Subject: Akynzeo Post Limit PA 1212-J P01-2025

Drug

AKYNZEO  (netupitant/palonosetron)

AKYNZEO  (fosnetupitant/palonosetron)

Policy:

Indications

FDA-approved Indications

Akynzeo capsules is indicated in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. Akynzeo capsules is a combination of palonosetron and netupitant: palonosetron prevents nausea and vomiting during the acute phase and netupitant prevents nausea and vomiting during both the acute and delayed phase after cancer chemotherapy.

Akynzeo for injection and Akynzeo injection are indicated in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy. Akynzeo for injection is a combination of palonosetron and fosnetupitant, a prodrug of netupitant: palonosetron prevents nausea and vomiting during the acute phase and fosnetupitant prevents nausea and vomiting during both the acute and delayed phase after cancer chemotherapy.

Limitations of Use

Akynzeo for injection and Akynzeo injection have not been studied for the prevention of nausea and vomiting associated with anthracycline plus cyclophosphamide chemotherapy.

Coverage Criteria

Nausea and Vomiting Associated with Cancer Chemotherapy

Authorization may be granted when the requested drug is being prescribed for the for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy.

Quantity Limits Apply

4 capsules of Akynzeo per 21 days; 4 vials of Akynzeo for injection per 21 days; 80 mL of Akynzeo injection per 21 days. No 3 month supplies should be filled.

The duration of 21 days is used for a 28-day fill period to allow time for refill processing.

These drugs are for short-term acute use; therefore, the intent is for prescriptions of the requested drug to be filled one month at a time; there should be no 3 month supplies filled.

Duration of Approval (DOA):

• 1212-J: DOA: 6 months

Place of Service:

Outpatient

The above policy is based on the following references:

1. Akynzeo [package insert]. Iselin, NJ: Helsinn Therapeutics (U.S.), Inc.; February 2023.
2. Lexicomp Online, AHFS DI (Adult and Pediatric) Online. Waltham, MA: UpToDate, Inc.; 2024. https://online.lexi.com. Accessed November 27, 2024.
3. Micromedex® (electronic version). Merative, Ann Arbor, Michigan, USA. Available at: https://www.micromedexsolutions.com/ (cited: 11/27/2024).
4. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Antiemesis. Version 2.2024. Available at: https://www.nccn.org/professionals/physician_gls/pdf/antiemesis.pdf. Accessed November 27, 2024.
5. American Cancer Society. How is Chemotherapy Used to Treat Cancer? https://www.cancer.org/treatment/treatments-and-side-effects/treatment-types/chemotherapy/how-is-chemotherapy-used-to-treat-cancer.html November 2019. Accessed November 27, 2024.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

June 06, 2025