00310-0950-XX Zoladex 3.6 MG IMPL (TERSERA THERAPEUTICS)
00310-0951-XX Zoladex 10.8 MG IMPL (TERSERA THERAPEUTICS)
54569-3943-XX Zoladex 3.6 MG IMPL (A-S MEDICATION SOLUTIONS)
Goserelin acetate is a synthetic decapeptide analogue of gonadotropin releasing hormone agonist dispersed for continuous release in a matrix of D,L-lactic and glycolic acids copolymer that is completely biodegradable with no demonstrable antigenic potential. Goserelin inhibits pituitary gonadotropin secretion as the implant degrades, following an initial increase in serum luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels and subsequent testosterone levels in males. Gradually the levels taper off to suppression with suppression of pituitary gonadotropins with levels of testosterone falling into the range normally seen in surgically castrated men within about two weeks of initiation of therapy.In women, a similar down-regulation of the pituitary gland on gonadotropin secretion is generally seen. Serum estradiol is suppressed to postmenopausal state within 3 weeks of initiating therapy, however certain individuals may experience isolated elevation of extradiol and suppression of FSH and LH hormone levels may not be attained in some females.
Goserelin acetate implant for the treatment of prostate cancer is considered medically necessary.
Goserelin acetate implant for the treatment of the following is considered medically necessary if the medical appropriateness criteria are met: (See Medical Appropriateness below.)
Goserelin acetate implant for the treatment of other conditions/diseases is considered investigational.
Goserelin acetate implant is considered medically appropriate for ANY ONE of the following:
Diagnosis of breast cancer with ALL of the following:
Individual is ANY ONE of the following:
Pre- or peri- menopausal female
Male with suppression of testicular steroidogenesis
Hormone receptor-positive disease if ANY ONE of the following:
Used in combination with adjuvant endocrine therapy
Used as palliative treatment for advanced disease
Used in combination with endocrine therapy for recurrent or metastatic disease
Endometrial thinning prior to endometrial ablation for dysfunctional uterine bleeding
Diagnosis of endometriosis if ALL of the following:
Female is 18 years of age or older
Individual has not received prior-treatment with goserelin acetate implant for this indication for a 6-month period
Goserelin acetate implant is considered medically appropriate for renewal for treatment of ANY ONE of the following if criteria are met:
Diagnosis of breast cancer or prostate cancer if ALL of the following:
Individual continues to meet the initial medical appropriateness criteria
Tumor response with stabilization of disease or decrease in size of tumor
Absence of unacceptable toxicity from the agent. Examples of unacceptable toxicity include the following: severe QT/QTc interval prolongation, severe hyperglycemia and diabetes, cardiovascular toxicity, severe tumor flare phenomenon, severe hypercalcemia, etc.
Endometrial thinning prior to endometrial ablation for dysfunctional uterine bleeding if ALL of the following:
Disease response to treatment
Absence of unacceptable toxicity from the agent. Examples of unacceptable toxicity include the following: severe QT/QTc interval prolongation, severe hyperglycemia and diabetes, cardiovascular toxicity, etc.
|INDICATION(S)||DOSAGE & ADMINISTRATION|
|Breast cancer||(3.6 mg only) every 28 days|
|Endometrial thinning||(3.6 mg only) for 1 or 2 doses with each depot is given 28 days apart. (When 1 depot is given, endometrial ablation surgery should be performed at 4 weeks. If 2 depots are given, surgery should be performed within 2-4 weeks following the second depot dosage).|
|Endometriosis||(3.6 mg only) every 28 days for 6 months|
|Prostate carcinoma||3.6 mg depot 8 weeks before radiotherapy, followed in 28 days by the Zoladex 10.8 mg depot, can be administered. Alternatively, four subcutaneous injections of 3.6 mg depot can be administered at 28-day intervals, two depots preceding and two during radiotherapy.|
Length of Authorization
Endometriosis: Coverage will be provided for six months and medication is NOT eligible for renewal
All other indications: Coverage will be provided 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).
No controlled studies were found in the published literature that validates the use of goserelin acetate implant for the treatment of any other conditions or diseases.
Lexicomp Online. (2018). AHFS DI. Goserelin acetate. Retrieved February 27, 2018 from Lexicomp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Evaluations. (2018, February). Goserelin. Retrieved February 27, 2018 from MICROMEDEX Healthcare Series.
National Comprehensive Cancer Network. (2018). NCCN Drugs & Biologics Compendium®. Goserelin Acetate. Retrieved February 27, 2018 from the National Comprehensive Cancer Network.
U. S. Food and Drug Administration. (2015, February). Center for Drug Evaluation and Research. Zoladex® (goserelin acetate implant). Retrieved February 27, 2018 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019726s059,020578s037lbl.pdf.
MOST RECENT REVIEW DATE: 7/10/2018
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.
This document has been classified as public information.
Maximum billable units per dose and over time by indication as a Medical Benefit 1 billable unit = 3.6 mg