ONIVYDE J Code: J9205

Drug & Product Overview

HCPCS Descriptor Injection, irinotecan liposome, 1 mg

HCPCS Added Date January 1, 2017

Manufacturer Ipsen Biopharma

Route of Administration Intravenous

Generic Status Single-Source; Branded

Dosage Type Single-Dose

Dosage Form Injection, Powder, For Solution

About ONIVYDE

Onivyde is a medication aligned to the HCPCS J Code: J9205 for billing, pricing, and reimbursement purposes in the United States. It is an Oncology drug administered via the intravenous route and manufactured by Ipsen Biopharma.

According to CMS Drug Use Information: Irinotecan liposomal is used to treat cancer of the pancreas.

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
15054-0043-01	Onivyde	Ipsen Biopharmaceuticals, Inc.	43	43 MG / 10 ML

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ONIVYDE Pricing & Reimbursement

J9205 Private Payer Reimbursement

$68.22 / 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 Q3 2026

Irinotecan Hydrochloride 505(b)(2) Information:

HCPCS Code	Manufacturer	Active Ingredient	HCPCS Description
J9205	Ipsen Biopharma	Irinotecan Hydrochloride	Injection, irinotecan liposome, 1 mg

ONIVYDE Claims Performance

Claims from Jan 2026 – Aug 2026

Claim Denial Rate 15.94%

Avg. Days to File 12.8days

Avg. Days to Pay 27.7days

Real-world claims performance from FocalPoint, OnPoint Oncology's reimbursement analytics platform, with claims data accrued at the clearing house level.

Explore J9205 claims analytics on FocalPoint →

ONIVYDE 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)

JW / JZ modifiers apply

CMS has identified Onivyde (J9205) as a HCPCS code with single-dose containers. Therefore, the JW/JZ wastage modifiers could be required for billing purposes. Wastage billing guide →

ONIVYDE Medically Unlikely Edits (MUE)

The most billing units of J9205 Medicare will pay for one patient in one day, as published by CMS. 1 unit = 1 mg.

Practitioner Office & Hospital Outpatient

215 units / day

= 215 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 →

ONIVYDE 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.

Metastatic pancreatic adenocarcinoma

Drug Class

Topoisomerase Inhibitor [EPC]Topoisomerase Inhibitors [MoA]

Frequently Asked Questions

Is there an available Onivyde billing and coding guide?

Billing and coding information for ONIVYDE can be found through Ipsen Biopharma. Visit Here →

Are there any available Onivyde patient assistance programs?

ONIVYDE patient assistance information can be found through Ipsen Biopharma. Visit Here →

Where can I find Onivyde prescribing information?

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

Where can I find Onivyde side effect information?

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

Does billing ONIVYDE require JZ/JW wastage modifiers?

CMS has identified ONIVYDE(J9205) as a HCPCS code with single-dose containers. Therefore, the JW/JZ wastage modifiers could be required for billing purposes. See CMS guidelines on use of the JZ and JW wastage modifiers below.

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