Last Review Date: 03/31/2023

Date of Origin: 10/17/2008

Dates Reviewed: 06/2009, 12/2009, 09/2010, 12/2010, 02/2011, 03/2011, 06/2011, 09/2011, 12/2011, 03/2012, 06/2012, 09/2012, 12/2012, 03/2013, 06/2013, 09/2013, 12/2013, 03/2014, 06/2014, 09/2014, 12/2014, 03/2015, 05/2015, 08/2015, 11/2015, 02/2016, 05/2016, 08/2016, 11/2016, 02/2017, 05/2017, 08/2017, 11/2017, 02/2018, 05/2018, 04/2019, 04/2020, 04/2021, 04/2022, 04/2023

I. Length of Authorization

Coverage will be provided for 6 months and may be renewed, unless otherwise specified.

• PONV: Coverage will be provided for 1 dose and may not be renewed.

II. Dosing Limits

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

• Aloxi 0.25 mg/5 mL solution for injection: 1 vial per 7 day supply
• Aloxi 0.075 mg/1.5 mL solution for injection: 1 vial

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

CINV:

• 10 billable units per 7 days

PONV:

• 3 billable units x 1 dose only

III. Initial Approval Criteria

Coverage is provided in the following conditions:

Prevention of Chemotherapy induced Nausea and vomiting (CINV) in Adults † ^1-4,6

• Patient is receiving highly emetogenic chemotherapy (HEC)*; OR
• Patient is receiving moderately emetogenic chemotherapy (MEC); AND
• Palonosetron is NOT covered for:

• Breakthrough emesis; OR
• Repeat dosing in multi-day emetogenic chemotherapy regimens

Prevention of Chemotherapy induced Nausea and vomiting (CINV) in Pediatric Patients † ^1-4,6

• Patient is at least 1 month old and less than 17 years old; AND
• Patient is receiving emetogenic chemotherapy; AND

•  Palonosetron is NOT covered for:
• Breakthrough emesis; OR
• Repeat dosing in multi-day emetogenic chemotherapy regimens

Prevention of post-operative nausea and vomiting (PONV) in Adults † ¹

*Highly emetogenic chemotherapy (HEC):

** Failure is defined as:

• Two or more documented episodes of vomiting attributed to the current chemotherapy regimen

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

IV. Renewal Criteria ^1-3

Coverage may be renewed based upon the following criteria:

• • Patient continues to meet indication-specific relevant criteria such as concomitant therapy requirements (not including prerequisite therapy), performance status, etc. identified in section III; AND
  • Disease response; AND
  • Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: serotonin syndrome, severe QT prolongation, severe hypersensitivity reactions (including anaphylaxis and anaphylactic shock), etc.

V. Dosage/Administration ¹

VI. Billing Code/Availability Information

HCPCS Code:

• J2469 – Injection, palonosetron HCl, 25 mcg: 1 billable unit = 25 mcg (0.025 mg)

NDC:

• Aloxi 0.25 mg/5 mL solution for injection; single-dose vial: 69639-103-xx*
• Aloxi 0.075 mg/1.5 mL solution for injection; single-dose vial: 69639-103-xx (not commercially available)

*Generics available from multiple manufacturers

VII. References

1. Aloxi [package insert]. Switzerland; Helsinn Healthcare SA; April 2020. Accessed March 2023.
2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium^®) palonosetron. National Comprehensive Cancer Network, 2023. 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 March 2023.
3. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium^®) Antiemesis. Version 1.2023. National Comprehensive Cancer Network, 2023. 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 March 2023.
4. Roila F, Molassiotis A, Herrstedt J, et al. MASCC and ESMO Consensus Guidelines for the Prevention of Chemotherapy and Radiotherapy-Induced Nausea and Vomiting: ESMO Clinical Practice Guidelines. Ann Oncol (2016) 27 (suppl 5): v119-v133.
5. Hesketh PJ, Kris MG, Basch E, et al. Antiemetics: American Society of Clinical Oncology Clinical Practice Guideline Update. J Clin Oncol. 2017 Oct 1;35(28):3240-3261.
6. Hesketh PJ, Kris MG, Basch E, et al. Antiemetics: ASCO Guideline Update. Journal of Clinical Oncology 2020 38:24, 2782-2797.

Appendix 1 – Covered Diagnosis Codes

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

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 Determination (NCD), Local Coverage Determinations (LCDs) and Local Coverage Article (LCAs) may exist and compliance with these policies is required where applicable. They can be found at: http://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications may be covered at the discretion of the health plan.

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

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