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Printer Friendly Version Leuprolide (Lupron®)

Leuprolide (Lupron®)

DESCRIPTION

Leuprolide, (Lupron®), a luteinizing hormone-releasing hormone agonist, is a synthetic analog of naturally occurring gonadotropin-releasing hormone (GnRH) possessing greater potency than the natural hormone. Initially, leuprolide (Lupron®) increases circulating levels of luteinizing hormone (LH) and follicle stimulating hormone (FSH), leading to a transient increase in gonadal steroids (testosterone and dihydrotestosterone in males; estrone and estradiol in premenopausal females.) However, continuous daily administration results in decreased LH and FSH in all patients. In males, testosterone levels decrease to castrate levels, and in premenopausal females, estrogens are reduced to postmenopausal levels. These decreases occur within 2 to 4 weeks after initiation of therapy.

FDA APPROVED INDICATIONS

Endometriosis
Precocious puberty
Prostate cancer, Palliative treatment of advanced disease
Uterine leiomyoma

IDENTIFICATION

Generic Name: Leuprolide
Brand Name: Lupron®

POLICY

Leuprolide (Lupron®) is considered medically necessary for the following disease states:

Endometriosis
Uterine leiomyoma
Precocious puberty
Prostate cancer
Breast cancer
Endometrial cancer

Leuprolide (Lupron®) is considered not medically necessary for ovarian stimulation (256.0 - 256.9)

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: Approval by Pharmacy & Therapeutics Committee (P & T)

11/1999: Revisions approved by P & T

1/17/2001: Added new HCPCS J9219 effective 1-01-2001

4/9/2001: Breast and Endometrial cancer added as covered indications, ICD-9 diagnosis code 174.0-174.9, 175.0-175.9, 182.0 added covered codes

1/30/2002: Prior authorization deleted

2/14/2002: Investigational definition added

5/1/2002: Type of Service and Place of Service deleted

11/13/2002: ICD-9 diagnosis codes moved to Code Reference section

9/10/2004: Code Reference section updated, ICD-9 diagnosis code range 174.0-174.9, 218.0-218.9, 617.0-617.9 listed separately, ICD-9 diagnosis code 173.5, 198.2, 198.81, 198.82, 232.5, 233.0, 233.2 added covered codes, ICD-9 diagnosis code 259.0 deleted covered codes, HCPCS S9560 added covered codes, non-covered codes table deleted, ICD-9 diagnosis code 256.4, 183.0, 198.6, 233.3 deleted non-covered codes, Catamenial pneumothorax, hypersexuality, ovarian stimulation deleted non-covered table

9/16/2005: Code Reference section updated, CPT code 90782 deleted, ICD-9 diagnosis code 233.4 added

10/29/2006: Dosing and off-label information removed

11/2/2006: Code Reference updated. ICD-9 diagnosis codes 173.5, 174-174.6, 174.8, 174.9, 175.0-175.9, 182.0, 198.2, 198.81, 232.5, 233.0 deleted from policy

7/12/2007: Code Reference updated. ICD-9 diagnosis codes 173.5, 174-174.6, 174.8, 174.9, 175.0-175.9, 182.0, 198.2, 198.81, 232.5, 233.0 added to policy. Breast and endometrial cancer added to policy statement as medically necessary. Ovarian stimulation (256.1) added to policy statement as not medically necessary.

8/25/2008: Added ICD-9 diagnosis code range 256.0 - 256.9 as not medically necessary for ovarian stimulation

SOURCE(S)

American Hospital Formulary Services 1998

Fact and Comparisons October, 1999

Micromedex, 1998, 2006

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

ICD-9 Diagnosis
173.5	Other malignant neoplasm of skin of trunk, except scrotum (added 9-10-2004) (re-added 7-12-2007)
174.0, 174.1, 174.2, 174.3, 174.4, 174.5, 174.6, 174.8, 174.9	Malignant neoplasm of female breast (added 4-9-2001) (re-added 7-12-2007)
175.0, 175.9	Malignant neoplasm of male breast (added 4-9-2001) (re-added 7-12-2007)
182.0	Malignant neoplasm of corpus uteri, except isthmus (endometrial cancer) (re-added 7-12-2007)
185	Malignant neoplasm of prostate
198.2	Secondary malignant neoplasm of skin (added 9-10-2004) (re-added 7-12-2007)
198.81	Secondary malignant neoplasm of breast (added 9-10-2004) (re-added 7-12-2007)
198.82	Secondary malignant neoplasm of genital organs (added 9-10-2004)
218.0, 218.1, 218.2, 218.9	Uterine leiomyoma
232.5	Carcinoma in situ of skin of trunk, except scrotum (added 9-10-2004) (re-added 7-12-2007)
233.0	Carcinoma in situ of breast (added 9-10-2004) (re-added 7-12-2007)
233.2	Carcinoma in situ of other and unspecified parts of uterus (added 9-10-2004)
233.4	Carcinoma in situ of prostate (added 9-16-2005)
259.1	Precocious sexual development and puberty, not elsewhere classified
617.0, 617.1, 617.2, 617.4, 617.5, 617.6, 617.8, 617.9	Endometriosis
HCPCS
J1950	Injection, leuprolide acetate (for depot suspension), per 3.75 mg.
J9217	Leuprolide acetate (for depot suspension), 7.5 mg.
J9218	Leuprolide acetate, per 1 mg.
J9219	Leuprolide acetate implant, 65 mg (effective 1-1-2001) (added 1-17-2001)
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 9-10-2004)

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