codes

Have a follow-up question?

J9332, Injection, efgartigimod alfa-fcab, 2mg

Prior Authorization

Medicare Pricing

Documentation Required

Key Coverage Criteria

20 Active Policies

Related Codes

Have a follow-up question?

J9332, Injection, efgartigimod alfa-fcab, 2mg

Prior Authorization

Medicare Pricing

Documentation Required

Key Coverage Criteria

20 Active Policies

Related Codes

Have a follow-up question?

`J9332`, Injection, efgartigimod alfa-fcab, 2mg

`J9332`, Injection, efgartigimod alfa-fcab, 2mg