MEDICAL POLICY I. POLICY POLICY TITLE GONADOTROPIN-RELEASING HORMONE AGONISTS AND ANTAGONISTS MP POLICY NUMBER

MEDICAL POLICY POLICY TITLE GONADOTROPIN-RELEASING HORMONE AGONISTS AND ANTAGONISTS POLICY NUMBER MP-2.107 Original Issue Date (Created): July 1,...
Author: Harvey Cain
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MEDICAL POLICY POLICY TITLE

GONADOTROPIN-RELEASING HORMONE AGONISTS AND ANTAGONISTS

POLICY NUMBER

MP-2.107

Original Issue Date (Created):

July 1, 2002

Most Recent Review Date (Revised):

August 30, 2011

Effective Date:

June 1, 2012- RETIRED

I.

POLICY GnRH Agonist Therapy GnRH agonist therapy (e.g. leuprolide acetate, goserelin acetate, histrelin, triptorelin pamoate) may be considered medically necessary for any one of the following diagnoses:

 Breast cancer, advanced; or  Central precocious puberty; or  Endometriosis; or  Excessive uterine bleeding (e.g. menorrhagia, metrorrhagia and menometrorrhagia), including treatment of excessive bleeding related to fibroids; or

 Dysmenorrhea, including treatment of pain related to fibroids; or  Prostate cancer. Implantable forms of GnRH agonists (e. g. Zoladex®, Viadur™, Vantas™) for the palliative treatment of advanced prostate cancer may be considered medically necessary when the following conditions are met:

 A urologist or oncologist is prescribing the treatment;  Documentation of an initial trial of at least three (3) months of GnRH injections (e.g. leuprolide acetate, goserelin acetate, and triptorelin pamoate) were effective and well tolerated. Histrelin acetate subcutaneous implant (Supprelin LA) may be considered medically necessary for the treatment of children with central precocious puberty. The use of GnRh agonists (injectable or implantable) for the treatment of a diagnosis other than those listed in the policy criteria is considered not medically necessary. GnRH Antagonist Therapy GnRH antagonist therapy (e.g. degarelix [Firmagon®]) may be considered medically necessary for treatment of advanced prostate cancer. Page 1 [Note: Final page is signature page and is kept on file, but not issued with Policy.]

MEDICAL POLICY POLICY TITLE

GONADOTROPIN-RELEASING HORMONE AGONISTS AND ANTAGONISTS

POLICY NUMBER

MP-2.107

II. PRODUCT VARIATIONS [N] = No product variation, policy applies as stated [Y] = Standard product coverage varies from application of this policy, see below [N] Capital Cares 4 Kids

[N] Indemnity

[N] PPO

[N] SpecialCare

[N] HMO

[N] POS

[Y] SeniorBlue HMO*

[Y] FEP PPO**

[Y] SeniorBlue PPO* * Refer to Highmark Medicare Services Local Coverage Determination (LCD), L27500, Luteinizing Hormone-Releasing Hormone (LHRH) Analogs, as prescribing provider is not required to be a urologist or oncologist. Also, documentation of an initial three month trial of GnRH injections is not required prior to coverage of implantable forms of GnRH agonists. ** The FEP program dictates that all drugs, devices or biological products approved by the U.S. Food and Drug Administration (FDA) may not be considered investigational. Therefore, FDA-approved drugs, devices or biological products may be assessed on the basis of medical necessity.

III. DESCRIPTION/BACKGROUND Gonadotropin releasing hormone (GnRH) is released by the hypothalamus. GnRH is also known as lutenizing hormone releasing hormone (LHRH). GnRH stimulates the pituitary gland to release gonadotropins (lutenizing hormone [LH] and follicular stimulating hormone [FSH]). In females, FSH and LH play a key role in ovulation and estrogen production. In males, LH stimulates testosterone production. GnRH Agonists GnRH agonists (also known as LHRH agonists) are synthetic analogs of gonadotropin releasing hormones. GnRH agonists block the action of GnRH, thus preventing the release of LH. Conditions treated by GnRH agonists include estrogen dependent conditions (e.g. endometriosis, fibroids), precocious puberty and hormonally sensitive cancers (e.g. breast, prostate). GnRH agonists are also used for the off-label treatment of excessive uterine bleeding (e.g. menorrhagia, metrorrhagia and menometrorrhagia) and dysmenorrhea in women who have contraindications to other medical therapy. GnRH agonists are available as injectables or long-acting implants and include leuprolide acetate (Lupron®, Eligard®, Viadur™), goserelin acetate (Zoladex®), histrelin (Vantas™) and triptorelin pamoate (Trelstar™). Page 2 [Note: Final page is signature page and is kept on file, but not issued with Policy.]

MEDICAL POLICY POLICY TITLE

GONADOTROPIN-RELEASING HORMONE AGONISTS AND ANTAGONISTS

POLICY NUMBER

MP-2.107

Goserelin acetate (Zoladex®) is available as a monthly and a 3-month implant that is administered by subcutaneous injection into the anterior abdominal wall. Leuprolide acetate is available as an injectable suspension (Eligard®) that may be given subcutaneously monthly, every three months, every four months or every six months, and as a long-acting depot formulation (Lupron® Depot) that is administered intramuscularly on a monthly, every three months, or every four months basis. The leuprolide acetate implant (Viadur™) is a once-yearly implant for the palliative treatment of advanced prostate cancer. It is a drug-filled, miniature titanium implant that is placed under the skin in the inner aspect of the upper arm via an in-office surgical procedure. Vantas™, (histrelin acetate) is a once-yearly diffusion-controlled reservoir drug delivery system implant for the palliative treatment of advanced prostate cancer Histrelin implant can be inserted into the inner aspect of the upper arm within the physician’s office setting. Supprelin LA (histrelin acetate) is a once yearly subcutaneous implant for the treatment of central precocious puberty (CPP). CCP develops when the hypothalamus releases GnRH and activates the hypothalamic-pituitary gonadal (HPG) axis (or puberty) early. Triptorelin pamoate (Trelstar™ Depot, Trelstar™ LA) is a long-acting formula for the palliative treatment of advanced prostate cancer administered every four (Depot) or twelve weeks (LA) as a single intramuscular injection. When given to males, GnRH agonists produce “chemical castration”, with a drop in testosterone production. Since prostate tumors require testosterone to grow, reducing the testosterone level helps prevent further growth and spread of the cancer. When initially treating prostate cancer, GnRH agonists can be given in conjunction with an oral antiandrogen (e.g. flutamide [Eulexin], bicalutamide [Casodex] and nilutamide [Nilandron]). Antiandrogens prevent disease flare-ups, which are characterized by tumor growth or an increase in pain related to bone metastases. GnRH Antagonists Gonadotropin-releasing hormone (GnRH) antagonists block GnRH receptors located on the surfaces of gonadotroph cells in the anterior pituitary, thereby reducing secretion of luteinizing hormone (LH) by pituitary gonadotroph cells and so decreasing testosterone production by interstitial (Leydig) cells in the testes. Testosterone levels do not exhibit an initial surge, or flare, as is typical with GnRH agonists. Degarelix (Firmagon®) is a GnRH antagonist approved by the FDA for the treatment of advanced prostate cancer. The recommended dosing schedule is an initial loading dose of 240 mg and maintenance dosing of 80 mg every 28 days. It is administered subcutaneously by a healthcare professional.

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MEDICAL POLICY POLICY TITLE

GONADOTROPIN-RELEASING HORMONE AGONISTS AND ANTAGONISTS

POLICY NUMBER

MP-2.107

IV. DEFINITIONS AGONIST refers to a drug that has affinity for and stimulates physiologic activity at cell receptors normally stimulated by naturally occurring substances. ANDROGEN is the general term for any male sex hormone. ANTAGONIST refers to a drug that binds to a cell receptor without eliciting a biological response. DYSMENORRHEA refers to pain associated with menstruation. ENDOMETRIOSIS is an abnormal gynecologic condition characterized by ectopic growth and function of endometrial tissue. FOLLICLE-STIMULATING HORMONE (FSH) is a gonadotropin that stimulates the growth and maturation of graafian follicles in the ovary and promotes spermatogenesis in the male. It is secreted by the anterior pituitary gland. GONADOTROPIN is a hormone capable of promoting gonadal (i.e. ovarian or testicular) growth and function. LUTEINIZING HORMONE (LH) is a glycoprotein hormone produced by the anterior pituitary gland. It stimulates the secretion of the sex hormones by the ovary and the testes and is involved in the maturation of spermatozoa and ova. MENOMETRORRHAGIA is excessive bleeding during and between menstrual periods. MENORRHAGIA is menstrual bleeding that is excessive in number of days or amount of blood, or both. METRORRHAGIA is intermenstrual bleeding. PRECOCIOUS PUBERTY is an abnormally early development of sexual maturity. It is usually marked by early breast development and ovulation in girls before eight (8) years of age and the production of mature sperm in boys before ten (10) years of age.

V. BENEFIT VARIATIONS The existence of this medical policy does not mean that this service is a covered benefit under the member’s contract. Benefit determinations should be based in all cases on the applicable contract language. Medical policies do not constitute a description of benefits. A member’s individual or group customer benefits govern which services are covered, which are excluded, and which are subject to benefit limits and which require preauthorization. Members and providers should consult the member’s benefit information or contact Capital for benefit information. Page 4 [Note: Final page is signature page and is kept on file, but not issued with Policy.]

MEDICAL POLICY POLICY TITLE

GONADOTROPIN-RELEASING HORMONE AGONISTS AND ANTAGONISTS

POLICY NUMBER

MP-2.107

VI. DISCLAIMER Capital’s medical policies are developed to assist in administering a member’s benefits, do not constitute medical advice and are subject to change. Treating providers are solely responsible for medical advice and treatment of members. Members should discuss any medical policy related to their coverage or condition with their provider and consult their benefit information to determine if the service is covered. If there is a discrepancy between this medical policy and a member’s benefit information, the benefit information will govern. Capital considers the information contained in this medical policy to be proprietary and it may only be disseminated as permitted by law.

VII. REFERENCES Abraham J. Degarelix, a new GnRH antagonist, in prostate cancer. Commun Oncol 2009;6:197201. Bulun S. Endometriosis. N Engl J Med 2009; 360:268-79. CenterWatch Clinical Trials Listing Service. Drugs Approved by the FDA: Supprelin LA (histrelin acetate). Updated May 17, 2007. [Website]: http://www.centerwatch.com/patient/drugs/dru950.html. Accessed June 1, 2011. Cuzick J, Ambroisine L, Davidson N, et al. Use of luteinising-hormone-releasing hormone agonists as adjuvant treatment in premenopausal patients with hormone-receptor-positive breast cancer: Ameta-analysis of individual patient data from randomised adjuvant trials. Lancet. 2007;369:17111723. Dawson N. Overview of treatment for advanced prostate cancer. In: UpToDate Online Journal [serial online]. Waltham, MA: UpToDate; updated July 30, 2009. [Website]: www.uptodate.com. Accessed March 30, 2010. D'Amico A. Global update on defining and treating high-risk localized prostate cancer with leuprorelin: a USA perspective--identifying men at diagnosis who are at high risk of prostate cancer death after surgery or radiation therapy. BJU International 2007;99 Suppl 1:13-6; discussion 17-8. ECRI Forecast. First new prostate cancer drug in years approved by FDA. 1/15/2009. Ellis M, Hayes D, Naughton M. Endocrine therapy of metastatic breast cancer. In: UpToDate Online Journal [serial online]. Waltham, MA: UpToDate; updated February 17, 2011. [Website] : www.uptodate.com . Accessed June 1, 2011. Engel JB, Schally AV. Drug Insight: clinical use of agonists and antagonists of luteinizinghormone-releasing hormone. Nature Clinical Practice. Endocrinology & Metabolism 2007;3(2):157-67. Eusgter EA, Clark W, et al. Efficacy and Safety of Hisrtrelin Subdermal Implant in children with Central Precocious Puberty: A Multicenter Trial. J Clin Endocrin Metabolism. 2007 May;92(5):1697-704.

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MEDICAL POLICY POLICY TITLE

GONADOTROPIN-RELEASING HORMONE AGONISTS AND ANTAGONISTS

POLICY NUMBER

MP-2.107

Firmagon prescribing information. Firmagon [Website]: http://www.firmagon.us/us/us-homeg/pclhomeg/accessser/0/261/0/default.html. Accessed June 1, 2011.French L. Dysmenorrhea. Am Fam Physician. 2005 Jan 15;71(2):285-91. Highmark Medicare Services Local Coverage Determination (LCD), L27500, Luteinizing Hormone-Releasing Hormone (LHRH) Analogs Effective 02/21/11. [Website]: https://www.highmarkmedicareservices.com/policy/mac-ab/l27500-r6.html Accessed June 1, 2011. Hirsch HJ, Gillis D, Strich D, et al. The histrelin implant: A novel treatment for central precocious puberty. Pediatrics. 2005;116(6):e798-e802. Hompes PG, Mijatovic V. Endometriosis: the way forward. Gynecological Endocrinology 2007;23(1):5-12. Hornstein M, Gibbons W. Gonadotropin releasing hormone agonists for long term treatment of endometriosis. In: UpToDate Online Journal [serial online]. Waltham, MA: UpToDate; updated January 6, 2011. [Website]: www.uptodate.com. Accessed June 1, 2011. Kaufmann M, et al. A randomised trial of goserelin versus control after adjuvant, risk-adapted chemotherapy in premenopausal patients with primary breast cancer - GABG-IV B-93. European Journal of Cancer 2007;43(16):2351-8. Klotz L, Boccon-Gibod L, Shore ND, et al. The efficacy and safety of degarelix: a 12-month, comparative, randomized, open-label, parallel-group phase III study in patients with prostate cancer.BJU Int. 2008 Dec;102(11):1531-8. Lee R, Smith M. Initial hormone therapy for metastatic prostate cancer. In: UpToDate Online Journal [serial online]. Waltham, MA: UpToDate; updated September 20, 2010. [Website]: www.uptodate.com. Accessed June 1, 2011. Lu-Yao G, Moore DF, Oleynick JU, DiPaola RS, Yao SL. Population based study of hormonal therapy and survival in men with metastatic prostate cancer. Journal of Urology 2007;177(2):5359. Mosby’s Medical, Nursing, & Allied Health Dictionary, 6th edition. Nanda A, Chen MH, Moran BJ, et al. Total androgen blockade versus a luteinizing hormonereleasing hormone agonist alone in men with high-risk prostate cancer treated with radiotherapy. Int J Radiat Oncol Biol Phys. 2010 Apr;76(5):1439-44. National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. Prostate Cancer. V.1.2010. [Website]: www.nccn.org. Accessed June 1, 2011. National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. Breast Cancer. V.2.2010. [Website]: www.nccn.org. Accessed June 1, 2011. National Institute for Health and Clinical Excellence (NICE): National Collaborating Centre for Women’s and Children’s Health. Heavy menstrual bleeding. Clinical Guideline CG44. London, UK: NICE; January 2007. [Website]: http://www.nice.org.uk/nicemedia/pdf/CG44FullGuideline.pdf Accessed June 1, 2011. Pilepich MV, Winter K, Lawton CA, Krisch RE, Wolkov HB et al. Androgen suppression adjuvant to definitive radiotherapy in prostate carcinoma-–long term results of phase III RTOG 85-31. Int J Page 6 [Note: Final page is signature page and is kept on file, but not issued with Policy.]

MEDICAL POLICY POLICY TITLE

GONADOTROPIN-RELEASING HORMONE AGONISTS AND ANTAGONISTS

POLICY NUMBER

MP-2.107

Radiat Oncol Biol Phys 2005; 61 (5): 1285-90.Roach M, et al. Short-term neoadjuvant androgen deprivation therapy and external-beam radiotherapy for locally advanced prostate cancer: longterm results of RTOG 8610. Journal of Clinical Oncology 2008;26(4):585-91. Saenger P. Overview of precocious puberty. In: UpToDate Online Journal [serial online]. Waltham, MA: UpToDate; updated October 5, 2011[Website] : www.uptodate.com . Accessed June 1, 2011. Sesti F, et al. Hormonal suppression treatment or dietary therapy versus placebo in the control of painful symptoms after conservative surgery for endometriosis stage III-IV. A randomized comparative trial. Fertility and Sterility 2007;88(6):1541-7. Supprelin LA prescribing information. Supprelin LA [Website]: http://www.supprelinla.com/endocrinologists/index.html Accessed June 1, 2011. Taber’s Cyclopedic Medical Dictionary, 20th edition. U.S. National Institutes of Health. National Cancer Institutes (NCI) Drug Dictionary. [Website]: http://www.cancer.gov/drugdictionary/ Accessed June 1, 2011. Van Voorhis B. A 41-Year-Old Woman With Menorrhagia, Anemia, and Fibroids: Review of Treatment of Uterine Fibroids. JAMA. 2009;301(1):82-93. Welt C. Physiology of gonadotropin-releasing hormone. In: UpToDate Online Journal [serial online]. Waltham, MA: UpToDate; updated February 11, 2011. [Website]: www.uptodate.com . Accessed April 2, 2010. Wilson AC, Meethal SV, Bowen RL, Atwood CS. Leuprolide acetate: a drug of diverse clinical applications. Expert Opinion on Investigational Drugs 2007;16(11):1851-63. Zacur H. Chronic menorrhagia or anovulatory bleeding. In: UpToDate Online Journal [serial online]. Waltham, MA: UpToDate; updated September 27, 2010. [Website] : www.uptodate.com . Accessed June 1, 2011.

VIII. CODING INFORMATION Note: This list of codes may not be all-inclusive, and codes are subject to change at any time. The identification of a code in this section does not denote coverage as coverage is determined by the terms of member benefit information. In addition, not all covered services are eligible for separate reimbursement.

Covered when medically necessary: CPT Codes ® 11981

11982

11983

Current Procedural Terminology (CPT) copyrighted by American Medical Association. All Rights Reserved.

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MEDICAL POLICY POLICY TITLE

GONADOTROPIN-RELEASING HORMONE AGONISTS AND ANTAGONISTS

POLICY NUMBER

MP-2.107

HCPCS Code

Description

J1675 J1950 J3315 J9155 J9202

INJECTION, HISTRELIN ACETATE, 10 MCG INJECTION, LEUPROLIDE ACETATE (FOR DEPOT SUSPENSION), PER 3.75 MG INJECTION, TRIPTORELIN PAMOATE, 3.75 MG INJECTION, DEGARELIX, 1 MG GOSERELIN ACETATE IMPLANT, PER 3.6 MG

J9217 J9218 J9219 J9225 J9226 S9560

LEUPROLIDE ACETATE (FOR DEPOT SUSPENSION), 7.5 MG LEUPROLIDE ACETATE, PER 1 MG LEUPROLIDE ACETATE IMPLANT, 65 MG HISTRELIN IMPLANT (VANTAS), 50 MG HISTRELIN IMPLANT (SUPPRELIN LA), 50 MG HOME INJECTABLE THERAPY; HORMONAL THERAPY DIEM

ICD-9-CM Diagnosis Code*

Description

174.0 – 174.9 185. 189.3 198.1 198.5

MALIGNANT NEOPLASM OF FEMALE BREAST MALIGNANT NEOPLASM OF PROSTATE MALIGNANT NEOPLASM OF URETHRA SECONDARY MALIGNANT NEOPLASM OF OTHER URINARY ORGANS SECONDARY MALIGNANT NEOPLASM OF BONE AND BONE MARROW

198.81 198.82 218.0 218.1 218.2 218.9

SECONDARY MALIGNANT NEOPLASM OF BREAST SECONDARY MALIGNANT NEOPLASM OF GENITAL ORGANS SUBMUCOUS LEIOMYOMA OF UTERUS INTRAMURAL LEIOMYOMA OF UTERUS SUBSEROUS LEIOMYOMA OF UTERUS LEIOMYOMA OF UTERUS, UNSPECIFIED

233.4 255.2 259.1 617.0 – 617.9 625.3 626.2

CARCINOMA IN SITU OF PROSTATE ADRENOGENITAL DISORDERS PRECOCIOUS SEXUAL DEVELOPMENT AND PUBERTY, NOT ELSEWHERE CLASSIFIED ENDOMETRIOSIS DYSMENORRHEA EXCESSIVE OR FREQUENT MENSTRUATION

626.3 626.6

PUBERTY BLEEDING METRORRHAGIA OTHER DISORDER OF MENSTRUATION AND OTHER ABNORMAL BLEEDING FROM FEMALE GENITAL TRACT Page 8

626.8

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MEDICAL POLICY POLICY TITLE

GONADOTROPIN-RELEASING HORMONE AGONISTS AND ANTAGONISTS

POLICY NUMBER

MP-2.107

ICD-9-CM Diagnosis Code*

Description

627.0 V10.3

PREMENOPAUSAL MENORRHAGIA PERSONAL HISTORY OF MALIGNANT NEOPLASM OF BREAST

V10.46

PERSONAL HISTORY OF MALIGNANT NEOPLASM OF PROSTATE *If applicable, please see Medicare LCD or NCD for additional covered diagnoses.

The following ICD-10 diagnosis codes will be effective October 1, 2013: ICD-10-CM Diagnosis Code*

Description

C50.012 C50.011 C50.019 C50.112 C50.111 C50.119 C50.212 C50.211 C50.219 C50.312 C50.311 C50.319 C50.412 C50.411 C50.419 C50.512 C50.511 C50.519 C50.612 C50.611 C50.619 C50.812 C50.811 C50.819 C50.912 C50.911

Malignant neoplasm of nipple and areola, left female breast Malignant neoplasm of nipple and areola, right female breast Malignant neoplasm of nipple and areola, unspecified female breast Malignant neoplasm of central portion of left female breast Malignant neoplasm of central portion of right female breast Malignant neoplasm of central portion of unspecified Malignant neoplasm of upper-inner quadrant of left female breast Malignant neoplasm of upper-inner quadrant of right female breast Malignant neoplasm of upper-inner quadrant of unspecified Malignant neoplasm of lower-inner quadrant of left female breast Malignant neoplasm of lower-inner quadrant of right female breast Malignant neoplasm of lower-inner quadrant of unspecified female breast Malignant neoplasm of upper-outer quadrant of left female breast Malignant neoplasm of upper-outer quadrant of right female breast Malignant neoplasm of upper-outer quadrant of unspecified female breast Malignant neoplasm of lower-outer quadrant of left female breast Malignant neoplasm of lower-outer quadrant of right Malignant neoplasm of lower-outer quadrant of unspecified female breast Malignant neoplasm of axillary tail of left female breast Malignant neoplasm of axillary tail of right female breast Malignant neoplasm of axillary tail of unspecified female breast Malignant neoplasm of overlapping sites of left female breast Malignant neoplasm of overlapping sites of right female breast Malignant neoplasm of overlapping sites of unspecified female breast Malignant neoplasm of unspecified site of left female breast Malignant neoplasm of unspecified site of right female breast Page 9 [Note: Final page is signature page and is kept on file, but not issued with Policy.]

MEDICAL POLICY POLICY TITLE

GONADOTROPIN-RELEASING HORMONE AGONISTS AND ANTAGONISTS

POLICY NUMBER

MP-2.107

ICD-10-CM Diagnosis Code*

Description

C50.919 C61 C68.0 C79.11 C79.19 C79.10 C79.51 C79.52 C79.81 C79.82 D25.0 D25.1 D25.2 D25.9 D07.5 E25.9 E25.0 E25.8 E30.8 E30.1 N80.0 N80.1 N80.2 N80.3 N80.4 N80.5 N80.6 N80.8 N80.9 N94.6 N94.4 N94.5 N92.0 N92.2 N92.1 N89.7 N93.8 N92.5

Malignant neoplasm of unspecified site of unspecified female breast Malignant neoplasm of prostate Malignant neoplasm of urethra Secondary malignant neoplasm of bladder Secondary malignant neoplasm of other urinary organs Secondary malignant neoplasm of unspecified urinary organs Secondary malignant neoplasm of bone Secondary malignant neoplasm of bone marrow Secondary malignant neoplasm of breast Secondary malignant neoplasm of genital organs Submucous leiomyoma of uterus Intramural leiomyoma of uterus Subserosal leiomyoma of uterus Leiomyoma of uterus, unspecified Carcinoma in situ of prostate Adrenogenital disorder, unspecified Congenital adrenogenital disorders associated with enzyme deficiency Other adrenogenital disorders Other disorders of puberty Precocious puberty Endometriosis of uterus Endometriosis of ovary Endometriosis of fallopian tube Endometriosis of pelvic peritoneum Endometriosis of rectovaginal septum and vagina Endometriosis of intestine Endometriosis in cutaneous scar Other endometriosis Endometriosis, unspecified Dysmenorrhea, unspecified Primary dysmenorrhea Secondary dysmenorrhea Excessive and frequent menstruation with regular cycle Excessive menstruation at puberty Excessive and frequent menstruation with irregular cycle Hematocolpos Other specified abnormal uterine and vaginal bleeding Other specified irregular menstruation Page 10 [Note: Final page is signature page and is kept on file, but not issued with Policy.]

MEDICAL POLICY POLICY TITLE

GONADOTROPIN-RELEASING HORMONE AGONISTS AND ANTAGONISTS

POLICY NUMBER

MP-2.107

ICD-10-CM Diagnosis Code*

Description

N92.4 Z85.3 Z85.46

Excessive bleeding in the premenopausal period Personal history of malignant Personal history of malignant neoplasm of prostate *If applicable, please see Medicare LCD or NCD for additional covered diagnoses.

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MEDICAL POLICY POLICY TITLE

GONADOTROPIN-RELEASING HORMONE AGONISTS AND ANTAGONISTS

POLICY NUMBER

MP-2.107

IX. POLICY HISTORY MP 2.107

CAC 6/29/04 CAC 10/26/04 CAC 3/29/05 CAC 8/30/05 CAC 6/27/06 CAC 3/27/07 CAC 7/29/08 J12 MAC 12/12/08 CAC 3/31/09 CAC 5/25/10 Added medical necessity criteria for GnRH antagonists (degarelix). Removed policy criteria for androgen blockade. Retitled policy. CAC 7/26/11 Consensus

Policy approved for retirement effective 6/1/2012.

Health care benefit programs issued or administered by Capital BlueCross and/or its subsidiaries, Capital Advantage Insurance Company® and Keystone Health Plan® Central. Independent licensees of the Blue Cross and Blue Shield Association. Communications issued by Capital BlueCross in its capacity as administrator of programs and provider relations for all companies.

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