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efgartigimod (Vyvgart) — Medicare Part B coverage and prior authorization criteria

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Medicare (Part B) coverage, prior authorization, and clinical criteria for efgartigimod products (Vyvgart IV and Vyvgart Hytrulo SC) for treatment of generalized myasthenia gravis in eligible members.

Policy Summary

PayerAloha Care

Policyefgartigimod (Vyvgart) — Medicare Part B coverage and prior authorization criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateAug 17, 2023

Last ReviewAug 17, 2023

Next Review DateN/A

Key ActionSubmit prior authorization for Vyvgart under the Medical Benefit (Pharmacy Benefit not covered) with documentation of MGFA class II–IV, MG‑ADL ≥5, prior therapy trials, and proposed dosing.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

26 wksinitial PA

12 morenewal

18+min age

>=5MG-ADL

II-IVMGFA class

Medicare Part B Coverage Criteria

Medicare Part B coverage criteria

Approval and renewal criteria for efgartigimod (Vyvgart) for acetylcholine receptor antibody–positive (AChR‑Ab+) generalized myasthenia gravis under Medicare Part B.

Member is 18 years of age or older

Diagnosis of acetylcholine receptor antibody-positive (AChR-Ab+) generalized myasthenia gravis

Myasthenia Gravis Foundation of America (MGFA) Clinical Classification II–IV

Baseline MG‑ADL total score ≥ 5 with ≥ 50% of the score attributable to non‑ocular symptoms

ALL of the following

Pyridostigmine
Corticosteroids
At least two steroid‑sparing immunomodulating agents (choose two of: azathioprine, mycophenolate, cyclosporine, tacrolimus)
Intravenous immunoglobulin (IVIG)

Exclusions: not to be used in combination with maintenance immunoglobulin treatment, eculizumab, ravulizumab, rituximab, or rozanolixizumab

Dosing and administration consistent with FDA labeling: Vyvgart IV 10 mg/kg weekly × 4 (maximum single infusion 1200 mg for ≥120 kg) OR Vyvgart Hytrulo SC 1,008 mg–11,200 units weekly × 4; subsequent treatment cycles may be administered ≥50 days from the start of the prior cycle

Authorization scope: Medical benefit — prior authorization required; initial authorization length 26 weeks; renewals considered per renewal criteria

Renewal requirement: For continuation of therapy, member must have had a prior clinical response to efgartigimod and documentation of at least a 2‑point reduction in MG‑ADL total score from pre‑treatment baseline

Initial Therapy Criteria

Initial approval requirements and dosing for efgartigimod (Vyvgart) products.

Member is 18 years of age or older

Diagnosis of acetylcholine receptor antibody-positive (AChR-Ab+) generalized myasthenia gravis

MGFA Clinical Classification II–IV

Baseline MG‑ADL total score ≥ 5 with ≥50% due to non‑ocular symptoms

Trial and failure of ALL of the following prior therapies: pyridostigmine; corticosteroids; at least two immunomodulating agents (azathioprine, mycophenolate, cyclosporine, tacrolimus); and IVIG

Dosing: Vyvgart IV 10 mg/kg weekly × 4 (maximum 1200 mg per infusion for ≥120 kg) OR Vyvgart Hytrulo SC 1,008 mg–11,200 units weekly × 4

Subsequent treatment cycles: may be administered at least 50 days from the start of the prior treatment cycle

Initial authorization length: 26 weeks

Continuation / Renewal Therapy

Renewal (continuation) requirements for ongoing coverage of efgartigimod.

Diagnosis of myasthenia gravis remains documented

Member has experienced a prior clinical response to efgartigimod defined by reduction in signs or symptoms that impact daily function

Documented clinical improvement of at least a 2‑point reduction in MG‑ADL total score from pre‑treatment baseline

Renewal authorization length: 12 months when renewal criteria are met

Billing and Coding

Listed HCPCS / CPT codesmixed

J9332	Injection efgartigimod alfa-fcab 2mg (Vyvgart 400mg/20mL SDV), IV infusion (preferred).
J9334	Injection efgartigimod alfa 2 mg and hyaluronidase-qvfc (Vyvgart Hytrulo 1,008mg-11,200units/5.6mL SDV), SC administered.
96365	IV infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); initial, up to 1 hour.
96372	Therapeutic, prophylactic, or diagnostic injection (specify substance or drug); SC or IM.

FDA dosing interval

FDA dosing interval (initial)Initial: weekly x4 (Vyvgart IV 10 mg/kg weekly x4; Vyvgart Hytrulo SC 1,008 mg–11,200 units weekly x4)

FDA dosing interval (subsequent cycles)Subsequent cycles: at least 50 days from start of prior treatment cycle

IV maximum per infusionVyvgart IV: up to 1200 mg per infusion for patients ≥120 kg

Prior Authorization, Transition, and Site-of-Care Notes

Prior Authorization

Prior authorization required; list billing codes and PA durations

Prior authorization is required when efgartigimod (Vyvgart) is billed to the Medical Benefit; the Pharmacy Benefit is not covered. Initial prior authorization is issued for 26 weeks; renewals are for 12 months. Relevant billing codes include HCPCS J9332 (efgartigimod IV), J9334 (efgartigimod alfa and hyaluronidase — Vyvgart Hytrulo SC), and administration CPT codes 96365 (IV infusion, initial, up to 1 hour) and 96372 (therapeutic/prophylactic/diagnostic SC or IM injection).

Medical Benefit: Authorization Required; Pharmacy Benefit: Not Covered
Initial PA duration: 26 weeks; Renewal: 12 months
HCPCS: J9332 (Injection efgartigimod alfa-fcab 2mg; IV infusion)
HCPCS: J9334 (Injection efgartigimod alfa and hyaluronidase‑qvfc; SC administered)
CPT: 96365 (IV infusion, initial, up to 1 hour); 96372 (therapeutic/prophylactic/diagnostic injection; SC or IM)

Documentation Required

Medicare 90-day transition — active courses exempt during first 90 days

A 90-day transition period applies for new Medicare members: if a member is currently on an active course of the requested treatment (including when furnished by an out-of-network provider), Coverage and Step Therapy do not apply during the first 90 days of enrollment; after 90 days, Coverage and Step Therapy Criteria must be met for continued coverage.

Transition applies to new Medicare members for first 90 days of enrollment
Active courses begun prior to enrollment are not subject to Coverage or Step Therapy during transition
After 90 days, requests must meet Coverage and Step Therapy Criteria

Step Therapy

Step therapy: required for new starts — policy also states 'No step therapy'

For new starts, Medicare Part B Step Therapy Criteria must be met in addition to the policy's Coverage Criteria; the policy also states 'No step therapy.'

New-start requests require meeting Medicare Part B Step Therapy Criteria plus Coverage Criteria
Policy text simultaneously notes 'No step therapy' (policy language)

Note

Site-of-care: IV infusion (Vyvgart) vs SC injection (Vyvgart Hytrulo); use appropriate setting

Vyvgart (IV) is administered via intravenous infusion and Vyvgart Hytrulo is administered subcutaneously; administration should occur in an appropriate infusion or injection setting per the provider.

Vyvgart (efgartigimod alfa-fcab): IV infusion
Vyvgart Hytrulo (efgartigimod alfa + hyaluronidase): SC administration
Select setting appropriate for infusion or subcutaneous injection per provider judgment

Clinical Definitions and Scales

MG-ADL score (functional assessment)

MG-ADL minimum scoreTotal MG-ADL score ≥5 required for approval

Symptom distribution requirementAt least 50% of MG-ADL score must be due to non-ocular symptoms

Use in criteria setMG-ADL is required as part of initial approval criteria for AChR‑Ab+ generalized myasthenia gravis

MGFA Clinical Classification

Required MGFA class for coverageMGFA Clinical Classification Class II–IV

Role in approvalMGFA class II–IV is a required disease-severity criterion for initial therapy approval

Age contextApplies to members aged 18 years and older as part of initial criteria

Step Therapy Policy

Step	Requirement
{"text":"1","status":""}\|{"text":"For new starts, Medicare Part B step therapy criteria must be met in addition to coverage criteria before a request may be approved; policy also states 'No step therapy'.","status":""}

Quantity Limits and Product Names

Vyvgart / Vyvgart Hytrulo — Quantity limits

Quantity limits specifiedNot specified

Drugs referencedVyvgart (efgartigimod alfa-fcab) and Vyvgart Hytrulo (efgartigimod alfa + hyaluronidase)

Benefit scopeMedical Benefit: authorization required; Pharmacy Benefit: not covered

Policy Summary

PayerAloha Care

Policyefgartigimod (Vyvgart) — Medicare Part B coverage and prior authorization criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateAug 17, 2023

Last ReviewAug 17, 2023

Next Review DateN/A

SourceLink

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efgartigimod (Vyvgart) — Medicare Part B coverage and prior authorization criteria

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Sign up for all Aloha Care policy alerts

Know when Aloha Care releases new policies or updates existing guidance.

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Medicare Part B Coverage Criteria

Medicare Part B coverage criteria

Approval and renewal criteria for efgartigimod (Vyvgart) for acetylcholine receptor antibody–positive (AChR‑Ab+) generalized myasthenia gravis under Medicare Part B.

Member is 18 years of age or older

Diagnosis of acetylcholine receptor antibody-positive (AChR-Ab+) generalized myasthenia gravis

Myasthenia Gravis Foundation of America (MGFA) Clinical Classification II–IV

Baseline MG‑ADL total score ≥ 5 with ≥ 50% of the score attributable to non‑ocular symptoms

ALL of the following

Pyridostigmine
Corticosteroids
At least two steroid‑sparing immunomodulating agents (choose two of: azathioprine, mycophenolate, cyclosporine, tacrolimus)
Intravenous immunoglobulin (IVIG)

Exclusions: not to be used in combination with maintenance immunoglobulin treatment, eculizumab, ravulizumab, rituximab, or rozanolixizumab

Authorization scope: Medical benefit — prior authorization required; initial authorization length 26 weeks; renewals considered per renewal criteria

Initial Therapy Criteria

Initial approval requirements and dosing for efgartigimod (Vyvgart) products.

Member is 18 years of age or older

Diagnosis of acetylcholine receptor antibody-positive (AChR-Ab+) generalized myasthenia gravis

MGFA Clinical Classification II–IV

Baseline MG‑ADL total score ≥ 5 with ≥50% due to non‑ocular symptoms

Trial and failure of ALL of the following prior therapies: pyridostigmine; corticosteroids; at least two immunomodulating agents (azathioprine, mycophenolate, cyclosporine, tacrolimus); and IVIG

Dosing: Vyvgart IV 10 mg/kg weekly × 4 (maximum 1200 mg per infusion for ≥120 kg) OR Vyvgart Hytrulo SC 1,008 mg–11,200 units weekly × 4

Subsequent treatment cycles: may be administered at least 50 days from the start of the prior treatment cycle

Initial authorization length: 26 weeks

Continuation / Renewal Therapy

Renewal (continuation) requirements for ongoing coverage of efgartigimod.

Diagnosis of myasthenia gravis remains documented

Member has experienced a prior clinical response to efgartigimod defined by reduction in signs or symptoms that impact daily function

Documented clinical improvement of at least a 2‑point reduction in MG‑ADL total score from pre‑treatment baseline

Renewal authorization length: 12 months when renewal criteria are met

Billing and Coding

Listed HCPCS / CPT codesmixed

J9332	Injection efgartigimod alfa-fcab 2mg (Vyvgart 400mg/20mL SDV), IV infusion (preferred).
J9334	Injection efgartigimod alfa 2 mg and hyaluronidase-qvfc (Vyvgart Hytrulo 1,008mg-11,200units/5.6mL SDV), SC administered.
96365	IV infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); initial, up to 1 hour.
96372	Therapeutic, prophylactic, or diagnostic injection (specify substance or drug); SC or IM.

FDA dosing interval

FDA dosing interval (initial)Initial: weekly x4 (Vyvgart IV 10 mg/kg weekly x4; Vyvgart Hytrulo SC 1,008 mg–11,200 units weekly x4)

FDA dosing interval (subsequent cycles)Subsequent cycles: at least 50 days from start of prior treatment cycle

IV maximum per infusionVyvgart IV: up to 1200 mg per infusion for patients ≥120 kg

Prior Authorization, Transition, and Site-of-Care Notes

Prior Authorization

Prior authorization required; list billing codes and PA durations

Medical Benefit: Authorization Required; Pharmacy Benefit: Not Covered
Initial PA duration: 26 weeks; Renewal: 12 months
HCPCS: J9332 (Injection efgartigimod alfa-fcab 2mg; IV infusion)
HCPCS: J9334 (Injection efgartigimod alfa and hyaluronidase‑qvfc; SC administered)
CPT: 96365 (IV infusion, initial, up to 1 hour); 96372 (therapeutic/prophylactic/diagnostic injection; SC or IM)

Documentation Required

Medicare 90-day transition — active courses exempt during first 90 days

Transition applies to new Medicare members for first 90 days of enrollment
Active courses begun prior to enrollment are not subject to Coverage or Step Therapy during transition
After 90 days, requests must meet Coverage and Step Therapy Criteria

Step Therapy

Step therapy: required for new starts — policy also states 'No step therapy'

For new starts, Medicare Part B Step Therapy Criteria must be met in addition to the policy's Coverage Criteria; the policy also states 'No step therapy.'

New-start requests require meeting Medicare Part B Step Therapy Criteria plus Coverage Criteria
Policy text simultaneously notes 'No step therapy' (policy language)

Note

Site-of-care: IV infusion (Vyvgart) vs SC injection (Vyvgart Hytrulo); use appropriate setting

Vyvgart (IV) is administered via intravenous infusion and Vyvgart Hytrulo is administered subcutaneously; administration should occur in an appropriate infusion or injection setting per the provider.

Vyvgart (efgartigimod alfa-fcab): IV infusion
Vyvgart Hytrulo (efgartigimod alfa + hyaluronidase): SC administration
Select setting appropriate for infusion or subcutaneous injection per provider judgment

Clinical Definitions and Scales

MG-ADL score (functional assessment)

MG-ADL minimum scoreTotal MG-ADL score ≥5 required for approval

Symptom distribution requirementAt least 50% of MG-ADL score must be due to non-ocular symptoms

Use in criteria setMG-ADL is required as part of initial approval criteria for AChR‑Ab+ generalized myasthenia gravis

MGFA Clinical Classification

Required MGFA class for coverageMGFA Clinical Classification Class II–IV

Role in approvalMGFA class II–IV is a required disease-severity criterion for initial therapy approval

Age contextApplies to members aged 18 years and older as part of initial criteria

Step	Requirement
{"text":"1","status":""}\|{"text":"For new starts, Medicare Part B step therapy criteria must be met in addition to coverage criteria before a request may be approved; policy also states 'No step therapy'.","status":""}

Step

Requirement

{"text":"1","status":""}|{"text":"For new starts, Medicare Part B step therapy criteria must be met in addition to coverage criteria before a request may be approved; policy also states 'No step therapy'.","status":""}