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DESCRIPTIONGoserelin (Zoladex®) is a synthetic analog of luteinizing hormone-releasing hormone (LHRH or GnRH). It acts as a potent inhibitor of pituitary gonadotropin secretion. In males, goserelin (Zoladex®) causes an initial increase in serum LH and FSH values with subsequent increases in serum levels of testosterone. Chronic administration leads to sustained suppression of pituitary gonadotropins; testosterone serum levels consequently fall into the range normally seen in surgically castrated men. This leads to accessory sex organ regression. In females, a similar down-regulation of the pituitary gland by chronic exposure to goserelin (Zoladex®) leads to suppression of gonadotropin secretion, a decrease in serum estradiol to levels consistent with the postmenopausal state, and would be expected to lead to a reduction of ovarian size and function, reduction in the size of the uterus and mammary gland and a regression of sex hormone-responsive tumor, if present.
FDA APPROVED INDICATIONS
Generic Name: Goserelin
POLICYGoserelin (Zoladex®) is considered medically necessary for the following disease states:
Investigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY5/1999: Approved by Pharmacy & Therapeutics (P & T) Committee
1/30/2002: Prior Authorization and Managed Care Requirements deleted
2/14/2002: Investigational definition added
3/26/2002: Endometrial thinning agent indication added
4/24/2002: Type of Service and Place of Service deleted. Code Reference section completed.
11/13/2002: Cancer endometrium added Policy section, Code Reference section updated
10/26/2005: Non-covered table deleted, CPT-4 codes 83727, 90782 deleted. ICD-9 diagnosis codes 189.3, 198.1 and 233.9 deleted. ICD-9 diagnosis codes 173.5, 232.5 and 233.2 added. Verbiage changed on ICD-9 codes 175.0, 182.0, 198.82 and 617.0. HCPCS codes J9202 and S9560 added
10/30/2006: Dosing, off-label, and investigational information removed
11/3/006: Code reference updated. Deleted ICD-9 code 182.0
SOURCE(S)American Hospital Formulary Services 1998
Fact and Comparisons, October, 1997
Micromedex, 1998, 2006
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.