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Printer Friendly Version Goserelin (Zoladex®)

Goserelin (Zoladex®)

DESCRIPTION

Goserelin (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

Breast cancer, Palliative treatment for advanced disease in pre- and peri-menopausal women
Endometriosis, Recommended duration is 6 months. Re-treatment cannot be recommended because safety data are not available.
Hypoplasia of endometrium
Prostate cancer, Advanced (palliative treatment)
Prostate cancer, Locally confined stage B2-C disease (in combination with flutamide)

IDENTIFICATION

Generic Name: Goserelin
Brand Name: Zoladex®

POLICY

Goserelin (Zoladex®) is considered medically necessary for the following disease states:

Breast cancer
Prostate cancer
Endometriosis
As an endometrial thinning agent prior to endometrial ablation (added 3/26/2002)

POLICY EXCEPTIONS

None

POLICY GUIDELINES

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 HISTORY

5/1999: 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

USPDI 1998

CODE REFERENCE

This is not intended to be a comprehensive list of codes. Some codes may be variable, and coverage will be based on the clinical indication for the service.

Covered Codes

Code Number	Description
CPT-4

ICD-9 Procedure
99.24	Injection of other hormone
ICD-9 Diagnosis
173.5	Other malignant neoplasm of skin of trunk, except scrotum (includes skin of breast) (added 10-26-2005)
174.0, 174.1, 174.2, 174.3, 174.4, 174.5, 174.6, 174.8,174.9	Malignant neoplasm of female breast code range
175.0,175.9	Malignant neoplasm of male breast code range (added 11-13-2002)
185	Malignant neoplasm of prostate
198.2	Secondary malignant neoplasm of skin of breast
198.81	Secondary malignant neoplasm of breast
198.82	Secondary malignant neoplasm of genital organs (includes prostate)
232.5	Carcinoma in situ of skin of trunk, except scrotum (includes skin of breast) (added 10-26-2005)
233.0	Carcinoma in situ of breast
233.2	Carcinoma in situ of other and unspecified parts of uterus (includes endometrium) (added 10-26-2005)
233.4	Carcinoma in situ of prostate
617.0, 617.1, 617.2, 617.3, 617.4, 617.5, 617.6, 617.8,617.9	Endometriosis code range
HCPCS
J9202	Goserelin acetate implant (Zoladex), per 3.6 mg (added 10-26-2005)
S9560	Home injectable therapy; hormonal therapy (e.g.; leuprolide, goserelin), including administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment (drugs and nursing visits coded separately), per diem (added 10-26-2005)