BlueCross BlueShield of Tennessee Medical Policy Manual

Leuprolide Acetate for Depot Suspension

 

NDC CODE(S)

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)

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.

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S)

DOSAGE & ADMINISTRATION

Endometriosis

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:

  • Administer 45 mg subcutaneously once every six months

Lupron Depot-Ped -  intramuscular injection:

  • >37.5kg: 15mg every 4 weeks

  • 25-37.5kg: 11.25mg every 4 weeks

  • <25kg: 7.5mg every 4 weeks OR

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

Prostate Cancer

(Lupron Depot/Eligard)

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

Refer to DOSAGE LIMITS below

APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS

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.

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 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)..

SOURCES

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

ID_MRx

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.

This document has been classified as public information

 

 

DOSAGE LIMITS

Maximum billable units per dose and over time by indication as a Medical Benefit   

Diagnosis

Products

Billable Units

Days’ Supply

Prostate/Breast/Ovarian Cancers

Prostate Cancer

Lupron Depot 1-Month & Eligard 7.5 mg

1

28

Lupron Depot 3-Month & Eligard 22.5 mg

3

84

Lupron Depot 4-Month & Eligard 30 mg

4

112

Lupron Depot 6-Month & Eligard 45 mg

6

168

Breast/Ovarian Cancers; Endometriosis; Uterine Fibroids

Lupron Depot 1-Month 3.75 mg

1

28

Lupron Depot 3-Month 11.25 mg

3

84

Salivary Gland Tumors

Lupron Depot 1-month & Eligard 7.5 mg

1

28

Lupron Depot 3-Month & Eligard 22.5 mg

3

84

Central Precocious Puberty

Lupron Depot-Ped 7.5 mg

2

28

Lupron Depot-Ped 11.25 mg

3

28

Lupron Depot-Ped 15 mg

4

28

Lupron Depot-Ped 30 mg

8

84

Fensolvi 45 mg Kit

(45 mg)

168