Subject: Ondansetron Products Limit 259-H P01-2025

Drug

Antiemetics

ondansetron (brand unavailable)  (ondansetron )

ondansetron hydrochloride (brand unavailable)  (ondansetron hydrochloride )

Policy:

Indications

FDA-approved Indications

Ondansetron Injection

Prevention of Nausea and Vomiting Associated with Initial and Repeat Courses of Emetogenic Cancer Chemotherapy

Ondansetron injection is indicated for the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including high-dose cisplatin. Ondansetron injection is approved for patients aged 6 months and older.

Prevention of Postoperative Nausea and/or Vomiting

Ondansetron injection is indicated for the prevention of postoperative nausea and/or vomiting. As with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients in whom nausea and/or vomiting must be avoided postoperatively, ondansetron injection is recommended even when the incidence of postoperative nausea and/or vomiting is low. For patients who do not receive prophylactic ondansetron injection and experience nausea and/or vomiting postoperatively, ondansetron injection may be given to prevent further episodes. Ondansetron injection is approved for patients aged 1 month and older.

Ondansetron Tablets, ODT, and Oral Solution

Ondansetron tablets, orally disintegrating tablets, and oral solution are indicated for the prevention of nausea and vomiting associated with:

• Highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m².
• Initial and repeat courses of moderately emetogenic cancer chemotherapy.
• Radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen.

Ondansetron tablets, orally disintegrating tablets, and oral solution are also indicated for the prevention of postoperative nausea and/or vomiting.

Initial Limit Quantity

Limits do not accumulate together; patient is allowed the maximum limit for each drug and strength.

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.

Drug	4 Week Limit	12 Week Limit
Ondansetron 2 mg / mL injection	20 mL / 21 days	Does Not Apply
Ondansetron 24 mg tablets	2 tablets / 21 days	Does Not Apply
Ondansetron 4 mg and 8 mg tablets/ODT	18 tablets / 21 days	Does Not Apply
Ondansetron 16 mg ODT	9 tablets / 21 days	Does Not Apply
Ondansetron 4mg / 5mL oral solution	200 mL / 21 days	Does Not Apply

Place of Service:

Outpatient

The above policy is based on the following references:

1. Ondansetron Injection [package insert]. Deerfield, IL: Baxter Health Corporation; February 2022.
2. Ondansetron Tablets [package insert]. Saddle Brook, NJ: Rising Health, LLC; July 2022.
3. Ondansetron Orally Disintegrating Tablets [package insert]. East Windsor, NJ: Aurobindo Pharma USA, Inc.; April 2024.
4. Ondansetron Orally Disintegrating Tablets 16mg [package insert]. New Brunswick, NJ: Lifsa Drugs LLC; June 2024.
5. Ondansetron Oral Solution [package insert]. Memphis, TN: Northstar Rx LLC; January 2022.
6. Lexicomp Online, AHFS DI (Adult and Pediatric) Online. Waltham, MA: UpToDate, Inc.; 2024. https://online.lexi.com. Accessed December 10, 2024.
7. Micromedex® (electronic version). Merative, Ann Arbor, Michigan, USA. Available at: https://www.micromedexsolutions.com/ (cited: 12/10/2024).
8. 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.

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