Print Leuprolide acetate (Lupron®)

Leuprolide acetate (Lupron®)



Leuprolide acetate (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 acetate (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 are as follows:

  • Endometriosis
  • Precocious puberty
  • Prostate cancer, palliative treatment of advanced disease
  • Uterine leiomyomata



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

  • Endometriosis
  • Uterine leiomyomata
  • Precocious puberty
  • Prostate cancer
  • Breast cancer
  • Endometrial cancer

Leuprolide (Lupron®) is considered not medically necessary for ovarian stimulation.






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

04/01/2014: Policy title changed from "Leuprolide (Lupron®)" to "Leuprolide acetate (Lupron®)." Policy description updated to add "acetate" to Leuprolide (Lupron®). Policy statement intent unchanged.

09/01/2015: Code Reference section updated for ICD-10.  Extended ICD-9 diagnosis code 173.5 to the fifth digit as 173.50, 173.51, 173.52, and 173.59.



American Hospital Formulary Services 1998

Fact and Comparisons October, 1999

Micromedex, 1998, 2006

Lupron® Prescribing Information



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






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


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

ICD-9 Procedure

ICD-10 Procedure




ICD-9 Diagnosis

ICD-10 Diagnosis

173.50, 173.51, 173.52, 173.59

Other malignant neoplasm of skin of trunk, except scrotum

C44.501, C44.511, C44.521, C44.591

Other and unspecified malignant neoplasm of skin of breast

174.0, 174.1, 174.2, 174.3, 174.4, 174.5, 174.6, 174.8, 174.9

Malignant neoplasm of female breast

C50.011, C50.012, C50.019, C50.111, C50.112, C50.119, C50.211, C50.212, C50.219, C50.311, C50.312, C50.319, C50.411, C50.412, C50.419, C50.511, C50.512, C50.519, C50.611, C50.612, C50.619, C50.811, C50.812, C50.819, C50.911, C50.912, C50.919

Malignant neoplasm of breast, female

175.0, 175.9

Malignant neoplasm of male breast

C50.021, C50.022, C50.029, C50.121, C50.122, C50.129, C50.221, C50.222, C50.229, C50.321, C50.322, C50.329, C50.421, C50.422, C50.429, C50.521, C50.522, C50.529, C50.621, C50.622, C50.629, C50.821, C50.822, C50.829, C50.921, C50.922, C50.929

Malignant neoplasm of breast, male


Malignant neoplasm of corpus uteri, except isthmus (endometrial cancer)

C54.1 - C54.9

Malignant neoplasm of corpus uteri, except isthmus


Malignant neoplasm of prostate


Malignant neoplasm of prostate


Secondary malignant neoplasm of skin


Secondary malignant neoplasm of skin


Secondary malignant neoplasm of breast


Secondary malignant neoplasm of breast


Secondary malignant neoplasm of genital organs


Secondary malignant neoplasm of genital organs

218.0, 218.1, 218.2, 218.9

Uterine leiomyoma

D25.0, D25.1, D25.2, D25.9

Uterine leiomyoma


Carcinoma in situ of skin of trunk, except scrotum


Carcinoma in situ of skin of trunk


Carcinoma in situ of breast

D05.00 - D05.92

Carcinoma in situ of breast


Carcinoma in situ of other and unspecified parts of uterus


Carcinoma in situ of endometrium


Carcinoma in situ of prostate


Carcinoma in situ of prostate


Precocious sexual development and puberty, not elsewhere classified


Precocious puberty

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


N80.0, N80.1, N80.2,

N80.4, N80.5, N80.6, N80.8, N80.9