Clinical UM Guideline

 

Subject: Gonadotropin Releasing Hormone Analogs for the Treatment of Non-Oncologic Indications
Guideline #:  CG-DRUG-61 Publish Date:    12/27/2017
Status: Revised Last Review Date:    11/02/2017

Description

This document addresses gonadotropin releasing hormone (GnRH) analogs for the treatment of non-oncologic indications. GnRH analogs include, but may not be limited to the following:

Note: This document does not address the use of GnRH analogs in the diagnosis of central precocious puberty or treatment of infertility.

Note: For additional information please see:

Clinical Indications

Central Precocious Puberty - Leuprolide acetate (Lupron Depot-Ped), nafarelin acetate (Synarel Nasal Spray), histrelin acetate subcutaneous implant (Supprelin LA), Triptodur (triptorelin pamoate intramuscular extended release)

Medically Necessary:

Leuprolide acetate (Lupron Depot-Ped), nafarelin acetate (Synarel Nasal Spray), histrelin acetate subcutaneous implant (Supprelin LA) and Triptodur* (triptorelin IM) are considered medically necessary for the treatment of children known to have central precocious puberty (defined as the beginning of secondary sexual characteristics before age 8 in girls and 9 in boys)**.

*Triptodur (triptorelin pamoate) is indicated for intramuscular injection every 6 months for pediatric persons 2 years of age or older with central precocious puberty. 
**See discussion section for additional information.

Not Medically Necessary:

Leuprolide acetate (Lupron Depot-Ped), nafarelin acetate (Synarel Nasal Spray), Supprelin LA (histrelin acetate subcutaneous implant) and Triptodur (triptorelin) are considered not medically necessary for the treatment of central precocious puberty when the criteria above are not met.

Gynecology Uses - Goserelin acetate, leuprolide acetate, leuprolide acetate for depot suspension and norethindrone (Lupaneta Pack), or nafarelin acetate

Medically Necessary:

  1. Goserelin acetate, leuprolide acetate or nafarelin acetate are considered medically necessary when any of the following indications are met:
    1. Chronic pelvic pain (noncyclical pain lasting 6 or more months that localizes to the anatomic pelvis, anterior abdominal wall at or below the umbilicus, the lumbosacral back, or the buttocks, and is of sufficient severity to cause functional disability or lead to medical care [ACOG, 2004])-not to continue beyond 3 months if there is no symptomatic relief; or
    2. To induce amenorrhea in women in certain populations, including menstruating women diagnosed with severe thrombocytopenia or aplastic anemia.
  2. Goserelin acetate is considered medically necessary for any of the following additional indications:
    1. Endometriosis (duration of treatment limited to 6 months); or
    2. Dysfunctional uterine bleeding; or
    3. Endometrial thinning prior to endometrial ablation for dysfunctional uterine bleeding (3.6 mg implant only).
  3. Leuprolide acetate is considered medically necessary for any of the following additional indications:
    1. Initial treatment of endometriosis (duration of treatment limited to 6 months); or
    2. Retreatment of endometriosis (duration of treatment limited to 6 months); or
    3. Preoperative treatment as adjunct to surgical treatment of uterine fibroids (leiomyoma uteri). May be used to reduce size of fibroids to allow for a vaginal procedure; or
    4. Prior to surgical treatment (myomectomy or hysterectomy) in individuals with documented anemia.
  4. Leuprolide acetate for depot suspension and norethindrone acetate tablets (Lupaneta Pack) are considered medically necessary for any of the following indications:
    1. Initial treatment of endometriosis (duration of treatment limited to 6 months); or
    2. Retreatment of endometriosis (duration of treatment limited to 6 months).
  5. Nafarelin acetate is considered medically necessary for the following additional indication:
    1. Endometriosis (duration of treatment limited to 6 months).

Not Medically Necessary:

Goserelin acetate, leuprolide acetate, leuprolide acetate for depot suspension and norethindrone acetate tablets or nafarelin acetate is considered not medically necessary for gynecological uses when the criteria above are not met.

Gender Dysphoria/Incongruence in Adolescents

Medically Necessary:

  1. GnRH analogs are considered medically necessary for adolescents with gender dysphoria when all of the following criteria are met:
    1. Fulfills the DSM V criteria for gender dysphoria; and
    2. Has experienced puberty to at least Tanner stage 2; and
    3. Has (early) pubertal changes that have resulted in an increase of their gender dysphoria; and
    4. Does not suffer from a psychiatric comorbidity that interferes with the diagnostic work-up or treatment; and
    5. Has psychological and social support during treatment; and
    6. Demonstrates knowledge and understanding of the expected outcomes of GnRH analog treatment.

Not Medically Necessary:

GnRH analogs are considered not medically necessary for adolescents with gender dysphoria 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.

HCPCS

 

C9016

Injection, triptorelin extended release, 3.75 mg [Triptodur]

J1675

Injection, histrelin acetate, 10 micrograms

J1950

Injection, leuprolide acetate (for depot suspension), per 3.75 mg [Lupron Depot, Lupron Depot-Ped]

J3315

Injection, triptorelin pamoate, 3.75 mg [Trelstar, Trelstar Depot, 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, Lupron Depot-Ped]

J9218

Leuprolide acetate, per 1 mg [Lupron]

J9225

Histrelin implant (Vantas), 50 mg

J9226

Histrelin implant (Supprelin LA), 50 mg

J3490

Unclassified drugs [when specified as triptorelin extended release (Triptodur)]

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

 

No code for Nafarelin acetate [Synarel Nasal Spray]

 

No code for leuprolide acetate for depot suspension and norethindrone acetate tablets [Lupaneta Pack]

 

 

ICD-10 Diagnosis

 

 

All diagnoses excluding oncologic diagnoses

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 include, but are not limited to: degarelix (Firmagon®), goserelin acetate (Zoladex®), histrelin acetate (Vantas® 12-month implant; Supprelin® LA 12-month implant), leuprolide acetate (Lupron Depot®, Lupron Depot-Ped®, Eligard®), nafarelin acetate (Synarel Nasal Spray®), and triptorelin pamoate (Trelstar ®, Trelstar LA®, Trelstar Depot®). Currently, the brand Lupron (leuprolide acetate) is not being marketed in the United States; however, the brands Lupron Depot, Lupron Depot-Ped and Eligard remain available. 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. 

Central Precocious Puberty

Central precocious puberty (CPP) refers to premature activation of the hypothalamic-pituitary-gonadal axis (Eugster, 2007; Phillip, 2005). Carel and colleagues (2009), on behalf of members of the European Society for Pediatric Endocrinology, indicated that precocious puberty is the development of secondary sexual characteristics before 8 years of age in girls and 9 years of age in boys. Treatment may be initiated following the establishment of a clinical diagnosis of CPP; however, the condition may not be detected or evaluated at onset and treatment can sometimes be started after age 8 or 9. Discontinuation of therapy is a clinical decision and there is insufficient evidence to rely on any one clinical variable to make that decision. In studies examined, wishes of the individual receiving treatment, family and the physician’s decision were stated as deciding factors for cessation of treatment. However, discontinuation guidance is provided in the product label. For example, the Supprelin LA product label indicates that discontinuation, “Should be considered at the discretion of the physician and at the appropriate time point for the onset of puberty (approximately 11 years for females and 12 years for males).” Treatment of CPP is  FDA approved for leuprolide acetate (Lupron Depot-Ped), nafarelin acetate (Synarel Nasal Spray) and histrelin acetate (Supprelin LA). In June 2017 the FDA approved a new formulation of triptorelin pamoate, Triptodur (Arbor Pharmaceuticals, LLC Atlanta GA), which is an extended release injectable suspension of GnRH. It is indicated for the treatment of pediatric subjects 2 years of age and older with CPP to be given every 6 months (FDA, 2017).

Gynecology Uses

The American College of Obstetrics and Gynecology (ACOG) (2004; reaffirmed 2008) practice bulletin for chronic pelvic pain includes the following Level A recommendation and conclusion which is stated to be based on good and consistent scientific evidence:

Level B recommendations which are based on limited or inconsistent scientific evidence include the following:

The ACOG (2010) practice bulletin for the management of endometriosis includes the following Level A recommendations and conclusions:

Level B recommendations include the following:

Guidelines from the Royal College of Obstetricians and Gynecologists (2005) state women with cyclical pelvic pain should be offered a therapeutic trial, using the combined oral contraceptive pill or a GnRH agonist for a period of 3-6 months before having a diagnostic laparoscopy.

FDA approved labels for goserelin acetate, leuprolide acetate, leuprolide acetate for depot suspension, norethindrone (Lupaneta Pack), and nafarelin acetate all specify a time limit for duration of treatment for endometriosis. Leuprolide acetate and leuprolide acetate for depot suspension with norethindrone (Lupaneta Pack) are approved for an initial 6-month course and a 6-month course of retreatment if necessary. Goserelin acetate and nafarelin acetate are limited to 6 month duration of treatment.

A small, short-term, randomized controlled trial (RCT) (Ling, 1999) supports empiric therapy for management of chronic pelvic pain.

Gender Dysphoria/Incongruence in Adolescents

Gender dysphoria or gender incongruence is a condition wherein an individual's experienced gender is the opposite of his or her natal gender (usually assigned at birth based on anatomic sex). This can result in distress associated with persistent feelings, such as being "Trapped in the wrong body." Gender dysphoria is distinct from cross dressing (transvestitism), inability to accept homosexual orientation, psychotic delusions or personality disorders. Most individuals who express gender dysphoria in adolescence and later are thought to sustain the experienced gender.

The Endocrine Society Clinical Practice Guidelines for endocrine treatment of transsexual persons (Hembree, 2009) state that adolescents are eligible and ready for GnRH treatment if they:

  1. Fulfill DSM V-TR or ICD-10 criteria for GID or transsexualism.
  2. Have experienced puberty to at least Tanner stage 2.
  3. Have (early) pubertal changes that have resulted in an increase of their gender dysphoria.
  4. Do not suffer from psychiatric comorbidity that interferes with the diagnostic work-up or treatment.
  5. Have adequate psychological and social support during treatment, AND
  6. Demonstrate knowledge and understanding of the expected outcomes of GnRH analog treatment, cross-sex hormone treatment, and sex reassignment surgery, as well as the medical and social risks and benefits of sex reassignment.

In 2017, the Endocrine Society updated its guideline for Endocrine Treatment of Gender-Dysphoric/ Gender-Incongruent Persons (Hembree, 2017), in which the terminology was updated to “Gender Dysphoria/Gender Incongruence (GD/gender incongruence).” The following recommendations were made to amend to the earlier recommendations:

The updated Endocrine Society guidelines document contains additional information about long-term care and monitoring for adverse outcomes prevention and about surgical options when being considered:

We suggest that clinicians delay gender-affirming genital surgery involving gonadectomy and/or hysterectomy until the patient is at least 18 years old or legal age of majority in his or her country (Hembree, 2017).

The World Professional Association for Transgender Health (WPATH) (2012) recommendations include the following regarding puberty suppression:

For puberty suppression, adolescents with male genitalia should be treated with GnRH analogues, which stop luteinizing hormone secretion and therefore testosterone secretion. Alternatively, they may be treated with progestins (such as medroxyprogesterone) or with other medications that block testosterone secretion and/or neutralize testosterone action. Adolescents with female genitalia should be treated with GnRH analogues, which stop the production of estrogens and progesterone. No large scale data to support these recommendations but short term data exists.

The WPATH 2012 Criteria for Puberty-Suppressing Hormones state:

In order for adolescents to receive puberty-suppressing hormones, the following minimum criteria must be met:

  1. The adolescent has demonstrated a long-lasting and intense pattern of gender nonconformity or gender dysphoria (whether suppressed or expressed);
  2. Gender dysphoria emerged or worsened with the onset of puberty;
  3. Any coexisting psychological, medical, or social problems that could interfere with treatment (e.g., that may compromise treatment adherence) have been addressed, such that the adolescent’s situation and functioning are stable enough to start treatment;
  4. The adolescent has given informed consent and, particularly when the adolescent has not reached the age of medical consent, the parents or other caretakers or guardians have consented to the treatment and are involved in supporting the adolescent throughout the treatment process.

In May 2013, the American Psychiatric Association published an update to their Diagnostic and Statistical Manual of Mental Disorders, Fifth edition (DSM-5). This update included a significant change to the nomenclature of conditions related to gender psychology. Specifically, the term "Gender Identify Disorder (GID)" was replaced with "Gender Dysphoria." Additionally, the DSM-5 provided updated diagnostic criteria for gender dysphoria for both children and adults. The new criteria are as follows:

Gender dysphoria in Children*

  1. A marked incongruence between one's experienced/expressed gender and assigned gender, of at least 6 months duration, as manifested by at least six of the following (one of which must be Criterion A1):
    1. A strong desire to be of the other gender or an insistence that one is the other gender (or some alternative gender, different from one's assigned gender).
    2. In boys (assigned gender), a strong preference for cross dressing or simulating female attire; or in girls (assigned gender), a strong preference for wearing only typical masculine clothing and a strong resistance to wearing of typical feminine clothing.
    3. A strong preference for cross-gender roles in make-believe play of fantasy play.
    4. A strong preference for toys, games, or activities stereotypically used or engaged in by the other gender.
    5. A strong preference for playmates of the other gender.
    6. In boys (assigned gender), a strong rejection of typically masculine toys, games and activities and a strong avoidance of rough and tumble play; or in girls (assigned gender), a strong rejection of typically feminine toys, games and activities.
    7. A strong dislike of one's sexual anatomy.
    8. A strong desire for the primary and/or secondary sex characteristics that match one's experienced gender.
  2. The condition is associated with clinically significant distress or impairment in social, school, or other important areas of functioning.

Specify if:

With a disorder of sex development (e.g., a congenital adrenogenital disorder such as 255.2 [E25.0] congenital adrenal hyperplasia or 259.0 [E34.50] androgen insensitivity syndrome)
Coding note: Code the disorder of sex development as well as gender dysphoria.

Gender dysphoria in Adolescents and Adults*

  1. A marked incongruence between one's experienced/expressed gender and assigned gender, of at least 6 months duration, as manifested by at least two of the following:
    1. A marked incongruence between one's experienced/expressed gender and primary and/or secondary sex characteristics (or in young adolescents, the anticipated secondary sex characteristics).
    2. A strong desire to be rid of one's primary and/or secondary sex characteristics because of a marked incongruence with one's experienced/expressed gender (or in young adolescents, a desire to prevent the development of the anticipated secondary sex characteristics).
    3. A strong desire for the primary and /or secondary sex characteristics of the other gender.
    4. A strong desire to be of the other gender (or some alternative gender different from one's assigned gender).
    5. A strong desire to be treated as the other gender (or some alternative gender different from one's assigned gender).
    6. A strong conviction that one has the typical feelings and reactions of the other gender (or some alternative gender different from one's assigned gender).
  2. The condition is associated with clinically significant distress or impairment in social, occupational, or other important areas of functioning.

Specify if:

With a disorder of sex development (e.g., a congenital adrenogenital disorder such as 255.2 [E25.0] congenital adrenal hyperplasia or 259.0 [E34.50] androgen insensitivity syndrome)
Coding note: Code the disorder of sex development as well as gender dysphoria.

Specify if:

Post transition: The individual has transitioned to full-time living in the desired gender (with or without legalization of gender change) and has undergone (or is preparing to have) at least one cross-sex medical procedure or treatment regimen- namely regular cross-sex treatment or gender reassignment surgery confirming the desired gender (e.g., penectomy, vaginoplasty in a natal male; mastectomy or phalloplasty in the natal female).

*From: Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. DSM-5. American Psychiatric Association. Washington, DC. May 2013. Page 451-459.

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 indications, including, but not limited to: premenstrual syndrome, menopause or mood related disorders, benign prostatic hypertrophy, and to stop pubertal development, in order to maximize growth for children of short stature on growth hormones.

Definitions

Central precocious puberty: The beginning of secondary sexual characteristics before age 8 in girls and age 9 in boys.

Chronic pelvic pain: Noncyclical pain lasting 6 or more months that localizes to the anatomic pelvis, anterior abdominal wall at or below the umbilicus, the lumbosacral back, or the buttocks, and is of sufficient severity to cause functional disability or lead to medical care (ACOG, 2004).

References

Peer Reviewed Publications:

  1. Carel JC. Can we increase adolescent growth? Eur J Endocrin. 2004; 151 Suppl 3:U101-U108.
  2. Carel JC. Management of short stature with GnRH agonist and co-treatment with growth hormone: a controversial issue. Mol Cell Endocrinol. 2006; 254-255:226-233.
  3. Carel JC, Eugster EA, Rogol A, et al. Consensus statement on the use of gonadotropin-releasing hormone analogs in children. Pediatrics. 2009; 123(4):e752-762.
  4. Ling FW. Randomized controlled trial of depot leuprolide in patients with chronic pelvic pain and clinically suspected endometriosis. Obstet Gynecol. 1999; 93(1):51-58.
  5. Phillip M, Lazar L. Precocious puberty: growth and genetics. Horm Res. 2005; 64 Suppl 2:56-61.
  6. van Gool SA, Kamp GA, Visser-van Balen H, et al. Final height outcome after three years of growth hormone and gonadotropic-releasing hormone agonist treatment in short adolescents with relatively early puberty. J Clin Endocrinol Metab. 2007; 92(4):1402-1408.
  7. Wit JM, Visser-van Balen H, Kamp GA, Oostdijk W. Benefit of postponing normal puberty for improving final height. Eur J Endocrin. 2004; 151 Suppl 1:S41-S45.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. American College of Obstetrics and Gynecology Committee on Practice Bulletins -- Gynecology. ACOG Practice Bulletin No. 51. Chronic pelvic pain. Obstet Gynecol. 2004 (reaffirmed 2008); 103(3):589-605.
  2. American College of Obstetrics and Gynecology Committee on Practice Bulletins -- Gynecology. ACOG Practice bulletin no. 114: management of endometriosis. Obstet Gynecol. 2010; 116(1):223-236.
  3. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. 2013. Washington, DC. Pages 451-459.
  4. Degarelix Acetate. In: DrugPoints® System [electronic version]. Truven Health Analytics, Greenwood Village, CO. Last Modified: March 30, 2016. Available at: http://www.micromedexsolutions.com. Accessed on September 28, 2017.
  5. Eligard (leuprolide acetate) [Product Information], Fort Collins, CO. Tolmar Pharmaceuticals, Inc.; February 2016. Available at: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b78d1919-9dee-44fa-90f9-e0a26d32481d. Accessed on September 25, 2017.
  6. Firmagon [Product Information], Parsippany, NJ. Ferring Pharmaceuticals Inc.: October 2015. Available at: http://www.ferringusa.com/wp-content/uploads/2016/03/FirmagonPI-10.2015.pdf. Accessed on September 27, 2017.
  7. Goserelin acetate Monograph. Lexicomp® Online, American Hospital Formulary Service® (AHFS®) Online, Hudson, Ohio. Lexi-Comp., Inc. Last revised February 7, 2012. Accessed on September 25, 2017.
  8. Goserelin acetate (Zoladex®). In: DrugPoints® System [electronic version]. Truven Health Analytics, Greenwood Village, CO. Last modified March 30, 2016. Available at: http://www.micromedexsolutions.com. Accessed on September 25, 2017.
  9. Hembree WC. Guidelines for pubertal suspension and gender reassignment for transgender adolescents. Child Adolesc Psychiatr Clin N Am. 2011; 20(4):725-732.
  10. Hembree WC, Cohen-Kettenis P, Delemarre-van de Waal HA, et al.; Endocrine Society. Endocrine treatment of transsexual persons: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2009; 94(9):3132-3154.
  11. Hembree WC, Cohen-Kettenis P, Gooren L, et al.; Endocrine Society. Endocrine Treatment of Gender Dysphoric/Gender Incongruent Persons. An Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2017; 102(11):1–35.
  12. Histrelin acetate (Vantas®, Supprelin®, Supprelin® LA). In: DrugPoints® System [electronic version]. Truven Health Analytics, Greenwood Village, CO. Last modified March 30, 2016. Available at: http://www.micromedexsolutions.com. Accessed on September 26, 2017.
  13. Lethaby A, Vollenhoven B, Sowter M. Pre-operative GnRH analogue therapy before hysterectomy or myomectomy for uterine fibroids. Cochrane Database Syst Rev. 2001; (2):CD000547.
  14. Leuprolide acetate Monograph. Lexicomp® Online, American Hospital Formulary Service® (AHFS®) Online, Hudson, Ohio. Lexi-Comp., Inc. Last revised February 2, 2012. Accessed on September 26, 2017.
  15. Leuprolide acetate (Lupron®, Lupron Depot®, Lupron Depot-Ped®, Eligard®). In: DrugPoints® System [electronic version]. Truven Health Analytics, Greenwood Village, CO. Last modified March 30, 2016. Available at: http://www.micromedexsolutions.com. Accessed on September 26, 2017.
  16. Leuprolide Acetate/Norethindrone Acetate (Lupaneta Pack). In: DrugPoints® System [electronic version]. Truven Health Analytics, Greenwood Village, CO. Last modified March 30, 2016. Available at: http://www.micromedexsolutions.com. Accessed on September 26, 2017.
  17. Lupaneta Pack [Product Information], North Chicago, IL. AbbVie Inc.; October 2013. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203696s001lbl.pdf. Accessed on September 25, 2017.
  18. 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 September 27, 2017.
  19. Lupron Depot-Ped [Product Information], North Chicago, IL. AbbVie Inc.; June 2013. Available at: http://www.rxabbott.com/pdf/lupronpediatric.pdf. Accessed on September 25, 2017.
  20. Nafarelin acetate Monograph. Lexicomp® Online, American Hospital Formulary Service® (AHFS®) Online, Hudson, Ohio. Lexi-Comp., Inc. Last revised February 8, 2012.
  21. Nafarelin acetate (Synarel Nasal Spray®). In: DrugPoints® System [electronic version]. Truven Health Analytics, Greenwood Village, CO. Last modified March 30, 2016. Available at: http://www.micromedexsolutions.com. Accessed on September 25, 2017.
  22. Royal College of Obstetricians and Gynecologists (RCOG). The initial management of chronic pelvic pain. RCOG Guideline No. 41. London, UK: RCOG; April 2005.
  23. Supprelin LA [Product Information], Chadds Ford, PA. Endo Pharmaceuticals, Inc.; April 2013. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022058s011lbl.pdf. Accessed on September 26, 2017.
  24. Synarel [Product Information], New York, NY. GD Searle LLC.; August 2015. Available at: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=D0AA57CB-D2F4-46D7-AF43-7C8B06AA81A6. Accessed on September 25, 2017.
  25. Tan YH, Lethaby A. Pre-operative endometrial thinning agents before endometrial destruction for heavy menstrual bleeding. Cochrane Database Syst Rev. 2013;(11):CD010241.
  26. Trelstar [Product Information], Parsippany, NJ. Watson Pharma, Inc.; February 2013. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020715s030,021288s027,022437s007lbl.pdf. Accessed on September 27, 2017.
  27. Triptodur (triptorelin pamoate) [Product Information], Arbor Pharmaceuticals, LLC. Atlanta, GA. June 2017. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208956s000lbl.pdf. Accessed on September 25, 2017.
  28. Triptorelin pamoate Monograph. Lexicomp® Online, American Hospital Formulary Service® (AHFS®) Online, Hudson, Ohio. Lexi-Comp., Inc. Last revised February 7, 2012.
  29. Triptorelin pamoate (TriptodurTrelstar®, Trelstar LA®, Trelstar Depot®). In: DrugPoints® System [electronic version]. Truven Health Analytics, Greenwood Village, CO. Last modified June 30, 2017. Available at: http://www.micromedexsolutions.com. Accessed on September 25, 2017.
  30. 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 September 26, 2017.
  31. World Professional Association for Transgender Health. The Harry Benjamin International Gender Dysphoria Association’s standards of care for gender identity disorders. Version 7. Minneapolis (MN): WPATH; 2012. Available at: https://s3.amazonaws.com/amo_hub_content/Association140/files/Standards%20of%20Care%20V7%20-%202011%20WPATH%20(2)(1).pdf. Accessed on September 25, 2017.
  32. 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 September 25, 2017.
  33. Zoladex (gosarelin acetate) Implant 10.8 mg. [Product Information], Wilmington, DE. AstraZeneca; February 2015. Available at: http://www.azpicentral.com/zoladex/zoladex10_8.pdf. Accessed on September 26, 2017.
Index

Central Precocious Puberty (CPP)
Chronic Pelvic Pain
Degarelix
Dysfunctional Uterine Bleeding
Eligard
Endometrial Thinning
Endometriosis
Firmagon
Gender Dysphoria
Gonadotropin Releasing Hormone (GnRH) Analogs
Goserelin Acetate
Histrelin Acetate
Leuprolide Acetate
Lupaneta Pack
Lupron Depot
Lupron Depot-Ped
Nafarelin Acetate
Supprelin LA
Synarel Nasal Spray
Trelstar
Trelstar Depot
Trelstar LA
Triptorelin Pamoate
Triptodur
Uterine Fibroids
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

11/02/2017

Medical Policy & Technology Assessment Committee (MPTAC) review. The criteria for CPP were revised to add Triptodur, a new formulation of triptorelin pamoate extended release agent, for CPP. The document header wording was updated from “Current Effective Date” to “Publish Date.” The Description, Discussion and References sections were updated.  Updated Coding section to include 01/01/2018 HCPCS changes.

New

11/03/2016

MPTAC review. Initial document development. Criteria were originally in CG-DRUG-15.