Last Review Date: 07/02/2024

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, 04/2024, 07/2024

1. 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.

2. Dosing Limits

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

• Aloxi and Palonosetron Hydrochloride 0.25 mg/5 mL solution for injection in a single-dose vial: 1 vial per 7 day supply
• Aloxi and Palonosetron Hydrochloride 0.075 mg/1.5 mL solution for injection in a single-dose vial: 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

3. 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 or moderately emetogenic anticancer chemotherapy (HEC*/MEC***); AND
• Palonosetron is NOT covered for any of the following:

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

Prevention of Chemotherapy Induced Nausea and Vomiting (CINV) in Pediatric Patients † ^1-5,7

• 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):

***Moderately emetogenic chemotherapy (MEC):

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

4. Renewal Criteria ^1-4

Coverage may be renewed based upon the following criteria:

4. • Patient continues to meet the indication-specific relevant criteria such as concomitant therapy requirements (not including prerequisite therapy), performance status, etc. identified in section III; AND
   • Beneficial response as evidenced by reduction in nausea and/or vomiting; AND
   • Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: serotonin syndrome (e.g., mental status changes, autonomic instability, neuromuscular symptoms, etc.), severe hypersensitivity reactions (including anaphylaxis and anaphylactic shock), etc.
5. Dosage/Administration ^1,2

6. Billing Code/Availability Information

HCPCS Code(s):

• J2469 – Injection, palonosetron hcl, 25 mcg: 1 billable unit = 25 mcg (0.025 mg)
• J2468 – Injection, palonosetron hydrochloride (avyxa), not therapeutically equivalent to J2469, 25 micrograms; 1 billable unit = 25 mcg (0.025 mg) Ψ

NDC(s):

• Aloxi§ 0.25 mg/5 mL solution for injection in a single-dose vial: 69639-103-xx
• Aloxi 0.075 mg/1.5 mL solution for injection in a single-dose vial: 69639-103-xx (not commercially available)
• Palonosetron Hydrochloride 0.25 mg/5 mL solution for injection in a single-dose vial: 43598-0530-xx Ψ
• Palonosetron Hydrochloride 0.075 mg/1.5 mL solution for injection in a single-dose vial: 43598-0531-xx Ψ

7. References

1. Aloxi [package insert]. Switzerland; Helsinn Healthcare SA; April 2020. Accessed March 2024.
2. Palonosetron Hydrochloride [package insert]. Bachupally, India; Dr. Reddy’s Laboratories Limited; March 2016. Accessed June 2024.
3. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium^®) palonosetron. 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 March 2024.
4. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium^®) Antiemesis. Version 1.2024. 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 March 2024.
5. 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.
6. 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.
7. 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)

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