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Date Printed: October 23, 2017: 07:30 AM

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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-J0000-87

Original Effective Date: 02/15/09

Reviewed: 07/09/14

Revised: 09/15/17

Next Review: No Longer Scheduled for Routine Review (NLR)

Subject: Palonosetron Hydrochloride (Aloxi®)

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 References Updates Other  
           

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.

Palonosetron (Aloxi) was approved by the U.S. Food and Drug Administration (FDA) in July 2003 for prevention of acute and delayed nausea and vomiting associated with cancer chemotherapy. Palonosetron selectively blocks serotonin 5-HT3 receptors to prevent emesis.

POSITION STATEMENT:

Palonosetron HCl (Aloxi®) IV 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 acute or delayed chemotherapy induced nausea and vomiting associated with initial or repeat courses of moderately or highly emetogenic chemotherapy (See Other: Table. Emetogenic Potential of Antineoplastic Agents)

b. Prevention of acute or delayed chemotherapy induced nausea and vomiting associated with initial or repeat courses of low emetogenic chemotherapy when the member has an inadequate response or contraindication to ondansetron, granisetron, or dolasetron

(See Other: Table. Emetogenic Potential of Antineoplastic Agents)

c. Prevention of post-operative nausea and vomiting when the member has an inadequate response or contraindication to intravenous granisetron (Kytril) or ondansetron (Zofran) at the FDA recommended dose

2. Dose does not exceed 0.25 mg prior to chemotherapy or 0.075 mg prior to induction of anesthesia

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

Adults: 0.25 mg IV approximately 30 minutes before start of chemotherapy

Pediatrics: (1 month to 17 years): 20 mcg/kg (max 1.5 mg) IV approximately 30 minutes before start of chemotherapy

Dose Adjustments

None

Drug Availability

0.25 mg/5 mL solution for injection

PRECAUTIONS:

Hypersensitivity reactions may occur in individuals who have exhibited hypersensitivity to other selective 5-HT3 receptor antagonists.

BILLING/CODING INFORMATION:

The following codes may be used to describe:

HCPCS Coding:

J2469

Injection, palonosetron HCl, 25 mcg

ICD-10 Diagnoses Codes That Support Medical Necessity:

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

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, initial encounter

T50.905S

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

T66.xxxS

Radiation sickness, unspecified, sequela

Z51.11

Encounter for antineoplastic chemotherapy

Z51.12

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:

Granisetron HCl (Kytril®) IV, 09-J0000-97
Ondansetron HCl (Zofran®) IV, 09-J0000-98

Oral Antiemetic Agents, 09-J0000-55

OTHER:

Emetogenic Potential of Antineoplastic Agents

 

High emetic risk

(>90% frequency of emesis)

Moderate emetic risk

(>30-90% frequency of emesis)

IV

AC combination (e.g., 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

IV

Low emetic risk (10 – 30% frequency of emesis)

 

Ado-trastuzumab emtansine

Aldesleukin <12 million international units/m2

Amifostine <300 mg/m2

Atezolizumab

Belinostat

Blinatumomab

Brentuximab vedotin

Cabazitaxel

Carfilzomib

Cytarabine (low dose) 100 – 200 mg/m2

Docetaxel

Doxorubicin (liposomal)

Eribulin

Etoposide

5-FU

Floxuridine

Gemcitabine

Interferon alfa >5 -<10 million international units/m2

Irinotecan (liposomal)

Ixabepilone

Methotrexate > 50 mg/m2 - <250 mg/m2

Mitomycin

Mitoxantrone

Necitumumab

Omacetaxine

Paclitaxel

Paclitaxel-albumin

Pemetrexed

Pentostatin

Pralatrexate

Romidepsin

Talimogene laherparepvec

Thiotepa

Topotecan

Ziv-aflibercept

REFERENCES:

  1. Eisai, Inc. ALOXI (palonosetron hydrochloride) injection. 2014 [cited 2017 Aug 8]. In: DailyMed [Internet]. Bethesda (MD): National Library of Medicine. Available from: http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=1b51c34d-9631-4520-83af-6f6fb21a58a4/.
  2. AHFS Drug Information. Bethesda (MD): American Society of Health-System Pharmacists, Inc; 2014 [cited 2014 Jun 16]. In: STAT!Ref Online Electronic Medical Library [Internet]. Available from: http://online.statref.com/.
  3. Clinical Pharmacology [Internet]. Tampa (FL): Gold Standard, Inc.; 2017 [cited 2017 Aug 8]. Available from: http://www.clinicalpharmacology.com/.
  4. DRUGDEX® System [Internet]. Greenwood Village (CO): Thomson Micromedex; Updated periodically [cited 2017 Aug 8]. Available from: http://www.thomsonhc.com/.
  5. NCCN Clinical practice guidelines in oncology (NCCN Guidelines®). Antiemesis, v. 2.2017 [cited 2017-Aug 8]. Available from: http://www.nccn.org/professionals/physician_gls/f_guidelines.asp.
  6. NCCN Drugs & Biologics Compendium [Internet]. Fort Washington (PA): National Comprehensive Cancer Network; 2017 [cited 2017 Aug 8]. Available from: http://www.nccn.org/professionals/drug_compendium/content/contents.asp/.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Pharmacy Policy Committee on 07/09/14.

GUIDELINE UPDATE INFORMATION:

02/15/09

New Medical Coverage Guideline.

04/15/09

Revision; consisting of removing criteria for failure of other agents for highly emetogenic chemo and adding maximum dosage per cycle.

05/15/09

Revision; consisting of adding ICD-9 codes.

08/15/10

Review and revision; consisting of updating references.

11/15/10

Revision; consisting of formatting changes.

01/01/11

Revision; consisting of removing the use of dolasetron from the position statement, and added ICD-10 codes.

06/15/11

Revision to guideline, consisting of defining emetogenic failure.

07/15/11

Revision to guideline, consisting of adding note regarding administration.

08/15/11

Review and revision to guideline; consisting of updating references.

08/15/12

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

10/15/12

Revision to guideline; consisting of modifying criteria for coverage of moderately emetogenic cancer chemotherapy.

08/15/13

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

08/15/14

Review and revision to guideline; consisting of position statement, dosing/administration, moderately emetogenic cancer chemotherapy, references

11/01/15

Revision: ICD-9 Codes deleted.

09/15/17

Revision to guideline; consisting of updating position statement, coding and references.

Date Printed: October 23, 2017: 07:30 AM