RXMP-21 Efgartigimod (Vyvgart) Form

efgartigimod (Vyvgart)

Updated on: 10/25/2025

Page 1 of 2 Policy Number RXMP-21 Line of Business Medicaid & Medicare Effective Date 10/1/2023 (Medicaid), 1/1/2024 (Medicare) Revision Date 10/25/2025

Products: Vyvgart (efgartigimod alfa-fcab) IV infusion Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-gvfc) – SC administered

Override(s)
Approval Duration
Prior Authorization
Initial Request: 26 weeks Renewal: 12 months

HCPCS Description Medical Benefit: Authorization Required; Pharmacy Benefit: Not Covered J9332 Injection efgartigimod alfa-fcab 2mg (Vyvgart 400mg/20mL SDV), IV infusion (preferred) 96372 Therapeutic, prophylactic, or diagnostic injection (specify substance or drug); SC or IM 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

Medicare Criteria
Medicare Part B Coverage Criteria
Review using the most current Local Coverage Determination (LCD), National Coverage Determination (NCD), or Local Coverage Article (LCA) that applies to the Hawaii region. The LCD, NCD, or LCA can be found at: https://www.cms.gov/medicare-coverage-database/search.aspx. • No LCD/NCD/LCA found as of 10/25/2025. Review the criteria below Medicare Part B 90-Day Transition Period For new Medicare members, a 90-day transition period applies. During this time, 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. After the first 90 days of enrollment, Coverage and Step Therapy Criteria must be met for continued coverage. Medicare Part B Step Therapy Criteria • For new starts, Medicare Part B Step Therapy Criteria must be met in addition to Coverage Criteria before a request may be approved.
• No step therapy

Approval Criteria Products Vyvgart (efgartigimod alfa-fcab) Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-gvfc) Line of Business Medicare and Medicaid Approval Length Initial Request: 26 weeks Renewal: 12 months Override Type PA, QL Initial Criteria Note: Pharmacy staff: For QUEST non-ABD members with cancer, send ADRC (Aid to Disability Referral Committee) referral with chart notes through G8 CM module.

1. Member is 18 years of age or older; AND
2. Diagnosis of acetylcholine receptor antibody-positive (AChR-Ab+) generalized myasthenia gravis (gGM); AND
3. Myasthenia Gravis Foundation of America (MGFA) Clinical Classification Class II to IV disease; AND
4. Documentation of Myasthenia Gravis Activities of Daily Living (MG-ADL) score of at least 5 with 50% or more of this score should be due to non-ocular symptoms; AND

efgartigimod (Vyvgart)

Updated on: 10/25/2025

Page 2 of 2

5. Trial and failure of ALL of the following:
   a. Pyridostigmine;
   b. Corticosteroids; c. At least 2 immune modulating agents: azathioprine, mycophenolate, cyclosporine, and tacrolimus; and d. IVIG
6. For Medicaid: J9334 - Vyvgart Hytrulo – Trial and failure of Vyvgart J9332. Renewal Criteria
7. Diagnosis of Myasthenia Gravis; AND
8. Member has experienced a prior clinical response to efgartigimod treatment as defined by a reduction in signs or symptoms that impact daily function; AND

9. Documentation shows at least a 2-point reduction in MG-MDL total score from pre-treatment baseline.

   Product Name:
   Diagnosis

   Approval Length

   Override Type Step Therapy, PA/NF, QL

10. Exclusion

11. Use in combination with maintenance immunoglobulin treatment, eculizumab, ravulizumab, rituximab, or rozanolixizumab-noli.

    FDA Indications & Dosing Indication Dosing/Administration Generalized Myasthenia Gravis Vyvgart: 10mg/kg (120kg+: up to 1200mg/infusion) IV QWk x4; subsequent cycles at least 50 days from start of previous treatment cycle Vyvgart Hytrulo: 1,008mg-11,200units SQ QWk x4; subsequent cycles at least 50 days from start of previous treatment cycle

    References

12. DailyMed. Package inserts. U.S. National Library of Medicine, National Institutes of Health website. http://dailymed.nlm.nih.gov/dailymed/about.cfm. Updated periodically.

13. UpToDate. Overview of the treatment of myasthenia gravis. Last Updated 8/17/2023.

    Review History 9/19/2023 PH: New
    6/5/2024 PH: Added Vyvgart Hytrulo