Date of Origin:  12/04/2015

Dates Reviewed: 12/2015, 07/2016, 02/2017, 05/2017, 08/2017, 11/2017, 02/2018, 05/2018, 04/2019, 04/2020, 04/2021, 04/2022, 04/2023, 03/2024

1. Length of Authorization

Coverage will be provided for 6 months and may be renewed.

2. Dosing Limits

1. Quantity Limit (max daily dose) [NDC Unit]:

• Onivyde 43 mg/10 mL single-dose vial: 4 vials per 14 days

2. Max Units (per dose and over time) [HCPCS Unit]:

• All indications: 172 billable units per 14 days

3. Initial Approval Criteria ¹

Coverage is provided in the following conditions:

• Patient is at least 18 years of age; AND

Universal Criteria ¹

• Patient does not have a bowel obstruction; AND
• Therapy will not be substituted for other drugs containing irinotecan HCl; AND

Pancreatic Adenocarcinoma † ‡ Ф ^1-4

• Used in combination with oxaliplatin, fluorouracil and leucovorin; AND
  • Used as first-line therapy; AND
    • • • • Patient has metastatic disease; OR
          • Patient has locally advanced disease; AND
            • • • Patient has good performance status (defined as ECOG PS 0-1, with good biliary drainage and adequate nutritional intake); OR
        • Used as induction therapy followed by chemoradiation in patients without systemic metastases; AND
          • Patient has locally advanced disease; AND
          • Patient has good performance status (defined as ECOG PS 0-1, with good biliary drainage and adequate nutritional intake); OR
• Used in combination with fluorouracil and leucovorin; AND
  • Patient has locally advanced or metastatic disease; AND

• • Used as subsequent therapy after disease progression with one of the following:
    • Fluoropyrimidine (5-FU or capecitabine) based therapy with no prior irinotecan; OR

• • • Gemcitabine-based therapy; OR

• • • Patient has local or metastatic disease recurrence after resection; AND
• Patient completed primary therapy < 6 months ago; AND
  • • Patient previously received one of the following:

• Fluoropyrimidine (5-FU or capecitabine) based therapy that did not include irinotecan; OR
• Gemcitabine-based therapy; OR

• Patient completed primary therapy ≥ 6 months ago; AND
  • Used as alternate systemic therapy not previously used

Ampullary Adenocarcinoma ‡ ²

• Used as subsequent therapy for disease progression; AND
• Used in combination with fluorouracil and leucovorin; AND
• Patient has pancreatobiliary or mixed type disease with good performance status (defined as ECOG PS 0-1, with good biliary drainage and adequate nutritional intake); AND
• Patient has previously been treated with one of the following:
  • • Gemcitabine-based therapy; OR
    • Fluoropyrimidine (5-FU or capecitabine) based therapy with no prior irinotecan; OR
    • Oxaliplatin-based therapy with no prior irinotecan

† FDA Approved Indication(s); ‡ Compendia Recommended Indication(s); Ф Orphan Drug

4. Renewal Criteria ¹

Coverage can be renewed based upon the following criteria:

• Patient continues to meet universal and other indication-specific relevant criteria such as concomitant therapy requirements (not including prerequisite therapy), performance status, etc. identified in section III; AND
• Disease response with treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread; AND
• Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: severe diarrhea, severe neutropenia, interstitial lung disease, severe hypersensitivity reactions (including anaphylactic reactions), etc.

5. Dosage/Administration ^1,3

6. Billing Code/Availability Information

HCPCS Code:

• J9205 – Injection, irinotecan liposome, 1 mg; 1 billable unit = 1 mg

NDC:

• Onivyde 43 mg/10 mL single dose vial: 15054-0043-xx

7. References

1. Onivyde [package insert]. Cambridge, MA; Ipsen Biopharmaceuticals, Inc.; February 2024. Accessed February 2024.
2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium^®) irinotecan liposomal. National Comprehensive Cancer Network, 2024. The NCCN Compendium^® is a derivative work of the NCCN Guidelines^®. NATIONAL COMPREHENSIVE CANCER NETWORK^®, NCCN^®, and NCCN GUIDELINES^® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed February 2024.
3. Wang-Gillam A, Li CP, Bodky G, NAPOLI-1 study group. Nanoliposomal irinotecan with fluorouracil and folinic acid in metastatic pancreatic cancer after previous gemcitabine-based therapy (NAPOLI-1): a global, randomised, open-label, phase 3 trial. Lancet. 2016 Feb 6;387(10018):545-557. Doi: 10.1016/S0140-6736(15)00986-1. Epub 2015 Nov 29.
4. O'Reilly EM, Melisi D, Macarulla T, et al. Liposomal irinotecan + 5-fluorouracil/leucovorin + oxaliplatin (NALIRIFOX) versus nab-paclitaxel + gemcitabine in treatment-naive patients with metastatic pancreatic ductal adenocarcinoma (mPDAC): 12- and 18-month survival rates from the phase 3 NAPOLI 3 trial. JCO 41, 4006-4006(2023). DOI:10.1200/JCO.2023.41.16_suppl.4006

Appendix 1 – Covered Diagnosis Codes

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

The preceding information is intended for non-Medicare coverage determinations. Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determinations (NCDs) and/or Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. Local Coverage Articles (LCAs) may also exist for claims payment purposes or to clarify benefit eligibility under Part B for drugs which may be self-administered. The following link may be used to search for NCD, LCD, or LCA documents: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications, including any preceding information, may be applied at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA): N/A