Subject: Lupron Depot Endometriosis-Fibroid 1970-A SGM P2022
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LUPRON DEPOT 3.75 mg
(leuprolide acetate for depot suspension)
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LUPRON DEPOT-3 Month 11.25 mg
(leuprolide acetate for depot suspension)
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Policy:
I. INDICATIONS
The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.
A. FDA-Approved Indications
1. Endometriosis
Lupron Depot 3.75 mg and Lupron Depot-3 Month 11.25 mg are indicated for management of
endometriosis, including pain relief and reduction of endometriotic lesions. Lupron Depot 3.75 mg
monthly and Lupron Depot-3 Month 11.25 mg with norethindrone acetate 5 mg daily are also
indicated for initial management of endometriosis and for management of recurrence of symptoms.
Use of norethindrone acetate in combination with Lupron Depot 3.75 mg and Lupron Depot 11.25 mg
is referred to as add-back therapy, and is intended to reduce the loss of bone mineral density (BMD)
and reduce vasomotor symptoms associated with use of Lupron Depot 3.75 mg and Lupron Depot 11.25 mg.
2. Uterine Leiomyomata (Fibroids)
When used concomitantly with iron therapy, Lupron Depot 3.75 mg and Lupron Depot-3
Month 11.25 mg are indicated for the preoperative hematologic improvement of patients with anemia
caused by fibroids for whom three months of hormonal suppression is deemed necessary. The clinician
may wish to consider a one-month trial period on iron alone, as some of the patients will respond to iron
alone. Lupron Depot may be added if the response to iron alone is considered inadequate.
Limitations of Use:
The total duration of therapy with Lupron Depot 3.75 mg and 11.25mg plus add-back therapy should
not exceed 12 months due to concerns about adverse impact on bone mineral density.
Lupron Depot 3.75 mg and 11.25 mg is not indicated for combination use with norethindrone acetate
add-back therapy for the preoperative hematologic improvement of women with anemia caused by
heavy menstrual bleeding due to fibroids.
B. Compendial Uses
1. Breast cancer
2. Ovarian Cancer – Epithelial ovarian cancer/fallopian tube cancer/primary peritoneal cancer,
and less common ovarian cancers [grade 1 endometrioid carcinoma, low-grade serous carcinoma,
carcinosarcoma (malignant mixed Müllerian tumors), mucinous carcinoma of the ovary, or clear
cell carcinoma of the ovary]
3. Preoperative use in uterine leiomyomata (fibroids) to facilitate surgery
4. Gender dysphoria (also known as gender non-conforming or transgender persons)
5. Preservation of ovarian function
6. Prevention of recurrent menstrual related attacks in acute porphyria
All other indications are considered experimental/investigational and not medically necessary.
II. PRESCRIBER SPECIALTIES
For gender dysphoria, the medication must be prescribed by or in consultation with a pediatric endocrinologist that has collaborated care with a mental health care provider for members less than 18 years of age.
III. CRITERIA FOR INITIAL APPROVAL
A. Endometriosis
Authorization of up to 6 months (one treatment course) may be granted to members for initial
treatment of endometriosis.
B. Uterine leiomyomata (fibroids)
Authorization of up to 3 months may be granted for initial treatment of uterine leiomyomata (fibroids)
when either of the following criteria is met:
1. Member has anemia due to uterine leiomyomata, or
2. Lupron Depot will be used prior to surgery for uterine leiomyomata.
C. Breast cancer
Authorization of 12 months may be granted for treatment of hormone receptor-positive breast cancer.
D. Ovarian cancer
Authorization of 12 months may be granted for treatment of persistent disease or recurrence of any of
the following types of ovarian cancer when used as a single agent:
1. Epithelial ovarian cancer
2. Fallopian tube cancer
3. Primary peritoneal cancer
4. Grade 1 endometrioid carcinoma
5. Low-grade serous carcinoma
6. Carcinosarcoma (malignant mixed Müllerian tumors)
7. Mucinous carcinoma of the ovary
8. Clear cell carcinoma of the ovary
E. Gender dysphoria
1. Authorization of 12 months may be granted for pubertal hormonal suppression in an adolescent
member when all of the following criteria are met:
a. The member has a diagnosis of gender dysphoria.
b. The member has reached Tanner stage 2 of puberty or greater.
c. The member’s comorbid conditions are reasonably controlled.
d. The member has been educated on any contraindications and side effects to therapy.
3. The member has been informed of fertility preservation options.
2. Authorization of 12 months may be granted for gender transition when all of the following criteria
are met:
a. The member has a diagnosis of gender dysphoria.
b. The member will receive Lupron Depot concomitantly with gender-affirming hormones.
c. The member’s comorbid conditions are reasonably controlled.
d. The member has been educated on any contraindications and side effects to therapy.
e. The member has been informed of fertility preservation options.
F. Preservation of ovarian function
Authorization of 3 months may be granted for preservation of ovarian function when the member
is premenopausal and undergoing chemotherapy.
G. Prevention of recurrent menstrual related attacks in acute porphyria
Authorization of 12 months may be granted for prevention of recurrent menstrual related attacks in
members with acute porphyria when the requested medication is prescribed by or in consultation with
a physician experienced in the management of porphyrias.
IV. CONTINUATION OF THERAPY
All members (including new members) requesting authorization for continuation of therapy must meet
all initial authorization criteria in addition to the following diagnosis-specific criteria (if applicable).
A. Endometriosis
Authorization of up to 6 months (for a lifetime maximum of 12 months total) may be granted for
retreatment of endometriosis when all of the following criteria are met:
1. The member has had a recurrence of symptoms.
2. The member has a bone mineral density within normal limits.
B. Uterine leiomyomata (fibroids)
Authorization of up to 3 months (for a lifetime maximum of 6 months total) may be granted when either
of the following criteria is met:
1. Member has anemia due to uterine leiomyomata, or
2. Lupron Depot will be used prior to surgery for uterine leiomyomata.
C. Breast cancer and ovarian cancer
Authorization of 12 months may be granted for continued treatment in members requesting authorization
when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.
D. All members (including new members) requesting authorization for continuation of therapy for
the specified indications below must meet all initial authorization criteria:
1. Preservation of ovarian function
2. Prevention of recurrent menstrual related attacks in acute porphyria
3. Gender dysphoria
Place of Service:
Outpatient
The above policy is based on the following references:
- Lupron Depot 3.75 mg [package insert]. North Chicago, IL: AbbVie Inc.; February 2021.
- Lupron Depot-3 Month 11.25 mg [package insert.]. North Chicago, IL: AbbVie Inc.; March 2020.
- The NCCN Drugs & Biologics Compendium® © 2022 National Comprehensive Cancer Network, Inc. http://www.nccn.org. Accessed February 2, 2022.
- Alternatives to hysterectomy in the management of leiomyomas. ACOG Practice Bulletin No. 96. American College of Obstetricians and Gynecologists. Obstet Gynecol. 2008;112:387-400.
- Marret H, Fritel X, Ouldamer L, et al. Therapeutic management of uterine fibroid tumors: updated French guidelines. European Journal of Obstetrics and Gynecology and Reproductive Biology. 2012;165:156-164.
- Hembree WC, Cohen-Kettenis PT, Gooren L, et al. Endocrine Treatment of Gender-Dysphoric/Gender-Incongruent Persons: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2017:102(11):3869–3903.
- Gender Identity Research and Education Society. Guidance for GPs and other clinicians on the treatment of gender variant people. UK Department of Health. Published March 10, 2008.
- Standards of care for the health of transsexual, transgender, and gender-nonconforming people, 7th version. ©2012 World Professional Association for Transgender Health. Available at http://www.wpath.org.
- Moore HCF, Unger JM, Phillips K-A, et al. Goserelin for ovarian protection during breast-cancer adjuvant chemotherapy. N Engl J Med. 2015;372:923-32. doi:10.1056/NEJMoa1413204.
- Clowse MEB, Behera MA, Anders CK, et al. Ovarian preservation by GnRH agonists during chemotherapy: a meta-analysis. J Womens Health (Larchmt). 2009 Mar; 18(3): 311–319. doi:10.1089/jwh.2008.0857
- Stein P, Badminton M, Barth J, Rees D, Stewart MF; British and Irish Porphyria Network. Best practice guidelines on clinical management of acute attacks of porphyria and their complications. Ann Clin Biochem. 2013 May;50(Pt 3):217-23.
- Innala, E, Bäckström, T, Bixo, M, Andersson, C. Evaluation of gonadotrophin-releasing hormone agonist treatment for prevention of menstrual-related attacks in acute porphyria. Acta Obstet Gynecol2010;89:95–100.
- Clinical Consult: CVS Caremark Clinical Programs Review. Focus on Gender Dysphoria Clinical Programs. July 2020.
Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
October 01, 2022
