67979-0002-XX Supprelin® LA 50 MG KIT(ENDO PHARMACEUTICALS)
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.
Histrelin acetate implant therapy for the treatment of central precocious puberty (CPP) is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Histrelin acetate implant therapy for the treatment of other conditions/diseases is considered investigational.
Histrelin acetate implant therapy is considered medically appropriate if ALL of the following:
Requested product is Supprelin® LA
Confirmed clinical diagnosis of central precocious puberty (CPP) with documentation of ALL the following:
Age less than 13 years old
Onset of secondary sexual characteristics before the age of 8 in females and 9 in males associated with pubertal pituitary gonadotropin activation
Diagnosis is confirmed by pubertal gonadal sex steroid levels and a pubertal LH response to stimulation by native GnRH
Bone age advanced greater than 2 standard deviations (SD) beyond chronological age
Diagnostic imaging of the brain to rule out intracranial tumor
Pelvic / testicular / adrenal ultrasound to rule out steroid secreting tumors
Human chorionic gonadotropin level to rule out chorionic gonadotropin secreting tumor
Histrelin acetate implant therapy with Supprelin® LA is considered medically appropriate for renewal if ALL of the following:
Individual continues to meet initial criteria
Treatment response indicated by lack of progression or stabilization of secondary sexual characteristics, characteristics, decrease in height velocity, and improvement in final height prediction
Absence of unacceptable toxicity from the agent, e.g., severe implant site reactions, convulsions/seizures, development or worsening of psychiatric symptoms, etc.
|INDICATION(S)||DOSAGE & ADMINISTRATION|
|Central precocious puberty (CPP)||1 implant (50 mg) inserted subcutaneously every12 months|
LENGTH OF AUTHORIZATION
Coverage will be for 12 months and may be renewed.
Refer to DOSAGE LIMITS below
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.
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.
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).
Lexi-Comp Online. (2017, November). AHFS DI. Histrelin. Retrieved February 19, 2018 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2018, September). Histrelin. Retrieved September 20, 2018 from MICROMEDEX Healthcare Series.
U. S. Food and Drug Administration. (2017, May). Center for Drug Evaluation and Research. Supprelin LA (histrelin acetate) subcutaneous implant. Retrieved September 20, 2018 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022058s014s015lbl.pdf.
ORIGINAL EFFECTIVE DATE: 12/1/2016
MOST RECENT REVIEW DATE: 10/9/2018
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.
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Maximum billable units per dose and over time by indication as a Medical Benefit