How is Vyvgart dosed?

Vyvgart IV: 10 mg/kg as a 1-hour intravenous infusion once weekly for 4 consecutive weeks per treatment cycle. Patients weighing more than 120 kg should receive a fixed 1,200 mg per dose. Vyvgart Hytrulo SC: fixed 1,008 mg subcutaneously over 30-90 seconds once weekly for 4 consecutive weeks per cycle. Both formulations are cyclic; subsequent cycles are based on clinical response with no specific minimum re-cycle interval mandated in the label.

Which antibody types does Vyvgart cover?

Vyvgart IV (J9332) and Vyvgart Hytrulo SC (J9334) are FDA-approved for adults with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive ONLY. MuSK-positive gMG is NOT a labeled indication for either Vyvgart formulation. Patients who are MuSK-antibody positive should be referred to Rystiggo (rozanolixizumab-noli, J9333), the only FcRn inhibitor labeled for MuSK+ gMG. Submitting J9332 or J9334 for a MuSK+ or seronegative patient triggers a hard denial.

What administration CPT do I use for Vyvgart?

For IV Vyvgart (J9332), use CPT 96365 (initial IV infusion of a therapeutic, prophylactic, or diagnostic drug, up to 1 hour) plus 96366 for each additional hour as applicable. The standard Vyvgart infusion is 1 hour so 96365 alone is typical. For SC Vyvgart Hytrulo (J9334), use CPT 96372 (subcutaneous therapeutic injection). Do NOT use 96413 (chemo IV infusion) — Vyvgart is non-chemotherapy. Bill the admin code once per weekly dose, four times per cycle.

Do I bill JZ or JW for Vyvgart?

Bill JW when partial single-dose vial waste occurs (the common case for weight-based IV dosing) and JZ when no waste occurs. Example IV: 70 kg patient x 10 mg/kg = 700 mg target. Each Vyvgart vial is 400 mg. Two vials = 800 mg drawn -> 700 mg administered (350 units of J9332, primary line) + 100 mg discarded (50 units, JW line). Both administered and discarded mg pay at ASP+6%. For SC Vyvgart Hytrulo at a fixed 1,008 mg dose drawn from 1,008 mg single-dose vials, JZ applies (no waste). One of JZ or JW must be on every J9332 / J9334 claim per CMS's July 2023 single-dose container policy.

What is the Medicare reimbursement for J9332?

For Q2 2026, the Medicare Part B payment limit for J9332 is $32.608 per unit (1 unit = 2 mg, ASP + 6%). That works out to roughly $16.304 per mg. A 700 mg dose (10 mg/kg x 70 kg) reimburses at approximately $11,412.80 before sequestration (350 units x $32.608). A full 4-week cycle for a 70 kg patient (~2,800 mg total, 1,400 units) reimburses at approximately $45,651.20. Sequestration (~2%) reduces actual paid to roughly ASP + 4.3%.

How does Vyvgart compare to Rystiggo (rozanolixizumab, J9333)?

Both are FcRn (neonatal Fc receptor) inhibitors that reduce circulating pathogenic IgG by ~60–70% per cycle. Key differences: (1) Vyvgart IV and Vyvgart Hytrulo SC (efgartigimod) are approved for AChR-positive gMG ONLY. Rystiggo (rozanolixizumab) is approved for both AChR+ AND MuSK+ gMG. (2) Vyvgart Hytrulo also carries an FDA-approved CIDP indication (June 2024); Rystiggo does not. (3) Vyvgart IV is 10 mg/kg weekly x 4; Vyvgart Hytrulo is fixed 1,008 mg SC weekly x 4; Rystiggo is 7 mg/kg SC weekly x 6. (4) Efgartigimod is a human IgG1 Fc fragment; rozanolixizumab is a full IgG4 monoclonal antibody. (5) HCPCS codes differ: J9332 IV Vyvgart, J9334 SC Vyvgart Hytrulo, J9333 Rystiggo.

How does Vyvgart compare to Soliris and Ultomiris for gMG?

Different mechanism, different setting, different antibody coverage. Soliris (eculizumab, J1299) and Ultomiris (ravulizumab, J1303) are C5 complement inhibitors approved for AChR-positive gMG only, delivered as continuous IV infusions (q2wk and q8wk respectively) in HOPD or office. Vyvgart (FcRn inhibitor) is approved for AChR+ gMG and is dosed cyclically (4-week treatment blocks). Soliris and Ultomiris require Alexion REMS due to meningococcal infection risk; Vyvgart has no REMS. Many neurologists trial FcRn first for milder AChR+ disease and escalate to complement for refractory cases.

What is the difference between Vyvgart IV and Vyvgart Hytrulo SC?

Same active drug (efgartigimod alfa) in two delivery formats. Vyvgart IV (J9332) is a 1-hour IV infusion of weight-based 10 mg/kg, supplied as 400 mg / 20 mL single-dose vials. Vyvgart Hytrulo (J9334) combines efgartigimod alfa with hyaluronidase-qvfc to enable a 30-90-second SC injection at a fixed 1,008 mg dose, supplied as a 1,008 mg / 5.6 mL single-dose vial. Vyvgart Hytrulo also has an FDA-approved indication for chronic inflammatory demyelinating polyneuropathy (CIDP) (June 2024) in addition to gMG. The two products are not interchangeable line items on a claim — code by route and product administered.

What ICD-10 codes do I use for Vyvgart?

G70.00 (myasthenia gravis without (acute) exacerbation) is the primary code for stable cyclic Vyvgart dosing in AChR+ gMG. G70.01 (myasthenia gravis with (acute) exacerbation) applies when chart documents MGFA Class III-V or rescue cycle. For Vyvgart Hytrulo CIDP use, code G61.81 (chronic inflammatory demyelinating polyneuritis). AChR antibody status is documented in chart and PA but does NOT change the ICD-10 — MuSK+ and seronegative gMG are NOT Vyvgart indications regardless of which G70.x code is selected.

Vyvgart (J9332) Billing & Coding Guide | Efgartigimod for gMG + CIDP

Phase 1 Identify what you're billing Confirm IV Vyvgart (J9332) vs SC Vyvgart Hytrulo (J9334), AChR antibody status, and gMG vs CIDP indication.

Two Vyvgart formulations + FcRn class context CMS HCPCS verified May 2026

Same active drug (efgartigimod alfa) in IV and SC formats with different HCPCS codes; class comparison vs Rystiggo and complement inhibitors.

Neonatal Fc receptor (FcRn) blockade is a 2021–2023 mechanism for autoantibody-driven autoimmunity. By preventing FcRn-mediated recycling of IgG in vascular endothelium, FcRn inhibitors accelerate catabolism of all circulating IgG (including pathogenic autoantibodies) by ~60–70% per treatment cycle, with recovery between cycles. argenx's efgartigimod alfa was the first FcRn inhibitor approved for any indication (Vyvgart IV, December 17, 2021), and the molecule is now offered in two delivery formats: IV Vyvgart (J9332) and SC Vyvgart Hytrulo (J9334, co-formulated with hyaluronidase-qvfc to enable rapid SC injection).

IV Vyvgart vs SC Vyvgart Hytrulo — same drug, different code

Side-by-side comparison of IV Vyvgart and SC Vyvgart Hytrulo formulations.
	Vyvgart IV (J9332)	Vyvgart Hytrulo SC (J9334)
Active ingredient	Efgartigimod alfa-fcab	Efgartigimod alfa + hyaluronidase-qvfc
HCPCS descriptor	Injection, efgartigimod alfa-fcab, 2 mg	Injection, efgart-alfa 2 mg / hya-qvfc
Unit = ?	1 unit = 2 mg	1 unit = 2 mg
FDA approval (gMG)	December 17, 2021	June 20, 2023
Other FDA indications	None (gMG only)	CIDP — June 2024
Route	IV infusion ~1 hour	SC injection 30–90 seconds
Dose	10 mg/kg IV weekly × 4 (fixed 1,200 mg if >120 kg)	Fixed 1,008 mg SC weekly × 4
Vial	400 mg / 20 mL (20 mg/mL)	1,008 mg / 5.6 mL (180 mg/mL drug + 2,000 U/mL hyaluronidase)
Cycle length	4 weeks; repeat per clinical response	4 weeks; repeat per clinical response
Typical admin CPT	96365 (initial IV non-chemo, up to 1 hr)	96372 (SC therapeutic injection)
Permanent HCPCS effective	April 1, 2022	April 1, 2024

Code by formulation administered, not by molecule. J9332 and J9334 are NOT interchangeable on claims. If the patient received IV Vyvgart, bill J9332 with 96365. If the patient received SC Vyvgart Hytrulo, bill J9334 with 96372. Cross-coding (J9332 for an SC dose, or J9334 for an IV dose) is an immediate denial.

FcRn class — Vyvgart vs Rystiggo (J9333)

Side-by-side comparison of the two FcRn inhibitor product families for generalized myasthenia gravis.
	Vyvgart / Vyvgart Hytrulo (J9332 / J9334)	Rystiggo (J9333)
Active ingredient	Efgartigimod alfa (human IgG1 Fc fragment) ± hyaluronidase	Rozanolixizumab-noli (full-length IgG4 mAb)
Manufacturer	argenx US, Inc.	UCB, Inc.
FDA approval (gMG)	Dec 17, 2021 (IV) / Jun 20, 2023 (Hytrulo SC)	June 26, 2023
Route options	IV (1 hr) OR SC injection (30–90 sec, Hytrulo)	SC infusion ~15 min
Dose	IV: 10 mg/kg weekly × 4; Hytrulo: fixed 1,008 mg SC weekly × 4	7 mg/kg SC weekly × 6
Cycle length	4 weeks	6 weeks
AChR+ gMG	Yes	Yes
MuSK+ gMG	NO — not labeled	Yes — only labeled FcRn option
Seronegative gMG	NOT approved	NOT approved
Other indications	CIDP (Vyvgart Hytrulo, June 2024)	None (gMG only)
REMS	None	None

FcRn vs complement (C5) inhibitors for gMG. Complement inhibitors (Soliris J1299, Ultomiris J1303) are continuous IV therapies (q2wk or q8wk) for AChR-positive gMG only, with mandatory Alexion REMS for meningococcal infection risk. FcRn inhibitors (Vyvgart J9332 / Vyvgart Hytrulo J9334 / Rystiggo J9333) are cyclic IV/SC therapies without REMS. Many neurologists trial FcRn first (lower-risk profile, cyclic dosing, lower cost per cycle in some scenarios) and reserve complement inhibitors for refractory AChR+ disease. IVIG and rituximab are also used off-label in gMG but lack a labeled indication and pay-per-mg ASP coverage.

Coverage gate is the antibody type, not brand preference. If your patient is MuSK-antibody positive, Vyvgart and Vyvgart Hytrulo will be denied as off-label — only Rystiggo is labeled for MuSK+. If AChR-positive, any of the three FcRn agents is potentially appropriate and payer preference (often via cost-effective contracting) determines first-line. Always pull and submit the antibody panel result with the initial PA.

Dosing & unit math FDA label verified May 2026

From the FDA-approved Vyvgart and Vyvgart Hytrulo prescribing information (BLA 761195 / BLA 761304; both labels revised May 13, 2026).

Per-cycle dosing schedule

Element	Vyvgart IV (J9332)	Vyvgart Hytrulo SC (J9334)
Dose	10 mg/kg IV once weekly	Fixed 1,008 mg SC once weekly
Doses per cycle	4 (one weekly dose for 4 consecutive weeks)	4 (one weekly dose for 4 consecutive weeks)
Infusion / injection duration	~1 hour IV infusion	30–90 seconds SC injection
Maximum dose	Fixed 1,200 mg for patients >120 kg (no further weight-based escalation)	Fixed 1,008 mg regardless of body weight
Repeat cycle	Based on clinical evaluation; no fixed minimum interval mandated in label	Based on clinical evaluation; no fixed minimum interval mandated in label
Vial increments	400 mg / 20 mL single-dose vial (1 unit = 2 mg)	1,008 mg / 5.6 mL single-dose vial (1 unit = 2 mg)

1 unit of J9332 / J9334 = 2 mg. Unlike Rystiggo (J9333, where 1 unit = 1 mg), the efgartigimod codes use a 2-mg unit basis. Always divide milligrams administered by 2 to compute units billed. A 700 mg IV dose = 350 units of J9332. A 1,008 mg SC dose = 504 units of J9334.

Worked example — 70 kg patient, IV Vyvgart

# Calculate dose Dose: 10 mg/kg \times 70 kg = 700 mg Vials drawn: 2 \times 400 mg = 800 mg Discarded: 800 - 700 = 100 mg (single-dose vial waste) # Per-dose drug claim lines Line 1 (administered): J9332 \cdot 350 units (700 mg \div 2) \cdot no JZ when JW present Line 2 (waste): J9332 \cdot 50 units (100 mg \div 2) \cdot modifier JW # Per-dose admin claim line 96365 (IV non-chemo, initial up to 1 hr) \cdot 1 unit # Per-dose reimbursement (Q2 2026) Total: 400 units \times $32.608 = $13,043.20 (administered + waste, both reimbursable) # Per cycle (4 weekly doses) Drug units: 4 \times 400 = 1,600 units Drug reimbursement: 1,600 \times $32.608 = $52,172.80 Admin codes: 4 \times 96365

Worked example — SC Vyvgart Hytrulo, fixed 1,008 mg

# Fixed dose: 1,008 mg SC (regardless of weight) Vials: 1 \times 1,008 mg = 1,008 mg (no waste) Per-dose claim: J9334 \cdot 504 units (1,008 mg \div 2) \cdot modifier JZ Admin code: 96372 (SC therapeutic injection) # Per cycle (4 doses) Drug units: 4 \times 504 = 2,016 units # Note: J9334 has its own ASP — see #medicare section.

>120 kg cap on IV Vyvgart. Per FDA label, patients exceeding 120 kg body weight receive a fixed 1,200 mg dose (600 units of J9332) rather than continuing the 10 mg/kg calculation. A 130 kg patient at strict 10 mg/kg would be 1,300 mg; the label caps this at 1,200 mg. Vial draw: 3 × 400 mg = 1,200 mg = no waste = JZ. Vyvgart Hytrulo SC has no such cap because the dose is fixed at 1,008 mg regardless of body weight.

Hytrulo prefilled-syringe presentation. The current Vyvgart Hytrulo label (revised May 13, 2026) authorizes two SC presentations: (1) the original 1,008 mg / 11,200 U single-dose vial infused over 30–90 seconds, and (2) a 1,000 mg / 10,000 U prefilled syringe injected over 20–30 seconds. Both presentations bill under J9334 ("Injection, efgart-alfa 2 mg / hya-qvfc"; 1 unit = 2 mg). The 1,000 mg syringe = 500 units; the 1,008 mg vial = 504 units. Verify which presentation was administered and bill the correct units per dose. CIDP and gMG dosing schedules apply to both presentations.

NDC reference FDA NDC Directory verified May 2026

Product	NDC (10-digit)	NDC (11-digit)	Strength	Package Size	Units / Vial
Vyvgart IV (J9332)	`73475-201-01`	`73475-0201-01`	400 mg / 20 mL (20 mg/mL)	1 single-dose vial per carton	200 units (1 unit = 2 mg)
Vyvgart Hytrulo SC (J9334)	`73475-301-01`	`73475-0301-01`	1,008 mg / 5.6 mL (180 mg/mL efgartigimod + 2,000 U/mL hyaluronidase-qvfc)	1 single-dose vial per carton	504 units

Use carton-level 11-digit NDC, not vial-level. Payers expect the 11-digit NDC with the N4 qualifier in the 24A shaded area of CMS-1500. Each Vyvgart vial NDC is product-specific — the IV (400 mg) and Hytrulo SC (1,008 mg) presentations have distinct NDCs and must not be cross-coded.

Single-source product: argenx is the sole manufacturer of both efgartigimod alfa-fcab (Vyvgart IV) and efgartigimod alfa + hyaluronidase-qvfc (Vyvgart Hytrulo). There is no biosimilar or therapeutic equivalent as of May 2026. Rystiggo (rozanolixizumab, J9333) is a different molecule, not a biosimilar.

Phase 2 Code the claim IV vs SC admin code by formulation; JW for IV waste; AChR serology must be in the chart.

Administration codes CPT verified May 2026

IV Vyvgart uses therapeutic IV non-chemo codes (96365/96366); SC Vyvgart Hytrulo uses 96372.

Code	Description	When to use
`96365`	Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); initial, up to 1 hour	Primary code for IV Vyvgart (J9332). The standard infusion is 1 hour. Bill once per weekly dose, four times per cycle.
`96366`	IV infusion for therapy; each additional hour	Add ONLY when actual infusion exceeds 1 hour (rare for Vyvgart unless slowed for tolerability). Document infusion duration in the medical record.
`96372`	Therapeutic, prophylactic, or diagnostic injection (specify substance or drug); subcutaneous or intramuscular	Primary code for SC Vyvgart Hytrulo (J9334). 30–90-second SC injection per weekly dose, four times per cycle.
`96413` / `96415`	Chemotherapy IV infusion	NOT appropriate. Vyvgart is non-chemotherapy. Submitting 96413 is the #4 denial reason.
`96401`	Chemotherapy administration, SC or IM, non-hormonal antineoplastic	NOT appropriate. Vyvgart is not antineoplastic.

96365 vs 96413 distinction. Vyvgart is delivered via IV infusion over ~1 hour per dose but is a therapeutic non-chemotherapy biologic. Always use 96365 (therapeutic IV) not 96413 (chemotherapy IV). Chemo admin codes pay at higher rates and trigger payer audit attention; using them for non-chemo biologics generates a high-frequency denial pattern.

Modifiers CMS verified May 2026

JW — expected on most IV Vyvgart claims

JW reports the discarded portion of a single-dose vial. Because IV Vyvgart is dosed by body weight (10 mg/kg) and supplied in 400 mg single-dose vials, partial-vial waste occurs on most weight-based doses (e.g., 70 kg → 700 mg target with 2 × 400 mg vials = 100 mg waste). Bill the administered units on the primary line and the wasted units on a separate line with the JW modifier. Both administered and discarded mg pay at ASP+6%.

JZ — when no waste occurs

JZ applies when no waste occurs — for example, a >120 kg patient receiving the fixed 1,200 mg cap (3 × 400 mg vials = exact draw) or any SC Vyvgart Hytrulo dose (fixed 1,008 mg per vial, no fractional waste). One of JZ or JW must be on every J9332 or J9334 claim per CMS's July 2023 single-dose container policy (CR 12056).

Worked example — JW with 10 mg/kg in a 70 kg patient

# Calculated dose 10 mg/kg \times 70 kg = 700 mg (target) # Vials drawn 2 \times 400 mg vial = 800 mg total # Claim lines (per weekly dose) Line 1: J9332 \cdot 350 units (700 mg administered \div 2) Line 2: J9332 \cdot 50 units \cdot modifier JW (100 mg discarded \div 2) Line 3: 96365 \cdot 1 unit (IV non-chemo, initial up to 1 hr) # NDC reporting (24A shaded area) N4 + 73475-0201-01 + UN + 2 (for two 400 mg vials drawn)

Common error: Failing to bill the JW waste line on a strict 10 mg/kg IV dose. CMS audits routinely catch this — the wasted drug is reimbursable but must be reported on a separate line. Both administered and discarded units pay at ASP+6%.

Modifier 25 — same-day E/M

Use modifier 25 on the E/M code when a significant, separately identifiable evaluation and management service is performed on the same day as the infusion or injection. Routine pre-infusion clinical assessment is bundled into 96365/96372.

340B modifiers (JG, TB)

For 340B-acquired Vyvgart or Vyvgart Hytrulo, follow your MAC's current 340B modifier policy. Hospital outpatient departments billing under OPPS are subject to specific 340B reporting requirements; office-based 340B reporting varies by MAC.

ICD-10-CM by indication FY2026 verified May 2026

Generalized myasthenia gravis (both products) plus CIDP (Vyvgart Hytrulo only). AChR antibody status documented in chart, not ICD-10.

ICD-10	Description	When to use
`G70.00`	Myasthenia gravis without (acute) exacerbation	Primary code for stable cyclic Vyvgart / Vyvgart Hytrulo dosing in clinic-confirmed AChR+ gMG without active crisis
`G70.01`	Myasthenia gravis with (acute) exacerbation	When chart documents MGFA Class III–V or rescue cycle initiated for symptom flare; supports medical-necessity narrative for re-cycle
`G61.81`	Chronic inflammatory demyelinating polyneuritis (CIDP)	Vyvgart Hytrulo (J9334) only. Approved for CIDP June 2024. NOT a labeled indication for IV Vyvgart (J9332).
`G70.2` / `G70.3` / `G70.8` / `G70.9`	Congenital and developmental myasthenia / Other / NOS	Not labeled. Off-label use; expect denial without strong narrative.

Antibody status: chart documentation, not ICD-10. Vyvgart and Vyvgart Hytrulo are approved for AChR-antibody-positive gMG only. MuSK-positive and seronegative gMG bill under the same G70.00 / G70.01 codes but are NOT Vyvgart indications. Submit the AChR antibody lab report (lab name, date, value, reference range) with the PA. MuSK+ patients must use Rystiggo (J9333).

Site of care & place of service Verified May 2026

Vyvgart is administered in neurology offices, ambulatory infusion centers, and hospital outpatient departments. The 1-hour IV infusion fits cleanly into office and AIC slots. Vyvgart Hytrulo's 30–90-second SC delivery makes it well-suited for home administration through a certified home infusion vendor after the first one or two cycles. The no-REMS / no-boxed-warning profile of both products supports site-of-care steering away from HOPD.

Setting	POS	Claim form	Payer steering
Neurology office	11	CMS-1500 / 837P	Preferred by commercial UM
Ambulatory infusion suite (AIC)	49	CMS-1500 / 837P	Preferred by commercial UM
Hospital outpatient (on-campus)	22	UB-04 / 837I	Allowed initial cycles; disfavored thereafter
Hospital outpatient (off-campus PBD)	19	UB-04 / 837I	Disfavored
Patient home (stable patients, SC Hytrulo)	12	CMS-1500 / 837P + home infusion S-codes	Excellent fit for Vyvgart Hytrulo; coordinate with certified home infusion vendor after 1–2 supervised cycles

Home administration is the natural fit for Vyvgart Hytrulo SC. Because Hytrulo has no REMS, no boxed warning, and a 30–90-second SC dose, payers actively prefer home administration for stable patients who have tolerated 1–2 cycles in a supervised setting. Pair with S9329 (home infusion per diem) and 99601/99602 (home infusion administration) per vendor billing protocol. IV Vyvgart can also transition home but requires nursing visit support; SC Hytrulo can be patient- or caregiver-administered after training.

Claim form field mapping My Vyvgart Path 2026

From argenx My Vyvgart Path HCP coding & coverage materials (vyvgarthcp.com).

Information	CMS-1500 box	Notes
NPI	17b	Rendering provider (neurologist or supervising MD)
NDC qualifier + 11-digit NDC + UoM + qty	24A shaded area	N4 + 73475-0201-01 (IV) or 73475-0301-01 (Hytrulo SC) + UN + vials drawn
HCPCS J9332 + JW (waste line)	24D (waste line)	Wasted units when strict 10 mg/kg IV results in partial-vial discard (units = wasted mg ÷ 2)
HCPCS J9332 (administered line)	24D (drug line)	Administered units (mg ÷ 2); this is the larger line for IV
HCPCS J9334 (Vyvgart Hytrulo)	24D (drug line)	504 units fixed per 1,008 mg SC dose
Drug units	24G	Actual mg administered ÷ 2 (e.g., 350 units for 700 mg IV at 10 mg/kg × 70 kg)
CPT 96365 or 96372 (admin line)	24D (admin line)	IV (96365) or SC (96372), 1 unit per weekly dose
ICD-10	21	G70.00 / G70.01 for gMG; G61.81 for CIDP (Hytrulo only)
PA number	23	Required by all major commercial payers and Medicare Advantage

Distinct NDCs per formulation: IV Vyvgart (400 mg vial) and Vyvgart Hytrulo (1,008 mg vial) have separate NDCs. Each claim line for J9332 must reference the 400 mg vial NDC; each J9334 line must reference the 1,008 mg Hytrulo vial NDC. Cross-referencing the wrong NDC for the formulation billed is a frequent rejection cause.

Phase 3 Get paid PA + AChR antibody documentation + prior immunosuppressant trial are the gating items.

Payer policy snapshot Reviewed May 2026

All major payers require PA. Anti-AChR antibody documentation is universal for Vyvgart (MuSK+ is NOT a labeled indication). Step through prior immunosuppressant is common.

Payer	PA?	Clinical criteria	Step therapy
UnitedHealthcare Med Benefit Drug Policy — Vyvgart / Vyvgart Hytrulo	Yes	Adult, generalized MG (not ocular-only), documented anti-AChR antibody positivity, baseline MG-ADL or QMG score	Trial and failure / intolerance of pyridostigmine + at least one immunosuppressant (corticosteroid, azathioprine, mycophenolate, or comparable)
Aetna CPB Vyvgart (efgartigimod)	Yes	Adult AChR+ gMG, prescribed by neurologist, baseline severity score documented. For Hytrulo CIDP: confirmed CIDP diagnosis with neurologist documentation.	Inadequate response to or intolerance of one or more conventional immunosuppressants
Cigna / Express Scripts Coverage Policy 2086	Yes	Adult AChR+ gMG, neurologist prescriber	Step through pyridostigmine + corticosteroid + immunosuppressant before FcRn class
BCBS plans Vary by plan	Yes	Generally aligned with FDA label + MGFA / AAN guidance; AChR+ required for gMG	Plan-specific; most require prior steroid + steroid-sparing immunosuppressant trial
Medicare (Part B) MAC LCDs (no NCD)	No prior auth at MAC level; coverage by indication	FDA-approved indication; MAC-specific local coverage articles	None at Medicare; coverage applies for on-label AChR+ gMG (or CIDP for Hytrulo) with appropriate documentation

Re-treatment cycle documentation

Most commercial payers require chart documentation supporting clinical need for each new cycle — typically a MG-ADL or QMG score showing return of symptoms above pre-cycle baseline, or neurologist attestation that the patient is approaching the lower bound of the between-cycle response window. Unlike Rystiggo, Vyvgart's FDA label does not mandate a fixed minimum re-cycle interval; payers commonly impose 4–12 weeks of UM-managed spacing. Document the trigger (symptom return, MG-ADL change, QMG change) in the chart at every re-cycle request.

MGFA / AAN guidance support

The Myasthenia Gravis Foundation of America (MGFA) International Consensus Guidance for the Management of Myasthenia Gravis (2020 update) supports FcRn inhibitors as targeted therapy for refractory gMG after inadequate response to conventional immunosuppression. AAN Quality Measurement and Reporting Subcommittee guidance similarly supports targeted biologics in moderate-to-severe gMG with documented autoantibody positivity.

Medicare reimbursement CMS Q2 2026 (live)

Quarterly ASP from CMS Part B Drug Pricing File. Refreshes automatically each quarter.

Q2 2026 payment snapshot — J9332 (IV Vyvgart)

Effective April 1 – June 30, 2026 · Based on Q4 2025 ASP submissions · 1 unit = 2 mg

ASP + 6%

$32.608

per unit (2 mg)

700 mg dose (70 kg)

$11,412.80

10 mg/kg × 70 kg = 350 units

4-week cycle (700 mg × 4)

$45,651.20

drug only, pre-sequestration

Q2 2026 payment snapshot — J9334 (Vyvgart Hytrulo SC)

J9334 has its own ASP separate from J9332. For Q2 2026 the Part B payment limit is approximately $34.325/unit (2 mg), or roughly $8.65/mg. A fixed 1,008 mg SC dose (504 units of J9334) reimburses at approximately $17,300 per weekly dose; a 4-week cycle (2,016 units) reimburses at approximately $69,200 before sequestration. Verify the current quarter's exact J9334 ASP in the CMS Part B Drug Pricing File before claim submission.

Wasted drug is reimbursable. Bill the JW line for the discarded portion on IV Vyvgart — both administered and discarded units pay at ASP+6%. For a strict 10 mg/kg IV dose in a 70 kg patient (700 mg administered + 100 mg waste from 2 × 400 mg vials = 400 units total), the per-dose drug reimbursement is 400 × $32.608 = $13,043.20 before sequestration.

Sequestration: Approximately 2% reduction applies to actual paid amount, bringing effective reimbursement to roughly ASP + 4.3% rather than ASP + 6%.

Coverage

No NCD specific to efgartigimod alfa. Coverage falls under MAC LCDs for Part B-administered biologics. All MACs cover J9332 for FDA-approved on-label AChR+ gMG with appropriate ICD-10 (G70.0x) and clinical documentation. J9334 (Vyvgart Hytrulo) is covered for AChR+ gMG and for CIDP (G61.81). Antibody serology results are expected in the medical record but are not a Medicare PA gate in the way they are at commercial payers.

Code history

J9332 — permanent code "Injection, efgartigimod alfa-fcab, 2 mg" effective April 1, 2022. Initially priced from manufacturer WAC; ASP-based pricing fully phased in by Q1 2023.
J9334 — permanent code "Injection, efgart-alfa 2 mg / hya-qvfc" effective April 1, 2024. Pre-permanent period (June 2023 – March 2024) billed under transitional Q-codes or unclassified J3490.
Q2 2026 ASP per CMS Part B file: J9332 $32.608/unit (2 mg); J9334 ~$34.325/unit (2 mg).

ASP trajectory

J9332 per-unit ASP+6% has drifted in a narrow band ($30–$32.6 per unit) across CY2025 into 2026; the current Q2 2026 figure ($32.608/unit) is the load-bearing number for live coverage estimates and is bound to the CareCost ASP layer. Historical per-quarter ASPs are available from the CMS Part B Drug ASP Pricing File archives.

Patient assistance — My Vyvgart Path argenx verified May 2026

My Vyvgart Path: 1-833-901-1937 / vyvgart.com — benefits investigation, prior authorization assistance, appeals support, nurse navigator program (My Vyvgart Path is argenx's patient support hub for both Vyvgart IV and Vyvgart Hytrulo)
argenx Copay Program: commercial copay support; eligible commercially-insured patients may pay as little as $0 per dose with annual program maximum (excludes Medicare, Medicaid, TRICARE, VA, and other federal program patients)
argenx Patient Assistance Program (PAP): free drug for uninsured / underinsured patients meeting income requirements; administered by My Vyvgart Path
Foundations (Medicare patients): verify open neuromuscular / myasthenia gravis / CIDP funds at:
- PAN Foundation — panfoundation.org / 1-866-316-7263
- HealthWell Foundation — healthwellfoundation.org / 1-800-675-8416
- Patient Advocate Foundation Co-Pay Relief — copays.org / 1-866-512-3861
- Myasthenia Gravis Foundation of America (MGFA) Patient Assistance — myasthenia.org / 1-800-541-5454
- GBS|CIDP Foundation International (for Hytrulo CIDP use) — gbs-cidp.org / 1-866-224-3301
Bridge / quick-start program: My Vyvgart Path offers a short-term bridge supply for patients with delayed PA approvals; enroll via the patient support center

Need to model what a specific patient will actually pay after copay assistance, deductible, coinsurance, and OOP max? Run a CareCost Estimate — J9332 pre-loaded.

Phase 4 Fix problems MuSK+ or seronegative attempts and missing AChR serology are the top denials.

Common denials & how to fix them

Rank	Denial reason	Common cause	Fix
#1	AChR-negative or MuSK-positive patient submitted for Vyvgart	Patient's antibody panel is MuSK-positive (or seronegative) but PA was submitted for Vyvgart or Vyvgart Hytrulo — these are NOT labeled for MuSK+ or seronegative gMG	If MuSK+: switch the PA to Rystiggo (J9333), the only FcRn inhibitor labeled for MuSK+. If seronegative: appeal with serology repeat, alternative diagnosis evaluation, or consider IVIG / off-label rituximab pathways. Do NOT resubmit Vyvgart for these populations.
#2	Anti-AChR antibody documentation missing	PA submitted without lab report or with serology pending at time of submission	Submit the AChR antibody lab report (lab name, draw date, antibody value with reference range). Acceptable assays include radioimmunoprecipitation (RIPA), cell-based assay (CBA), or fluorescence immunoprecipitation. Bridge program via My Vyvgart Path can hold the patient while serology is being repeated.
#3	Re-treatment cycle justification missing	Continuation PA submitted without evidence of symptom return or score change	Submit MG-ADL or QMG score from current visit showing return toward pre-cycle baseline. Include neurologist attestation that cycle re-initiation is clinically indicated. Some payers expect a 4–12-week minimum interval between cycles; verify the plan-specific UM rule.
#4	Wrong CPT admin code (96413 chemo IV)	96413 (chemotherapy IV) billed in place of 96365 for IV Vyvgart, or 96401 (chemo SC) instead of 96372 for Hytrulo	Resubmit with 96365 (IV non-chemo) for J9332 or 96372 (SC therapeutic injection) for J9334. Vyvgart is non-chemotherapy; chemo admin codes are inappropriate and pay differently.
#5	JW waste line missing	Wasted units not reported on a strict 10 mg/kg IV dose	Add JW line for discarded units (wasted mg ÷ 2 = units). Both administered and discarded units pay at ASP+6%.
#6	Wrong HCPCS (J9332 vs J9334 cross-coded)	Patient received SC Vyvgart Hytrulo but claim was submitted as J9332 (IV code), or vice versa	Resubmit with the correct code for the actual formulation administered: J9332 for IV Vyvgart, J9334 for SC Vyvgart Hytrulo. Each has its own NDC and admin CPT.
#7	Wrong HCPCS (J3590 unclassified)	Pre-permanent-code claim or biller defaulted to unclassified J3490 / J3590	Resubmit with J9332 (permanent eff. 4/1/2022) for IV or J9334 (permanent eff. 4/1/2024) for SC Hytrulo. Both have permanent codes and should not be billed under unclassified.
#8	Site of care (HOPD) on commercial plan	HOPD administration with active site-of-care UM	Move to office (POS 11), AIC (POS 49), or home (POS 12) for subsequent cycles. SC Vyvgart Hytrulo is particularly suitable for home transition. Submit medical-necessity letter if HOPD required (e.g., first dose monitoring).
#9	Wrong NDC format (vial-level instead of carton)	10-digit vial NDC submitted instead of 11-digit carton NDC with N4 qualifier	Use 11-digit carton NDC (73475-0201-01 for IV; 73475-0301-01 for Hytrulo) with N4 qualifier in 24A shaded area.
#10	Off-label diagnosis (seronegative gMG, ocular MG, non-CIDP polyneuropathy)	ICD-10 submitted but chart documents non-labeled population	Vyvgart is not approved for these populations. CIDP coverage applies only to Vyvgart Hytrulo (J9334) with G61.81. Discontinue PA or pursue exception with payer medical director.
#11	Unit math error (mg billed instead of units of 2 mg)	Biller submitted 700 units for a 700 mg IV dose, expecting 1 unit = 1 mg (Rystiggo convention)	Resubmit with mg ÷ 2 = units. A 700 mg dose is 350 units of J9332, not 700 units. Confused with Rystiggo (J9333) where 1 unit = 1 mg.

Frequently asked questions

What is the HCPCS code for Vyvgart?

Vyvgart (efgartigimod alfa-fcab) IV is billed under HCPCS J9332 — "Injection, efgartigimod alfa-fcab, 2 mg." Each 2 mg equals one billable unit. A typical 10 mg/kg IV dose in a 70 kg patient is 700 mg = 350 units. Vyvgart Hytrulo SC has its own code, J9334 ("Injection, efgart-alfa 2 mg / hya-qvfc"). J9332 became permanent April 1, 2022; J9334 became permanent April 1, 2024.

Vyvgart vs Rystiggo — when which?

Antibody status decides. If your patient is AChR-positive: either Vyvgart (IV or Hytrulo SC) or Rystiggo is potentially appropriate — payer preference (often via contracting), prescriber preference, and route (IV vs SC, dose frequency) determine the pick. If your patient is MuSK-positive: only Rystiggo (J9333) is labeled — Vyvgart will be denied. If your patient has CIDP: only Vyvgart Hytrulo (J9334) is labeled — Rystiggo is gMG only. See Rystiggo (J9333) for the sister-drug billing reference.

AChR+ vs MuSK+ documentation — what does the PA need?

Every major commercial payer requires the antibody panel lab report in the PA packet (lab name, draw date, antibody value, reference range). For Vyvgart specifically, the report must show anti-AChR positivity; MuSK+ alone (or seronegative) is a hard denial. Acceptable AChR assays include radioimmunoprecipitation (RIPA), cell-based assay (CBA), or fluorescence immunoprecipitation. Vyvgart Hytrulo for CIDP requires confirmed CIDP diagnosis per EFNS/PNS criteria, not antibody serology.

IV Vyvgart vs SC Vyvgart Hytrulo — how does the billing differ?

Different HCPCS codes, different NDCs, different admin CPTs. IV Vyvgart is J9332 with CPT 96365 (IV non-chemo, up to 1 hr); NDC 73475-0201-01 (400 mg / 20 mL vial); dose is 10 mg/kg weight-based. SC Vyvgart Hytrulo is J9334 with CPT 96372 (SC therapeutic injection); NDC 73475-0301-01 (1,008 mg / 5.6 mL vial); dose is fixed 1,008 mg regardless of weight. Both are 1 unit = 2 mg. Each formulation has its own ASP. Cross-coding J9332 for an SC dose (or J9334 for an IV dose) is an immediate denial.

When can a re-treatment cycle be billed?

Per FDA label, Vyvgart and Vyvgart Hytrulo cycles are repeated based on clinical evaluation with no fixed minimum interval mandated in the label. Clinical re-treatment timing is based on the neurologist's assessment of symptom return — MG-ADL or QMG score trending back toward pre-cycle baseline. Most commercial payers impose 4–12 weeks of UM-managed spacing between cycles; document the clinical trigger (symptom return, score change) at every continuation PA.

Vyvgart Hytrulo CIDP indication — how is that billed differently?

For CIDP use of Vyvgart Hytrulo, bill J9334 with ICD-10 G61.81 (chronic inflammatory demyelinating polyneuritis) and CPT 96372 (SC therapeutic injection). The CIDP indication applies only to Vyvgart Hytrulo (J9334), not to IV Vyvgart (J9332). PA documentation for CIDP includes confirmed diagnosis per EFNS/PNS criteria, neurologist prescriber, and prior IVIG or corticosteroid trial. Foundations covering CIDP (e.g., GBS|CIDP Foundation International) may help with Medicare patient cost-sharing.

Vyvgart vs Soliris (J1299) / Ultomiris (J1303) for gMG?

Different mechanism, different setting, different antibody coverage but both target AChR+ gMG. Soliris (eculizumab) and Ultomiris (ravulizumab) are C5 complement inhibitors approved for AChR-positive gMG only, given as continuous IV therapy (Soliris q2wk; Ultomiris q8wk) with mandatory Alexion REMS for meningococcal infection risk. Vyvgart is an FcRn inhibitor approved for AChR+ gMG and given as cyclic IV (or SC Hytrulo) therapy (4 weekly doses per cycle), without REMS. Many neurologists trial FcRn first (Vyvgart or Rystiggo) and reserve complement inhibitors for refractory AChR+ disease where IgG-lowering alone is insufficient.

How does Vyvgart compare to IVIG and rituximab for gMG?

IVIG (Octagam, Privigen, Gamunex-C, etc.) and rituximab (Rituxan, biosimilars) are used off-label in gMG and lack a labeled gMG indication. IVIG is broadly accessible and acts via multiple immune modulation mechanisms but is logistically heavy (multi-day high-volume IV infusions) and expensive at 2 g/kg dose cycles. Rituximab depletes B cells (mechanism distinct from FcRn or complement) and is particularly favored by some neurologists for MuSK+ refractory gMG. Vyvgart (and Rystiggo) provide FDA-labeled, evidence-based targeted therapy that fits within payer formularies as on-label coverage rather than off-label exception requests.

Is Vyvgart approved in pediatric patients?

No. Vyvgart and Vyvgart Hytrulo are FDA-approved for adults only (18 years and older). Safety and effectiveness in pediatric patients have not been established. Pediatric gMG patients should be managed per pediatric neurology guidance with FDA-approved pediatric agents and supportive care; off-label Vyvgart use in pediatrics will be denied.

What is an FcRn inhibitor and how does it work?

The neonatal Fc receptor (FcRn) is a salvage receptor in vascular endothelium and other tissues that binds circulating IgG and returns it to the bloodstream, dramatically extending IgG half-life (~21 days for endogenous IgG vs ~1–3 days for other plasma proteins). FcRn inhibitors competitively block FcRn-IgG binding, accelerating IgG catabolism and lowering circulating IgG (including pathogenic autoantibodies) by ~60–70% per treatment cycle. In gMG, this transiently reduces anti-AChR autoantibody levels and improves neuromuscular transmission. In CIDP, the same IgG-lowering mechanism reduces presumed pathogenic autoantibodies driving demyelination. The effect is reversible; IgG levels recover between cycles, which is why dosing is cyclic rather than continuous. Vyvgart (efgartigimod) was the first FcRn inhibitor approved for any indication (December 2021).

Why is the J9332 unit different from J9333 (Rystiggo)?

CMS assigns HCPCS unit sizes per product based on manufacturer submission and typical dispensing increments. J9332 (Vyvgart) is "per 2 mg" and J9334 (Vyvgart Hytrulo) is also "per 2 mg." J9333 (Rystiggo) is "per 1 mg." When converting an mg dose to billable units, always check the descriptor unit before multiplying. A common biller error is treating all three FcRn codes as 1 mg = 1 unit and billing twice the correct units of J9332 / J9334.

Reference Sources & methodology Every claim on this page is sourced. Methodology and review history below.

Source documents

FDA — VYVGART (efgartigimod alfa-fcab) prescribing information (BLA 761195, approved December 17, 2021; label revised May 13, 2026)
Current FDA-approved IV label (DailyMed setid 8aefc8e3-26d6-4ff6-aab9-a7542927e084); first FcRn inhibitor approved for any indication; AChR+ gMG only (CIDP indication is Hytrulo-only); warnings cover infections, hypersensitivity, infusion reactions
FDA — VYVGART HYTRULO (efgartigimod alfa + hyaluronidase-qvfc) prescribing information (BLA 761304, approved June 20, 2023; label revised May 13, 2026)
SC Hytrulo label; gMG approval 2023; CIDP indication added June 2024; current label adds prefilled-syringe (1,000 mg / 10,000 U) presentation alongside the original 1,008 mg / 11,200 U single-dose vial
DailyMed — VYVGART / VYVGART HYTRULO current prescribing information
Current FDA labels, NDCs, package inserts for both formulations
Howard JF Jr, et al. — ADAPT pivotal trial of efgartigimod in generalized myasthenia gravis (Lancet Neurology, 2021)
Phase 3 randomized controlled trial supporting initial FDA approval; MG-ADL and QMG response data
argenx — Vyvgart HCP coding & coverage (vyvgarthcp.com)
Manufacturer billing guide, claim form mapping, My Vyvgart Path Patient Support program details
CMS — Medicare Part B Drug ASP Pricing File
Q2 2026 quarterly file, effective April 1 – June 30, 2026; J9332 = $32.608/unit (2 mg); J9334 ~$34.325/unit (2 mg)
SEER CanMED — HCPCS J9332 reference
HCPCS code descriptor and history (J9332 permanent eff. 4/1/2022; J9334 permanent eff. 4/1/2024)
MGFA — International Consensus Guidance for Management of Myasthenia Gravis (2020 update)
Targeted biologics positioning in refractory gMG
UnitedHealthcare — Medical Benefit Drug Policies (Vyvgart / Vyvgart Hytrulo)
Aetna Clinical Policy Bulletins — Efgartigimod (Vyvgart)
CMS HCPCS Level II Quarterly Updates
J9332 permanent code effective 4/1/2022; J9334 permanent code effective 4/1/2024
FDA National Drug Code Directory
argenx labeler 73475; 400 mg/20 mL IV vial and 1,008 mg/5.6 mL Hytrulo SC vial
CMS — JW/JZ modifier policy (CR 12056, eff. July 2023)

About this page

We maintain this page as a living reference. Medicare ASP pricing is bound to our underlying CareCost data layer and refreshes automatically when CMS publishes new quarterly files. Coding and policy content is reviewed at least quarterly and updated whenever a source document changes.

Found an error? Email hello@carecostestimate.com.

Refresh cadence

Element	Cadence	How it's refreshed
Medicare ASP pricing	Quarterly	Auto-bound to CareCost ASP layer; updates on CMS file release.
Payer policies (UHC, Aetna, BCBS, Cigna)	Semi-annual	Manual review against published payer policy documents.
HCPCS / CPT / modifier rules	Annual	Reviewed against CMS HCPCS quarterly files and AMA CPT releases.
NDC, dosing, FDA label	Event-driven	Tied to manufacturer document version + FDA label revision date.

Reviewer

Primary-source verified May 22, 2026. BLA numbers, label revision dates, indications, warnings, dosing, vial strengths, NDCs, HCPCS codes, and ASP+6% pricing all confirmed against current DailyMed FDA labels (Vyvgart IV setid 8aefc8e3-26d6-4ff6-aab9-a7542927e084 and Vyvgart Hytrulo SC setid 7104d9e5-9910-47f5-9a93-741ac50f43b6, both revised May 13, 2026), the CMS Q2 2026 Part B Drug ASP Pricing File, and CMS HCPCS Level II quarterly updates. Independent clinician/coding SME review pending.

Change log

May 22, 2026 — Primary-source audit pass. Corrected Vyvgart Hytrulo BLA number from 761322 to 761304. Confirmed current DailyMed label revision date (both products) as May 13, 2026. Added prefilled-syringe presentation (1,000 mg / 10,000 U) for Vyvgart Hytrulo — both syringe and vial presentations bill under J9334 at 1 unit = 2 mg. ASP data: Q2 2026 (J9332 $32.608/unit, J9334 ~$34.325/unit). Manufacturer source: My Vyvgart Path 2026. Coverage: gMG in adults AChR+ (both products); CIDP (Hytrulo only). FcRn class comparison vs Rystiggo (J9333). Cross-links to Soliris (J1299) and Ultomiris (J1303) for gMG class context.

Methodology

Every claim on this page is sourced inline. Pricing reflects the current CMS Part B Drug ASP Pricing File. Payer policies are read directly from each payer's published medical/pharmacy policy documents. Indication list and dosing are verified against the current FDA label revision. We do not paraphrase from billing-software vendor blogs.

Vyvgart (efgartigimod alfa-fcab) — HCPCS J9332

Instant Answer — the 5 things you need to bill J9332

Two Vyvgart formulations + FcRn class context CMS HCPCS verified May 2026

IV Vyvgart vs SC Vyvgart Hytrulo — same drug, different code

FcRn class — Vyvgart vs Rystiggo (J9333)

Dosing & unit math FDA label verified May 2026

Per-cycle dosing schedule

Worked example — 70 kg patient, IV Vyvgart

Worked example — SC Vyvgart Hytrulo, fixed 1,008 mg

NDC reference FDA NDC Directory verified May 2026

Administration codes CPT verified May 2026

Modifiers CMS verified May 2026

JW — expected on most IV Vyvgart claims

JZ — when no waste occurs

Worked example — JW with 10 mg/kg in a 70 kg patient

Modifier 25 — same-day E/M

340B modifiers (JG, TB)

ICD-10-CM by indication FY2026 verified May 2026

Site of care & place of service Verified May 2026

Claim form field mapping My Vyvgart Path 2026

Payer policy snapshot Reviewed May 2026

Re-treatment cycle documentation

MGFA / AAN guidance support

Medicare reimbursement CMS Q2 2026 (live)

Q2 2026 payment snapshot — J9332 (IV Vyvgart)

Q2 2026 payment snapshot — J9334 (Vyvgart Hytrulo SC)

Coverage

Code history

ASP trajectory

Patient assistance — My Vyvgart Path argenx verified May 2026

Common denials & how to fix them

Frequently asked questions

What is the HCPCS code for Vyvgart?

Vyvgart vs Rystiggo — when which?

AChR+ vs MuSK+ documentation — what does the PA need?

IV Vyvgart vs SC Vyvgart Hytrulo — how does the billing differ?

When can a re-treatment cycle be billed?

Vyvgart Hytrulo CIDP indication — how is that billed differently?

Vyvgart vs Soliris (J1299) / Ultomiris (J1303) for gMG?

How does Vyvgart compare to IVIG and rituximab for gMG?

Is Vyvgart approved in pediatric patients?

What is an FcRn inhibitor and how does it work?

Why is the J9332 unit different from J9333 (Rystiggo)?

Source documents

About this page

Refresh cadence

Reviewer

Change log

Methodology

Stop calculating Vyvgart copays by hand.