|24338-0150-XX Triptodur 22.5 MG SRER (ARBOR PHARMACEUTICALS)|
Triptorelin is a synthetic decapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH). In this extended-release formulation, triptorelin is absorbed in two phases, an initial burst phase followed by a maintenance release. As a GnRH agonist, following the initial administration there is a transient surge of circulating levels of LH, FSH, testosterone and estradiol. By four weeks of continuous therapy, a sustained decrease in LH and FSH secretion along with marked reduction in sex steroids are observed.
Triptorelin-extended-release injectable suspension for the treatment of central precocious puberty (CPP) is considered medically necessary if the medical appropriateness criteria are met: (See Medical Appropriateness below.)
Triptorelin extended-release injectable suspension for the treatment of other conditions/diseases is considered investigational.
Triptorelin extended-release injectable suspension is considered medically appropriate if ALL of the following criteria are met:
Diagnosis of central precocious puberty (CPP) confirmed by documentation of ALL the following:
Age is between 2 and 13 years
Onset of secondary sexual characteristics earlier than age 8 for girls and 9 for boys 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
Triptorelin extended-release injectable suspension is considered medically appropriate for renewal of the request if ALL of the following:
Individual continues to meet initial criteria
Treatment response indicated by lack of progression or stabilization of secondary sexual characteristics decrease in height velocity, and improvement in final height prediction
Absence of unacceptable toxicity from the agent, e.g., psychiatric events, convulsions, etc.
DOSAGE & ADMINISTRATION
Central Precocious Puberty (CPP)
22.5 mg by a healthcare professional by intramuscular injection once every 24 weeks
LENGTH OF AUTHORIZATION
Coverage will be provided for 12 months and may be renewed
Refer to DOSAGE LIMITS below
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).
MICROMEDEX Healthcare Series. Drugdex Evaluations. (2018, September). Triptorelin. Retrieved September 26, 2018 from MICROMEDEX Healthcare Series.
U. S. Food and Drug Administration. (2017, June). Center for Drug Evaluation and Research. Triptodur™ (triptorelin) for extended-release injectable suspension, for intramuscular use. Retrieved September 26, 2018 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208956s000lbl.pdf.
ORIGINAL EFFECTIVE DATE: 1/18/2018
MOST RECENT REVIEW DATE: 1/31/2019
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