Clinical UM Guideline



Subject: Gonadotropin Releasing Hormone Analogs for the Treatment of Oncologic Indications
Guideline #:  CG-DRUG-60 Current Effective Date:    06/28/2017
Status: Revised Last Review Date:    05/04/2017

Description

This document addresses gonadotropin releasing hormone (GnRH) analogs for the treatment of oncologic indications. GnRH analogs used for oncologic indications include the following:

Note: Please see the following documents for additional information:

Clinical Indications

I.     Breast Cancer–Goserelin acetate or leuprolide acetate (Lupron Depot 3.75 mg)

Medically Necessary:

Goserelin acetate or leuprolide acetate (Lupron Depot 3.75 mg) is considered medically necessary for the treatment of men and pre- or peri-menopausal women with hormone receptor positive breast cancer.

Not Medically Necessary:

Goserelin acetate or leuprolide acetate is considered not medically necessary for the treatment of breast cancer when the criteria above are not met.

II.     Ovarian Cancer (including fallopian tube cancer and primary peritoneal cancer)–Leuprolide acetate (Lupron Depot 3.75 mg, Lupron Depot-3 Month 11.25 mg)

Medically Necessary:

Leuprolide acetate (Lupron Depot 3.75 mg, Lupron Depot-3 Month 11.25 mg) is considered medically necessary for the treatment of ovarian cancer when any of the following are met:

  1. Hormonal therapy for clinical relapse in individuals with stage II-IV granulosa cell tumors; or
  2. Hormonal therapy for treatment of epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer as a single agent for persistent disease or recurrence.

Not Medically Necessary:

Leuprolide acetate is considered not medically necessary for the treatment of ovarian cancer when the criteria above are not met.

III.     Prostate Cancer-
Degarelix; goserelin acetate; histrelin acetate (Vantas); leuprolide acetate (Eligard 7.5 mg [1 Month], 22.5 mg [3 Month], 30 mg [4 month], 45 mg [6 Month]; Lupron Depot 7.5 mg [1 Month], 22.5 mg [3 Month], 30 mg [4 Month], 45 mg [6 Month]), or triptorelin pamoate

Medically Necessary:

Degarelix; goserelin acetate; histrelin acetate (Vantas); leuprolide acetate (Eligard 7.5 mg [1 Month], 22.5 mg [3 Month], 30 mg [4 month], 45 mg [6 Month]; Lupron Depot 7.5 mg [1 Month], 22.5 mg [3 Month], 30 mg [4 Month], 45 mg [6 Month]), or triptorelin pamoate is considered medically necessary for the treatment of prostate cancer when any of the following indications are met:

  1. Used as androgen deprivation therapy as a single agent or in combination with an antiandrogen; or
  2. Used for clinically localized disease* with intermediate (T2b to T2c cancer, Gleason score of 7/Gleason grade group 2-3, or prostate specific antigen (PSA) value of 10-20 ng/mL) or higher risk of recurrence as neoadjuvant therapy with radiation therapy or cryosurgery; or
  3. Used for progressive castration-naïve disease; or
  4. Used for castration-recurrent disease; or
  5. Other advanced*, recurrent, or metastatic* disease.

*See definition section below for description of term.

Not Medically Necessary:

Degarelix, goserelin acetate, histrelin acetate (Vantas), leuprolide acetate, or triptorelin pamoate is considered not medically necessary for treatment of prostate cancer when the criteria above are not met.

IV.     Ovarian Preservation for Fertility during Chemotherapy

Medically Necessary:

GnRH analogs are considered medically necessary for preservation of fertility in pre-menopausal women that will receive chemotherapy with curative intent.

Not Medically Necessary:

GnRH analogs are considered not medically necessary for preservation of fertility when the criteria above are not met.

Coding

The following codes for treatments and procedures applicable to this guideline are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

I.     Breast cancer treatment

HCPCS  
J1950 Injection, leuprolide acetate (for depot suspension), per 3.75 mg [Lupron Depot 3.75 ]
J9202 Goserelin acetate implant, per 3.6 mg [Zoladex]
J9218 Leuprolide acetate, per 1 mg [Lupron]
S9560 Home injectable therapy; hormonal therapy (e.g.; Leuprolide, Goserelin), including administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment (drugs and nursing visits coded separately), per diem
   
ICD-10 Diagnosis  
C50.011-C50.929 Malignant neoplasm of breast
Z85.3 Personal history of malignant neoplasm of breast

II.     Ovarian cancer treatment

HCPCS  
J1950 Injection, leuprolide acetate (for depot suspension), per 3.75 mg [Lupron Depot 3.75, Lupron Depot 3-month 11.25]
J9218 Leuprolide acetate, per 1 mg [Lupron]
S9560 Home injectable therapy; hormonal therapy (e.g.; Leuprolide, Goserelin), including administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment (drugs and nursing visits coded separately), per diem
   
ICD-10 Diagnosis  
C48.1-C48.8 Malignant neoplasm of peritoneum
C56.1-C56.9 Malignant neoplasm of ovary
C57.00-C57.9 Malignant neoplasm of other and unspecified female genital organs
Z85.43 Personal history of malignant neoplasm of ovary

III.    Prostate cancer treatment

HCPCS  
J3315 Injection, triptorelin pamoate, 3.75 mg [Trelstar, Trelstar LA]
J9155 Injection, degarelix, 1 mg [Firmagon]
J9202 Goserelin acetate implant, per 3.6 mg [Zoladex]
J9217 Leuprolide acetate (for depot suspension), 7.5 mg [Eligard, Lupron Depot 7.5, including 22.5 mg (3-month), 30 mg (4-month), 45 mg (6-month)]
J9218 Leuprolide acetate, per 1 mg [Lupron]
J9225 Histrelin implant (Vantas), 50 mg
S9560 Home injectable therapy; hormonal therapy (e.g.; Leuprolide, Goserelin), including administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment (drugs and nursing visits coded separately), per diem
   
ICD-10 Diagnosis  
C61 Malignant neoplasm or prostate
Z85.46 Personal history of malignant neoplasm of prostate

IV.  Ovarian preservation

HCPCS  
J1675 Injection, histrelin acetate, 10 micrograms
J1950 Injection, leuprolide acetate (for depot suspension), per 3.75 mg [Lupron Depot]
J3315 Injection, triptorelin pamoate, 3.75 mg [Trelstar, Trelstar LA]
J9155 Injection, degarelix, 1 mg [Firmagon]
J9202 Goserelin acetate implant, per 3.6 mg [Zoladex]
J9217 Leuprolide acetate (for depot suspension), 7.5 mg [Eligard, Lupron Depot]
J9218 Leuprolide acetate, per 1 mg [Lupron]
J9225 Histrelin implant (Vantas), 50 mg
S9560 Home injectable therapy; hormonal therapy (e.g.; Leuprolide, Goserelin), including administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment (drugs and nursing visits coded separately), per diem
   
ICD-10 Diagnosis  
C00.0-C58 Malignant neoplasms
C64.1-C96.9 Malignant neoplasms
Z85.00-Z85.44 Personal history of malignant neoplasms
Z85.50-Z85.9 Personal history of malignant neoplasms
   
Discussion/General Information

GnRH analogs are a group of hormonal drugs consisting of GnRH agonists and antagonists, both of which suppress pituitary hormones. GnRH agonists typically act over several days and GnRH antagonists act quickly within several hours. Affecting the pituitary gland in the brain, GnRH analogs suppress function of the ovaries and testes, blocking the production of testosterone in males and estrogen in females. Repeated administration of these drugs will cause gonadal hormone dependent tissues/organs to reduce or cease activity, such as the normal prostate gland that is dependent on testosterone for growth and function. This effect is reversible on discontinuation of the drug therapy.

Drugs classified as GnRH analogs that are used for the treatment of oncologic indications include: degarelix (Firmagon® ), goserelin acetate (Zoladex® ), histrelin acetate (Vantas® 12-month implant;), leuprolide acetate (Lupron Depot® , Eligard® ), and triptorelin pamoate (Trelstar ® , Trelstar LA® ). Currently, the brand Lupron (leuprolide acetate) is not being marketed in the United States. There are both U.S. Food and Drug Administration (FDA) approved and non-FDA approved indications for these drugs. The non-FDA approved indications listed in this document are based on drug compendia (National Comprehensive Cancer Network® NCCN Drugs & Biologic Compendium, DrugPoints® Compendium, and the American Hospital Formulary Service® ) and published peer reviewed literature as detailed in CG-DRUG-01 Off-Label Drug and Approved Orphan Drug Use.

Although GnRH products may differ in specific labeled indications and dosing requirements, clinical evidence does not support differential effectiveness of one product over the other for FDA approved clinical indications. 

Breast Cancer

Breast cancer is the most common cancer diagnosed in women today with the exception of skin cancer. Suppression of ovarian function with the use of luteinizing hormone-releasing hormone (LHRH) agonists has been shown to be effective in the treatment of hormone receptor positive breast cancer in pre- or peri-menopausal women. LHRH agonists currently available in the United States include goserelin acetate and leuprolide acetate.

Breast cancer in men is a relatively rare disease. Due to this rarity, studies are limited in number and size. However, several authors (Giordano, 2002; Hotko, 2013) report that additive hormonal therapy has been shown to have substantial response rates in metastatic breast carcinoma in men.

The National Comprehensive Cancer Network (NCCN) Drugs and Biologics Compendium (2017) and Clinical Practice Guidelines for Breast Cancer (V2.2017) indicate that leuprolide acetate and goserelin acetate may be used to treat premenopausal women with hormone receptor-positive disease in combination with adjuvant endocrine therapy for recurrent or metastatic disease. Additionally, NCCN notes that men with breast cancer should be treated similarly to postmenopausal women, except that use of an aromatase inhibitor is ineffective without concomitant suppression of testicular steroidogenesis. These recommendations are NCCN category 1 and 2A.

Two randomized phase III clinical trials) (TEXT and SOFT) (Pagani, 2014) demonstrated that the aromatase inhibitor exemestane plus ovarian suppression significantly reduced breast cancer recurrences as compared to tamoxifen plus ovarian suppression. The primary analysis combined data from 4690 subjects from the two trials. The rate of disease-free survival at 5 years was 91.1% (95% confidence interval [CI], 89.7 to 92.3) for subjects assigned to exemestane plus ovarian suppression, compared to 87.3% (95% CI, 85.7-88.7) for those in the tamoxifen plus ovarian suppression group. A GnRH analog was used for ovarian suppression in both groups. Based on results of these trials, NCCN included ovarian suppression plus an aromatase inhibitor for 5 years as adjuvant endocrine therapy option for premenopausal women with hormone receptor positive breast cancer at a higher risk of recurrence. Factors indicating a higher risk of recurrence include young age, high-grade tumor and lymph node involvement.

Ovarian Cancer

Leuprolide acetate is a viable option for treatment of ovarian cancer under certain circumstances (Rao, 2006; Yokoyama, 2013). Fishman (1996) evaluated 6 women with recurrent or persistent ovarian granulosa cell tumor who were treated with monthly leuprolide acetate injections. Cessation of disease progression was noted in 5 subjects. The 6th subject remained disease free after her primary cytoreductive surgery while on adjuvant therapy with leuprolide acetate for 24 months. There were no major side effects noted and the treatment was well tolerated. The authors concluded that a reasonable disease progression-free interval occurred and leuprolide treatment should be considered for further trials of therapy. Balbi (2004) reported on a study in which 12 women with advanced ovarian cancer previously treated with paclitaxel were administered leuprolide on days 1, 8, and 28. Progression-free survival was 6 months and the treatment was well tolerated. The authors noted: "the high tolerability and the results obtained with leuprolide versus platinum in second-line therapy might permit a better use of the analogs for advanced ovarian cancer."

The NCCN Drugs and Biologics Compendium (2017) and Clinical Practice Guidelines for Ovarian Cancer (V1.2017) indicate that leuprolide acetate may be used for hormonal therapy as a single agent for persistent disease or recurrence of ovarian cancer (epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer) and for clinical relapse of stage II-IV granulosa cell tumors (2A recommendations).

Prostate Cancer

Prostate cancer is the most common form of cancer, other than skin cancer, among men. Wilt and colleagues (2008) report that approximately 90% of men with prostate cancer have disease confined to the prostate gland (clinically localized disease). GnRH analogs are commonly used in the treatment of prostate cancer under specific conditions as indicated by current FDA approved labels and NCCN.

Men with prostate cancer are categorized according to their recurrence risk into those with clinically localized disease at low, intermediate and high risk of recurrence, or those with locally advanced disease at very high risk of recurrence, or those with metastatic disease. The NCCN Clinical Practice Guidelines for Prostate Cancer (V2.2017) include the following additional information defining prostate cancer recurrence risk categories:

Very low risk category includes individuals with tumors stage T1c, biopsy Gleason score (less than or equal to 6)/Gleason grade group 1 and serum PSA below 10 ng/ml, presence of disease in fewer than 3 biopsy cores, 50% or less prostate involvement in any core and PSA density less than 0.15 ng/ml/g.

Low risk category includes individuals with tumors stage T1-T2a, Gleason score 6/Gleason grade group 1, and serum PSA level below 10 ng/ml.

Intermediate risk category includes individuals with clinical stage T2b to T2c cancer, Gleason score 7/Gleason grade group 2-3, or PSA value of 10-20 ng/mL. Those with multiple adverse factors may be shifted into the high risk category.

High risk category includes individuals with prostate cancer that is stage T3a,  Gleason score 8-10/Gleason grade group 4-5, or PSA level greater than 20 ng/mL.

Very high risk of recurrence (locally advanced) includes individuals with stage T3b to T4  disease, primary Gleason pattern 5, or more than 4 biopsy cores with Gleason score 8-10/Gleason grade group 4-5.

Neoadjuvant androgen deprivation therapy (ADT) (which includes GnRH analogs) may be used to shrink the prostate to an acceptable size prior to brachytherapy, however increased toxicity would be expected from ADT and prostate size may not decline in some men (NCCN Clinical Practice Guidelines for Prostate Cancer, V2.2017). The American Academy of Urology (2008) indicates that there is evidence of benefit from hormone therapy prior to cryosurgery for downsizing purposes.

Ovarian Preservation for Fertility during Chemotherapy

The effect of GnRH analogs on fertility preservation during chemotherapy has been investigated in multiple randomized clinical trials. Del Mastro and colleagues (2011) reported that the use of triptorelin to induce temporary ovarian suppression during chemotherapy in premenopausal women with early-stage breast cancer reduced the occurrence of chemotherapy-induced early menopause. In another study, Gerber and colleagues (2011) concluded that premenopausal women with breast cancer receiving goserelin acetate during chemotherapy did not experience statistically significantly less amenorrhea 6 months after end of chemotherapy compared with those receiving chemotherapy alone. Although the resumption of menses was more favorable in the triptorelin study, the actual number of live births between both groups was not significantly different.

Several recent meta-analyses reported on randomized trials which used GnRH for the prevention of chemotherapy induced ovarian failure. Vitek and colleagues (2014) analyzed the use of GnRH agonists for the preservation of ovarian function in women with breast cancer who did not use tamoxifen after chemotherapy. Four randomized studies were analyzed (Del Mastro, 2011; Elgnidy, 2013; Gerber, 2011; Sverrisdottir, 2009). The authors concluded that concurrent GnRH agonists with chemotherapy may not preserve ovarian function in women with breast cancer.

However, Del Mastro and colleagues (2014) analyzed nine randomized studies, including four from the Vitek meta-analysis and concluded that temporary ovarian suppression induced by GnRH reduced the risk of chemotherapy induced primary ovarian failure in young women with cancer. In addition to the studies previously addressed in the Vitek meta-analysis, Del Mastro included other randomized trials for breast cancer (Badawy, 2009; Munster, 2012), as well as ovarian cancer (article not published in U.S.) and Hodgkin's or non-Hodgkin's lymphoma (Behringer, 2010; Demeestere, 2013).

In 2015, Moore and colleagues published results of the international phase III POEMS trial of GnRH analog during chemotherapy to reduce ovarian failure in early-stage, hormone receptor-negative breast cancer. A total of 257 premenopausal women with operable hormone-receptor negative breast cancer were randomly assigned to receive either standard chemotherapy consisting of goserelin acetate (goserelin group) or standard chemotherapy without goserelin (chemotherapy alone group). The primary end point of the study was rate of ovarian dysfunction at 2 years. Ovarian failure was defined as the absence of menses in the preceding 6 months and levels of follicle-stimulating hormone (FSH) in the postmenopausal range. Secondary end points included pregnancy outcomes and disease-free and overall survival. The median time of follow-up was 4.1 years for those that remained alive at the time of end-point study analysis. Menstrual status and FSH levels were available for 135 of the 218 women who could be evaluated for primary end-point data. Of the 135 women with complete primary end-point data, the ovarian failure rate was 8% in the goserelin group and 22% in the chemotherapy-alone group (odds ratio, 0.30; 95% confidence interval, 0.09 to 0.97; two-sided P=0.04). Sensitivity analyses were performed due to missing primary end-point data and results were consistent with the main findings. Among the 218 women evaluated, pregnancy occurred more in the goserelin group than in the chemotherapy-alone group (21% vs. 11%, P=0.03). Women in the goserelin group also had improved disease-free survival (P=0.04) and overall survival (P=0.05).

A 2013 American Society of Clinical Oncology clinical practice guideline on fertility preservation for individuals with cancer indicated that evidence was insufficient regarding the effectiveness of GnRHa and other means of ovarian suppression in fertility preservation. However, the most recent NCCN Oncology Guidelines for Adolescents and Young Adults (V2.2017) indicate that GnRH agonists may protect ovarian function. Additionally, NCCN breast cancer guidelines (V2.2017) indicate randomized trials have shown that ovarian suppression with GnRH agonist therapy given during adjuvant chemotherapy in premenopausal women with ER-negative tumors may preserve ovarian function.

Conclusion

The uses of GnRH analogs considered to be medically necessary in this document have sufficient published evidence available to support them. However, there is a lack of scientific evidence found from which conclusions could be made concerning the safety and efficacy of treating various other oncologic indications, including, but not limited to cancers of the endometrium and liver.

Definitions

Adjuvant therapy: Treatment given after the primary treatment to increase the chances of a cure; may include chemotherapy, radiation, hormone, or biological therapy.

Advanced prostate cancer: Disease that has spread beyond the prostate to surrounding tissues or distant organs.

Androgen deprivation therapy (also known as androgen ablation or androgen suppression): Treatment to suppress or block the production or action of male hormones. This is done by having the testicles removed, by taking female sex hormones, or by taking drugs called antiandrogens or GnRH analogs.

Brachytherapy (also known as internal radiation): A type of radiation treatment used to stop the growth of cancer cells by implanting radioactive material directly into the tumor or into the surrounding tissues.

Cancer staging: The process of determining how much cancer there is in the body and where it is located; describes the extent or severity of an individual's cancer based on the extent of the original (primary) tumor and the extent of spread in the body.

Clinically localized prostate cancer: Cancer presumed to be confined within the prostate based on pre-treatment findings such as physical exam, imaging, and biopsy findings.

Cryosurgery (also called cryotherapy or cryosurgical ablation): Is the use of extreme cold produced by liquid nitrogen (or argon gas) to destroy abnormal tissue. Cryosurgery may be used to treat tumors on the skin (external tumors), such as basal cell carcinoma, or tumors inside the body (internal tumors), such as prostate cancer.    

External beam radiation therapy (EBRT) (also known as teletherapy): A form of therapy using radiation to stop the growth of cancer cells. A linear accelerator directs a photon or electron beam from outside the body through normal body tissue to reach the cancer and the radiation is given 5 days per week for a period of 3 to 8 weeks.

Gleason Grade Group: Assigns grade groups from 1-5, derived from the Gleason score.
Gleason grade group 1: Gleason score 6 and only individual discrete well-formed glands.
Gleason grade group 2: Gleason score 3+4=7 and predominantly well-formed glands with lesser component of poorly formed/fused/cribriform glands.
Gleason grade group 3: Gleason score 4+3=7 and predominantly poorly formed/fused/cribriform glands with lesser component of well-formed glands.
Gleason grade group 4: Gleason score 4+4=8; 3+5=8; 5+3=8

Gleason grade group 5: Gleason score 9-10 and lack of gland formation (or with necrosis) with or without poorly formed/fused/cribriform glands2 .

1 Poorly formed/fused/cribriform glands can be a more minor component
2 For cases with more than 95% poorly formed/fused/cribriform glands or lack of glands on a core or at RP, the component of less than 5% well-formed glands is not factored into the grade.

(Epstein, 2016a, Epstein, 2016b, Loeb, 2016)

Gleason Grading System: A prostate cancer grading system. A primary and secondary pattern, the number range of each is from 1 to 5, are assigned and then summed to yield a total score.

Gleason score: Represents the sum of the two most common Gleason grades observed by the pathologist on a specimen, the first number is the most frequent grade seen.

Locally advanced disease (prostate cancer): Cancer that has spread from where it started to nearby tissue or lymph nodes.

Metastatic: The spread of cancer from one part of the body to another; a metastatic tumor contains cells that are like those in the original (primary) tumor and have spread.

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  6. Goserelin acetate (Zoladex® ). In: DrugPoints® System [electronic version]. Truven Health Analytics, Greenwood Village, CO. Last modified April 7, 2017. Available at: http://www.micromedexsolutions.com. Accessed on April 13, 2017.
  7. Histrelin acetate (Vantas® , Supprelin® , Supprelin® LA). In: DrugPoints® System [electronic version]. Truven Health Analytics, Greenwood Village, CO. Last modified April 7, 2017. Available at: http://www.micromedexsolutions.com. Accessed on April 13, 2017.
  8. Lee SJ, Schover LR, Partridge A, et al. American Society of Clinical Oncology Recommendations on fertility preservation in cancer patients. J Clin Oncol. 2006; 24(18):2917-2931.
  9. Leuprolide acetate Monograph. Lexicomp® Online, American Hospital Formulary Service® (AHFS® ) Online, Hudson, Ohio. Lexi-Comp., Inc. Last revised February 2, 2012. Accessed on April 13, 2017.
  10. Leuprolide acetate (Lupron® , Lupron Depot® , Lupron Depot-Ped® , Eligard® ). In: DrugPoints® System [electronic version]. Truven Health Analytics, Greenwood Village, CO. Last modified April 7, 2017. Available at: http://www.micromedexsolutions.com. Accessed on April 13, 2017.
  11. Loblaw DA, Virgo KS, Nam R, et al.; American Society of Clinical Oncology. Initial hormonal management of androgen-sensitive metastatic, recurrent, or progressive prostate cancer: 2006 update of an American Society of Clinical Oncology practice guideline. J Clin Oncol. 2007; 25(12):1596-1605.
  12. Loren AW, Mangu PB, Beck LN, et al.; American Society of Clinical Oncology. Fertility preservation for patients with cancer: American Society of Clinical Oncology clinical practice guideline update. J Clin Oncol. 2013; 31(19):2500-2510.
  13. Lupron Depot [Product Information], North Chicago, IL. AbbVie Inc.; June 2014. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020517s036_019732s041lbl.pdf. Accessed on April 13, 2017.
  14. National Comprehensive Cancer Network® . NCCN Drugs & Biologic Compendium (electronic version). 2017. For additional information visit the NCCN website: http://www.nccn.org. Accessed on April 12, 2017.
    • Degarelix
    • Goserelin acetate
    • Histrelin acetate
    • Leuprolide acetate
    • Leuprolide acetate for depot suspension
    • Triptorelin pamoate
  15. National Comprehensive Cancer Network® (NCCN). Clinical Practice Guidelines in Oncology. 2017. For additional information visit the NCCN website: http://www.nccn.org/index.asp. Accessed on April 12, 2017.
    • Adolescent and Young Adult Oncology (V.2.2017). Revised January 13, 2017.
    • Breast Cancer (V.2.2017). Revised April 6, 2017.
    • Ovarian Cancer (V.1.2017). Revised April 12, 2017.
    • Prostate Cancer (V.2.2017). Revised February 21, 2017.
  16. Thompson I, Thrasher JB, Aus G, et al.; AUA Prostate Cancer Clinical Guideline Update Panel. Guideline for the management of clinically localized prostate cancer: 2007 update. J Urol. 2007; 177(6):2106-2131.
  17. Trelstar [Product Information], Irvine, CA. Allergan USA, Inc.; August 2016. Available at: https://www.allergan.com/assets/pdf/trelstar_pi . Accessed on April 13, 2017.
  18. Triptorelin pamoate Monograph. Lexicomp® Online, American Hospital Formulary Service® (AHFS® ) Online, Hudson, Ohio. Lexi-Comp., Inc. Last revised February 7, 2012. Accessed on April 13, 2017.
  19. Triptorelin pamoate (Trelstar® , Trelstar LA® , Trelstar Depot® ). In: DrugPoints® System [electronic version]. Truven Health Analytics, Greenwood Village, CO. Last modified April 7, 2017. Available at: http://www.micromedexsolutions.com. Accessed on April 13, 2017.
  20. Vantas (histrelin) Implant [Product Information], Malvern, PA. Endo Pharmaceuticals, Inc.; July 2014. Available at: http://www.endo.com/File%20Library/Products/Prescribing%20Information/Vantas_prescribing_information.html. Accessed on April 13, 2017.
  21. Zoladex (goserelin acetate) Implant 3.6 mg. [Product Information], Wilmington, DE. AstraZeneca; February 2016. Available at: http://www.azpicentral.com/zoladex-36/zoladex3_6.pdf. Accessed on April 13, 2017.
  22. Zoladex (goserelin acetate) Implant 10.8 mg. [Product Information], Wilmington, DE. AstraZeneca; February 2016. Available at: http://www.azpicentral.com/zoladex/zoladex10_8.pdf. Accessed on April 13, 2017.
Websites for Additional Information
  1. American Cancer Society. Breast Cancer. Available at: https://www.cancer.org/cancer/breast-cancer.html . Accessed on April 14, 2017.
  2. American Cancer Society. Breast Cancer in Men. Last revised 01/26/2016. Available at: http://www.cancer.org/cancer/breastcancerinmen/detailedguide/breast-cancer-in-men-what-is-breast-cancer-in-men. Accessed on April 14, 2017.
  3. American Cancer Society. Ovarian Cancer. Available at: https://www.cancer.org/cancer/ovarian-cancer.html . Accessed on April 14, 2017.
  4. American Cancer Society. Prostate Cancer. Hormone (androgen deprivation) therapy. Last revised: 03/11/2016. Available at: http://www.cancer.org/Cancer/ProstateCancer/DetailedGuide/prostate-cancer-treating-hormone-therapy. Accessed on April 14, 2017.
Index

Breast Cancer
Degarelix
Eligard
Firmagon
Gonadotropin Releasing Hormone (GnRH) Analogs
Goserelin Acetate
Histrelin Acetate
Leuprolide Acetate
Lupron Depot
Ovarian Cancer
Prostate Cancer
Trelstar
Trelstar LA
Triptorelin Pamoate
Vantas
Zoladex

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

History

Status

Date

Action

Revised 05/04/2017 Medical Policy & Technology Assessment Committee (MPTAC) review.
Revised 05/03/2017 Hematology/Oncology Subcommittee review. Updated medically necessary statements with dosages for leuprolide acetate brands. Updated prostate cancer medically necessary indications related to androgen deprivation therapy, clinically localized disease, progressive castration-naïve disease, and castration-recurrent disease.  Description, Discussion, Definitions, Coding, References and Index sections updated.
New 11/03/2016 MPTAC review. Initial document development. Criteria were originally in CG-DRUG-15.