ph-0150
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Zofran® (ondansetron)

Policy Number: PH-0150

Intravenous

 

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

Precertification requirements do not apply for this policy. Pre-payment claim edits are applied to diagnosis criteria within this policy.

FOR PEEHIP Members Only -Coverage excludes the provider-administered medication(s) outlined in this drug policy from being accessed through a specialty pharmacy. It must be obtained through buy and bill.

  1. Length of Authorization

Coverage is provided for 6 months and may be renewed.

  1. 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
  1. Initial Approval Criteria1,2,3,4,5

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)

  1. Renewal Criteria1,2,3,4,5

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.
  1. Dosage/Administration1,3 

    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

  2. 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.

  1. 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

ICD-10

ICD-10 Description

R11.0

Nausea 

R11.10

Vomiting, unspecified

R11.11

Vomiting without nausea

R11.12

Projectile vomiting

R11.2

Nausea with vomiting, unspecified

T41.0X5A

Adverse effect of inhaled anesthetics, initial encounter

T41.1X5A

Adverse effect of intravenous anesthetics, initial encounter

T41.205A

Adverse effect of unspecified general anesthetics, initial encounter

T41.295A

Adverse effect of other general anesthetics, initial encounter

T41.45XA

Adverse effect of unspecified anesthetic, initial encounter

T45.1X5A

Adverse effect of antineoplastic and immunosuppressive drugs, initial encounter

T45.1X5S

Adverse effect of antineoplastic and immunosuppressive drugs, sequela

T45.95XA

Adverse effect of unspecified primarily systemic and hematological agent, initial encounter

T50.905A

Adverse effect of unspecified drugs, medicaments and biological substances, initial encounter

T50.995A

Adverse effect of other drugs, medicaments and biological substances, initial encounter

T88.59XA

Other complications of anesthesia, initial encounter

Z51.11

Encounter for antineoplastic chemotherapy

Z51.12

Encounter for antineoplastic immunotherapy

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

Medicare Part B Administrative Contractor (MAC) Jurisdictions

Jurisdiction

Applicable State/US Territory

Contractor

E (1)

CA, HI, NV, AS, GU, CNMI

Noridian Healthcare Solutions, LLC

F (2 & 3)

AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ

Noridian Healthcare Solutions, LLC

5

KS, NE, IA, MO

Wisconsin Physicians Service Insurance Corp (WPS)

6

MN, WI, IL

National Government Services, Inc. (NGS)

H (4 & 7)

LA, AR, MS, TX, OK, CO, NM

Novitas Solutions, Inc.

8

MI, IN

Wisconsin Physicians Service Insurance Corp (WPS)

N (9)

FL, PR, VI

First Coast Service Options, Inc.

J (10)

TN, GA, AL

Palmetto Government Benefit Administrators, LLC

M (11)

NC, SC, WV, VA (excluding below)

Palmetto GBA, LLC

L (12)

DE, MD, PA, NJ, DC (includes Arlington & Fairfax counties and the city of Alexandria in VA)

Novitas Solutions, Inc.

K (13 & 14)

NY, CT, MA, RI, VT, ME, NH

National Government Services, Inc. (NGS)

15

KY, OH

CGS Administrators, LLC

 

 

 

ZOFRAN® (ondansetron) Prior Auth Criteria
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