Leuprolide Acetate for Depot Suspension
00074-2108-XX LUPRON DEPOT-PED 7.5MG Kit (ABBVIE)
00074-2282-XX LUPRON DEPOT-PED 11.25MG Kit (ABBVIE)
00074-2440-XX LUPRON DEPOT-PED 15MG Kit (ABBVIE)
00074-3641-XX LUPRON DEPOT 3.75MG Kit (ABBVIE)
00074-3663-XX LUPRON DEPOT 11.25MG Kit (ABBVIE)
00074-3779-XX LUPRON DEPOT-PED 11.25MG Kit (ABBVIE)
00074-9694-XX LUPRON DEPOT-PED 30MG Kit (ABBVIE)
00074-3346-XX LUPRON DEPOT 22.5MG Kit (ABBVIE)
00074-3473-XX LUPRON DEPOT 45MG Kit (ABBVIE)
00074-3642-XX LUPRON DEPOT 7.5MG Kit (ABBVIE)
00074-3683-XX LUPRON DEPOT 30MG Kit (ABBVIE)
62935-0153-XX FENSOLVI 45MG Kit (TOLMAR PHARMACEUTICALS)
62935-0220-XX ELIGARD 22.5MG SYRINGE (TOLMAR PHARMACEUTICALS)
62935-0221-XX ELIGARD 22.5MG SYRINGE (TOLMAR PHARMACEUTICALS)
62935-0223-XX ELIGARD 22.5MG KIT (TOLMAR PHARMACEUTICALS)
62935-0303-XX ELIGARD 30MG KIT (TOLMAR PHARMACEUTICALS)
62935-0305-XX ELIGARD 30MG SYRINGE (TOLMAR PHARMACEUTICALS)
62935-0453-XX ELIGARD 45MG KIT (TOLMAR PHARMACEUTICALS)
62935-0454-XX ELIGARD 45MG SYRINGE (TOLMAR PHARMACEUTICALS)
62935-0753-XX ELIGARD 7.5MG KIT (TOLMAR PHARMACEUTICALS)
62935-0754-XX ELIGARD 7.5MG SYRINGE (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.
Individual is 18 years of age or older unless otherwise specified
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
Disease is hormone receptor positive
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
Will not be used in combination with growth hormone
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 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 (excluding immediate treatment of biochemical relapse)
Head and Neck Cancer - Salivary Gland Tumors if ANY ONE of the following:
Disease is recurrent androgen receptor-positive with distant metastases with performance status of 0-3
Disease is unresectable locoregional recurrence or second primary with prior radiation therapy
Uterine leiomyomas (fibroid tumors) if ALL of the following:
Diagnosis confirmed by a workup/evaluation (versus presumptive treatment)
Documentation individual is receiving iron therapy
Individual continues to meet the indication-specific relevant criteria in Initial Approval section
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:
Disease response with treatment as defined by 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 (e.g., less than 13 years of age and will not be used in combination with growth hormone)
Disease response as indicated by lack of progression or stabilization of secondary sexual characteristics, decrease in growth velocity and bone age advancement, and improvement in final height prediction;
Absence of unacceptable toxicity from the drug, e.g., convulsions, development or worsening of psychiatric symptoms, etc.
Endometriosis if individual has or will have ALL of the following:
Not received a total of 12 months of therapy of a GnRH-agonist (i.e., leuprolide acetate, etc.)
Continues to have symptoms of endometriosis or symptoms recur after the initial 6-month course of therapy
Will have bone density assessment prior to retreatment
Will use in combination with add-back therapy in combination with norethindrone
Leuprolide acetate for depot suspension is considered NOT medically appropriate for renewal for or Uterine leiomyomata (fibroids)
DOSAGE & ADMINISTRATION
Administer intramuscularly - 3.75mg monthly or 11.25mg every 3 months for a duration of 6 months ONLY
Breast Cancer/Ovarian CA
Administer, intramuscularly or subcutaneously - 3.75mg/7.5mg IM monthly or 11.25mg/22.5mg IM every 3 months
Central Precocious Puberty (CPP)
Fensolvi subcutaneous kit:
Lupron Depot-Ped - intramuscular injection:
Ages 2 to 11 yrs: 11.25mg or 30mg every 12 weeks
Uterine leiomyomata (fibroids)
Administer, intramuscularly - 3.75mg monthly or 11.25mg every 3 months for a duration of 6 months
Administer, intramuscularly or subcutaneously - 7.5mg every 4 weeks, 22.5mg every 12 weeks, 30mg every 16 weeks, or 45mg every 24 weeks
Salivary Gland tumors
Administer, intramuscularly or subcutaneously - 7.5 mg every 4 weeks, 22.5 mg every 12 weeks
Lupron is administered intramuscularly (IM); Eligard and Fensolvi are administered subcutaneously (SQ)
Do not use concurrently a fractional dose, or a combination of doses of this or any depot formulation due to different release characteristics.
LENGTH OF AUTHORIZATION
Endometriosis coverage will be provided for 6 months and is eligible for renewal one time only.
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)..
AbbVie Inc. (2020, March). LUPRON DEPOT 11.25 mg (leuprolide acetate for depot suspension) for injection, for intramuscular use. Retrieved August 17, 2020 from https://www.rxabbvie.com/pdf/lupron3month11_25mg.pdf.
Lexi-Comp Online. (2020). AHFS-DI. Leuprolide acetate. Retrieved August 17, 2020 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2020, August). Leuprolide. Retrieved August 17, 2020 from MICROMEDEX Healthcare Series.
National Comprehensive Cancer Network. (2020). NCCN Drugs & Biologics Compendium®. Leuprolide acetate. Retrieved August 17, 2020 from the National Comprehensive Cancer Network.
National Comprehensive Cancer Network. (2020). NCCN Drugs & Biologics Compendium®. Leuprolide acetate for depot suspension. Retrieved August 17, 2020 from the National Comprehensive Cancer Network.
U. S. Food and Drug Administration. (2019, February). Center for Drug Evaluation and Research. Eligard (leuprolide acetate) suspension for subcutaneous injection. Retrieved August 17, 2020 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021343s039,021379s041,021488s036,021731s037lbl.pdf.
U. S. Food and Drug Administration. (2020, May). Center for Drug Evaluation and Research. FENSOLVI (leuprolide acetate) for injectable suspension, for subcutaneous use. Retrieved August 17, 2020 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213150s000lbl.pdf.
U. S. Food and Drug Administration. (2019, March). Center for Drug Evaluation and Research. Lupron depot (leuprolide acetate for depot suspension). Retrieved August 17, 2020 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020517s042,019732s044lbl.pdf.
U. S. Food and Drug Administration. (2020, April). Center for Drug Evaluation and Research. Lupron depot-ped (leuprolide acetate for depot suspension). Retrieved August 17, 2020 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020263s042lbl.pdf.
ORIGINAL EFFECTIVE DATE: 5/1/2004
MOST RECENT REVIEW DATE: 12/31/2020
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