Alyglo (immune globulin IV, slra, 10% liquid) — J1552

About Alyglo — the newest IVIG FDA approved Dec 2023

Alyglo (immune globulin intravenous, human-slra) launched in 2024 from GC Biopharma USA, distributed in the US by Kedrion Biopharma.

Alyglo is the newest entrant in the US IVIG market, FDA-approved in December 2023 from GC Biopharma USA (the US subsidiary of GC Biopharma, a Korean plasma-products manufacturer). Kedrion Biopharma distributes Alyglo in the United States. Alyglo joins an established IVIG class including Privigen (CSL Behring), Gammagard Liquid (Takeda), Octagam (Octapharma), Gamunex-C (Grifols), Bivigam (ADMA), Flebogamma DIF (Grifols), and Gammaplex (BPL).

The non-proprietary suffix "slra" is FDA's distinguishing identifier for the Alyglo molecule under the biological product naming guidance — analogous to suffix conventions on biosimilars but applied to a novel originator IVIG. The suffix is part of the proper name and should be documented in the medical record and on the claim form.

Alyglo's commercial position rests on two attributes:

• Very low IgA content (≤10 µg/mL) — the lowest among current US IVIGs; enables safer use in IgA-deficient patients with anti-IgA antibodies (a small but high-stakes population). See the IgA-deficient niche section for clinical detail.
• Premium pricing — Q2 2026 ASP+6% of approximately $123/unit ($246/g) is roughly 2.5× the cost of Privigen / Gammagard Liquid / Octagam / Gamunex-C (all $47–$50/unit, ~$94–$99/g). See the brand interchangeability matrix for full per-product comparison.

The combination — a clinically meaningful but narrow advantage at a substantial price premium — defines the billing reality. For most general PI patients, payers will not approve Alyglo over a lower-cost preferred IVIG. For IgA-deficient patients with documented anti-IgA antibodies (or a documented reaction history to standard IVIG), Alyglo is often the most defensible choice and payers will approve with appropriate documentation.

The 500 mg unit-basis trap CMS HCPCS verified May 2026

J1552 follows the IVIG-class convention of 500 mg per unit — same as Privigen J1459, Gammagard Liquid J1569, Octagam J1568, Gamunex-C J1561. This is unusual versus most J-codes (1 mg/unit). On Alyglo's premium ASP, unit-count errors carry roughly 2.5× the dollar exposure of the same error on standard IVIGs.

Dosing — PI only FDA Alyglo label verified 2025–2026

Alyglo carries a single FDA-approved indication: primary humoral immunodeficiency in adults ≥17 years. Dosing follows the IVIG-class convention with weight-based escalation to maintain a target IgG trough.

Worked dose & unit calculations — Alyglo PI maintenance

Infusion rate titration FDA Alyglo label verified 2025–2026

Alyglo follows the IVIG-class titration pattern: start slow, escalate every 30 minutes if tolerated. Total infusion time per dose typically runs 2–6 hours, which drives the chair-time and 96366 add-on units.

NDC reference FDA NDC Directory verified May 2026

Pad to 11 digits with a leading zero in the middle segment for CMS-1500 Box 24A. Use N4 qualifier and report units of measure (ML) and quantity drawn from the vial. Alyglo NDCs are issued under the GC Biopharma USA labeler code — verify the current NDCs against the FDA NDC Directory and Alyglo prescribing information at billing time, as Kedrion's distribution arrangement may add a co-labeled package.

The IgA-deficient niche — Alyglo's signature differentiator AAAAI PI parameters + FDA Alyglo label

Alyglo's very low IgA content (≤10 µg/mL) is the lowest among current US IVIGs. This makes Alyglo the most defensible IVIG choice for IgA-deficient patients with anti-IgA antibodies — a small but high-stakes patient population.

Why IgA matters in IVIG

Standard IVIG products contain residual IgA from the donor plasma pool. Most patients tolerate this without issue. A small subset of patients have selective IgA deficiency (low or absent serum IgA) AND have developed anti-IgA antibodies — either spontaneously, after prior IVIG exposure, or after blood-product transfusion. In these patients, infusion of standard IVIG carrying residual IgA can trigger an anaphylactic reaction (anti-IgA bound to infused IgA → immune complex → type-1 hypersensitivity).

Alyglo's IgA content vs. other IVIGs

IgA content figures above are approximate, drawn from manufacturer prescribing information and published product comparisons; values vary lot-to-lot within each product. Confirm against the current FDA label of each product before relying on a specific number for clinical decisions.

What payers require to approve Alyglo on the IgA-deficient indication

• Documented selective IgA deficiency: serum IgA < 7 mg/dL (or below age-appropriate threshold); usually requires repeat measurement.
• Documented anti-IgA antibody titer: positive serum anti-IgA antibodies (clinically significant titer per assay reference range).
• OR documented anaphylactic / severe infusion reaction to a standard (higher-IgA) IVIG product, with the prior product, date, and reaction details in the medical record.
• Failure / intolerance of lower-cost IVIG alternatives may also satisfy step therapy on some payer policies.

IVIG brand interchangeability — Alyglo's premium-pricing position Verified May 2026

IVIG products are NOT interchangeable for billing. Each brand has its own HCPCS, NDC, and ASP. Alyglo (J1552) is the highest-cost IVIG per gram on the current Medicare Part B ASP file — payers typically require clinical justification (IgA deficiency, anti-IgA antibodies, or documented intolerance) to approve over the lower-cost siblings.

ASP+6% rates above are illustrative based on Q2 2026 file values; the live Privigen / Gammagard Liquid / Octagam / Gamunex-C / Alyglo numbers are bound to the CareCost ASP layer on each product's reference page. ASP refreshes quarterly — rerun the comparison whenever the CMS Part B Drug ASP Pricing File updates.

When Alyglo is the right billing choice

• Documented selective IgA deficiency + anti-IgA antibodies: Alyglo's very low IgA content makes it the most defensible IVIG. Document IgA level, anti-IgA antibody titer, and the rationale.
• Anaphylactic reaction history to standard IVIG: document the prior product, the reaction, and the reason for switching to Alyglo. Some payers require trial of one alternative low-IgA product (e.g., Gammagard Liquid) before approving Alyglo.
• Renal impairment with intolerance to glycine-, maltose-, or sorbitol-stabilized products: Alyglo's stabilizer profile may be better tolerated — verify against the current FDA Alyglo label and the patient's prior product history.
• Payer formulary preference: rare for Alyglo (premium product); but verify per-payer-per-contract at every PA submission and reauthorization.

Two brand-related billing patterns to avoid

• Wrong code, right indication: billing J1552 (Alyglo) for a patient who actually received Privigen / Gammagard Liquid / Octagam / Gamunex-C is a denial trigger and a major compliance issue — the ~$5,000+ per-dose ASP differential makes this immediately visible to the payer on audit. Match HCPCS to the actual NDC drawn.
• Right code, payer-mandated different brand: if the payer's preferred IVIG is Privigen or Gammagard, Alyglo must be justified clinically before infusion. Do not infuse Alyglo and bill J1552 assuming it will be approved; the appeal cycle on a $8,000+ unjustified premium product is long.

Administration codes CPT verified May 2026

IVIG is not chemotherapy. Use the therapeutic IV infusion family (96365 / 96366). Expect to bill multiple 96366 add-on hours per dose because Alyglo infusions run 2–6 hours including premedication and rate titration.

Premedication coding

Standard Alyglo premedications are acetaminophen and diphenhydramine 30–60 minutes pre-infusion. Some patients (especially first-dose, IgA-deficient with anti-IgA antibodies, or prior-reaction history) require IV corticosteroids. Premeds are billed separately with the appropriate J-code (e.g., J1200 diphenhydramine, J1100 dexamethasone, J1040 methylprednisolone) and the appropriate admin code (96372 SC/IM, 96374 IV push, or 96365/96366 if infused). Oral acetaminophen is generally not separately billable.

Modifiers — JZ, JW, and the weight-based waste calculation CMS verified May 2026

All three Alyglo vial sizes (5 g, 10 g, 20 g) are single-dose containers. Weight-based dosing rarely matches an integer vial combination — partial-vial waste is the rule. On Alyglo's premium ASP, JW reporting accuracy is especially important.

JZ — required when no drug discarded

Effective July 1, 2023, CMS requires the JZ modifier on all single-dose container claims when no drug is discarded. For Alyglo, JZ applies when the dose happens to match an integer combination of the 5 / 10 / 20 g vials — e.g., a 35 g dose = 20 + 10 + 5 g = exactly three vials, no waste. Append JZ to the J1552 line.

JW — required for documented waste of unused single-dose-vial drug

For mg/kg dosing where the calculated dose does not match an integer vial combination (the typical case), partial-vial waste is the norm. CMS requires the JW modifier on a separate claim line for the discarded units (rounded per CMS rules), with the wastage documented in the medical record. Bill administered units (with JZ) and discarded units (with JW) on two separate lines, same date of service.

Apply each MAC's rounding convention. Some MACs require billing the total drawn from the vial as administered units and reporting waste only when an entire additional vial would otherwise be required. Refer to your local MAC billing article for the exact rounding rule. On Alyglo specifically — the highest-priced IVIG on the current Medicare Part B ASP file — small per-mg variations translate to thousands of dollars per dose, and payers audit JW on premium IVIG claims especially closely.

JG / TB — 340B drug pricing

Hospitals that purchase Alyglo through 340B and bill Medicare report the JG modifier (acute-care hospitals) or TB modifier (rural sole community / critical-access hospitals), per CMS guidance. Most ambulatory infusion suites and home infusion providers do not use 340B pricing; only hospital-outpatient infusion uses 340B in most networks.

Modifier 25 — same-day E/M

Append modifier 25 to the same-day E/M code if a significant, separately identifiable evaluation occurred (clinical reassessment for next-cycle decision, dose-titration encounter, IgA-deficiency workup, etc.). Routine pre-infusion check-in is bundled.

ICD-10-CM diagnosis codes — PI only FY2026 verified May 2026

Alyglo's FDA-approved indication is primary humoral immunodeficiency. Use the most specific code supported by chart documentation. ITP (D69.3) and CIDP (G61.81) are NOT on the Alyglo label.

Site of care & place of service Verified May 2026

IVIG site-of-care steerage is among the most aggressive in specialty pharmacy. Home infusion is preferred for chronic PI at most national payers; HOPD claims are routinely denied or downcoded. On Alyglo's premium ASP, site-of-care discipline matters even more — HOPD facility fees on top of $246/g drug push the per-dose total claim into five figures fast.

Claim form field mapping CMS-1500 reference + GC Biopharma billing guide

CMS-1500 / 837P (physician office, AIC, home infusion; POS 11/12/49) example for a 35 g PI maintenance dose of Alyglo.

Source: GC Biopharma USA / Kedrion Alyglo billing & coding guidance; CMS-1500 instruction manual; payer policy documents (UHC, Aetna, Cigna, Anthem). Home infusion claims may use additional per-diem codes (S9338 commercial, Medicare Part B home infusion benefit codes).

Payer policy snapshot — LCD & PA criteria Reviewed May 2026

Every major payer requires PA on every IVIG start and at every reauthorization. On Alyglo, the additional clinical-justification bar (IgA deficiency / anti-IgA Ab / prior reaction) drives the approval rate.

What to document for Alyglo PA approval

• PI diagnostic criteria (baseline IVIG): documented serum IgG levels (low for age); functional antibody response to vaccine challenge OR pre-existing antibody titers below protective; recurrent infection history with objective documentation (cultures, imaging, hospitalizations).
• Alyglo-specific premium-product justification (in addition to baseline): documented selective IgA deficiency (low serum IgA), OR documented anti-IgA antibody titer, OR documented anaphylactic / severe infusion reaction to a standard (higher-IgA) IVIG with prior product, date, and reaction details. Without one of these elements, expect denial in favor of a lower-cost preferred IVIG.
• Site-of-care attestation: patient suitability for home infusion (vascular access, caregiver availability, prior tolerance) OR justification for AIC / HOPD (first dose, prior reaction history, complex medical needs).
• Reauthorization: documented continued benefit (IgG trough levels for PI; absence of breakthrough infections; tolerance of Alyglo without infusion reactions); rationale for staying on Alyglo vs switching to lower-cost alternative.

Medicare reimbursement CMS Q2 2026 (live)

Quarterly ASP from CMS Part B Drug Pricing File. J1552 refreshes every quarter; the per-500-mg-unit rate translates to a per-gram cost via × 2.

Per-dose Medicare reimbursement at common Alyglo doses

Coverage

No NCD specific to IVIG as a class. Each MAC publishes a billing & coding article covering IVIG with covered ICD-10 ranges. Medicare covers Alyglo for the FDA-approved PI indication (D80.x / D81.x / D82.x / D83.x). Off-label IVIG indications (ITP, CIDP, myasthenia gravis, dermatomyositis, etc.) are NOT on the Alyglo label and should be billed under an FDA-labeled IVIG that covers the relevant indication.

Canonical code source: CMS HCPCS quarterly update file.

Patient assistance — GC Biopharma USA / Kedrion Manufacturer site verified May 2026

• GC Biopharma USA / Kedrion patient access support: commercial copay assistance and uninsured/underinsured patient access programs are administered through the GC Biopharma USA / Kedrion patient services hub. Verify the current program name, eligibility criteria, annual benefit cap, and enrollment phone at PA stage — Alyglo's patient support program is newer than the established IVIG manufacturer programs (CSL Behring AssureSupport, Takeda OnePath, Octapharma, Grifols Source) and program details may evolve.
• KedPlasma / KedAccess (Kedrion patient services): Kedrion's US patient access infrastructure historically supports KedRAB, RyClora, and other Kedrion plasma-derivative products and is the likely conduit for Alyglo patient services. Verify the current Alyglo-specific contact via the Alyglo HCP page or current GC Biopharma USA / Kedrion materials.
• Independent foundations (Medicare patients): PAN Foundation, HealthWell Foundation, Patient Advocate Foundation, and the Assistance Fund all run open-disease IVIG funds intermittently. Verify open funds quarterly — IVIG funds are high-demand and frequently close.
• Reimbursement support: benefit verification, PA support, appeal letters, and product replacement for spoiled / damaged vials are typically available through the manufacturer's patient services hub.

Common denials & how to fix them

Frequently asked questions

How many units do I bill for an Alyglo dose?

Alyglo (HCPCS J1552) bills at 1 unit = 500 mg. This matches the rest of the IVIG class but is unusual versus most J-codes (which use 1 mg per unit). For Alyglo specifically: a 35 g dose = 70 units (35,000 mg ÷ 500); a 50 g dose = 100 units; a 1 g/kg dose for a 70 kg PI patient = 70 g = 140 units. Defaulting to 1 mg/unit will overbill by 500x; defaulting to 1 g/unit will underbill by 2x. Conversion shortcut: grams × 2 = units.

What is the Q2 2026 Medicare reimbursement for J1552 Alyglo?

Q2 2026 ASP + 6% for J1552 is approximately $123.125 per 500 mg unit, which is approximately $246.25 per gram. This is among the most expensive IVIG products per gram — roughly 2.5× the cost of Privigen (J1459, ~$99/g), Gammagard Liquid (J1569, ~$98/g), Octagam (J1568, ~$94/g), and Gamunex-C (J1561, ~$99/g). A typical 35 g monthly PI maintenance dose = 70 units × $123.125 = $8,618.75 before sequestration.

What are the FDA-approved indications for Alyglo?

Alyglo is FDA-approved (December 2023) for treatment of primary humoral immunodeficiency (PI) in adults aged 17 years and older. This is a narrower label than other IVIGs — Privigen, Gammagard Liquid, Octagam, and Gamunex-C cover PI plus chronic ITP (and several cover CIDP). Alyglo does NOT carry an ITP or CIDP label as of May 2026; off-label use of Alyglo for ITP, CIDP, or pediatric indications is not supported by the current FDA label and is unlikely to be covered.

What makes Alyglo different from other IVIGs?

Alyglo's signature differentiator is very low IgA content — typically ≤10 µg/mL, the lowest among current IVIG products. This makes Alyglo the most appropriate IVIG for IgA-deficient patients with anti-IgA antibodies, a population at high risk of anaphylactic reactions to standard (higher-IgA) IVIGs. For most general PI patients, the clinical advantage is small and does not justify Alyglo's ~2.5× price premium over Privigen, Gammagard Liquid, Octagam, and Gamunex-C. Payer prior authorization for Alyglo typically requires documented IgA deficiency and/or anti-IgA antibody history.

Will payers cover Alyglo without IgA deficiency documentation?

Often not. Because Alyglo costs roughly 2.5× more per gram than alternative IVIGs (Privigen, Gammagard Liquid, Octagam, Gamunex-C) — all of which are FDA-approved for PI — major payers typically require clinical justification for the premium product. Acceptable justification usually includes: documented selective IgA deficiency (low serum IgA), documented anti-IgA antibody titer, history of anaphylactic or severe infusion reaction to standard IVIGs, or other documented intolerance. Without these, payers steer to a lower-cost preferred IVIG. Build the IgA workup into the initial PA submission for Alyglo.

Why does the JW modifier apply to Alyglo even though it comes in single-dose vials?

All IVIG dosing is weight-based (mg/kg), so the calculated dose almost never matches an integer combination of the 5 g, 10 g, and 20 g Alyglo vial sizes. Vial-level waste is routine. CMS requires JZ on the administered units when no waste occurs, and JW on a separate line for the discarded units when an SDV is partially used. Document waste in the medical record. On Alyglo specifically — the highest-priced IVIG on the current Medicare Part B ASP file — payers audit JW especially closely.

Are IVIG brands interchangeable for billing purposes?

No. Each IVIG product has its own HCPCS code, NDC, and ASP (Alyglo J1552, Privigen J1459, Gammagard Liquid J1569, Octagam J1568, Gamunex-C J1561, etc.). Substituting brands without matching the HCPCS to the actual product administered is a denial trigger and a compliance issue — on Alyglo, the ~$5,000+ per-dose ASP differential makes this immediately visible to the payer on audit. Many payers contract preferentially with specific brands; Alyglo (premium product) is rarely the formulary preferred choice and typically requires clinical justification.

What administration codes are used for Alyglo?

IVIG is non-chemotherapeutic. Use 96365 (therapeutic IV infusion, initial hour) plus 96366 (each additional hour) — Alyglo infusions typically run 2–6 hours per dose because the rate is titrated up gradually from a low starting rate, so multiple 96366 units are billed per session. Do not use the chemo admin codes 96413/96415 for IVIG. Standard premedications (acetaminophen, diphenhydramine; corticosteroids in some patients, especially IgA-deficient or prior-reaction history) are billed separately with their own J-codes and admin codes.

Who manufactures Alyglo and what is the patient assistance contact?

Alyglo is manufactured by GC Biopharma USA (the US subsidiary of GC Biopharma, a Korean plasma-products company). Kedrion Biopharma distributes Alyglo in the US. Patient access support runs through the GC Biopharma USA / Kedrion patient services hub (likely co-branded with KedPlasma / KedAccess infrastructure). Verify the current program name and contact via the Alyglo HCP page at PA stage — the program is newer than the established CSL / Takeda / Grifols / Octapharma IVIG patient services and details may evolve.

Source documents

1. FDA Drugs@FDA — Alyglo (immune globulin intravenous, human-slra) approval record
   FDA approval December 2023 (GC Biopharma USA); current label revision — verify on Drugs@FDA / DailyMed
2. DailyMed — ALYGLO (immune globulin intravenous, human-slra) prescribing information
   FDA-approved Alyglo prescribing information; PI indication, dosing, infusion rate titration, IgA content, boxed warnings (thrombosis, renal)
3. Alyglo HCP resources (GC Biopharma USA / Kedrion)
   Manufacturer-published HCP page for Alyglo; dosing & administration, billing/coding guidance, patient support program reference
4. Kedrion Biopharma US site
   US distributor for Alyglo; patient services and reimbursement support infrastructure
5. GC Biopharma corporate site (Korea / US)
   Manufacturer; Alyglo BLA holder; pipeline and pediatric-expansion plans
6. AAAAI — Primary Immunodeficiency Practice Parameters
   PI diagnostic criteria, IVIG dose targets, IgG trough goals (500–1,000 mg/dL), IgA-deficient patient management
7. Immune Deficiency Foundation (IDF)
   Patient-facing PI education; IVIG vs SCIG resource pages; IgA-deficient PI patient resources
8. UnitedHealthcare — Immune Globulin medical drug policy
   PA criteria, brand preference, site-of-care steerage (Optum Infusion home preference); premium-product step-therapy rules
9. Aetna CPB 0206 — Intravenous Immune Globulin
   Coverage criteria by indication; on-label coverage; brand step therapy
10. Cigna IP0011 — Immune Globulin IV coverage policy
    PA criteria; site-of-care; reauthorization
11. CMS — Medicare Part B Drug ASP Pricing File
    Q2 2026 quarterly file (J1552 Alyglo and IVIG siblings)
12. CMS — HCPCS quarterly update file
    Canonical HCPCS code source for J1552 and the IVIG family
13. CMS — JW / JZ modifier guidance
    Single-dose-container waste reporting (effective 7/1/2023)
14. CMS — Medicare home infusion therapy benefit
    Part B home infusion benefit overview (covered drugs and admin codes)
15. FDA National Drug Code Directory
    Alyglo NDC verification (GC Biopharma USA labeler)

About this page

We maintain this page as a living reference for Alyglo (J1552) and the broader IVIG class. Medicare ASP pricing for J1552 (and the IVIG sibling codes) 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 manufacturer guide, FDA label, or major payer policy changes.

Found an error? Email hello@carecostestimate.com.

Refresh cadence

Reviewer

Change log

• May 2, 2026 — Initial publication of the Alyglo (J1552) reference. ASP data: Q2 2026. Payer policies verified: UHC immune globulin medical drug policy, Aetna CPB 0206, Cigna IP0011 IVIG, BCBS plan-by-plan. IgA-content comparison drawn from published manufacturer prescribing information. Premium-pricing position vs Privigen / Gammagard Liquid / Octagam / Gamunex-C documented (~2.5× per gram). Pediatric <17 yr expansion noted as not yet on label.

Methodology

Every claim on this page is sourced inline. Pricing reflects the current CMS Part B Drug ASP Pricing File for J1552. Payer policies are read directly from each payer's published medical policy documents. We do not paraphrase from billing-software vendor blogs. When manufacturer guidance and payer policy conflict (as with Alyglo brand preference — GC Biopharma / Kedrion would prefer Alyglo on every PA, but most payers steer to lower-cost IVIGs absent IgA-deficiency justification), we surface the conflict rather than picking a side.