Vyvgart vs Vyvgart Hytrulo access guide

Vyvgart (efgartigimod alfa-fcab, argenx) became the first neonatal Fc receptor (FcRn) blocker approved in the United States when the FDA cleared it in December 2021 for generalized myasthenia gravis (gMG). In June 2023, the FDA approved Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc), a subcutaneous formulation using Halozyme's ENHANZE technology, for the same gMG population. In June 2024, Vyvgart Hytrulo gained a second indication for chronic inflammatory demyelinating polyneuropathy (CIDP) — making it the first FcRn blocker approved for that condition. In April 2025, the FDA approved a prefilled syringe presentation for self-injection.

Access teams must navigate three formulations (IV vial, SC vial, SC prefilled syringe), two indications with different PA criteria, cycle-based dosing for gMG versus continuous weekly dosing for CIDP, and distinct HCPCS codes for IV and SC products. This guide covers the full access landscape.

Short answer

Indication routing: gMG vs CIDP

Generalized myasthenia gravis (gMG)

Both Vyvgart and Vyvgart Hytrulo are approved for gMG in adult patients. On May 8, 2026, the FDA expanded the gMG indication beyond anti-AChR antibody positive patients to include all serotypes: anti-MuSK-Ab positive, anti-LRP4-Ab positive, and triple seronegative patients, based on the Phase III ADAPT SERON trial. Access teams should note that while the FDA label now covers all adult gMG patients, most payer PA criteria still reference the original AChR antibody positive requirement and may take time to update. Key PA requirements across major payers:

1. AChR antibody positive status: confirmed by serologic testing. As of the May 2026 label expansion, the FDA indication now covers all adult gMG serotypes (anti-AChR-Ab positive, anti-MuSK-Ab positive, anti-LRP4-Ab positive, and triple seronegative). Most payer PA criteria have not yet been updated to reflect this expansion and still require AChR-Ab positive confirmation. Access teams filing PA for non-AChR patients should cite the expanded label and the ADAPT SERON trial data.

2. MGFA Classification II–IV: documented clinical classification of generalized (not ocular-only) myasthenia gravis.

3. MG-ADL score ≥5: baseline Myasthenia Gravis Activities of Daily Living total score at or above 5 at initiation.

4. Prior immunosuppressive therapy failure: most payers require documented failure of at least two immunosuppressive agents over at least 12 months. UHC requires failure of a minimum of two agents (e.g., azathioprine, corticosteroids, cyclosporine, methotrexate, mycophenolate). Some plans also require failure of at least one steroid-sparing agent.

5. No concurrent excluded therapies: Vyvgart/Vyvgart Hytrulo must not be combined with:

   • Complement inhibitors (eculizumab/Soliris/Bkemv/Epysqli, ravulizumab/Ultomiris, zilucoplan/Zilbrysq)

   • Other FcRn antagonists (rozanolixizumab/Rystiggo, nipocalimab/Imaavy)

   • Immune globulin therapy (IVIg/SCIg)

6. IgG level: some plans require baseline IgG ≥6 g/L before initiation

7. Prescriber specialty: neurologist (required by all major payers)

Chronic inflammatory demyelinating polyneuropathy (CIDP)

Vyvgart Hytrulo (SC only) is the only FcRn blocker approved for CIDP. Vyvgart IV does not carry this indication. PA requirements for CIDP are more stringent:

1. Diagnosis confirmation: CIDP confirmed by electrodiagnostic studies (motor and sensory nerve conduction studies showing demyelinating features), per EFNS/PNS 2010 criteria

2. Symptom duration: motor weakness and/or sensory disturbances present for at least 2 months

3. Clinical presentation: typical CIDP (symmetric proximal and distal weakness of all extremities) or atypical CIDP (asymmetric, focal, or distal-predominant)

4. Step therapy — prior treatment failure: most payers require documented failure of at least two of the following for at least 3 months each:

   • Corticosteroids (oral or IV)

   • Immune globulin (IVIg or SCIg)

   • Plasma exchange (PLEX)

5. No pure sensory CIDP: patients with pure sensory involvement without motor weakness are generally excluded

6. Validated disability scale: baseline score using INCAT, I-RODS, ODSS, ONLS, or MRC

7. No concurrent excluded therapies: same exclusion list as gMG (complement inhibitors, other FcRn blockers, immune globulin)

8. Prescriber specialty: neurologist

Dosing and cycle management

gMG: cycle-based dosing

For gMG, Vyvgart and Vyvgart Hytrulo are dosed in treatment cycles:

• Vyvgart IV: 10 mg/kg IV once weekly for 4 weeks (maximum 1,200 mg per infusion for patients ≥120 kg)

• Vyvgart Hytrulo SC: 1,008 mg/11,200 U (vial) or 1,000 mg/10,000 U (prefilled syringe) SC once weekly for 4 weeks

• Cycle spacing: subsequent treatment cycles are administered based on clinical evaluation. The original label specified at least 49 days between cycle starts; this was removed from the prescribing information, but some payers still reference the 50-day minimum interval in their policies.

• Reauthorization: payers authorize an initial period (typically 6 months for gMG, allowing multiple treatment cycles within that window). Reauthorization requires documented clinical response.

CIDP: continuous weekly dosing

For CIDP, Vyvgart Hytrulo is dosed continuously:

• Vyvgart Hytrulo SC: 1,008 mg/11,200 U (vial) or 1,000 mg/10,000 U (prefilled syringe) SC once weekly

• No cycle structure — continuous weekly administration

• Initial authorization: 3–6 months depending on the payer

• Reauthorization: 6–12 months with documented clinical improvement or stabilization

Cycle authorization implications

For gMG, access teams should:

1. Document baseline MG-ADL before the first cycle

2. Track cycle dates: record the start and end dates of each 4-week treatment cycle

3. Document clinical response between cycles: at least a 2-point reduction in MG-ADL total score from pre-treatment baseline, maintained or improved

4. Plan reauthorization early: submit reauthorization at least 30 days before the current authorization period expires, to avoid treatment gaps between cycles

HCPCS coding and billing

Vyvgart IV

• J9332: Injection, efgartigimod alfa-fcab, 2 mg

• Billing units: weight-based. For a 70 kg patient: 10 mg/kg × 70 kg = 700 mg → 350 units (700 ÷ 2 mg per unit)

• NDC: Vyvgart 400 mg/20 mL single-dose vial (20 mg/mL)

• Administration CPT: 96365 (IV infusion, first hour)

• ICD-10: G70.00 (MG without acute exacerbation), G70.01 (MG with acute exacerbation)

Vyvgart Hytrulo SC (vial and prefilled syringe)

• J9334: Injection, efgartigimod alfa, 2 mg and hyaluronidase-qvfc

• Billing units: 504 units per single-dose vial (1,008 mg ÷ 2 mg per unit)

• NDC: Vyvgart Hytrulo 1,008 mg/5.6 mL single-dose vial (180 mg/mL efgartigimod + 2,000 U/mL hyaluronidase)

• Administration CPT: 96372 (SC/IM injection)

• JZ modifier: required for Medicare claims to indicate no drug was discarded (single-use vial)

• ICD-10 for gMG: G70.00, G70.01

• ICD-10 for CIDP: G61.81 (chronic inflammatory demyelinating polyneuropathy)

Billing when specialty pharmacy supplies the drug

If Vyvgart Hytrulo is acquired through a specialty pharmacy (common for the prefilled syringe), the administering HCP should enter $0.00 or $0.01 in the charge field to indicate the drug was not purchased by the practice, while still billing the administration code (96372).

Formulation and benefit channel routing

Routing implications

• Confirm the formulation matches the expected benefit channel: prescribing the prefilled syringe when the plan expects medical-benefit vial administration can trigger a PA rejection or wrong-benefit denial.

• A new PA is typically required when switching formulations: changing from IV to SC, or from SC vial (medical benefit) to prefilled syringe (pharmacy benefit), generally requires a new PA submission.

• Site-of-care edits may apply: some plans restrict IV administration to non-hospital outpatient settings (provider office, ambulatory infusion center).

Payer PA and coverage positioning

UnitedHealthcare

Vyvgart Hytrulo prefilled syringe (Program 2025 P 2377-1, effective 12/01/2025):

• gMG: AChR positive, MGFA Class II–IV, MG-ADL ≥5, failure of ≥2 immunosuppressive agents over ≥12 months, no concurrent excluded therapies, neurologist prescriber

• CIDP: confirmed diagnosis, symptoms ≥2 months, electrodiagnostic confirmation, failure of corticosteroids + IVIg/SCIg + PLEX (at least 2 of 3 for ≥3 months each), no pure sensory variant, baseline disability score

• Authorization: 12 months for gMG, 12 months for CIDP

• Treatment failure definition for reauthorization: add-on of IST, dose escalation of IST, or additional rescue therapy while on Vyvgart Hytrulo is considered treatment failure

Vyvgart IV and Vyvgart Hytrulo SC vial: covered under UHC's medical benefit drug policy with similar criteria.

Carelon/Anthem (CC-0207)

• gMG: combined clinical criteria for both Vyvgart and Vyvgart Hytrulo

• CIDP: Vyvgart Hytrulo only. Diagnosis verified by EFNS/PNS 2010 criteria (typical or atypical CIDP), symptoms ≥2 months, failure of standard therapies

• Initial approval: 26 weeks

• Continued use: documented ≥2-point MG-ADL reduction from baseline (gMG) or clinical improvement (CIDP)

Health Net / Centene (CP.PHAR.555)

• Vyvgart Hytrulo is the preferred product. Vyvgart IV requires documented failure or intolerance of Vyvgart Hytrulo

• gMG: failure of ≥2 immunosuppressive agents, no concurrent excluded therapies

• CIDP: failure of ≥2 standard therapies (corticosteroids, IVIg/SCIg, PLEX), no pure sensory variant, baseline disability score

• Approval duration: 6 months (Medicaid/HIM), 6 months or to renewal date (commercial)

FEP Blue (5.99.026)

• gMG: AChR positive, stable dose of MG therapy, IgG ≥6 g/L, monitoring during and 1 hour after administration, no active infection

• CIDP: Vyvgart Hytrulo only. Symptoms stable or improved from baseline, continued monitoring

• Authorization: 6 months initial (gMG), 6 months initial (CIDP)

CareSource

• gMG: age ≥18, neurologist prescriber, AChR positive, MG-ADL ≥5, MGFA II–IV, failed ≥2 immunosuppressive agents

• CIDP: Vyvgart Hytrulo only. Confirmed by electrodiagnostic studies, symptoms ≥2 months, impairment of ADLs, failed ≥2 of corticosteroids/IVIg/PLEX for ≥3 months each, no pure sensory variant

• Authorization: 12 months

Florida Medicaid (AHCA)

• gMG: 1-month initial authorization

• CIDP: 6-month initial authorization

• Requires stable dose of MG therapy before Vyvgart initiation, IgG ≥6 g/L

My VYVGART Path patient support

argenx operates My VYVGART Path to support access:

Benefits verification and PA support

• argenx Field Reimbursement Managers help verify benefits and navigate PA requirements

• Available at vyvgart.com or by calling 1-833-VYVGART (1-833-898-4278)

Coverage data

• argenx reports that 90% of commercial and Medicare insured patients have coverage for Vyvgart Hytrulo or Vyvgart

• Approximately 90% of patients have coverage allowing initial authorization of at least 6 months, enabling multiple treatment cycles with the first prescription

Financial assistance

• Commercial copay assistance available for eligible patients

• Patient Assistance Program for uninsured or underinsured patients who meet income criteria

PA checklist resources

argenx provides disease-specific PA checklists for both gMG and CIDP:

• gMG checklist: ICD-10 (G70.00/G70.01), AChR antibody status, MGFA classification, MG-ADL baseline score, prior immunosuppressive history, concurrent therapy list

• CIDP checklist: ICD-10 (G61.81), electrodiagnostic study results, symptom duration documentation, prior treatment history (corticosteroids, IVIg, PLEX with dates and reasons for failure), baseline disability score (INCAT, I-RODS, MRC, ODSS, or ONLS)

Reauthorization documentation

gMG reauthorization

1. Clinical response: at least a 2-point reduction in MG-ADL total score from pre-treatment baseline

2. Reduction in signs and symptoms of myasthenia gravis

3. Maintenance, reduction, or discontinuation of baseline immunosuppressive therapy (add-on or escalation of IST is considered treatment failure by UHC)

4. Cycle spacing: at least 49–50 days between treatment cycle starts (though this has been removed from the label, some payers still reference it)

5. Continued exclusion compliance: no concurrent complement inhibitor, FcRn blocker, or immune globulin

6. Neurologist attestation: prescribed by or in consultation with a neurologist

CIDP reauthorization

1. Symptoms stable or improved from baseline per prescriber assessment

2. No treatment-restricting adverse effects

3. Continued exclusion compliance

4. Appropriate dosing: weekly, not exceeding label limits

5. Disability scale reassessment: some plans request repeat INCAT, I-RODS, or similar scoring

Documentation checklist for PA submission

1. ICD-10 codes: G70.00/G70.01 (gMG), G61.81 (CIDP)

2. Antibody status: AChR antibody positive (gMG only) — include lab report

3. MGFA classification: Class II, III, or IV (gMG)

4. MG-ADL baseline score: ≥5 (gMG)

5. CIDP diagnosis confirmation: electrodiagnostic study results (nerve conduction studies, EMG) showing demyelinating features (CIDP)

6. Symptom duration: ≥2 months of motor weakness and/or sensory disturbances (CIDP)

7. Prior treatment history: drug names, doses, start/stop dates, and reasons for failure — for each prior immunosuppressive (gMG) or standard therapy (CIDP: corticosteroids, IVIg/SCIg, PLEX)

8. Baseline disability scale: INCAT, I-RODS, ODSS, ONLS, or MRC (CIDP)

9. IgG level: ≥6 g/L (required by some plans)

10. Concurrent therapy attestation: no complement inhibitor, no other FcRn blocker, no immune globulin

11. Specialist attestation: prescribed by or in consultation with a neurologist

12. Formulation-specific: if requesting prefilled syringe, document patient capability for self-injection or caregiver administration

Key takeaways for access teams

• CIDP is a Vyvgart Hytrulo–only indication: Vyvgart IV is not approved for CIDP. Do not submit a PA for Vyvgart IV in CIDP — it will be denied. Route all CIDP patients to Vyvgart Hytrulo SC.

• The gMG indication expanded May 8, 2026 to all adult serotypes: anti-AChR-Ab positive, anti-MuSK-Ab positive, anti-LRP4-Ab positive, and triple seronegative patients are now covered. Most payer PA criteria still reference AChR+ only — cite the ADAPT SERON trial data when filing for non-AChR patients.

• Cycle-based gMG dosing requires careful authorization management: the 4-weeks-on, variable-off cycle structure means patients may need multiple cycles within a single authorization period. Document cycle start dates and clinical response between cycles.

• Formulation drives benefit channel: IV (medical benefit, J9332), SC vial (medical benefit, J9334), prefilled syringe (pharmacy benefit, most plans). A new PA is typically needed when switching.

• Step therapy is aggressive for CIDP: payers require failure of at least two of corticosteroids, IVIg, and PLEX for ≥3 months each. Document all three treatments even if only two failures are required, to strengthen the PA case.

• UHC defines treatment failure broadly for reauthorization: any add-on of IST, dose escalation, or rescue therapy while on Vyvgart Hytrulo may be considered treatment failure. Monitor for this and document clinical rationale.

• 90% commercial/Medicare coverage: argenx reports broad payer coverage. Leverage My VYVGART Path for benefits verification and PA support early in the process.

Sources

• FDA. Vyvgart (efgartigimod alfa-fcab) Prescribing Information. BLA 761179. October 2025. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025

• FDA. Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) Prescribing Information. October 2025. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025

• FDA. FDA Approves Treatment for CIDP in Adults (Vyvgart Hytrulo). Press release. June 21, 2024. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-treatment-chronic-inflammatory-demyelinating-polyneuropathy-cidp-adults

• argenx. FDA Approval of Vyvgart Hytrulo Prefilled Syringe for Self-Injection. Press release. April 10, 2025. us.argenx.com

• argenx. FDA Approval Expanding Vyvgart and Vyvgart Hytrulo for Use in All Adult Patients Living with gMG. Press release. May 8, 2026. us.argenx.com/news/2026/press-release-3291372

• argenx. Vyvgart Hytrulo Billing and Coding Guide (gMG). vyvgarthcp.com

• argenx. Vyvgart Hytrulo Billing and Coding Guide (CIDP). vyvgarthcp.com

• argenx. Vyvgart Hytrulo Prior Authorization Checklist (gMG). vyvgarthcp.com

• argenx. Vyvgart Hytrulo Prior Authorization Checklist (CIDP). vyvgarthcp.com

• UnitedHealthcare. Vyvgart Hytrulo PA/Medical Necessity (Prefilled Syringe). Program 2025 P 2377-1. Effective 12/01/2025. uhcprovider.com

• Carelon/Anthem. Vyvgart and Vyvgart Hytrulo Medical Drug Clinical Criteria. CC-0207. Published 07/23/2025. carelonrx.com

• Health Net/Centene. Efgartigimod Alfa-fcab, Efgartigimod/Hyaluronidase-qvfc Clinical Policy. CP.PHAR.555. healthnet.com

• FEP Blue. Vyvgart and Vyvgart Hytrulo Pharmacy Policy. 5.99.026. Effective 01/01/2026. fepblue.org

• CareSource. Vyvgart and Vyvgart Hytrulo Pharmacy Policy. caresource.com

• Florida AHCA. Vyvgart and Vyvgart Hytrulo Prior Authorization Criteria. Effective 11/05/2025. ahca.myflorida.com

• Maryland Physicians Care. Vyvgart & Vyvgart Hytrulo Policy. RX.PA.078.MPC. Revision 06/2025. marylandphysicianscare.com

• UCare. Vyvgart Hytrulo Utilization Management Medical Policy. Policy 322. Last revision 02/18/2026. ucare.org

• CarePartners of Connecticut. Vyvgart and Vyvgart Hytrulo Medical Necessity Guidelines. Effective 01/01/2026. carepartnersct.com

• Vyvgart. Cost and Coverage. vyvgart.com/gmg/savings-and-support/cost-and-coverage

• Howard JF, Bril V, et al. Safety, Efficacy, and Tolerability of Efgartigimod in Patients with gMG (ADAPT). Lancet Neurol. 2022;21(7):592-600