Last Review Date: 4/06/2021

Date of Origin: 12/01/2011

Dates Reviewed: 03/2012, 06/2012, 09/2012, 12/2012, 03/2013, 06/2013, 09/2013, 12/2013, 03/2014, 02/2015, 01/2016, 01/2017, 01/2018, 02/2019, 02/2020, 04/2021

1. Length of Authorization

Coverage is provided for 6 months and may be renewed.

2. Dosing Limits

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

• Up to 48 mg daily

B.  Max Units (per dose and over time) [HCPCS Unit]:

• Chemotherapy related nausea and vomiting: 48 billable units per day
• All other indications: 8 billable units per day

3. Initial Approval Criteria^1,2,3,4,5

Coverage is provided in the following conditions:

Universal Criteria

Prevention of chemotherapy induced nausea and vomiting (CINV) †

• Patient is receiving emetogenic chemotherapy

Prevention of post-operative nausea and/or vomiting †

Breakthrough treatment for chemotherapy-induced nausea/vomiting ‡

† FDA Approved Indication(s); ‡ Compendia Recommended Indication(s)

4. Renewal Criteria^1,2,3,4,5

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 (anaphylaxis and bronchospasm), QT prolongation, serotonin syndrome, etc.

5. Dosage/Administration^1,3 

   Indication	Dose
   Prevention of chemotherapy induced nausea and vomiting & Breakthrough treatment for chemotherapy-induced nausea/vomiting	0.15 mg/kg intravenously (IV) x 3 doses on the day of chemotherapy up to a maximum of 16 mg per dose Note: A single maximum daily dose of 8 mg should be used in patients with severe hepatic impairment
   Postoperative nausea and vomiting	Adults and pediatric patients 1 month to 12 years and >40 kg: 4mg intravenously (IV) given as a single dose Pediatric patients 1 month to 12 years and <40 kg: 0.1 mg/kg intravenously (IV) given as a single dose

6. Billing Code/Availability Information

HCPCS Code:

• J2405 – Injection, ondansetron hydrochloride, per 1 mg: 1 billable unit = 1 mg

NDC(s):

• Zofran injection, 2 mg/mL, 20 mL multi-dose vial: 00173-0442-xx

* Branded product no longer available on market. Generics available from numerous manufacturers.

7. References

1. Zofran [package insert]. Research Triangle Park, NJ; GlaxoSmithKline; March 2017. Accessed February 2021.
2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for ondansetron. National Comprehensive Cancer Network, 2021. 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 February 2021.
3. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium^®) Antiemesis. Version 1.2020. National Comprehensive Cancer Network, 2021. 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 February 2021.
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.

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 Determinations (LCDs)  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/ LCD): N/A