BlueCross BlueShield of Tennessee Medical Policy Manual

Histrelin Acetate Implant for Prostate Cancer  

NDC CODE(S)

67979-0500-xx Vantas 50mg implant Endo

DESCRIPTION

Histrelin acetate is a synthetic nonapeptide analog of the naturally occurring gonadotropin releasing hormone (GnRH) or luteinizing hormone (LH).  It has greater potency than the naturally occurring hormone and is a GnRH agonist.   It inhibits the secretion of gonadotropin in continuous dosage.   Histrelin acetate is imbedded in a hydrophilic polymer surgically implanted in the subcutaneous tissue of the upper arm as the delivery system.

After subcutaneous implantation of histrelin acetate, there is an initial stimulatory phase of increased circulating levels of LH and FSH (follicle stimulating hormone) resulting in a transient increase in the concentration of gonadal steroids.   Long-term treatment with histrelin acetate leads to a reversible down-regulation of GnRH receptors in the pituitary gland and desensitization of the pituitary gonadotropes. As a result, FSH and LH levels decrease to castrate or prepubertal levels within a month.  Serum concentrations of estrogen and testosterone also decrease, generally leading to the cessation of secondary sexual development and slowing of linear growth velocity in children.  It is used in the treatment of central precocious puberty and prostate cancer. 

This policy addresses only the use of histrelin acetate for the treatment of prostate cancer.

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S) DOSAGE & ADMINISTRATION
Prostate Cancer One 50 mg implant inserted subcutaneously every 12 months

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).

No controlled studies were found in the published literature that validate the use of histrelin acetate implant for the treatment or prevention of other conditions or diseases.

SOURCES

Lexi-Comp Online. (2016, March). AHFS DI. Histrelin. Retrieved June 14, 2016 from Lexi-Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2016, June). Histrelin. Retrieved June 14, 2016 from MICROMEDEX Healthcare Series.

National Comprehensive Cancer Network. (2016). NCCN Drugs & Biologics Compendium™. Histrelin acetate. Retrieved June 14, 2016 from National Comprehensive Cancer Network.

U. S. Food and Drug Administration. (2013, April). Center for Drug Evaluation and Research. Supprelin LA (histrelin acetate) subcutaneous implant. Retrieved June 14, 2016 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022058s011lbl.pdf.

U. S. Food and Drug Administration. (2013, April). Center for Drug Evaluation and Research. Vantas® (histrelin acetate) subcutaneous implant. Retrieved June 14, 2016 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021732s018lbl.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

Histrelin Acetate Implant for Prostate Cancer (Vantas®)

  1. Is this an initial request for therapy with this agent?

If yes, go to question #2

If no, go to question #5

  1. Is the individual an adult male, 18 years of age or older, with a diagnosis of prostate cancer requesting the product Vantas®?

If yes, go to question #3

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

  1. Is the request for ANY ONE of the following?

  1. Following radiation therapy in an individual with biochemical failure or positive digital rectal examination

If yes, go to question #4

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

  1. Is the request for one 50 mg implant (1 billable unit) to be inserted subcutaneously once every 12 months?

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 continue to meet the criteria for initial medical necessity for questions 2 through 4?

If yes, go to question #6

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

  1. Does the individual show evidence of tumor response from treatment with absence of unacceptable toxicity from treatment with the implant?

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

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

This document has been classified as public information.