BlueCross BlueShield of Tennessee Medical Policy Manual

Leuprolide Acetate for Depot Suspension

NDC CODE(S)

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)

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

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

>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)

3.75 mg monthly x 3 doses or 11.25 mg x 1 dose

Prostate Cancer

(Lupron Depot/Eligard)

7.5mg every 4 weeks, 22.5mg every 12 weeks, 30mg every 16 weeks, or 45mg every 24 weeks

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.

Click here to view DOSAGE LIMITS

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).

No controlled studies were found in the published literature that validate the use of leuprolide acetate for depot suspension for the treatment or prevention of other conditions or diseases.

SOURCES

Kaplowitz, P. B. (2017, July). Precocious Puberty Workup: Laboratory Studies, Imaging Studies, Histologic Findings. Hoffman, R. P., Speiser, P. W., Eds. In MedScape. Retrieved December 20, 2017 from https://emedicine.medscape.com/article/924002-workup.

Lexi-Comp Online. (2017, December). AHFS-DI. Leuprolide acetate. Retrieved December 19, 2017 from Lexi-Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2016, November). Leuprolide. Retrieved December 19, 2017  from MICROMEDEX Healthcare Series.

National Comprehensive Cancer Network. (2016). NCCN Drugs & Biologics Compendium®. Leuprolide acetate for depot suspension. Retrieved December 19, 2017 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 December 19, 2017 fromhttps://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021343s033,021379s033,021488s030,021731s029lbl.pdf.

U. S. Food and Drug Administration. (2016, June). Center for Drug Evaluation and Research. Lupron Depot (leuprolide acetate for depot suspension). Retrieved December 19, 2017 fromhttps://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019732s042,020517s038lbl.pdf.

U. S. Food and Drug Administration. (2017, May). Center for Drug Evaluation and Research. Lupron depot-ped (leuprolide acetate for depot suspension). Retrieved December 19, 2017 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020263s042lbl.pdf.

ORIGINAL EFFECTIVE DATE:  5/1/2004

MOST RECENT REVIEW DATE:  2/16/2018

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 Cancer

Lupron Depot 1-Month & Eligard 7.5 mg

1

28

Lupron Depot 3-Month & Eligard 22.5 mg

3

84

Prostate Cancer

Lupron Depot 4-Month & Eligard 30 mg

4

112

Lupron Depot 6-Month & Eligard 45 mg

6

168

Breast/Ovarian Cancer; Endometriosis; Uterine Fibroids

Lupron Depot 1-Month 3.75 mg

1

28

Lupron Depot 3-Month 11.25 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