ELFABRIO J Code: J2508

Drug & Product Overview

HCPCS Descriptor Injection, pegunigalsidase alfa-iwxj, 1 mg

HCPCS Added Date January 1, 2024

Manufacturer Chiesi USA

Route of Administration Intravenous

Generic Status Single-Source; Branded

Dosage Type Single-Dose

Dosage Form Injection, Solution, Concentrate

About ELFABRIO

Elfabrio is a medication aligned to the HCPCS J Code: J2508 for billing, pricing, and reimbursement purposes in the United States. This Enzyme Replacement Therapy medication is administered via the intravenous route and manufactured by Chiesi USA.

According to CMS Drug Use Information: This medication is used to treat a certain inherited disorder (Fabry disease) that causes buildup of a certain fat substance (Gb3) in some parts of your body. If this condition gets worse, it can lead to kidney disease, heart attack, or stroke. Pegunigalsidase alfa works by replacing an enzyme that your body lacks, which helps break down the fat substance Gb3 in your body. This can help to lessen the buildup of Gb3 in the kidneys and blood.

Disclaimer: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your healthcare professional.

NDC Code Information

Based on publicly available CMS files. The list of NDCs below is not exhaustive.

NDC Code	Drug	Manufacturer	Billing Units / Pkg	Package Size
10122-0160-02	Elfabrio	Chiesi USA, Inc.	20	20 MG / 10 ML
10122-0160-05	Elfabrio	Chiesi USA, Inc.	100	20 MG / 10 ML
10122-0160-10	Elfabrio	Chiesi USA, Inc.	200	20 MG / 10 ML
10122-0165-02	Elfabrio	Chiesi USA, Inc.	5	5 MG / 2.5 ML

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ELFABRIO Pricing & Reimbursement

J2508 Private Payer Reimbursement

$227.34 / HCPCS unit as of Jan 2026

National median reimbursement across major commercial payers.

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Historical Graphing and Billing Calculator

per HCPCS unit

As of Q4 2026

ELFABRIO CPT Administration Codes

CPT Code	Description
96413	Chemotherapy administration, intravenous infusion technique; up to 1 hour, single or initial substance/drug
96415	Chemotherapy administration, intravenous infusion technique; each additional hour (List separately in addition to code for primary procedure)

Not on the CMS JW / JZ list

This product is new and does not yet appear on the CMS list of HCPCS pertaining to single-dose containers. Wastage billing guide →

ELFABRIO Medically Unlikely Edits (MUE)

The most billing units of J2508 Medicare will pay for one patient in one day, as published by CMS. 1 unit = 1 mg.

Practitioner Office & Hospital Outpatient

160 units / day

= 160 mg per day

MAI 3 · Date of Service Edit: Clinical. Per-day limit based on clinical expectations; excess units are denied but may be appealed with documentation of medical necessity. See all MUE limits →

ELFABRIO Clinical Information

Indications and drug classification.

Treated Diseases & Conditions

This list of indications is not exhaustive and may be subject to errors. The information on BuyandBill.com is intended for informational purposes only and should not be used for medical advice.

Fabry disease

Frequently Asked Questions

Is there an available Elfabrio billing and coding guide?

Billing and coding information for ELFABRIO can be found through Chiesi USA. Visit Here →

Are there any available Elfabrio patient assistance programs?

ELFABRIO patient assistance information can be found through Chiesi USA. Visit Here →

Where can I find Elfabrio prescribing information?

ELFABRIO prescribing information can be found at the link below: Visit Here →

Where can I find Elfabrio side effect information?

Information regarding ELFABRIO's side effects can be found at MedlinePlus Visit Here →

Does billing ELFABRIO require JZ/JW wastage modifiers?

CMS does not include ELFABRIO (J2508) on its list of HCPCS pertaining to single-dose containers. Per CMS guidelines, the JZ/JW wastage modifiers may not apply when billing J2508. For more information, visit the link below.

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