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Last Review Date: 04/04/2024

Date of Origin: 05/01/2018

Dates Reviewed: 05/2018, 06/2018, 02/2019, 02/2020, 10/2020, 04/2021, 4/2022, 04/2023, 04/2024

1. Length of Authorization

Coverage is provided for 6 months and may be renewed.

2. Dosing Limits

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

• Akynzeo 235 mg/0.25 mg (fosnetupitant/palonosetron) single-dose vial: 1 vial per 7 days

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

• 1 billable unit per 7 days

3. Initial Approval Criteria ¹

Coverage is provided in the following conditions:

• Patient is at least 18 years of age; AND

Prevention of chemotherapy-induced nausea and vomiting (CINV) † ‡ ^1-5

• Patient meets one of the following criteria:
  • Used in combination with dexamethasone; AND

• Patient is receiving highly emetogenic anticancer chemotherapy (HEC)*; OR
• Patient is receiving moderately emetogenic anticancer chemotherapy (MEC) **; OR
  • Patient has experienced emesis during a previous cycle of anticancer chemotherapy with a 3-drug regimen (olanzapine or NK-1 receptor antagonist-containing regimen); AND
    • Used in combination with olanzapine and dexamethasone as a component of a 4-drug regimen if not previously given; AND

• Akynzeo is NOT covered for any of the following:
  • Breakthrough emesis
  • Repeat dosing in multi-day emetogenic chemotherapy regimens
  • CINV related to an anthracycline plus cyclophosphamide chemotherapy regimen

*Highly emetogenic chemotherapy (HEC):

**Moderately emetogenic chemotherapy (MEC):

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

4. Renewal Criteria ^1-3

Coverage can be renewed based upon the following criteria:

• 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: severe hypersensitivity reactions (including anaphylaxis), serotonin syndrome (e.g., mental status changes, autonomic instability, neuromuscular symptoms, seizures, etc.)

5. Dosage/Administration ^1-3

6. Billing Code/Availability Information

HCPCS Code:

• J1454 - Injection, fosnetupitant 235 mg and palonosetron 0.25 mg; 1 billable unit = fosnetupitant 235 mg and palonosetron 0.25 mg

NDC(s):

• Akynzeo (235 mg fosnetupitant/0.25 mg palonosetron); single-dose vial for injection (lyophilized powder): 69639-0102-xx
• Akynzeo (235 mg fosnetupitant/0.25 mg palonosetron per 20 mL); single-dose vial for injection (solution; to-be-diluted): 69639-0105-xx
• Akynzeo (235 mg fosnetupitant/0.25 mg palonosetron per 20 mL); single-dose vial for injection (solution; ready-to-use): 69639-0106-xx

7. References

1. Akynzeo [package insert]. Helsinn Therapeutics (U.S.), Inc., Iselin, NJ, under license of Helsinn Healthcare SA, Switzerland. February 2023. Accessed March 2024.
2. Referenced with permission from the NCCN Drugs and Biologics Compendium (NCCN Compendium®) fosnetupitant/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.
3. 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.
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 Guideline Update. J Clin Oncol. 2020 Aug 20;38(24):2782-2797. Doi: 10.1200/JCO.20.01296.
6. Karthaus M, Szabo P, Voisin D, et al. Phase III study of palonosetron (PALO) given as 30-min IV infusion (IV inf) versus 30-sec IV bolus (IV bol) for prevention of chemotherapy-induced nausea and vomiting (CINV) associated with highly emetogenic chemotherapy (HEC). Journal of Clinical Oncology 35(31_suppl):227-227; November 2017. DOI: 10.1200/JCO.2017.35.31_suppl.227. 
7. Schwartzberg L, Roeland E, Andric Z, et al. Phase III safety study of intravenous NEPA: a novel fixed antiemetic combination of fosnetupitant and palonosetron in patients receiving highly emetogenic chemotherapy. Ann Oncol. 2018 Jul 1;29(7):1535-1540. Doi: 10.1093/annonc/mdy169.

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

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