Leuprolide Acetate
DESCRIPTION
Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin releasing hormone (GnRH or LH-RH) that, when given continuously, inhibits pituitary gonadotropin secretion and suppresses testicular and ovarian steroidogenesis. The analog possesses greater potency than the natural hormone.
Examples of preparations of leuprolide acetate are: Lupron®, Lupron Depot®, Lupron Depot-Ped®, Lupron Depot® - 3 Month, Lupron Depot® - 4 Month, and Eligard®.
REFER TO DECISION SUPPORT TREE
POLICY
Leuprolide acetate for the palliative treatment of the following conditions is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Advanced prostatic cancer
Endometriosis
Uterine leiomyomas
Central precocious puberty (CPP)
Advanced breast cancer
Leuprolide acetate for the treatment of other conditions/diseases, including, but not limited to, the following: premenstrual syndrome and polycystic ovarian disease is considered investigational. (See Applicable Tennessee State Mandate Requirements below.)
MEDICAL APPROPRIATENESS
Leuprolide acetate is considered medically appropriate for the palliative treatment of ANY ONE of the following:
Advanced prostatic cancer with ANY ONE of the following:
Orchiectomy is not indicated or is unacceptable to the individual
Estrogen administration is either not indicated or is unacceptable to the individual
Endometriosis in women 18 years of age and older
Anemia due to uterine leiomyomas when being used prior to surgery in women 18 years of age and older
Central precocious puberty with ALL of the following criteria:
Confirmed clinical diagnosis of central precocious puberty by pubertal response to a gonadotropin releasing hormone analogue (GnRHa) stimulation test or an ultrasensitive assay showing pubertal levels
Bone age that is advanced 1 year beyond the chronological age
Onset of secondary sexual characteristics in females before the age of 8 and in males before the age of 9
Willingness to comply with dosing requirements and frequent monitoring required by the physician during the first 6 to 8 weeks of treatment to assure that suppression of gonadal-pituitary function is rapid
Advanced breast cancer in premenopausal women when used as palliative care
APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS
Tennessee State law requires coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is relative to life-threatening illnesses, such as cancer, AIDS, and coronary heart disease and recognized in one of the standard reference compendia (As defined in the statute: The United States Pharmacopoeia Drug Information, The American Medical Association Drug Evaluations, & The American Hospital Formulary Service Drug Information) or in the medical literature. This law is applicable to all fully insured members. The law is not applicable to self-funded accounts, but coverage for off-label uses may be provided based on the contractual agreement.
The NCCN Drugs & Biologics Compendium recognizes the use of leuprolide acetate for additional uses beyond the FDA-approved labeling in the treatment of the following conditions (Refer to the NCCN Drugs & Biologics Compendium or NCCN Clinical Practice Guidelines for detailed recommendations):
Breast cancer - invasive
Ovarian cancer
Ovarian stromal tumors
Epithelial Ovarian Cancer/Fallopian Tube Cancer/Primary Peritoneal Cancer
Prostate cancer
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
ADDITIONAL INFORMATION
For appropriate dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., The American Hospital Formulary Service Drug Information).
There is insufficient evidence supporting the use of leuprolide acetate for the treatment of other conditions/diseases.
SOURCES
BlueCross BlueShield Association. Medical Policy Reference Manual. (1:2003). Combined androgen blockage for the treatment of metastatic prostate cancer (5.01.14). Retrieved April 15, 2011 from BlueWeb.
Kletter, G. B. (2008). How should we diagnosis and monitor central precocious puberty? Journal of Pediatric Endocrinology & Metabolism, 21 (12), 1105-1106.
Lexi-Comp Online. (2011). AHFS DI. Leuprolide acetate. Retrieved April 15, 2011 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2011, February). Leuprolide. Retrieved April 15, 2011 from MICROMEDEX Healthcare Series.
National Comprehensive Cancer Network. (2011). NCCN Drugs & Biologics Compendium™. Leuprolide acetate. Retrieved April 15, 2011 from the National Comprehensive Cancer Network.
U. S. Food and Drug Administration. (2010, August). Center for Drug Evaluation and Research. Lupron depot - Ped (leuprolide acetate for depot suspension) injection, powder, lyophilized, for suspension. Retrieved April 15, 2011 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020263s035lbl.pdf.
U. S. Food and Drug Administration. (2010, October). Center for Drug Evaluation and Research. Lupron depot (leuprolide acetate). Retrieved April 15, 2011 from http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Overview&DrugName=LUPRON%20DEPOT.
U. S. Food and Drug Administration. (2011, January). Center for Drug Evaluation and Research. Lupron depot (leuprolide acetate). Retrieved April 15, 2011 from http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Overview&DrugName=LUPRON%20DEPOT.
U. S. Food and Drug Administration. (2011, April). Center for Drug Evaluation and Research. ELIGARD (leuprolide acetate) suspension for subcutaneous injection. Retrieved April 15, 2011 from http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Overview&DrugName=ELIGARD.
ORIGINAL EFFECTIVE DATE: 5/1/2004
MOST RECENT REVIEW DATE: 10/8/2011
ID_BT
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
Pharmaceutical Decision Support Tree
Leuprolide Acetate (Lupron®, Lupron Depot®, Lupron Depot-Ped®, Lupron Depot® - 3 Month, Lupron Depot® - 4 Month, and Eligard®)
Is the requested medication being used to treat premenstrual syndrome and polycystic ovarian disease?
If yes, this does not meet medical necessity and/or medical appropriateness criteria
If no, go to question #2
Is the agent being used for the palliative treatment advanced prostatic cancer with ANY ONE of the following?
Orchiectomy is not indicated or is unacceptable to the individual
Estrogen administration is either not indicated or is unacceptable to the individual
If yes, this satisfies medical necessity and medical appropriateness criteria
If no, go to question #3
Is the individual 18 years of age or older with a diagnosis of endometriosis?
If yes, this satisfies medical necessity and medical appropriateness criteria
If no, go to question #4
Does the individual have a diagnosis of anemia due to uterine leiomyomas with ALL of the following?
Is 18 years of age and older
The agent is being used prior to surgery
If yes, this satisfies medical necessity and medical appropriateness criteria
If no, go to question #5
Does the individual have a diagnosis of central precocious puberty (CPP) with ALL of the following criteria?
Confirmed clinical diagnosis of central precocious puberty by pubertal response to a gonadotropin releasing hormone analogue (GnRHa) stimulation test or an ultrasensitive assay showing pubertal levels
By bone age that is advanced 1 year beyond the chronological age
Onset of secondary sexual characteristics in females before the age of 8 and in males before the age of 9
Willingness to comply with dosing requirements and frequent monitoring required by the physician during the first 6 to 8 weeks of treatment to assure that suppression of gonadal-pituitary function is rapid
If yes, this satisfies medical necessity and medical appropriateness criteria
If no, go to question #6
Is the individual premenopausal with advanced breast cancer and is the agent being used for palliative treatment?
If yes, this satisfies medical necessity and medical appropriateness criteria
If no, this does not meet medical necessity and/or medical appropriateness criteria
This document has been classified as public information.