BlueCross BlueShield of Tennessee Medical Policy Manual

Palonosetron Hydrochloride

NDC CODE(S)

00143-9513-XX Palonosetron HCl 0.25 MG/2ML SOLN (HIKMA)

00703-4094-XX Palonosetron HCl 0.25 MG/5ML SOLN (TEVA PARENTERAL MEDICINES)

00781-3312-XX Palonosetron HCl 0.25 MG/5ML SOLN (SANDOZ)

16714-0834-XX Palonosetron HCl 0.25 MG/5ML SOLN (NORTHSTAR RX)

16729-0365-XX Palonosetron HCl 0.25 MG/5ML SOLN (ACCORD HEALTHCARE)

25021-0783-XX Palonosetron HCl 0.25 MG/5ML SOLN (SAGENT PHARMACEUTICAL)

55111-0694-XX Palonosetron HCl 0.25 MG/5ML SOLN (DR.REDDY'S LABORATORIES,INC.)

60505-6193-XX Palonosetron HCl 0.25 MG/5ML SOLN (APOTEX)

62856-0797-XX Aloxi 0.25 MG/5ML SOLN (HELSINN THERAPEUTICS U.S.)

63323-0673-XX Palonosetron HCl 0.25 MG/5ML SOSY (FRESENIUS KABI USA)

63323-0942-XX Palonosetron HCl 0.25 MG/5ML SOLN (FRESENIUS KABI USA)

67457-0317-XX Palonosetron HCl 0.25 MG/5ML SOLN (MYLAN INSTITUTIONAL)

68001-0355-XX Palonosetron HCl 0.25 MG/5ML SOLN (BLUE POINT LABORATORIES)

69097-0927-XX Palonosetron HCl 0.25 MG/5ML SOLN (CIPLA USA)

69543-0371-XX Palonosetron HCl 0.25 MG/5ML SOLN (VIRTUS PHARMACEUTICALS)

DESCRIPTION

Palonosetron hydrochloride is a serotonin-3 or 5-HT3 receptor antagonist.  As such, it serves to halt the cascade of the emetic response of nausea and vomiting caused by cancer chemotherapy as well as that of postoperative nausea and vomiting (PONV).  Certain chemotherapeutic agents such as cisplatin to are thought to produce nausea and vomiting through the release of serotonin from the enterochromaffin cells of the small intestine.  The serotonin then activates 5-HT3 receptors located on vagal afferents to initiate the vomiting reflex.  Palonosetron, by binding with the 5-HT3 receptors, prevents completion of the emetic response.

As in the chemotherapeutic role, in PONV multiple factors may trigger the release of 5-HT in a cascade of events involving both the central nervous system and the gastrointestinal tract.  By binding with the 5-HT3 receptors, palonosetron blocks initiation of the vomiting reflex.

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

* Highly Emetogenic Chemotherapy (HEC)

Carboplatin Cyclophosphamide Epirubicin Streptozocin
Carmustine Dacarbazine Ifosfamide  
Cisplatin Doxorubicin Mechlorethamine  
The following chemotherapy can be considered HEC in certain patients:
Dactinomycin Irinotecan Oxaliplatin Trabectedin
Daunorubicin Methotrexate > 250mg/m2    
The following regimens can be considered HEC:
FOLFOX

RENEWAL CRITERIA

INDICATION(S) DOSAGE & ADMINISTRATION
Prevention of chemotherapy-induced nausea and vomiting in adults 0.25 mg weekly prior to highly emetogenic chemotherapy
Prevention of chemotherapy-induced nausea and vomiting in pediatrics 20 mcg/kg prior to emetogenic chemotherapy
Post-operative nausea and vomiting 0.075 mg given immediately before anesthesia

Coverage is provided for six months and may be renewed. Coverage cannot be renewed for the indication of PONV.

Click here to view DOSAGE LIMITS

APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS

BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.

IMPORTANT REMINDER

We develop Medical Policies to provide guidance to Members and Providers.  This Medical Policy relates only to the services or supplies described in it.  The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy.  For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed.  If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.

ADDITIONAL INFORMATION 

For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).

SOURCES

Lexi-Comp Online. (2018, ). AHFS Dl. Palonosetron. Retrieved October 16, 2018 from Lexi-Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2018, ). Palonosetron. Retrieved October 16, 2018 from MICROMEDEX Healthcare Series.

National Comprehensive Cancer Network. (2018). NCCN Drugs & Biologics Compendium™. Palonosetron. Retrieved October 16, 2018 from the National Comprehensive Cancer Network.

U.S. Food and Drug Administration. (2014, September). Center for Drug Evaluation and Research. Aloxi® (palonosetron HCl) injection for intravenous use. Retrieved October  16, 2018 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021372s020lbl.pdf.

ORIGINAL EFFECTIVE DATE:  12/1/2016

MOST RECENT REVIEW DATE:  3/2/2019

ID_MRx

Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

This document has been classified as public information.

 

DOSAGE LIMITS

Maximum billable units per dose and over time by indication as a Medical Benefit  

1 billable unit = 25 mcg (0.025 mg)  

DIAGNOSIS

MAXIMUM UNITS

Chemotherapy-induced nausea and vomiting 10 billable units per 7 days
Post-operative nausea and vomiting 3 billable units as one time only