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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-J2000-60

Original Effective Date: 06/15/16

Reviewed: 05/10/17

Revised: 06/15/17

Subject: Fosaprepitant (Emend®) 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   Previous Version
           

DESCRIPTION:

Chemotherapy-induced nausea and vomiting (CINV) can significantly affect a patient’s quality of life, leading to poor compliance with further chemotherapy. The severity and incidence of CINV are affected by factors such as the selected agent and dose of chemotherapy, schedule and route of administration, and patient specific factors (e.g., age, sex, prior chemotherapy, history of alcohol use).

Fosaprepitant is a prodrug of aprepitant that blocks substance P/neurokinin-1(NK1) receptors to prevent emesis. Fosaprepitant (Emend) injection was approved by the U.S. Food and Drug Administration (FDA) in 2008 for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic chemotherapy. In a randomized, double-blind study, fosaprepitant injection was shown to be non-inferior to a 3-day regimen of oral aprepitant in prevention of nausea and vomiting in patients receiving a highly emetogenic chemotherapy regimen that included cisplatin. Both treatment groups in the study received dexamethasone and ondansetron. Fosaprepitant injection is also FDA approved for prevention of delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy. In a randomized, double-blind study, fosaprepitant injection, in combination with dexamethasone and ondansetron, was shown to more effectively control delayed nausea and vomiting as compared to ondansetron and dexamethasone alone in patients receiving a moderately emetogenic chemotherapy regimen.

National Comprehensive Cancer Network (NCCN) Guidelines for Antiemesis recommend fosaprepitant injection for acute and delayed emesis prevention in combination with dexamethasone and a serotonin antagonist with or without lorazepam, histamine-2 blockers, or proton pump inhibitors before intravenous antineoplastic therapy with high or moderate emetic risk. Fosaprepitant is also recommended in combination with olanzapine, dexamethasone, and a serotonin antagonist for high risk antineoplastic therapy. NCCN specifically states that use is for prevention of CINV, not treatment of CINV.

POSITION STATEMENT:

I. Fosaprepitant injection (Emend) meets the definition of medical necessity when ALL of the following are met:

1. Use is for prevention of acute or delayed chemotherapy-induced nausea and vomiting associated with initial or repeat courses of chemotherapy

2. ONE of the following:

a. Chemotherapy has a moderate or high emetogenic potential (Table 1)

b. Member has an inadequate response or contraindication to use of a serotonin antagonist (i.e., ondansetron, dolasetron, granisetron, or palonosetron) to prevent chemotherapy-induced nausea and vomiting

3. Use is in combination with a corticosteroid (i.e.,dexamethasone) and a serotonin antagonist (i.e., ondansetron, dolasetron, granisetron, or palonosetron) OR the member has a contraindication to corticosteroids or serotonin antagonist therapy

4. The dose does not exceed 150 mg per chemotherapy cycle

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

Fosaprepitant injection is indicated in adults, in combination with other antiemetic agents, for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy including high-dose cisplatin. It is also indicated in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. Fosaprepitant has not been studied for the treatment of established nausea and vomiting.

The recommended dosing of fosaprepitant injection is 150 mg intravenously over 20 to 30 minutes approximately 30 minutes prior to chemotherapy in combination with dexamethasone and a 5HT3 antagonist.

Dose Adjustments

Drug Availability

PRECAUTIONS:

Contraindications

Precautions/Warnings

BILLING/CODING INFORMATION:

The following codes may be used to describe:

HCPCS Coding

J1453

Injection, fosaprepitant 1mg

ICD-10 Diagnoses Codes That Support Medical Necessity

R11.0

Nausea

R11.10 – R11.12

Vomiting, unspecified

R11.2

Nausea with vomiting, unspecified

T45.1X5A

Adverse effect of antineoplastic and immunosuppressive drugs, initial encounter

T45.1X5D

Adverse effect of antineoplastic and immunosuppressive drugs, subsequent 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

Z51.11

Encounter for antineoplastic chemotherapy

Z51.12

Encounter for antineoplastic immunotherapy

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 Part D: BCBSF has delegated to Prime Therapeutics authority to make coverage determinations for the Medicare Part D services referenced in this guideline.

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

DEFINITIONS:

Acute chemotherapy-induced nausea and vomiting – nausea and/or vomiting that occurs within a few minutes to several hours after drug administration and commonly resolves within the first 24 hours.

Delayed chemotherapy-induced nausea and vomiting – nausea and/or vomiting that occurs 24 hours after drug administration.

RELATED GUIDELINES:

Palonosetron Hydrochloride (Aloxi®), 09-J0000-87

OTHER:

Table 1

Emetogenic Potential of Antineoplastic Agents

 

High emetic risk

(>90% frequency of emesis)

Moderate emetic risk

(30-90% frequency of emesis)

IV

AC combination (doxorubicin or epirubicin with cyclophosphamide)

Carboplatin AUC > 4

Carmustine (>250 mg/m2)

Cisplatin

Cyclophosphamide (> 1500 mg/m2)

Dacarbazine

Doxorubicin (>60 mg/m2)

Epirubicin (>90 mg/ m2)

Ifosfamide (≥2 g/ m2)

Mechlorethamine

Streptozocin

Aldesleukin (>12-15 million IU/m2)

Amifostine (>300 mg/m2)

Arsenic trioxide

Azacitidine

Bendamustine

Busulfan

Carboplatin AUC < 4

Carmustine (≤250 mg/m2)

Clofarabine

Cyclophosphamide (≤1500 mg/m2)

Cytarabine (>200 mg/m2)

Dactinomycin

Daunorubicin

Dinutuximab

Doxorubicin (<60 mg/m2)

Epirubicin (≤90 mg/m2)

Idarubicin

Ifosfamide (< 2g/m2)

Interferon alfa (≥10 million IU/m2)

Irinotecan

Melphalan

Methotrexate (≥250 mg/m2)

Oxaliplatin

Temozolomide

Trabectedin

REFERENCES:

  1. AHFS Drug Information. Bethesda (MD): American Society of Health-System Pharmacists, Inc; 2017 [cited 2017 Apr 20]. In: STAT!Ref Online Electronic Medical Library [Internet]. Available from: http://online.statref.com/.
  2. Clinical Pharmacology [Internet]. Tampa (FL): Gold Standard, Inc.; 2017 [cited 2017 Apr 20]. Available from: http://www.clinicalpharmacology.com/.
  3. DRUGDEX® System [Internet]. Greenwood Village (CO): Thomson Micromedex; Updated periodically [cited 2017 Apr 20]. Available from: http://www.thomsonhc.com/.
  4. Emend [prescribing information]. Merck Sharp & Dohme Corp. Whitehouse Station, NJ. February 2016.
  5. National Comprehensive Cancer Network (NCCN). Drugs & Biologics Compendium [Internet]. Fort Washington (PA): National Comprehensive Cancer Network; 2017 [cited 2017 Apr 26] Available from: http://www.nccn.org/professionals/drug_compendium/content/contents.asp/.
  6. NCCN Clinical practice guidelines in oncology (NCCN Guidelines®). Antiemesis, v. 2.2017 [cited 2017 Apr 26]. Available from: http://www.nccn.org/professionals/physician_gls/f_guidelines.asp.
  7. Orphan Drug Designations and Approval [Internet]. Silver Spring (MD): US Food and Drug Administration; 2017 [cited 2017 Apr 20]. Available from: http://www.accessdata.fda.gov/scripts/opdlisting/oopd/index.cfm/

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Pharmacy Policy Committee on 05/10/17.

GUIDELINE UPDATE INFORMATION:

06/15/16

New Medical Coverage Guideline.

06/15/17

Review and revision to guideline consisting of updating position statement and references.

Date Printed: October 23, 2017: 02:12 AM