Last Review Date: 10/01/2020

Date of Origin: 05/01/2018

Dates Reviewed: 05/2018, 06/2018, 02/2019, 02/2020, 10/2020

1. Length of Authorization

Coverage is provided for six months and may be renewed.

2. Dosing Limits

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

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

B.  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 must be at least 18 years of age; AND

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

• Used in combination with dexamethasone; AND
  • Patient is receiving highly emetogenic chemotherapy (HEC)*; OR
  • Patient is receiving moderately emetogenic chemotherapy (MEC); AND
• Akynzeo is NOT covered for:

• Breakthrough emesis; OR
• Repeat dosing in multi-day emetogenic chemotherapy regimens; OR
• CINV related to an anthracycline plus cyclophosphamide chemotherapy regimen

*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)

4. Renewal Criteria ^1-3

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; AND
• Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: severe hypersensitivity reactions, serotonin syndrome, 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

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 injection (solution):  69639-0105-xx

7. References

1. Akynzeo [package insert]. Helsinn Therapeutics (U.S.), Inc., Iselin, NJ, under license of Helsinn Healthcare SA, Switzerland. May 2020. Accessed September 2020.
2. Referenced with permission from the NCCN Drugs and Biologics Compendium (NCCN Compendium^®) fosnetupitant/palonosetron. National Comprehensive Cancer Network, 2020. 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 September 2020.
3. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium^®) Antiemesis. Version 2.2020. National Comprehensive Cancer Network, 2020. 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 September 2020.
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. 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)

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 Articles (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/advanced-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