Leuprolide Acetate for Depot Suspension
00074-2108-XX Lupron Depot-Ped (1-Month) 7.5 MG KIT (ABBVIE)
00074-2282-XX Lupron Depot-Ped (1-Month) 11.25 MG KIT (ABBVIE)
00074-2440-XX Lupron Depot-Ped (1-Month) 15 MG KIT (ABBVIE)
00074-3346-XX Lupron Depot (3-Month) 22.5 MG KIT (ABBVIE)
00074-3473-XX Lupron Depot (6-Month) 45 MG KIT (ABBVIE)
00074-3641-XX Lupron Depot (1-Month) 3.75 MG KIT (ABBVIE)
00074-3642-XX Lupron Depot (1-Month) 7.5 MG KIT (ABBVIE)
00074-3663-XX Lupron Depot (3-Month) 11.25 MG KIT (ABBVIE)
00074-3683-XX Lupron Depot (4-Month) 30 MG KIT (ABBVIE)
00074-3779-XX Lupron Depot-Ped (3-Month) 11.25 MG (Ped) KIT (ABBVIE)
00074-9694-XX Lupron Depot-Ped (3-Month) 30 MG (Ped) KIT (ABBVIE)
62935-0220-XX ELIGARD 22.5 MG SYRINGE B (TOLMAR PHARMACEUTICALS)
62935-0221-XX ELIGARD 22.5 MG SYRINGE B (TOLMAR PHARMACEUTICALS)
62935-0223-XX Eligard 22.5 MG KIT (TOLMAR PHARMACEUTICALS)
62935-0303-XX Eligard 30 MG KIT (TOLMAR PHARMACEUTICALS)
62935-0305-XX ELIGARD 30 MG SYRINGE B (TOLMAR PHARMACEUTICALS)
62935-0453-XX Eligard 45 MG KIT (TOLMAR PHARMACEUTICALS)
62935-0454-XX ELIGARD 45 MG SYRINGE B (TOLMAR PHARMACEUTICALS)
62935-0753-XX Eligard 7.5 MG KIT (TOLMAR PHARMACEUTICALS)
62935-0754-XX ELIGARD 7.5 MG SYRINGE B (TOLMAR PHARMACEUTICALS)
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.
Leuprolide acetate for depot suspension for the treatment of the following is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Central precocious puberty (CPP)
Salivary Gland Tumors
Uterine leiomyomas (fibroid tumors)
Leuprolide acetate for depot suspension for the treatment or prevention of other conditions/diseases is considered investigational.
Leuprolide acetate for depot suspension is considered medically appropriate for a diagnosis of ANY ONE of the following:
Breast cancer with ALL of the following:
Individual is ANY ONE of the following:
Premenopausal female with hormone receptor-positive disease
Male having concomitant suppression of testicular steroidogenesis
Treatment is ANY ONE of the following:
Used in combination with adjuvant endocrine therapy
Endocrine therapy for recurrent or metastatic disease
Central precocious puberty (CPP) with ALL of the following:
Individual is less than 13 years of age
Diagnosis is confirmed by a pubertal gonadal sex steroid level and a pubertal LH response to stimulation by native GnRH
Bone age greater than 2 standard deviations (SD) beyond chronological age
Onset of secondary sexual characteristics prior to ANY ONE of the following:
Age 8 in females
Age 9 in males
Tumor activity ruled out by testing such as diagnostic imaging of the brain to rule out intracranial tumor, pelvic/testicular/adrenal ultrasound to rule out steroid secreting tumors and human chorionic gonadotropin levels to rule out a chorionic gonadotropin secreting tumor
Endometriosis in a female 18 years of age or older with documentation of diagnosis confirmed by a workup/evaluation (versus presumptive treatment)
Ovarian cancer if used as a single agent and ANY ONE of the following:
Diagnosis of Stage II-IV granulosa cell tumors of the ovary that has relapsed
Diagnosis of epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer that is persistent or recurrent
Salivary Gland Tumors if ALL of the following:
Disease is recurrent androgen receptor-positive with distant metastases
Individual has a performance status of 0-3
Uterine leiomyomas (fibroid tumors) if ALL of the following:
Individual is a female 18 years of age or older
Diagnosis confirmed by a workup/evaluation (versus presumptive treatment)
Documentation individual is receiving iron therapy
Leuprolide acetate for depot suspension is considered medically appropriate for renewal for a diagnosis of ANY ONE of the following:
Breast, Ovarian, Prostate Cancer or Salivary Gland tumor if ALL of the following:
Tumor response with stabilization of disease or decrease in size of tumor or tumor spread
Absence of unacceptable toxicity from the drug, e.g., tumor flare, hyperglycemia/diabetes, cardiovascular disease (myocardial infarction, sudden cardiac death, stroke), QT/QTc prolongation, convulsions, etc.
Central precocious puberty (CPP) if ALL of the following:
Individual continues to meet initial approval criteria
Disease response as indicated by lack of progression or stabilization of secondary sexual characteristics
Absence of unacceptable toxicity from the drug, e.g., convulsions, development or worsening of psychiatric symptoms, etc.
Leuprolide acetate for depot suspension is considered NOT medically appropriate for renewal for Endometriosis or Uterine leiomyomata (fibroids)
DOSAGE & ADMINISTRATION
3.75mg monthly or 11.25mg every 3 months for a duration of 6 months
Breast Cancer/Ovarian Cancer
3.75mg/7.5mg IM monthly or 11.25mg/22.5mg IM every 3 months
Central Precocious Puberty (CPP)
Lupron Depot-Ped IM injection:
>37.5kg: 15mg every 4 weeks
25-37.5kg: 11.25mg every 4 weeks
<25kg: 7.5mg every 4 weeks
Ages 2 to 11 yrs: 11.25mg or 30mg every 12 weeks
Uterine leiomyomata (fibroids)
3.75mg monthly or 11.25mg every 3 months for a duration of 6 months
Prostate Cancer (Lupron Depot/Eligard)
7.5mg every 4 weeks, 22.5mg every 12 weeks, 30mg every 16 weeks, or 45mg every 24 weeks
Salivary Gland tumors
7.5 mg every 4 weeks, 22.5 mg every 12 weeks
|Lupron is administered intramuscularly (IM); Eligard is administered subcutaneously (SQ)|
LENGTH OF AUTHORIZATION
Endometriosis/ Uterine leiomyomata (fibroids) coverage will be provided for 6 months and is NOT eligible for renewal. Coverage for all other indications will be provided for 12 months and may be renewed.
Refer to DOSAGE LIMITS below
BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.
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.
For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).
Lexi-Comp Online. (2018). AHFS-DI. Leuprolide acetate. Retrieved September 17, 2018 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2018, February). Leuprolide. Retrieved September 17, 2018 from MICROMEDEX Healthcare Series.
National Comprehensive Cancer Network. (2018). NCCN Drugs & Biologics Compendium®. Leuprolide acetate for depot suspension. Retrieved September 17, 2018 from the National Comprehensive Cancer Network.
U. S. Food and Drug Administration. (2016, February). Center for Drug Evaluation and Research. Eligard (leuprolide acetate) suspension for subcutaneous injection. Retrieved September 17, 2018 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021343s033,021379s033,021488s030,021731s029lbl.pdf.
U. S. Food and Drug Administration. (2017, May). Center for Drug Evaluation and Research. Lupron depot-ped (leuprolide acetate for depot suspension). Retrieved September 17, 2018 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020263s042lbl.pdf.
U. S. Food and Drug Administration. (2018, April). Center for Drug Evaluation and Research. Lupron depot (leuprolide acetate for depot suspension). Retrieved September 17, 2018 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020708s035lbl.pdf.
ORIGINAL EFFECTIVE DATE: 5/1/2004
MOST RECENT REVIEW DATE: 10/9/2018
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.
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Maximum billable units per dose and over time by indication as a Medical Benefit