BlueCross BlueShield of Tennessee Medical Policy Manual

Granisetron Extended-Release Injection

NDC CODE(S)

47426-0101-XX - Sustol ER 10 MG/0.4 ML PRSY (HERON THERAPEUTICS)

DESCRIPTION

Granisetron is a serotonin-3 (5-HT3) receptor antagonist.  Granisetron blocks serotonin stimulation and vomiting after emetogenic stimulation such as moderate emetogenic chemotherapeutic agents.  In this formulation, granisetron is incorporated in an extended-release polymer-based drug delivery system.  The granisetron remains detectable in plasma for 7 days post-dose.

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

*Highly Emetogenic Chemotherapy (HEC)

Cisplatin

Mechlorethamine

Streptozocin

Cyclophosphamide

Carmustine

Dacarbazine

Doxorubicin

Epirubicin

Ifosfamide

Carboplatin

FOLFOX regimen

 

 

HEC in certain individuals

Dactinomycin

Daunorubicin

Irinotecan

Oxaliplatin

Trabectedin

Methotrexate > 250mg/m2

RENEWAL CRITERIA

INDICATION(S)

DOSAGE & ADMINISTRATION

Prevention of chemotherapy-induced nausea and vomiting in adults

10 mg administered subcutaneously by a healthcare provider on Day 1 of chemotherapy; not more frequently than once every 7 days.

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).

SOURCE

U. S. Food and Drug Administration. (2016, August). Center for Drug Evaluation and Research. Sustol®(granisetron) extended-release injection, for subcutaneous use. Retrieved March 10, 2017 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022445s000lbl.pdf.

ORIGINAL EFFECTIVE DATE:  3/30/2017

MOST RECENT REVIEW DATE:  11/28/2017

ID_MRxEx

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.

Pharmaceutical Decision Support Tree

Granisetron Extended-Release Injection (Sustol®)

  1. Is this the initial request for the agent?

If yes, go to question #2

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the request show ALL of the following?

If yes, go to question #3

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the individual ANY ONE of the following?

If yes, go to question #4

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the request show evidence that the agent will NOT be used for ANY ONE of the following?

If yes, go to question #5

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the request for 10 billable units per 7 days for dosage of 10 mg subcutaneously to be administered by a healthcare provider no more frequently than every 7 days for an authorization period of 6 months?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

This document has been classified as public information.