BlueCross BlueShield of Tennessee Medical Policy Manual

Histrelin Acetate for Central Precocious Puberty (CPP)

NDC CODE(S)

67979-0002-xx Supprelin® LA 50 mg 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 central precocious puberty.

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

RENEWAL CRITERIA

INDICATION(S) DOSAGE & ADMINISTRATION
Central precocious puberty (CPP) 1 implant annually

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 dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., 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

Głab E, Wikiera B, Bieniasz J, Barg E. (2016). The influence of GnRH analog therapy on growth in central precocious puberty. Advanced Clinical Experimental Medicine, 25 (1):27-32.

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 for Central Precocious Puberty (CPP) (Supprelin® LA)

  1. Is this the initial request for treatment of with this agent?

If yes, go to question #2

If no, go to question #5

  1. Is the request for the product Supprelin® LA with a confirmed clinical diagnosis of central precocious puberty (CPP) including measurement of blood concentrations of ALL the following after stimulation with a GnRH analog?

If yes, go to question #3

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

  1. Do baseline evaluations include ALL of the following?

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 unit or kit (1 kit = 50 mg implant = 1 billable unit) and dosage of one implant for a length of authorization of one year?

If yes, this satisfies medical necessity and 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 in the baseline evaluations originally requested in questions 2 through 4?

If yes, go to question #6

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

  1. Doe the individual show treatment response indicated by lack of progression of secondary sexual characteristics and/or suppression of gonadotropins (luteinizing hormone and follicle stimulating hormone) or gonadal sex steroids)?

If yes, go to question #7

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

  1. Does the individual have absence of unacceptable toxicity from the agent, e.g., severe implant site reactions?

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.