Download Lupron Depot - CVS Specialty

SPECIALTY GUIDELINE MANAGEMENT
LUPRON DEPOT 3.75 mg
LUPRON DEPOT-3 MONTH 11.25 mg
(leuprolide acetate for depot suspension)
POLICY
A. 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.
FDA-Approved Indications
• Endometriosis
o Lupron Depot 3.75 mg and Lupron Depot-3 Month 11.25 mg are indicated for the 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 indicated for
initial management of endometriosis and for management of recurrence of symptoms. Duration of
initial treatment and retreatment should be limited to six months each and use is not recommended
longer than a total of 12 months.
• Uterine Leiomyomata (Fibroids)
o 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
uterine leiomyomata. The clinician may wish to consider a one-month trial period on iron alone
inasmuch as some of the patients will respond to iron alone. Lupron may be added if the response to
iron alone is considered inadequate. Recommended duration of therapy is up to 3 months, either
given as Lupron Depot 3.75 mg monthly or as a single injection of Lupron Depot-3 Month 11.25 mg.
The Lupron Depot-3 Month 11.25 mg is indicated only for women for whom three months of hormonal
suppression is deemed necessary.
Experience with Lupron Depot in females has been limited to women 18 years of age and older, and
experience with the Lupron Depot-3 Month 11.25 mg formulation is limited to treatment for no longer than six
months.
Compendial Uses
• Ovarian cancer:
o Ovarian stromal tumors: for clinical relapse in patients with stage II-IV granulosa cell tumors
o Epithelial ovarian cancer/fallopian tube cancer/primary peritoneal cancer (3.75 mg only): as a single
agent for persistent disease or recurrence
• Breast cancer (Lupron Depot 3.75 mg only) :
o As a consideration with adjuvant endocrine therapy in premenopausal women with hormone receptorpositive disease
o In combination with endocrine therapy for premenopausal women with hormone receptor-positive
recurrent or metastatic disease
• Preoperative use for uterine leiomyomata (fibroids) to facilitate surgery
All other indications are considered experimental/investigational and are not a covered benefit.
B. EXCLUSIONS
• Pregnancy
• Breastfeeding
• Undiagnosed abnormal vaginal bleeding
Lupron Depot Endometriosis-Fibroids SGM P2014.doc
© 2014 Caremark. All rights reserved.
This document contains confidential and proprietary information of CVS/caremark and cannot be reproduced, distributed or printed without written permission from CVS/caremark. This page contains
prescription brand name drugs that are trademarks or registered trademarks of pharmaceutical manufacturers that are not affiliated with CVS/caremark.
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C. CRITERIA FOR APPROVAL
1. Endometriosis
Authorization of 6 months (one treatment course) may be granted to adult female members for initial treatment of
endometriosis who have not received previous therapy with Lupron Depot or Lupaneta Pack.
2. Uterine fibroids
Authorization of 3 months (one treatment course) may be granted to adult female members for initial treatment of
uterine fibroids who have not received previous therapy with Lupron Depot when EITHER of the following criteria is
met:
a.
The member has a diagnosis of anemia (Hct ≤ 30% and/or Hgb ≤ 10 g/dL) AND Lupron Depot will be
used in conjunction with iron therapy
b.
Lupron Depot will be used in the preoperative setting to facilitate surgery
3. Ovarian cancer
3.1. Ovarian stromal tumor
Authorization of 12 months may be granted to adult female members for initial treatment of ovarian stromal tumor.
3.2. Epithelial ovarian cancer
Authorization of 12 months may be granted to adult female members who are prescribed Lupron Depot 3.75 mg as
a single agent for persistent or recurrent epithelial ovarian cancer.
4. Fallopian tube cancer
Authorization of 12 months may be granted to adult female members who are prescribed Lupron Depot 3.75 mg as
a single agent for persistent or recurrent fallopian tube cancer.
5. Primary peritoneal cancer
Authorization of 12 months may be granted to adult female members who are prescribed Lupron Depot 3.75 mg as
a single agent for persistent or recurrent primary peritoneal cancer.
6. Breast cancer
Authorization of 12 months may be granted to premenopausal adult female members who are prescribed Lupron
Depot 3.75 mg for hormone receptor positive breast cancer.
D. CONTINUATION OF THERAPY
1. Endometriosis
Authorization of 6 months (one treatment course) may be granted to adult female members for retreatment of
endometriosis who have received previous therapy with Lupron Depot or Lupaneta Pack for ≥ 6 months but < 12
months when ALL of the following criteria are met:
a. The member had a recurrence of symptoms
b. The member has a bone mineral density within normal limits
c. The member will be receiving add-back therapy (e.g., norethindrone)
2. Uterine Fibroids
Authorization of 3 months (one treatment course) may be granted to adult female members for retreatment of
uterine fibroids who have received previous therapy with Lupron Depot for less than 6 months AND have
documentation of bone mineral density within normal limits and EITHER of the following criteria is met:
a.
The member has a diagnosis of anemia (Hct ≤ 30% and/or Hgb ≤ 10 g/dL) AND Lupron Depot will be
used in conjunction with iron therapy
b.
Lupron Depot will be used in the preoperative setting to facilitate surgery
3. Ovarian cancer, fallopian tube cancer, primary peritoneal cancer, breast cancer
All members (including new members) requesting authorization for continuation of therapy must meet ALL initial
authorization criteria.
Lupron Depot Endometriosis-Fibroids SGM P2014.doc
© 2014 Caremark. All rights reserved.
This document contains confidential and proprietary information of CVS/caremark and cannot be reproduced, distributed or printed without written permission from CVS/caremark. This page contains
prescription brand name drugs that are trademarks or registered trademarks of pharmaceutical manufacturers that are not affiliated with CVS/caremark.
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E. DOSAGE AND ADMINISTRATION
Approvals may be subject to dosing limits in accordance with FDA-approved labeling, accepted compendia, and/or
evidence-based practice guidelines.
1. Dosing Limits
The following dosing limits apply to all approvable diagnoses:
• Maximum dose of Lupron Depot is 3.75 mg per month
REFERENCES
1. Lupron Depot 3.75 mg and Lupron Depot-3 Month 11.25 mg [package insert]. North Chicago, IL: AbbVie Inc.; October 2013.
2. The NCCN Drugs & Biologics Compendium™ © 2014 National Comprehensive Cancer Network, Inc. http://www.nccn.org.
Accessed May 1, 2014.
3. Micromedex Solutions [database online]. Ann Arbor, MI: Truven Health Analytics Inc. Updated periodically.
www.micromedexsolutions.com [available with subscription]. Accessed May 28, 2014.
4. 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.
5. 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.
Lupron Depot Endometriosis-Fibroids SGM P2014.doc
© 2014 Caremark. All rights reserved.
This document contains confidential and proprietary information of CVS/caremark and cannot be reproduced, distributed or printed without written permission from CVS/caremark. This page contains
prescription brand name drugs that are trademarks or registered trademarks of pharmaceutical manufacturers that are not affiliated with CVS/caremark.
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