Irinotecan (Camptosar generic) — HCPCS J9206

About irinotecan (Camptosar generic) FDA verified May 2026

Conventional, non-liposomal topoisomerase I inhibitor. Originator brand Camptosar; widely generic since 2008. Workhorse of FOLFIRI and FOLFIRINOX.

Irinotecan hydrochloride is a semi-synthetic analog of camptothecin and a potent inhibitor of DNA topoisomerase I. Its active metabolite, SN-38 (7-ethyl-10-hydroxycamptothecin), is approximately 100–1,000× more cytotoxic than the parent compound. SN-38 is cleared primarily by UGT1A1-mediated glucuronidation to inactive SN-38G, which is why UGT1A1 polymorphisms drive both efficacy and toxicity. The drug is approved as a single agent and in combination regimens for metastatic colorectal carcinoma; it is also a backbone component of FOLFIRINOX (pancreatic) and is used off-label in many other GI, lung, gynecologic, and pediatric solid-tumor regimens supported by NCCN.

Conventional irinotecan (J9206) is the standard aqueous-solution formulation originally branded Camptosar by Pharmacia & Upjohn (now Pfizer), first approved in June 1996 for 2L metastatic colorectal cancer after 5-FU failure, with the 1L combination indication added in 2000. ANDA generic approvals began in 2008–2010 (Hospira, Teva, Sandoz, Accord, Fresenius Kabi, Sun Pharma, Areva, others); Camptosar branded sales were discontinued by Pfizer in 2019 and the market is now entirely generic. This page is for the conventional formulation only — Onivyde (irinotecan liposomal pegylated) is a different product with its own HCPCS code (J9205) and its own clinical use case (see formulation comparison).

J9206 (conventional) vs J9205 (Onivyde liposomal) CMS Q2 2026

Two HCPCS codes for two different drugs. The cost differential is dramatic and the regimens do not overlap.

Conventional irinotecan and Onivyde are not interchangeable — not in the pharmacy (different concentration, different reconstitution, different storage), not in the clinic (different toxicity time course and severity), and not in billing. The single most common high-dollar coding error in irinotecan-containing regimens is selecting the wrong HCPCS, usually because the billing system or pharmacy record was ambiguous about which formulation was administered.

For full Onivyde billing detail, see our Onivyde (J9205) billing reference.

Dosing & regimens FDA label + NCCN v2.2026

Three dominant regimens (FOLFIRI / FOLFIRINOX / monotherapy) plus several documented combinations. All BSA-based.

FOLFIRI — 1L metastatic colorectal cancer (most common use)

• Irinotecan 180 mg/m² IV over 90 minutes, Day 1
• Leucovorin 400 mg/m² IV Day 1 (concurrent with irinotecan via Y-line, then continued)
• 5-FU 400 mg/m² IV bolus Day 1, followed by
• 5-FU 2,400 mg/m² IV over 46 hours (continuous infusion via portable pump) starting Day 1
• Cycle: every 14 days; continue until progression or unacceptable toxicity
• Common biologic add-ons: bevacizumab 5 mg/kg (any RAS); cetuximab 400 mg/m² load then 250 mg/m² weekly (or 500 mg/m² q2w) for RAS/BRAF-WT left-sided CRC; panitumumab 6 mg/kg q2w (same population)

FOLFIRINOX — 1L metastatic pancreatic adenocarcinoma (and adjuvant pancreatic)

• Oxaliplatin 85 mg/m² IV over 2 hours, Day 1
• Irinotecan 180 mg/m² IV over 90 minutes, Day 1
• Leucovorin 400 mg/m² IV Day 1
• 5-FU 400 mg/m² IV bolus Day 1, then 2,400 mg/m² over 46 hr
• Cycle: every 14 days
• Modified FOLFIRINOX (mFOLFIRINOX): drops the 5-FU bolus; some protocols also reduce irinotecan to 150 mg/m² for tolerability. Document the modification in the chart and on the regimen authorization request.

Single-agent irinotecan (2L+ metastatic colorectal, refractory)

• 350 mg/m² IV over 90 minutes every 21 days (most common), OR
• 125 mg/m² IV over 90 minutes weekly for 4 weeks, then 2-week rest (legacy weekly schedule)

Irinotecan + cetuximab (EGFR-WT mCRC, post-FOLFIRI progression)

• Irinotecan 180 mg/m² IV q14d (or prior tolerated dose) + cetuximab 400 mg/m² load → 250 mg/m² weekly. NCCN-supported regimen for KRAS/NRAS/BRAF-WT metastatic CRC after progression on irinotecan-based therapy.

Pediatric off-label (BSA-based, COG/NCI protocol-specific)

• VI (rhabdomyosarcoma): vincristine + irinotecan 50 mg/m² IV daily × 5 days every 21 days
• IT (Ewing sarcoma): irinotecan 20 mg/m² IV daily × 5 days × 2 weeks + temozolomide; q21d
• I/T ± dinutuximab (neuroblastoma): irinotecan + temozolomide ± anti-GD2; protocol-specific
• UGT1A1 testing strongly recommended pre-treatment in pediatric patients

UGT1A1 dose modification (all regimens)

• UGT1A1*28 homozygotes have impaired SN-38 glucuronidation and increased SN-38 exposure
• FOLFIRI 180 mg/m² → 150 mg/m² starting dose (one level reduction)
• Monotherapy 350 mg/m² → 250–300 mg/m² starting dose
• Subsequent cycles: titrate back to standard dose if tolerated (no grade 3+ neutropenia or diarrhea on cycle 1)
• See UGT1A1 testing detail

Worked example — FOLFIRI dose for BSA 1.8 m²

Worked example — monotherapy 350 mg/m² for BSA 1.8 m²

Annualized FOLFIRI cost — BSA 1.8 m²

Premedication

• Standard antiemetic regimen: 5-HT3 antagonist (ondansetron, palonosetron, granisetron) + dexamethasone — 30 min before infusion. Irinotecan is moderate-to-high emetogenic.
• Atropine 0.25–1 mg IV/SC available at chair-side for acute cholinergic syndrome (during or within 24 hr of infusion). Some protocols use prophylactic atropine in patients with prior cholinergic episodes.
• Loperamide high-dose protocol prescribed at every cycle (4 mg loading, 2 mg q2h until diarrhea-free for 12 hr) for delayed-onset diarrhea (days 3–10)
• NK1 antagonist optional (consider for FOLFIRINOX, which is highly emetogenic with oxaliplatin)

UGT1A1 testing & dose modification FDA label + NCCN 2026

UGT1A1*28 homozygotes have markedly elevated SN-38 exposure and risk of severe neutropenia / diarrhea. Testing is FDA-label-recommended.

Irinotecan is converted to its active metabolite SN-38 by carboxylesterases. SN-38 is then glucuronidated (inactivated) by the UGT1A1 enzyme. Patients homozygous for the UGT1A1*28 allele (a TA₇TAA promoter polymorphism, also called Gilbert's syndrome variant) have markedly reduced UGT1A1 transcription, resulting in higher SN-38 exposure and increased risk of severe neutropenia, severe delayed diarrhea, and treatment-related death. The FDA label for Camptosar (and generic irinotecan) carries a warning regarding UGT1A1*28 homozygotes and recommends consideration of starting-dose reduction.

Testing logistics

• CPT 81350 — UGT1A1 (UDP glucuronosyltransferase family 1, polypeptide A1) gene analysis (common variants — e.g., *28, *6, *36, *37)
• Send-out lab (Mayo, Quest, LabCorp, or local molecular pathology) — typical turnaround 5–10 business days
• Germline polymorphism — single test, valid for life (store in chart problem list for future irinotecan, sacituzumab, belinostat exposure)
• Document genotype in chart and on any PA submission for high-dose irinotecan regimens
• East Asian and some other ancestries carry *6 / *27 variants more commonly than *28; consider expanded-panel UGT1A1 testing when available

NDC reference (multi-generic) FDA NDC Directory verified May 2026

Conventional irinotecan is multi-source generic. The following represent the major US generic suppliers; the specific NDC on your shelf depends on procurement. Confirm with the actual vial label.

Administration codes CPT verified May 2026

Standard 90-minute IV infusion crosses the 1-hour boundary, so 96415 (each additional hour) is required.

Modifiers CMS verified May 2026

JW — required when single-dose vial waste is discarded

Conventional irinotecan is dispensed in single-dose vials (40, 100, 300, 500 mg) from most generic manufacturers. When the assembled vial combination produces a remainder that is discarded, bill the discarded mg on a separate claim line with the JW modifier. CMS reimburses both the administered units (drug line) and the waste units (JW line) for single-dose vial drugs.

JZ — required when there is no waste

Effective July 1, 2023, CMS requires either JZ (no waste) or JW (waste reported) on every single-dose container claim. Because irinotecan comes in multiple vial sizes, billers can often assemble a BSA-based dose with negligible or zero waste — in that case use JZ on the single drug line. For multi-dose preserved generic presentations (available from select manufacturers), there is no single-dose vial waste and JZ applies.

Worked example — JW + JZ decision for FOLFIRI 324 mg dose

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 — for example, management of acute cholinergic syndrome, decision to dose-reduce for prior delayed diarrhea, or other clinically distinct work. Routine pre-infusion clinical assessment is bundled into the chemo admin code.

340B modifiers (JG, TB)

For 340B-acquired irinotecan, follow your MAC's current 340B modifier policy. Hospital outpatient settings and qualifying clinics commonly append JG (acquired via 340B) or TB (tracking only) per MAC and payer guidance. Generic irinotecan economics are tight enough that 340B status often does not change the encounter-level reimbursement materially, but the modifier is still required when applicable.

ICD-10-CM by indication FY2026 verified May 2026

Irinotecan is on-label for colorectal cancer and supported by NCCN for several other GI, GYN, lung, sarcoma, and pediatric indications. Use the most specific code supported by the encounter documentation.

Site of care & place of service Verified May 2026

FOLFIRI requires roughly 2.5–3 hours of in-clinic chair time on Day 1 (90-min irinotecan + leucovorin concurrent + 5-FU bolus + pump start), plus 5-FU pump disconnect on Day 3. FOLFIRINOX adds oxaliplatin (~2 hr), pushing Day 1 chair time to 4–5 hours. Most administrations occur in physician oncology offices (POS 11) or ambulatory infusion centers (POS 49). Generic irinotecan is inexpensive enough that site-of-care steering is less aggressive than for higher-cost specialty drugs, but commercial UM still discourages routine HOPD administration of stable patients on long-running regimens.

Claim form field mapping Verified May 2026

Standard CMS-1500 / 837P fields. NDC qualifier, JZ vs JW selection, and regimen-line documentation are the high-value fields to verify.

Payer policy snapshot Reviewed May 2026

Conventional irinotecan is rarely the gating drug for PA — concurrent biologics (bevacizumab, cetuximab, panitumumab) and oxaliplatin usually drive the regimen-level review.

Step therapy

For 1L metastatic colorectal cancer, FOLFIRI is interchangeable with FOLFOX (oxaliplatin-containing) and the choice is generally clinician-led without step therapy. For 2L irinotecan monotherapy or irinotecan + cetuximab, documentation of prior 1L progression is required. For FOLFIRINOX in pancreatic 1L, documentation of performance status (ECOG 0–1) and absence of contraindications is typically required.

Medicare reimbursement CMS Q2 2026 (live)

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

Coverage

No NCD specific to irinotecan. Coverage falls under MAC LCDs for chemotherapy and the generic-drug coverage framework. All MACs cover J9206 for FDA-approved on-label CRC indications with appropriate ICD-10; NCCN-supported off-label uses (FOLFIRINOX in pancreatic, FOLFIRI in gastric / esophageal / sarcoma) are generally covered under the standard chemo LCD by reference to NCCN compendium listings.

Code history

• J9206 — permanent code, "Irinotecan injection," 20 mg per unit — effective shortly after the original 1996 Camptosar FDA approval
• Originator brand Camptosar (Pfizer / Pharmacia & Upjohn) discontinued 2019 (commercial decision); generics fully supply the US market
• 2015 introduction of Onivyde (J9205) created a separate liposomal pegylated code — J9206 is for the conventional formulation only and did not change

Patient assistance — generic drug, foundation-driven Verified May 2026

Because conventional irinotecan is multi-source generic, there is no single manufacturer-branded copay program or PAP equivalent to the Onivyde / Camptosar legacy programs. Patient assistance is therefore foundation-driven and focused on covering the patient cost-share of the overall regimen (irinotecan + biologic + admin), not irinotecan alone. The irinotecan component is typically a small fraction of regimen cost; the patient impact comes from the biologic (bevacizumab, cetuximab, panitumumab) and the administration burden.

• CancerCare Co-Payment Assistance Foundation: 1-866-552-6729 / cancercare.org — covers chemotherapy and biologic copays for eligible patients with insurance. CRC, pancreatic, and other irinotecan-relevant funds; eligibility based on Federal Poverty Level (typically ≤500% FPL) and active diagnosis
• PAN Foundation (Patient Access Network): 1-866-316-7263 / panfoundation.org — disease-state-specific funds for copay assistance; verify open fund status quarterly (oncology funds open and close based on donations)
• HealthWell Foundation: 1-800-675-8416 / healthwellfoundation.org — copay and premium assistance for insured patients with cancer; FPL-based eligibility
• Patient Advocate Foundation Co-Pay Relief: 1-866-512-3861 / copays.org — copay assistance for chemotherapy regimens
• Manufacturer-specific support for concurrent biologics: Avastin Access Solutions (bevacizumab), ErbituxAccess (cetuximab), Vectibix Patient Resources (panitumumab) — the biologic in FOLFIRI + biologic regimens typically has its own copay program that dominates patient out-of-pocket

Diarrhea management FDA label + NCCN 2026

Irinotecan causes two distinct diarrhea syndromes — both billing-relevant for premedication documentation and same-day E/M.

Common denials & how to fix them

Frequently asked questions

What is the HCPCS code for conventional irinotecan?

Conventional irinotecan (originator Camptosar by Pfizer, now widely generic) is billed under HCPCS J9206 — "Injection, irinotecan, 20 mg." Each unit equals 20 mg of irinotecan. J9206 is NOT the same as J9205 (Onivyde, irinotecan liposomal pegylated). Different drug, different toxicity, ~860× per-mg cost differential.

What is the difference between conventional irinotecan (J9206) and Onivyde liposomal (J9205)?

J9206 is conventional irinotecan (Camptosar / generic), Q2 2026 ASP+6% $1.532 per 20 mg unit (~$0.077/mg). Used in FOLFIRI (180 mg/m² q2w) and FOLFIRINOX for colorectal, pancreatic, gastric, and esophageal cancers. J9205 is Onivyde, the pegylated liposomal formulation by Ipsen, Q2 2026 ASP+6% $66.374/mg. Used only in NALIRIFOX 1L and NAPOLI 2L for metastatic pancreatic adenocarcinoma. Onivyde costs approximately 860× more per mg.

Is UGT1A1 testing required before irinotecan?

The FDA label recommends — but does not absolutely require — UGT1A1 genotyping before initiation. Patients homozygous for UGT1A1*28 have impaired SN-38 glucuronidation, higher metabolite exposure, and elevated risk of severe neutropenia and severe delayed diarrhea. NCCN and many oncologists test pre-treatment and reduce starting dose by one level in *28/*28 homozygotes. UGT1A1 testing is billed under CPT 81350. Some commercial payers (notably select BCBS plans and UnitedHealthcare oncology programs) require UGT1A1 status documentation in the PA submission for high-dose irinotecan regimens.

What is the standard FOLFIRI dose for irinotecan?

FOLFIRI uses irinotecan 180 mg/m² IV over 90 minutes on Day 1, every 14 days, combined with leucovorin 400 mg/m² + 5-FU 400 mg/m² bolus + 5-FU 2,400 mg/m² over 46 hours via portable pump. For BSA 1.8 m², that's 324 mg of irinotecan per cycle = 16.2 units of J9206. FOLFIRI is a 1L standard for metastatic colorectal cancer, often combined with bevacizumab, cetuximab (KRAS/NRAS/BRAF-WT, left-sided), or panitumumab.

What is FOLFIRINOX and how does irinotecan billing differ from FOLFIRI?

FOLFIRINOX adds oxaliplatin 85 mg/m² to the FOLFIRI backbone, used primarily in metastatic pancreatic adenocarcinoma 1L. The irinotecan component (J9206) bills identically — 180 mg/m² q14d, billed as mg administered ÷ 20 mg per unit. Document "FOLFIRINOX" explicitly on the PA and claim notes; regimen-level documentation matters for PA review and ICD-10 selection. Modified FOLFIRINOX (mFOLFIRINOX) drops the 5-FU bolus and reduces irinotecan to 150 mg/m² for tolerability.

What administration CPT do I use for irinotecan?

CPT 96413 (chemo IV, up to 1 hour, initial) plus 96415 × 1 (each additional hour). Irinotecan is a 90-minute infusion, so 96413 covers the first hour and one unit of 96415 covers the additional 30 min. In FOLFIRI / FOLFIRINOX combo, add 96417 for each additional sequential drug (leucovorin, oxaliplatin) and 96416 for the 5-FU 46-hour pump start. Do NOT use 96365 (therapeutic IV) — irinotecan is cytotoxic chemotherapy.

Acute cholinergic syndrome — what's the billing impact?

Acute (cholinergic) diarrhea / cramping / salivation during or within 24 hours of irinotecan infusion is treated with atropine 0.25–1 mg IV/SC at onset. If management of the episode constitutes significant separately identifiable E/M (decision to dose-reduce, decision to switch to prophylactic atropine going forward, evaluation of severity), bill the E/M code with modifier 25. Routine pre-infusion clinical assessment is bundled into the chemo admin code. Document the cholinergic episode, severity, atropine dose, and any plan change in the infusion note — this supports both the E/M and any subsequent dose-reduction billing.

Can irinotecan be used in pediatric patients?

Yes — off-label in pediatric refractory solid tumors. Common protocols: VI (rhabdomyosarcoma): vincristine + irinotecan 50 mg/m² IV daily × 5 days q21d. IT (Ewing sarcoma): irinotecan 20 mg/m² IV daily × 5 days × 2 weeks + temozolomide; q21d. Neuroblastoma: irinotecan + temozolomide ± dinutuximab. UGT1A1 testing is even more strongly recommended pre-treatment in pediatric patients because severe toxicity is harder to recover from. ICD-10 mapping uses C49.x (soft tissue sarcoma), C40.x / C41.x (bone sarcoma), C74.x (neuroblastoma). Pediatric off-label use generally requires NCCN / COG citation in the PA submission.

Source documents

1. FDA — CAMPTOSAR (irinotecan hydrochloride) Prescribing Information
   Original FDA-approved label, Pfizer / Pharmacia & Upjohn; NDA 020571 (1996); subsequent revisions through brand discontinuation in 2019
2. DailyMed — irinotecan hydrochloride generic labels (multi-manufacturer)
   Hospira / Pfizer, Teva, Accord, Fresenius Kabi, Sandoz, Sun Pharma, Areva, West-Ward / Hikma generic ANDA labels
3. CMS — Medicare Part B Drug ASP Pricing File
   Q2 2026 quarterly file, effective April 1 – June 30, 2026 (J9206 verified; J9205 cross-checked)
4. NCCN Clinical Practice Guidelines in Oncology — Colon Cancer (v2.2026)
   FOLFIRI, mFOLFIRINOX, irinotecan monotherapy, irinotecan + cetuximab regimens for metastatic CRC
5. NCCN Clinical Practice Guidelines in Oncology — Pancreatic Adenocarcinoma (v2.2026)
   FOLFIRINOX and modified FOLFIRINOX as 1L preferred regimens for metastatic pancreatic adenocarcinoma in fit patients
6. NCCN Clinical Practice Guidelines — Gastric Cancer / Esophageal & Esophagogastric Junction Cancers
   FOLFIRI off-label support for advanced gastric / esophageal adenocarcinoma
7. CPIC — Clinical Pharmacogenetics Implementation Consortium Guideline for UGT1A1 and Irinotecan
   Pharmacogenetic dosing guidance for UGT1A1*28, *6, *37; clinical pharmacogenetics standard reference
8. SEER CanMED — HCPCS J9206 reference (conventional irinotecan)
9. SEER CanMED — HCPCS J9205 reference (Onivyde liposomal, comparison)
10. FDA National Drug Code Directory
    Multi-manufacturer generic NDC verification (Hospira/Pfizer, Teva, Accord, Fresenius Kabi, Sandoz, Sun Pharma, Areva, West-Ward / Hikma)
11. CancerCare Co-Payment Assistance Foundation
    Foundation copay support; 1-866-552-6729
12. PAN Foundation
    Disease-state copay funds; 1-866-316-7263; quarterly fund-status verification recommended
13. HealthWell Foundation
    Copay and premium assistance; 1-800-675-8416
14. UnitedHealthcare — Oncology Medication Clinical Coverage Policy

Refresh cadence

Change log

• May 22, 2026 — Initial publication. ASP data: Q2 2026 ($1.532 per 20 mg unit). FDA label: Camptosar 1996 originator + multi-manufacturer ANDA generic labels. Includes formulation comparison vs J9205 Onivyde liposomal, UGT1A1 testing protocol, FOLFIRI / FOLFIRINOX / monotherapy regimen detail, diarrhea management, pediatric off-label dosing.