Print Leuprolide (Lupron®)

Leuprolide (Lupron®)



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.


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



Generic Name: Leuprolide
Brand Name: Lupron®



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)






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.



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



American Hospital Formulary Services 1998

Fact and Comparisons October, 1999

Micromedex, 1998, 2006



This 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.

Covered Codes

Code Number





ICD-9 Procedure



ICD-9 Diagnosis

173.5Other 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, 174.9Malignant neoplasm of female breast (added 4-9-2001) (re-added 7-12-2007)
175.0, 175.9Malignant neoplasm of male breast (added 4-9-2001) (re-added 7-12-2007)
182.0Malignant neoplasm of corpus uteri, except isthmus (endometrial cancer) (re-added 7-12-2007)


Malignant neoplasm of prostate

198.2Secondary malignant neoplasm of skin (added 9-10-2004) (re-added 7-12-2007)
198.81Secondary malignant neoplasm of breast (added 9-10-2004) (re-added 7-12-2007)


Secondary malignant neoplasm of genital organs (added 9-10-2004)

218.0, 218.1, 218.2, 218.9

Uterine leiomyoma

232.5Carcinoma in situ of skin of trunk, except scrotum (added 9-10-2004) (re-added 7-12-2007)
233.0Carcinoma in situ of breast (added 9-10-2004) (re-added 7-12-2007)


Carcinoma in situ of other and unspecified parts of uterus (added 9-10-2004)


Carcinoma in situ of prostate (added 9-16-2005)


Precocious sexual development and puberty, not elsewhere classified

617.0, 617.1, 617.2, 617.4, 617.5, 617.6, 617.8, 617.9




Injection, leuprolide acetate (for depot suspension), per 3.75 mg.


Leuprolide acetate (for depot suspension), 7.5 mg.


Leuprolide acetate, per 1 mg.


Leuprolide acetate implant, 65 mg (effective 1-1-2001) (added 1-17-2001)


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)