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Date Printed: December 16, 2017: 09:32 PM

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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

09-J0000-98

Original Effective Date: 05/15/09

Reviewed: 07/10/13

Revised: 11/01/15

Subject: Ondansetron HCl (Zofran®) Injection

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Dosage/ Administration Position Statement Billing/Coding Reimbursement Program Exceptions Definitions
           
Related Guidelines Other References Updates
           

DESCRIPTION:

Chemotherapy induced (or radiation therapy induced) vomiting and nausea can significantly affect a patient’s quality of life, leading to poor compliance with further chemotherapy or radiation therapy treatment. The severity and incidence of chemotherapy or radiation therapy induced nausea and vomiting are affected by factors such as the selected agent and dose of chemotherapy, route of administration, location of radiation therapy, prior chemotherapy use, and patient age and sex.

In general, to provide maximal protection against chemotherapy induced nausea and vomiting, antiemetic therapy should be initiated before chemotherapy. The antiemetic therapy should also be continued for the same length of time as the duration of the emetic activity of the chemotherapeutic agent being used. However, daily use of antiemetics is not recommended for some therapeutic agents that are taken long term (e.g., imatinib, erlotinib). Antiemetic agents can be administered by the oral, rectal, IV, intramuscular, or transdermal route. It should be noted that oral and IV 5-HT3 antagonists have equivalent efficacy when used at the appropriate doses.

Ondansetron (Zofran) was approved by the U.S. Food and Drug Administration (FDA) in January 1991 for prevention of nausea and vomiting associated with cancer chemotherapy. Ondansetron blocks serotonin 5-HT3 receptors to prevent emesis.

In 2004, the American College of Obstetrics and Gynecology (ACOG) published an algorithm that includes ondansetron IV as a treatment option for the management of nausea and vomiting in pregnancy. There are no large trials of the effectiveness of ondansetron (or other 5-HT3 inhibitors) in nausea and vomiting in pregnancy. One small randomized controlled trial of 30 women with severe hyperemesis gravidarum found that ondansetron was no more effective than promethazine in the management of nausea and vomiting. Additionally, there is no evidence that any one antiemetic is superior to another.

POSITION STATEMENT:

Ondansetron HCl (Zofran®) injection meets the definition of medical necessity for members meeting ALL of the following criteria:

1. Indication for use is ONE of the following:

a. Prevention of chemotherapy induced nausea and vomiting

b. Treatment of chemotherapy induced nausea and vomiting

c. Prevention of nausea and vomiting associated with radiation treatment

d. Prevention and treatment of post-operative nausea and vomiting

2. Member is 6 months of age or older

3. Dose does not exceed 0.15 mg/kg or 16 mg (whichever is less)

Duration of approval: 1 year

Ondansetron HCl (Zofran®) injection meets the definition of medical necessity for members with nausea or vomiting during pregnancy when the ALL of the following criteria are met:

1. Member presents with clinical signs of dehydration OR nausea and vomiting have persisted for more than 3 weeks

2. Conservative treatment has failed (e.g., dietary changes, ginger, multi-vitamin, vitamin B6 (pyridoxine) with or without doxylamine (Unisom))

3. Oral, sublingual, or rectal antiemetics have failed or are contraindicated including 4 or more of the following:

a. Dimenhydrinate (Dramamine)

b. Ondansetron (Zofran) or granisetron (Kytril)

c. Promethazine (Phenergan)

d. Trimethobenzamide (Tigan)

e. Metoclopramide (Reglan)

4. Other injectable antiemetics have failed or are contraindicated including all of the following:

a. Dimenhydrinate (Dramamine)

b. Promethazine (Phenergan)

c. Metoclopramide (Reglan)

5. Dose does not exceed 24 mg/day

Duration of approval: 1 year

DOSAGE/ADMINISTRATION:

THIS INFORMATION IS PROVIDED FOR INFORMATIONAL PURPOSES ONLY AND SHOULD NOT BE USED AS A SOURCE FOR MAKING PRESCRIBING OR OTHER MEDICAL DETERMINATIONS. PROVIDERS SHOULD REFER TO THE MANUFACTURER’S FULL PRESCRIBING INFORMATION FOR DOSAGE GUIDELINES AND OTHER INFORMATION RELATED TO THIS MEDICATION BEFORE MAKING ANY CLINICAL DECISIONS REGARDING ITS USAGE.

FDA-approved

Dose Adjustments

Drug Availability

PRECAUTIONS:

Contraindications

Precautions/Warnings

BILLING/CODING INFORMATION:

The following codes may be used to describe:

HCPCS Coding:

J2405

Injection, ondansetron hydrochloride, per 1mg

ICD-10 Diagnoses Codes That Support Medical Necessity: (Effective 10/01/15)

021.0 – 021.9

Hyperemesis gravidarum

L59.9

Disorder of the skin and subcutaneous tissue related to radiation, unspecified

R11.0

Nausea

R11.10

Vomiting, unspecified

R11.11

Vomiting without nausea

R11.12

Projectile vomiting

R11.2

Nausea with vomiting, unspecified

T45.1x5A

Adverse effect of antineoplastic and immunosuppressive drugs, initial encounter

T50.905A

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

T50.905S

Adverse effect of unspecified drugs, medicaments and biological substances, sequel

T66.xxxA

Radiation sickness, unspecified, initial encounter

T66.xxxS

Radiation sickness, unspecified, sequela

T88.7xxS

Unspecified adverse effect of drug or medicament, sequel

Z51.0

Encounter for antineoplastic radiation therapy

Z51.11

Encounter for antineoplastic chemotherapy

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage Products: No National Coverage Determination (NCD) and/or Local Coverage Determination (LCD) were found at the time of the last guideline revised date.

DEFINITIONS:

No guideline specific definitions apply.

RELATED GUIDELINES:

Palonosetron Hydrochloride (Aloxi®), 09-J0000-87
Granisetron HCl (Kytril®) IV, 09-J0000-97

OTHER:

None applicable.

REFERENCES:

1. GlaxoSmithKline LLC. ZOFRAN (ondansetron hydrochloride) injection. 2012 [cited 2013 Jun 6]. In: DailyMed [Internet]. Bethesda (MD): National Library of Medicine. Available from: http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d9a71b42-ddfc-49d5-7280-0fc0041dba41/.

2. AHFS Drug Information. Bethesda (MD): American Society of Health-System Pharmacists, Inc; 2013 [cited 2013 Jun 6]. In: STAT!Ref Online Electronic Medical Library [Internet]. Available from: http://online.statref.com/.

3. Clinical Pharmacology [Internet]. Tampa (FL): Gold Standard, Inc.; 2013 [cited 20013 Jun 6]. Available from: http://www.clinicalpharmacology.com/.

4. DRUGDEX® System [Internet]. Greenwood Village (CO): Thomson Micromedex; Updated periodically [cited 2013 Jun 6]. Available from: http://www.thomsonhc.com/.

5. NCCN Drugs & Biologics Compendium [Internet]. Fort Washington (PA): National Comprehensive Cancer Network; 2013 [cited 2013 Jun 6]. Available from: http://www.nccn.org/professionals/drug_compendium/content/contents.asp/.

6. ACOG (American College of Obstetrics and Gynecology) practice bulletin: nausea and vomiting of pregnancy. Obstet Gynecol. 2004;103:803-14.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Pharmacy Policy Committee on 07/10/13.

GUIDELINE UPDATE INFORMATION:

05/15/09

New Medical Coverage Guideline.

10/15/09

Revision; consisting of clarifying dosage.

01/01/10

Revision; consisting of adding a fixed dose alternative to position statement.

08/15/10

Review and revision; consisting of updating references

01/15/11

Revision; consisting of adding ICD-10 codes.

08/15/11

Review and revision to guideline; consisting of updating position statement, dosage and administration section and references.

08/15/12

Review and revision to guideline; consisting of updating position statement, dosage maximum, precautions and references.

08/15/13

Review and revision to guideline; consisting of description, position statement, dosage/administration, precautions, program exceptions, and references.

11/01/15

Revision: ICD-9 Codes deleted.

Date Printed: December 16, 2017: 09:32 PM