BlueCross BlueShield of Tennessee Medical Policy Manual

Triptorelin Pamoate

NDC CODE(S)

52544-0189-xx Trelstar Mixject 3.75 MG SUSR (ACTAVIS PHARMA)

 

52544-0188-xx Trelstar Mixject 11.25 MG SUSR (ACTAVIS PHARMA)

 

52544-0092-xx Trelstar Mixject 22.5 MG SUSR (ACTAVIS PHARMA)

DESCRIPTION

Triptorelin pamoate is a synthetic decapeptide agonist analog of gonadotropin releasing hormone (GnRH).  It is more active than native GnRH in both luteinizing hormone-releasing activity (LH) and follicle-stimulating hormone-releasing (FSH) activity.  After its initial administration, there is a transient surge in circulating levels of LH, FSH, testosterone and estradiol.  With continued sustained use, levels of LH and FSH are decreased and a marked decrease of testicular steroidogenesis is observed until levels typically seen in surgically castrated subjects are reached.  These effects are generally reversible after the cessation of therapy.

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S) DOSAGE & ADMINISTRATION
Prostate Cancer 3.75 mg intramuscularly (IM) once every 4 weeks, 11.25 mg IM once every 12 weeks, or 22.5 mg IM once every 24 weeks

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® or The American Hospital Formulary Service Drug Information).

A review of the published literature found no controlled studies that validate the use of triptorelin pamoate for the treatment of other conditions or diseases.

SOURCES

Lexi-Comp Online. (2016, March). AHFS Dl. Triptorelin pamoate. Retrieved July 5, 2016 from Lexi-Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2016, June). Triptorelin pamoate. Retrieved July 5, 2016 from MICROMEDEX Healthcare Series.

National Comprehensive Cancer Network. (2016). NCCN Drugs & Biologics Compendium®. Triptorelin pamoate. Retrieved July 5, 2016 from the National Comprehensive Cancer Network.

U.S. Food and Drug Administration. (2014, July). Center for Drug Evaluation and Research. Trelstar® (triptorelin pamoate for injectable suspension). Retrieved July 5, 2016 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020715s032,021288s028,022437s008lbl.pdf.

ORIGINAL EFFECTIVE DATE:  12/1/2016

MOST RECENT REVIEW DATE:  12/1/2016

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.

Pharmaceutical Decision Support Tree

Triptorelin Pamoate (Trelstar®)

  1. Is this the initial request for this agent for this individual?

If yes, go to question #2

If no, go to question #4

  1. Does the individual have a diagnosis of prostate cancer and is requesting ANY ONE 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 request for 6 billable units every 168 days or less (1 billable unit = 3.75 mg) for a dosage of 3.75 mg intramuscularly (IM) once every 4 weeks, 11.25 mg IM once every 12 weeks, or 22.5 mg IM once every 24 weeks requested authorization for a period of twelve months or less (with possible renewal)?

If yes, this meets medical necessity and/or medical appropriateness criteria

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

  1. Does the individual show tumor response with stabilization of disease or decrease in size or tumor spread?

If yes, go to question #5

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

  1. Was there absence of unacceptable toxicity or disabling adverse reaction from the agent?

If yes, this meets medical necessity and/or medical appropriateness criteria for renewal

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

This document has been classified as public information.