Payment Policy

Policy Num:       PP.001.002
Policy Name:     Leuprolide
Policy ID:          [PP.001.002]

Last Review:       May 10, 2024
Next Review:      May 20, 2025

Leuprolide

Summary

(Leuprolide acetate) – A drug that is a manufactured version of a hormone. It is a hormone-releasing hormone agonist which is a synthetic analog of naturally occurring gonadotropin-releasing hormone (GnRH) possessing greater potency than the natural hormone. Lupron Depot is indicated for several conditions, including prostate cancer, endometriosis, and uterine leiomyomas.

Policy Statements

Initial Approval Criteria
A. Prostate Cancer (must meet all):

1. Diagnosis of prostate cancer;

2. Request is for leuprolide acetate injection, Eligard, or Lupron Depot (7.5 mg, 22.5mg, 30 mg, 45 mg);

3. Prescribed by or in consultation with an oncologist or urologist;

4. Age ≥ 18 years;

5. Request meets one of the following (a, b, or c):*
 

a. Leuprolide acetate injection (SC): Dose does not exceed 1 mg per day;

b. Eligard (SC)/Lupron Depot (IM): Dose does not exceed 7.5 mg per month, 22.5mg per 3 months, 30 mg per 4 months, 45 mg per 6 months;

c. Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).

*Prescribed regimen must be FDA-approved or recommended by NCCN

DOSAGE/ADMINISTRATION

Advanced Prostate Cancer

Lupron: 7.5 mg IM monthly, 22.5 mg IM every 3 months, 30 mg IM every 4 months, or 45 mg IM every 6 months

Eligard: 7.5 mg SC monthly, 22.5 mg SC every 3 months, 30 mg SC every 4 months, 45 mg SC every 6 months

Lutrate Depot: 22.5 mg SC every 3 months

Leuprolide acetate: 1 mg/0.2 mL/day SC

Camcevi: 42 mg SC every 6 months

PolicY GUIDELINES

Within the approved indications for leuprolide, Triple S only recognizes Eligard for the shared indication of treatment of prostate cancer.  In order to use other Leuprolide agents, there has to be documented history of intolerance, allergy, therapeutic failure or contraindications to Eligard.

The following criteria are required to be documented on the prescription. 

Information Medical Required

1) Diagnosis:

a) Palliative treatment of advanced prostate cancer,

2) For prostate cancer document: 

a) Prostate biopsy results

Limits of Age

18 years or older

Prescribing Specialty Limits

1) Hematologist
2) Oncologist
3) Urologist
 

Duration of cover
 

12 months

Other Criteria N/A

BENEFIT APPLICATION

This payment policy applies to Commecial and Medicare Advantage LOB. For Medicaid LOB Leuprolide is coverred under pharmacy benefit according to ASES normative letter 18-0813

References

1. Leuprolide Acetate Injection Prescribing Information. Bedford, OH: Ben Venue Laboratories, Inc.; August 2011. Available at https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/074728s011lbl.pdf. Accessed August 1, 2019.

2. Eligard Prescribing Information. Fort Collins CO: TOLMAR Pharmaceuticals, Inc.; February 2019. Available at https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021343s039,021379s041,02148 8s036,021731s037lbl.pdf. Accessed August 1, 2019.

Codes

Policy History