Subject: Zofran-Zuplenz Limit Policy 259-H 02-2022

Drug

ANTIEMETICS

ZOFRAN (ALL DOSAGE FORMS)  (ondansetron and ondansetron hydrochloride)

ZUPLENZ  (ondansetron oral soluble film)

Policy:

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 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 is approved for patients aged 1 month and older. 

Zofran Tablets, Zofran ODT, and Zofran Oral Solution
Zofran is 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
Zofran is also indicated for the prevention of postoperative nausea and/or vomiting.

Zuplenz
Zuplenz (ondansetron) oral soluble film is indicated for the prevention of nausea and vomiting associated with:
   •   Highly emetogenic cancer chemotherapy, including cisplatin ≥ 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

Zuplenz is also 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 where nausea and/or vomiting must be avoided postoperatively, Zuplenz is recommended even where the incidence of postoperative nausea and/or vomiting is low. 

LIMIT CRITERIA Limits do not accumulate together, patient is allowed the maximum limit for each drug and strength
Drug	4 Week Limit*	12 Week Limit*
Ondansetron injection	20 mL / 21 days (available in boxes of 5 or 10 vials of 2 mL each)	Does Not Apply*
Ondansetron 24 mg tablets	2 tablets / 21 days	Does Not Apply*
Ondansetron (Zofran) 4 mg and 8 mg tablets/ODT	18 tablets / 21 days	Does Not Apply*
Ondansetron (Zofran) oral solution	200 mL / 21 days	Does Not Apply*
Zuplenz 4 mg oral soluble film	36 films / 21 days	Does Not Apply*
Zuplenz 8 mg oral soluble film	18 films / 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. Ondansetron Injection [package insert]. Weston, Florida: Apotex Corp; July 2021.
2. Ondansetron Tablets [package insert]. Saddle Brook, New Jersey: Rising Health, LLC; December 2021.
3. Ondansetron Orally Disintegrating Tablets [package insert]. East Windsor, New Jersey: Aurobindo Pharma USA, Inc.; November 2021.
4. Ondansetron Oral Solution [package insert]. East Windsor, New Jersey: Aurobindo Pharma USA, Inc.; November 2021.
5. Zofran Tablets [package insert]. East Hanover, New Jersey: Novartis Pharmaceuticals Corporation; October 2021.
6. Zuplenz [package insert]. Raleigh, North Carolina: Fortovia Therapeutics Inc.; June 2019.
7. Lexicomp Online, AHFS DI (Adult and Pediatric) Online. Hudson, OH: UpToDate, Inc.; 2021; Accessed December 23, 2021.
8. Micromedex (electronic version). IBM Watson Health, Greenwood Village, Colorado, USA. https://www.micromedexsolutions.com/. Accessed December 22, 2021.
9. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Antiemesis. Version 1.2021. Available at: https://www.nccn.org/professionals/physician_gls/pdf/antiemesis.pdf. Accessed December 28, 2021.

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 12, 2022