Onivyde (irinotecan liposomal) — HCPCS J9205
CareCost Estimate · Billing Cheat Sheet
Ipsen Biopharmaceuticals
43 mg / 10 mL single-dose vial (4.3 mg/mL)
IV infusion 90 min · q14d
Reviewed: May 2, 2026
ASP: Q2 2026
HCPCS
J9205
1 mg = 1 unit (NOT J9206)
NALIRIFOX dose
90 units
50 mg/m² × 1.8 m² BSA
Modifier
JW
Waste expected (BSA + 43 mg vial)
Admin CPT
96413+96415
90-min chemo IV
Medicare ASP+6%
$66.374
/mg · $5,973.66/90 mg
J9205 ≠ J9206. J9205 = Onivyde liposomal pegylated ($66.374/mg). J9206 = conventional irinotecan / Camptosar / generic ($1.532 per 20 mg unit, ~$0.077/mg). Onivyde is ~860× more expensive per mg. Different drug, different toxicity, different regimens (NALIRIFOX/NAPOLI vs FOLFIRI/FOLFIRINOX).
Codes & NDC
| HCPCS | J9205 — "Inj irinotecan liposome 1 mg" (permanent; effective shortly after Oct 2015 FDA approval) |
|---|
| NDC | 15054-0001-01 — N4 qualifier |
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| Vial | 43 mg / 10 mL (4.3 mg/mL) single-dose — unusual concentration, not 20 mg/mL |
|---|
| Reference comparison | Conventional irinotecan = J9206 (Camptosar, generic), 20 mg per unit, ~$0.077/mg |
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| Benefit | Medical (provider buy-and-bill); Part B for Medicare |
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NALIRIFOX 1L pancreatic (FDA Feb 2024)
| Drug | Dose | Time | CPT |
|---|
| Onivyde (J9205) | 50 mg/m² (free base) | 90 min IV | 96413+96415 |
| Oxaliplatin (J9263) | 60 mg/m² | 2 hr IV | 96417+96415 |
| Leucovorin (J0640) | 400 mg/m² | 30 min IV | 96417 |
| 5-FU (J9190) | 2,400 mg/m² | 46 hr CIVI | 96416 + pump |
Cycle: Day 1 every 14 days · Trial: NAPOLI 3 (OS 11.1 vs 9.2 mo) · NCCN Cat 1 preferred 1L
NAPOLI 2L post-gemcitabine (Oct 2015)
- Onivyde 70 mg/m² (free base) IV Day 1 q14d
- + leucovorin 400 mg/m² + 5-FU 2,400 mg/m² (46-hr)
- UGT1A1*28 homozygotes: 50 mg/m² (28% reduction)
UGT1A1 testing & dose mod
| Genotype | Freq | NALIRIFOX | NAPOLI |
|---|
| *1/*1 (wt) | ~45-50% | 50 mg/m² | 70 mg/m² |
| *1/*28 (het) | ~40-45% | 50 mg/m² | 70 mg/m² |
| *28/*28 (hom) | ~10% | 36 mg/m² | 50 mg/m² |
Test pre-treatment: CPT 81350 (UGT1A1 gene analysis). Many payers (UHC, BCBS) require UGT1A1 status in PA. Send-out lab, 5–10 day TAT, valid for life.
Administration & modifiers
| Code | When |
|---|
96413 | Initial 1 hr chemo IV (primary) |
96415 × 1 | Additional 30 min (90-min infusion) |
96365 | NOT appropriate — Onivyde is chemo |
JW > JZ for Onivyde: 43 mg vial + BSA dosing = waste on most claims. Default to JW; reserve JZ for exact 43 mg multiples. Bill waste on separate line — CMS reimburses both.
ICD-10 — pancreatic adenocarcinoma
| Code | For |
|---|
C25.0 | Head of pancreas (most common) |
C25.1 | Body of pancreas |
C25.2 | Tail of pancreas |
C25.3 | Pancreatic duct |
C25.7-9 | Other / overlapping / unspecified |
C78.x | Secondary — for documented mets (liver C78.7, peritoneum C78.6, lung C78.0x) |
C25.4 | NOT for Onivyde — endocrine pancreas (PNETs not on label) |
Adenocarcinoma + metastatic required. PNETs, acinar cell, locally advanced unresectable = denied.
Diarrhea management (W&P, no Boxed)
| Early-onset | Late-onset |
|---|
| Time | <24 hr | Days 3–10 |
| Mechanism | Cholinergic (AChE inhibit) | SN-38 gut tox |
| Treatment | Atropine 0.25-1 mg IV/SC | Loperamide high-dose: 4 mg load, 2 mg q2h |
| Severity | Mild-mod usually | Often severe (G3+ in 13% NAPOLI 3) |
Hospitalize G3+ diarrhea. Reduce dose 25% next cycle. Atropine + loperamide must be available at every infusion.
Payer requirements (May 2026)
| Payer | PA | Documentation |
|---|
| UnitedHealthcare | Yes | Met'd adeno + regimen-specific (NALIRIFOX 1L vs NAPOLI 2L); UGT1A1 often required; concurrent PA on combo agents |
| Aetna | Yes | Path report (adeno), met stage, line of therapy, UGT1A1 recommended |
| BCBS plans | Yes | Per NCCN + FDA label |
| Medicare Part B | No (FFS) | FDA on-label coverage; MA plans may apply UM |
Medicare reimbursement (Q2 2026)
| Field | Value |
|---|
| ASP + 6% | $66.374 / mg (eff. 4/1 – 6/30/2026) |
| NALIRIFOX 90 mg dose | $5,973.66 (administered, 90 × $66.374) |
| + 39 mg waste reimbursement | $2,588.59 — bill JW separate line |
| NAPOLI 126 mg dose | $8,363.12 (administered) |
| Annual NALIRIFOX (26 cycles) | ~$222,617 (admin + waste) |
| vs J9206 conventional irinotecan | $1.532 per 20 mg unit (~$0.077/mg) — Onivyde ~860× cost |
Site of care
| Setting | POS | Notes |
|---|
| Physician office | 11 | Preferred; ~4 hr Day 1 |
| Ambulatory infusion suite | 49 | Preferred |
| Oncology ASC | 24 | Acceptable |
| Hospital outpatient | 22/19 | Disfavored after first 1-2 cycles |
Patient assistance — Ipsen Cares
- Phone: 1-866-435-5677 (Ipsen Cares / Onivyde Patient Support)
- Onivyde Co-Pay Program: commercial copay support (excludes Medicare/Medicaid)
- PAP: free product for uninsured/underinsured
- Foundations: PAN, HealthWell, CancerCare — verify open pancreatic cancer funds quarterly
- Web: ipsencares.com
Pending SME review. Staff-authored from FDA label, CMS Q2 2026 ASP, NCCN Pancreatic Cancer Guidelines, Ipsen Cares, UHC oncology LCDs. Verify cited sources for high-stakes claims.