Subject: Akynzeo Limit Policy 1211-H 01-2023

Drug

AKYNZEO CAPSULES  (netupitant/palonosetron)

AKYNZEO INJECTION  (fosnetupitant/palonosetron)

Policy:

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.

INITIAL LIMIT QUANTITY   Limits do not accumulate together; patient is allowed the maximum limit for each drug   and strength
Drug	4 Week Limit*	12 Week Limit*
Akynzeo capsules   (netupitant/palonosetron)	2 capsules / 21 days	Does Not Apply**
Akynzeo for injection   (fosnetupitant/palonosetron lyophilized   powder in single-dose vial for reconstitution)	2 vials / 21 days	Does Not Apply**
Akynzeo injection   (fosnetupitant/palonosetron   solution in single dose 20 mL vial)	40 mL / 21 days	Does Not Apply**
* 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 mail limit will be the same as the retail limit. The intent is for   prescriptions of the requested drug to be filled one month at a time, even if filled at mail order; there should be no 3 month   supplies filled.

 

 

Place of Service:

Outpatient

The above policy is based on the following references:

1. Akynzeo [package insert]. Iselin, NJ: Helsinn Therapeutics (U.S.), Inc.; June 2021.
2. Lexicomp Online, AHFS DI (Adult and Pediatric) Online, Hudson, Ohio: UpToDate, Inc.; 2022; Accessed November 14, 2022.
3. Micromedex (electronic version). IBM Watson Health, Greenwood Village, Colorado, USA. Available at: https://www.micromedexsolutions.com. Accessed November 11, 2022.

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 15, 2023