Effective Date

Date of Origin 

4/1/2023

Anadrol-50®

(oxymetholone)

Tablet

Treatment of anemias caused by deficient red cell production. Acquired aplastic anemia, congenital aplastic anemia, myelofibrosis and the hypoplastic anemias due to the administration of myelotoxic drugs often respond

Androderm®

(testosterone)

Transdermal patch system

For replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone

-Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter syndrome, chemotherapy, or toxic damage from alcohol or heavy metals.

-Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation.

Limitations of use:

-Safety and efficacy in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established

-Safety and efficacy in males less than 18 years old have not been established

AndroGel®, Testosterone

Gel*

For replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone

-Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter syndrome, chemotherapy, or toxic damage from alcohol or heavy metals.

-Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation.

Limitations of use:

-Safety and efficacy in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established

-Safety and efficacy in males less than 18 years old have not been established

* – Generic available   

danazol*

Capsule

-Endometriosis amenable to hormone management

-Prevention of attacks of angioedema of all types

* – Generic available   

Fortesta®, Testosterone

Gel*

For replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone

-Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter syndrome, chemotherapy, or toxic damage from alcohol or heavy metals.

-Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation.

Limitations of use:

-Safety and efficacy in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established

-Safety and efficacy in males less than 18 years old have not been established

* – Generic available     

Jatenzo®

(testosterone undecanoate)

Capsule

Testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone:

- Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter syndrome, chemotherapy, or toxic damage from alcohol or heavy metals.

-Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation

Limitations of use: Safety and efficacy in males less than 18 years old have not been established.

Kyzatrex™

(testosterone undecanoate)

Capsule

For testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone

50

Methitest®

(methyltestosterone)

Tablet

-Primary hypogonadism (congenital or acquired) - testicular failure due to cryptorchidism, bilateral torsions, orchitis, vanishing testis syndrome; or orchiectomy

-Hypogonadotropic hypogonadism (congenital or acquired) - idiopathic gonadotropin or LHRH deficiency, or pituitary hypothalamic injury from tumors, trauma, or radiation

-Delayed puberty in males

-Palliative treatment of breast cancer in women

Methyltestosterone

Capsule

-Primary hypogonadism (congenital or acquired) - testicular failure due to cryptorchidism, bilateral torsions, orchitis, vanishing testis syndrome; or orchiectomy

-Hypogonadotropic hypogonadism (congenital or acquired) - idiopathic gonadotropin or LHRH deficiency, or pituitary hypothalamic injury from tumors, trauma, or radiation

-Delayed puberty in males

-Palliative treatment of breast cancer in women

Natesto®

(testosterone)

Nasal gel metered-dose pump

For replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone

-Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter syndrome, chemotherapy, or toxic damage from alcohol or heavy metals.

-Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation.

Limitations of use:

-Safety and efficacy in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established

-Safety and efficacy in males less than 18 years old have not been established

Oxandrin®

(oxandrolone)*

Tablet

Adjunctive therapy to promote weight gain after weight loss following extensive surgery, chronic infections, severe trauma, and in some patients without definite pathophysiologic reasons who fail to gain or to maintain normal weight, to offset the protein catabolism associated with prolonged administration of corticosteroids, and for the relief of the bone pain frequently accompanying osteoporosis

* – Generic available     

Striant®

(testosterone)

Buccal system

For replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone

-Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter syndrome, chemotherapy, or toxic damage from alcohol or heavy metals.

-Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation.

Limitations of use:

-Safety and efficacy in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established

-Safety and efficacy in males less than 18 years old have not been established

Testim®, Testosterone

Gel*

For replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone

-Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter syndrome, chemotherapy, or toxic damage from alcohol or heavy metals.

-Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation.

Limitations of use:

-Safety and efficacy in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established

-Safety and efficacy in males less than 18 years old have not been established

* – Generic available     

testosterone

Topical solution*

For replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone

-Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter syndrome, chemotherapy, or toxic damage from alcohol or heavy metals.

-Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation.

Limitations of use:

-Safety and efficacy in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established

-Safety and efficacy in males less than 18 years old have not been established

* - Generic available

Tlando™

(testosterone undecanoate)

Capsule

Testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone:

- Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter syndrome, chemotherapy, or toxic damage from alcohol or heavy metals.

-Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation

Limitations of use: Safety and efficacy in males less than 18 years old have not been established.

Vogelxo®, Testosterone

Gel*

For testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone:

-Primary hypogonadism (congenital or acquired)

-Hypogonadotropic hypogonadism (congenital or acquired)

* – Generic available    

Testosterone Deficiency

Testosterone is the predominant androgen in males and is involved in a multitude of physiological and biological processes throughout the body.  The American Urological Association (AUA) recommends that clinicians use a total testosterone level below 300 ng/dL as a reasonable cut-off in support of the diagnosis of low testosterone.  The clinical diagnosis of testosterone deficiency is only made when patients have low total testosterone levels combined with symptoms and/or signs.  A challenge in making the diagnosis of testosterone deficiency is that many of the symptoms are non-specific and might be related to conditions other than low testosterone.  Clinicians should conduct a targeted physical exam for signs that are associated with low testosterone.  Signs and symptoms associated with testosterone deficiency include:(16)

• Physical symptoms and signs:
  • Reduced energy
  • Reduced endurance
  • Diminished work and/or physical performance
  • Loss of body hair and/or reduced beard growth
  • Very small testes (especially less than 6 ml)
  • Fatigue
  • Reduced lean muscle mass
  • Obesity
• Cognitive symptoms and signs:
  • Depressive symptoms
  • Cognitive dysfunction
  • Reduced motivation
  • Poor concentration
  • Poor memory
  • Irritability
• Sexual symptoms and signs:
  • Reduced sex drive
  • Erectile dysfunction

The goal of testosterone therapy is the normalization of total testosterone levels combined with improvement in symptoms or signs.  The AUA recommends that clinicians use the minimal dosing necessary to drive testosterone levels to the normal physiologic range of 450-600 ng/dL.  Testosterone levels should be measured every 6-12 months while on testosterone therapy.(16)

Delayed Puberty

Delayed puberty in boys is the absence of testicular growth to at least 4 mL in volume or 2.5 cm in length by 14 years of age.  Constitutional delay of growth and puberty is a common cause of delayed puberty; however, functional or persistent hypogonadism should be excluded.  For more than 75% of patients with constitutional delay of growth and puberty, family history may reveal parental puberty delay.  Boys older than 14 years with possible constitutional delay of growth and puberty may be offered jump-start therapy to induce puberty.  Treating boys with testosterone for three to six months may accelerate attainment of final adult height and generally does not lead to premature epiphysis closure.(17)

Hereditary Angioedema (HAE)

C1-INH (C1 inhibitor) concentrate is the prophylaxis of choice for HAE.  Attenuated androgens (e.g., danazol) have been recommended in the past, but frequent short courses may lead to long-term associated side effects.  For scheduled pre-procedural prophylaxis, androgens are used for 5 days before and 2 to 3 days post event.(18)

Off Label Use - AIDS/HIV

Men who are seropositive for HIV have been shown to have a higher rate of testosterone deficiency than the general population.  It is postulated that the etiology of testosterone deficiency can be attributed to malnutrition, cytokine activity, opportunistic infections/acute illnesses, or the HIV medications themselves.  HIV infected men who are testosterone deficient have also been shown to have concomitant elevated HbA1c levels and are at higher risk for CVD when compared to HIV-positive patients who have normal testosterone levels.(16) Weight loss and muscle wasting remain significant clinical problems, even in the era of potent antiviral therapy.  Studies conducted in men on HAART (highly active antiretroviral therapy) show a 20% prevalence of hypogonadism among men with AIDS wasting.  Treatment of associated opportunistic infections and optimization of antiretroviral therapy should be the first goal in patients with wasting.  Clinical studies support the use of the following agents in men for AIDS/HIV-associated wasting syndrome: testosterone transdermal system(31), testosterone enanthate(32-34), oxandrolone(30,35) and testosterone cypionate(36). Up to 60% of women suffering from AIDS wasting are androgen deficient.(19) The use of transdermal testosterone to treat AIDS wasting in women is supported by literature.(20,21) Oxandrolone was studied in both male and female pediatric patients.(30)

The diagnosis of HIV wasting requires one of the following:(10)

• Unintentional weight loss of greater than:
  • 10% over 12 months
  • 7.5% within 6 months
• At least 5% total body cell mass (BCM) loss within 6 months
• Body mass index (BMI) less than 20 kg/m²
• In men: BCM less than 35% of total body weight and BMI less than 27 kg/m²
• In women: BCM less than 23% of total body weight and BMI less than 27 kg/m²

Off Label Use - Turner Syndrome

The Turner Syndrome Consensus Group recommends oxandrolone for treatment of Turner syndrome, when used in conjunction with growth hormone (GH).  Recommended dose of oxandrolone is 0.03 mg/kg/d and maintained below 0.05 mg/kg/d if the diagnosis of Turner Syndrome (and therefore GH treatment initiation) is delayed, and/or adult height outcome is likely to be unsatisfactory with the standard GH dose alone.  If the decision is made to add oxandrolone, this should not be done until around 10 years.(23)

Off Label Use - Chronic Kidney Disease Anemia

The Kidney Disease Improving Global Outcomes (KDIGO) Clinical Practice Guideline for Anemia in Chronic Kidney Disease recommends not using androgens as an adjuvant to erythropoiesis stimulating agents.  They cite the risks of androgen therapy and their uncertain benefit on hemoglobin concentration or clinical outcomes.(24)

Off Label Use - Vulvar Skin Disorder

The American Congress of Obstetricians and Gynecologists (ACOG) guidelines for vulvar skin disorders recommend a high potency topical steroid such as clobetasol propionate for treatment of lichen sclerosus.  Topical testosterone has shown inconsistent results in trials.(25) The Endocrine Society recommends against the generalized use of testosterone by women for infertility, sexual dysfunction (except for a specific diagnosis of hypoactive sexual desire disorder), cognitive dysfunction, cardiovascular dysfunction, metabolic dysfunction, bone health, or well-being.  There are no clear indications for these uses, and evidence of safety in long-term studies is lacking.(26) 

Off Label Use - Erectile Dysfunction

The American Urology Association (AUA) recommends that PDE5i (phosphodiesterase type 5 inhibitors) should be first-line therapy for erectile dysfunction.  AUA also recommend that testosterone therapy is not an effective monotherapy for ED.  If a man with ED has testosterone deficiency, he should be counseled that testosterone therapy in combination with a PDE5i is more likely to be effective than the PDE5i alone.  There is insufficient data to address other combined treatments.(27)

Off Label Use - Myeloproliferative Neoplasms

Management of myelofibrosis associated anemia includes epoetin or darbepoetin for individuals with serum epoetin levels less than 500 mU/mL.  Those with no response or loss of response should be managed as patients with serum epoetin ≥500 mU/mL. Immunomodulatory agents (lenalidomide or thalidomide) with or without prednisone or danazol are recommended for the treatment of anemia in patients with serum epoetin levels greater than or equal to 500 mU/mL.(29)

Safety

AndroGel, testosterone solution, Fortesta, Testim, and Vogelxo carry a black box warning about secondary exposure to testosterone.

• Virilization has been reported in children who were secondarily exposed to testosterone gel.
• Children should avoid contact with unwashed or unclothed application sites in men using testosterone gel.
• Healthcare providers should advise patients to strictly adhere to recommended instructions for use.(2,4,5,8,9)

Anadrol-50 and Oxandrin, carry a black box warning for several reasons.

• Peliosis hepatitis, a condition in which liver and sometimes splenic tissue is replaced with blood-filled cysts, has been reported in patients receiving androgenic anabolic steroid therapy. These cysts are sometimes present with minimal hepatic dysfunction, but at other times they have been associated with liver failure. They are often not recognized until life-threatening liver failure or intra-abdominal hemorrhage develops. Withdrawal of drug usually results in complete disappearance of lesions.

• Liver cell tumors are also reported. Most often these tumors are benign and androgen-dependent, but fatal malignant tumors have been reported. Withdrawal of drug often results in regression or cessation of progression of the tumor. However, hepatic tumors associated with androgens or anabolic steroids are much more vascular than other hepatic tumors and may be silent until life-threatening intra-abdominal hemorrhage develops.
• Blood lipid changes that are known to be associated with increased risk of atherosclerosis are seen in patients treated with androgens and anabolic steroids. These changes include decreased high-density lipoprotein and sometimes increased low density lipoprotein. The changes may be very marked and could have a serious impact on the risk of atherosclerosis and coronary artery disease.(13)

Danazol carries a black box warning for several reasons.

• Use of danazol in pregnancy is contraindicated. A sensitive test (e.g., beta subunit test if available) capable of determining early pregnancy is recommended immediately prior to start of therapy. Additionally, a non-hormonal method of contraception should be us ed during therapy. If a patient becomes pregnant while taking danazol, administration of the drug should be discontinued, and the patient should be apprised of the potential risk to the fetus. Exposure to danazol in utero may result in androgenic effects on the female fetus; reports of clitoral hypertrophy, labial fusion, urogenital sinus defect, vaginal atresia, and ambiguous genitalia have been received (see PRECAUTIONS: Pregnancy, Teratogenic Effects).
• Thromboembolism, thrombotic and thrombophlebitic events including sagittal sinus thrombosis and life-threatening or fatal strokes have been reported. Experience with long-term therapy with danazol is limited.
• Peliosis hepatis and benign hepatic adenoma have been observed with long-term use. Peliosis hepatis and hepatic adenoma may be silent until complicated by acute, potentially life-threatening intraabdominal hemorrhage. The physician therefore should be alert to this possibility. Attempts should be made to determine the lowest dose that will provide adequate protection. If the drug was begun at a time of exacerbation of hereditary angioneurotic edema due to trauma, stress or other cause, periodic attempts to decrease or withdraw therapy should be considered.
• Danazol has been associated with several cases of benign intracranial hypertension also known as pseudotumor cerebri. Early signs and symptoms of benign intracranial hypertension include papilledema, headache, nausea and vomiting, and visual disturbances. Patients with these symptoms should be screened for papilledema and, if present, the patients should be advised to discontinue danazol immediately and be referred to a neurologist for further diagnosis and care.(14,15)

Jatenzo and Tlando carry a black box warning for blood pressure increases.(12)

For additional clinical information see Prime Therapeutics Formulary Chapter 4.2: Androgens/Anabolic Steroids.

Additional Information - Gender Dysphoria

Gender Dysphoria

Gender Dysphoria (previously named Gender Identity Disorder, sometimes used synonymously with Transsexualism) refers to “discomfort or distress that is caused by a discrepancy between a person’s gender identity and that person’s sex assigned at birth (and the associated gender role and/or primary and secondary sex characteristics)."(38) Distress can be severe, resulting in higher prevalence of depression and anxiety.(38-42) Global prevalence is difficult to ascertain, but recent estimates approximate that transgender people make up 0.3%-0.5% of the total U.S. population.(43) Treatment for gender dysphoria varies based on individualized assessment for each patient, but generally includes some combination of psychotherapy, cross-sex hormonal therapy, and sometimes surgical intervention.(37,38,43-46) The goals of treatment for Gender Dysphoria are to minimize dysphoria and help patients function in society in their desired gender role.(48)

The World Professional Association for Transgender Health (WPATH) established criteria for hormone therapy for patients with gender dysphoria. Hormone therapy must be individualized based on a patient’s goals, the risk/benefit ratio of medications, the presence of other medical conditions, and consideration of social and economic issues. Hormone therapy can provide significant comfort to patients who do not wish to make a social gender role transition or undergo surgery, or who are unable to do so.

WPATH guidelines advise that initiation of hormone therapy may be undertaken after a psychosocial assessment has been conducted and informed consent has been obtained by a qualified health professional.

The WPATH criteria for hormone therapy are as follows:

1. Persistent, well-documented gender dysphoria;
2. Capacity to make a fully informed decision and to consent for treatment;
3. Age of majority in a given country
4. If significant medical or mental health concerns are present, they must be reasonably well controlled. The presence of co-existing mental health concerns does not necessarily preclude access to feminizing/masculinizing hormones; rather, these concerns need to be managed prior to or concurrent with treatment of gender dysphoria.(49)

1

Androderm prescribing information. Allergan, Inc. May 2020.

2

AndroGel 1% prescribing information. AbbVie Inc. May 2019.

3

AndroGel 1.62% prescribing information. AbbVie Inc. May 2019.

4

Testosterone solution pump prescribing information. Cipla USA, Inc. March 2019.

5

Fortesta prescribing information. Endo Pharma, Inc. May 2020.

6

Natesto Gel prescribing information. Aytu BioScience, Inc. October 2016.

7

Striant prescribing information. Endo Pharma, Inc.  November 2016.

8

Testim prescribing information. Auxilium Pharma, Inc. May 2019.

9

Vogelxo prescribing information. Upsher-Smith Laboratories, Inc. May 2019.

10

Methyltestosterone capsule Prescribing Information.  Amneal Pharmaceuticals, LLC.  May 2019. 

11

Methitest Prescribing Information. Amneal Pharmaceuticals, LLC.  May 2019.

12

Jatenzo prescribing information. Clarus Therapeutics, Inc. June 2019.

13

Anadrol-50 prescribing information. Unimed Pharma, Inc. October 2012.

14

Danazol prescribing information. Lannett Company, Inc. April 2020.

15

Oxandrin prescribing information. Savient Pharma, Inc. April 2007.

16

Mulhall JP, Trost LW, Brannigan RE, et. al.  Evaluation and Management of Testosterone Deficiency: AUA Guideline.  American Urological Association.  2018.  Available at: https://www.auanet.org/guidelines/testosterone-deficiency-guideline  Accessed 06/30/2021

17

Klein DA, Emerick JE, Sylvester JE, et.al,. Disorders of Puberty: An Approach to Diagnosis and Management.  American Family Physician.  2017 Nov 1;96(9):590-599.  Accessed 6/30/2021. https://www.aafp.org/afp/2017/1101/p590.html

18

Maurer M, Magerl M, Ansotegui, et.al.  The International WAO/EAACI guideline for the management of hereditary angioedema – the 2017 revision and update.  World Allergy Organization Journal 11, 5(2018).  February 2018.  Available at: https://waojournal.biomedcentral.com/articles/10.1186/s40413-017-0180-1  Accessed 6/30/2021.

19

Grinspoon S and Mulligan K.  Weight Loss and Wasting in Patients Infected with Human Immunodeficiency Virus.  Clinical Infectious Diseases.  Volume 36, Supplement 2, April 2003, pS69-S78.  Available at: https://academic.oup.com/cid/article/36/Supplement_2/S69/351477  Accessed 6/30/2021.

20

Miller K, Corcoran C, Armstrong C, et al. Transdermal testosterone administration in women with acquired immunodeficiency syndrome wasting: a pilot study. J Clin Endocrinol Metab. 1998;83:2712-2725  Available at: https://academic.oup.com/jcem/article/83/8/2717/2660479  Accessed 6/30/2021.

21

Dolan S, Wilkie S, Aliabadi N, et al. Effects of testosterone administration in human immunodeficiency virus-infected women with low weight. Arch Intern Med. 2004;164:897-904.  Available at:  https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/216981  Accessed 6/30/2021.

22

Polsky B, Kotler D, Steinhart C.  HIV-Associated Wasting in the HAART Era: Guidelines for Assessment, Diagnosis, and Treatment AIDS Patient Care STDS. 2001;15(8):411-423

23

Gravholt CH, Andersen NH, Conway GS et. al. “Clinical Practice Guidelines for the Care of Girls and Women with Turner Syndrome: Proceedings from the 2016 Cincinnati International Turner Syndrome Meeting.  European Journal of Endocrinology.  2017;177(3):G1-G70.  Available at: https://eje.bioscientifica.com/view/journals/eje/177/3/EJE-17-0430.xml  Accessed 6/30/2021

24

KDIGO Clinical Practice Guideline for Anemia in Chronic Kidney Disease.  Kidney International Supplements, Journal of the International Society of Nephrology.  2012; 2(4): 279-335.  Available at: https://kdigo.org/wp-content/uploads/2016/10/KDIGO-2012-Anemia-Guideline-English.pdf  Accessed 6/30/21

25

American Congress of Obstetricians and Gynecologists (ACOG). ACOG Practice Bulletin No. 93: diagnosis and management of vulvar skin disorders. Obstet Gynecol. 2008 May;111(5):1243-53. Accessed June 25, 2020.

26

Wierman ME, Arlt W, Basson R, et. al. Androgen Therapy in Women: A Reappraisal: An Endocrine Society Clinical Practice Guideline.  The Journal of Clinical Endocrinology & Metabolism October 1, 2014;99(10) 3489-3510.  Available at:  https://pubmed.ncbi.nlm.nih.gov/25279570/ Accessed 6/30/21.

27

Burnett AL, Nehra A, Breau RH, et. al.  Erectile Dysfunction: AUA Guideline.  2018.  Available at: https://www.auanet.org/guidelines/erectile-dysfunction-(ed)-guideline  Accessed 6/30/2021.

28

Endocrine treatment of gender-dysphoric/gender-incongruent persons: an Endocrine Society Clinical Practice Guideline. Journal of Clinical Endocrinology and Metabolism. November 2017, 102(11):3869-3903

29

Myeloproliferative Neoplasms. NCCN Clinical Practice Guidelines in Oncology. Version 1.2021, page MF-3.  Accessed 8/2/2021.

30

Fox-Wheeler S, Heller L, Salata CM, et al. Evaluation of the effects of oxandrolone on malnourished HIV-positive pediatric patients. Pediatrics 1999;104:E731-E737.

31

Bhasin S, Storer TW, Asbel-Sethi N, et al. Effects of testosterone replacement with a nongenital, transdermal system, Androderm, in human immunodeficiency virus-infected men with low testosterone levels. J Clin Endocrinol Metab. 1998 Sep;83(9):3155-62.

32

Grinspoon S, Corcoran C, Askari H, et al. Effects of androgen administration in men with the AIDS wasting syndrome: a randomized, double-blind, placebo-controlled trial. Ann Intern Med 1998;129:18-26.

33

Grinspoon S, Corcoran C, Parlman K, et al. Effects of testosterone and progressive resistance training in eugonadal men with AIDS wasting. Ann Intern Med 2000;133:348-355.

34

Coodley GO, Coodley MK. A trial of testosterone therapy for HIV-associated weight loss. AIDS. 1997 Sep;11(11):1347-52.

35

Berger JR, Pall L, Hall CD, et al. Oxandrolone in AIDS-wasting myopathy. AIDS 1996;10:1657-1662.

36

Mylonakis E, Koutkia P, Grinspoon S, et al.  Diagnosis and treatment of androgen deficiency in human immunodeficiency virus-infected men and women.  Clin Infect Dis 33:857-64, 2001.  Available at: https://pubmed.ncbi.nlm.nih.gov/11512091/  Accessed 6/30/2021.

37

Tlando prescribing information. Antares Pharma, Inc.  March 2022.

38

Coleman E, Bockting W, Botzer M, et al. Standards of care for the health of transsexual, transgender, and gender-nonconforming people, version 7. Int J Transgenderism. 2012;13(4):165–232.

39

Byne W, Bradley SJ, Coleman E, et al. Report of the American Psychiatric Association task force on treatment of gender identity disorder. Arch Sex Behav. 2012;41(4):759–796.

40

Colizzi M, Costa R, Todarello O. Transsexual patients’ psychiatric comorbidity and positive effect of cross-sex hormonal treatment on mental health: Results from a longitudinal study. Psychoneuroendocrinology. 2014;39:65–73.

41

Gorin-Lazard A, Baumstarck K, Boyer L, et al. Hormonal therapy is associated with better self-esteem, mood, and quality of life in transsexuals. J Nerv Ment Dis. 2013;201(11):996– 1000.

42

Murad MH, Elamin MB, Garcia MZ, et al. Hormonal therapy and sex reassignment: a systematic review and meta-analysis of quality of life and psychosocial outcomes. Clin Endocrinol (Oxf). 2010;72(2):214–231.

43

Gates GJ. How many people are lesbian, gay, bisexual and transgender? 2011.

44

Hembree WC, Cohen-Kettenis P, Delemarre-van de Waal HA, et al. Endocrine treatment of transsexual persons: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2009;94(9):3132–3154.

45

Spack NP. Management of transgenderism. JAMA. 2013;309(5):478–484.

46

Gooren LJ. Care of transsexual persons. N Engl J Med. 2011;364(13):1251–1257.

47

Knezevich EL, Viereck LK, Drincic AT. Medical management of adult transsexual persons. Pharmacother J Hum Pharmacol Drug Ther. 2012;32(1):54–66.

48

https://www.cms.gov/Medicare/Coverage/DeterminationProcess/Downloads/Kalra_comment_01022016_b.pdf

49

Standards of care for the health of transsexual, transgender, and gender nonconforming people V7. The World Professional Association for Transgender Health. 2011.

50

Kyzatrex prescribing information. Marius Pharmaceuticals. September 2022. 

M ; N ; O ; Y

N

danazol cap

100 MG ; 200 MG ; 50 MG

M ; N ; O ; Y

Y

methyltestosterone cap

10 MG

M ; N ; O ; Y

O ; Y

oxandrolone tab

10 MG ; 2.5 MG

M ; N ; O ; Y

O ; Y

testosterone td soln

30 MG/ACT

M ; N ; O ; Y

O ; Y

Anadrol-50

oxandrolone tab  ; oxymetholone tab

10 MG ; 2.5 MG ; 50 MG

M ; N ; O ; Y

N ; O ; Y

Anadrol-50

oxymetholone tab

50 MG

M ; N ; O ; Y

N

Androderm

testosterone td patch

2 MG/24HR ; 4 MG/24HR

M ; N ; O ; Y

N

Androgel ; Androgel pump ; Fortesta ; Natesto ; Testim ; Vogelxo ; Vogelxo pump

testosterone nasal gel  ; testosterone td gel

1 % ; 1.62 % ; 10 MG/ACT ; 20.25 MG/1.25GM ; 25 MG/2.5GM ; 40.5 MG/2.5GM ; 5.5 MG/ACT ; 50 MG/5GM

M ; N ; O ; Y

M ; N ; O ; Y

Jatenzo ; Kyzatrex ; Tlando

testosterone undecanoate cap

100 MG ; 112.5 MG ; 150 MG ; 158 MG ; 198 MG ; 200 MG ; 237 MG

M ; N ; O ; Y

N

Methitest

Methyltestosterone Oral Tab 10 MG

10 MG

M ; N ; O ; Y

N

60.0

SYSTMS

30

Days

Methyltestosterone Cap 10 MG

10 MG

600.0

CAPS

30

Days

testosterone td soln

30 MG/ACT

2.0

BOTTS

30

Days

Androderm

testosterone td patch

2 MG/24HR ; 4 MG/24HR

30.0

PATCHS

30

Days

Androgel

Testosterone TD Gel 20.25 MG/1.25GM (1.62%)

20.25 MG/1.25GM

30.0

PACKTS

30

Days

Androgel

Testosterone TD Gel 25 MG/2.5GM (1%)

25 MG/2.5GM

60.0

PACKTS

30

Days

Androgel

Testosterone TD Gel 40.5 MG/2.5GM (1.62%)

40.5 MG/2.5GM

60.0

PACKTS

30

Days

Androgel ; Testim ; Vogelxo

Testosterone TD Gel 50 MG/5GM (1%)

1 % ; 50 MG/5GM

60.0

TUBES

30

Days

Androgel ; Testim ; Vogelxo

Testosterone TD Gel 50 MG/5GM (1%)

1 % ; 50 MG/5GM

60.0

PACKTS

30

Days

Androgel ; Testim ; Vogelxo

Testosterone TD Gel 50 MG/5GM (1%)

1 % ; 50 MG/5GM

60.0

PACKTS

30

Days

Androgel pump

Testosterone TD Gel 20.25 MG/ACT (1.62%)

1.62 %

2.0

BOTTS

30

Days

Fortesta

Testosterone TD Gel 10MG/ACT (2%)

10 MG/ACT

2.0

PUMPS

30

Days

Jatenzo

Testosterone Undecanoate Cap 158 MG

158 MG

120.0

CAPS

30

Days

Jatenzo

Testosterone Undecanoate Cap 198 MG

198 MG

120.0

CAPS

30

Days

Jatenzo

Testosterone Undecanoate Cap 237 MG

237 MG

60.0

CAPS

30

Days

Kyzatrex

Testosterone Undecanoate Cap

150 MG

120.0

CAPS

30

Days

Kyzatrex

Testosterone Undecanoate Cap

200 MG

120.0

CAPS

30

Days

Kyzatrex

Testosterone Undecanoate Cap

100 MG

60.0

CAPS

30

Days

Methitest

Methyltestosterone Oral Tab 10 MG

10 MG

600.0

TABS

30

Days

Natesto

Testosterone Nasal Gel 5.5 MG/ACT

5.5 MG/ACT

3.0

PUMPS

30

Days

Tlando

Testosterone Undecanoate Cap

112.5 MG

120.0

CAPS

30

Days

Vogelxo pump

Testosterone TD Gel 12.5 MG/ACT (1%)

1 %

4.0

BOTTS

30

Days

Vogelxo pump

Testosterone TD Gel 12.5 MG/ACT (1%)

1 %

4.0

BOTTS

30

Days

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Anadrol-50

oxymetholone tab

50 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Anadrol-50

oxandrolone tab  ; oxymetholone tab

10 MG ; 2.5 MG ; 50 MG

Androderm

testosterone td patch

2 MG/24HR ; 4 MG/24HR

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Androgel ; Androgel pump ; Fortesta ; Natesto ; Testim ; Vogelxo ; Vogelxo pump

testosterone nasal gel  ; testosterone td gel

1 % ; 1.62 % ; 10 MG/ACT ; 20.25 MG/1.25GM ; 25 MG/2.5GM ; 40.5 MG/2.5GM ; 5.5 MG/ACT ; 50 MG/5GM

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

danazol cap

100 MG ; 200 MG ; 50 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Jatenzo ; Kyzatrex ; Tlando

testosterone undecanoate cap

100 MG ; 112.5 MG ; 150 MG ; 158 MG ; 198 MG ; 200 MG ; 237 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Methitest

Methyltestosterone Oral Tab 10 MG

10 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

methyltestosterone cap

10 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

oxandrolone tab

10 MG ; 2.5 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

testosterone td soln

30 MG/ACT

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Androderm

testosterone td patch

2 MG/24HR ; 4 MG/24HR

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Androgel pump

Testosterone TD Gel 20.25 MG/ACT (1.62%)

1.62 %

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Androgel

Testosterone TD Gel 20.25 MG/1.25GM (1.62%)

20.25 MG/1.25GM

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Androgel

Testosterone TD Gel 25 MG/2.5GM (1%)

25 MG/2.5GM

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Androgel

Testosterone TD Gel 40.5 MG/2.5GM (1.62%)

40.5 MG/2.5GM

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Androgel ; Testim ; Vogelxo

Testosterone TD Gel 50 MG/5GM (1%)

1 % ; 50 MG/5GM

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Fortesta

Testosterone TD Gel 10MG/ACT (2%)

10 MG/ACT

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Jatenzo

Testosterone Undecanoate Cap 158 MG

158 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Jatenzo

Testosterone Undecanoate Cap 198 MG

198 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Jatenzo

Testosterone Undecanoate Cap 237 MG

237 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Kyzatrex

Testosterone Undecanoate Cap

100 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Kyzatrex

Testosterone Undecanoate Cap

150 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Kyzatrex

Testosterone Undecanoate Cap

200 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Methitest

Methyltestosterone Oral Tab 10 MG

10 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Methyltestosterone Cap 10 MG

10 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Natesto

Testosterone Nasal Gel 5.5 MG/ACT

5.5 MG/ACT

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Androgel ; Testim ; Vogelxo

Testosterone TD Gel 50 MG/5GM (1%)

1 % ; 50 MG/5GM

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Androgel ; Testim ; Vogelxo

Testosterone TD Gel 50 MG/5GM (1%)

1 % ; 50 MG/5GM

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Vogelxo pump

Testosterone TD Gel 12.5 MG/ACT (1%)

1 %

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

testosterone td soln

30 MG/ACT

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Tlando

Testosterone Undecanoate Cap

112.5 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Vogelxo pump

Testosterone TD Gel 12.5 MG/ACT (1%)

1 %

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Prior Authorization with Quantity Limit - Through Generic

Initial Evaluation

Target Agent(s) will be approved when ALL of the following are met: 

1. ONE of the following:
   1. If the request is for Androderm, Androgel, Testosterone gel, testosterone solution, Fortesta, Natesto, Striant, Testim, or Vogelxo, the patient has a diagnosis of ONE of the following:
      1. Primary or secondary (hypogonadotropic) hypogonadism OR
      2. AIDS/HIV-associated wasting syndrome OR
      3. Gender identity disorder (GID), gender dysphoria, or gender incongruence OR
   2. If the request is for Anadrol-50, the patient has a diagnosis of anemia OR
   3. If the request is for danazol, the patient has a diagnosis of ONE of the following:
      1. Endometriosis amenable to hormone management OR
      2. Angioedema, and will be taking for the prevention of attacks OR
      3. Myeloproliferative neoplasms OR
      4. Fibrocystic breast disease OR
   4. If the request is for oxandrolone, the requested agent will be used for ONE of the following:
      1. To promote weight gain OR
      2. Bone pain frequently accompanying osteoporosis OR
      3. AIDS/HIV-associated wasting syndrome OR
      4. Turner syndrome OR
      5. Gender identity disorder (GID), gender dysphoria, or gender incongruence OR
   5. If the request is for Jatenzo, Kyzatrex or Tlando, the patient has a diagnosis of primary or secondary (hypogonadotropic) hypogonadism OR
   6. If the request is for methyltestosterone or Methitest, the patient has a diagnosis of ONE of the following:
      1. Primary or secondary (hypogonadotropic) hypogonadism OR
      2. Metastatic/inoperable breast cancer OR
      3. Delayed puberty in an adolescent AND
2. ONE of the following:
   1. If the request is for primary or secondary hypogonadism, then ONE of the following:
      1. The patient is NOT currently receiving testosterone replacement therapy AND meets BOTH of the following:
         1. The patient has a sign or symptom of hypogonadism AND
         2. The patient has ONE of the following pretreatment levels:
            1. Total serum testosterone level that is below the testing laboratory’s normal range or is less than 300 ng/dL OR
            2. Free serum testosterone level that is below the testing laboratory’s normal range OR
      2. The patient is currently receiving testosterone replacement therapy AND has ONE of the following current levels:
         1. Total serum testosterone level that is within OR below the testing laboratory’s normal range OR is less than 300 ng/dL OR
         2. Free serum testosterone level that is within OR below the testing laboratory’s normal range OR
   2. If the request is for AIDS/HIV-associated wasting syndrome, BOTH of the following:
      1. ONE of the following:
         1. The patient has had weight loss that meets ONE of the following:
            1. 10% within 12 months OR
            2. 7.5% within 6 months OR
         2. The patient has a body cell mass (BCM) loss greater than or equal to 5% within 6 months OR
         3. The patient’s sex is male and has BCM less than 35% of total body weight and body mass index (BMI) less than 27 kg/m2 OR
         4. The patient’s sex is female and has BCM less than 23% of total body weight and BMI less than 27 kg/m2 OR
         5. The prescriber has provided information that the patient's BCM less than 35% or less than 23% and BMI less than 27 kg/m2 are medically appropriate for diagnosing AIDS wasting/cachexia for the patient's sex OR
         6. The patient’s BMI is less than 20 kg/m² AND
      2. All other causes of weight loss have been ruled out OR
   3. If the request is for gender identity disorder (GID), gender dysphoria, or gender incongruence, then ALL of the following:
      1. The patient is an adult (18 years of age or older) AND
      2. The patient has received evaluation from TWO qualified mental health professionals who have independently assessed the patient and ALL of the following:
         1. At least one of the evaluating professionals must have a doctoral degree (PhD, MD, Ed.B, D.Sc, D.S.W. or Psy.D) and be capable of adequately evaluating co-morbid psychiatric conditions AND
         2. One evaluation should be from a person who has only had an evaluative role with the patient AND
         3. The evaluations document that the patient has demonstrated a knowledge and understanding of the expected outcomes of cross-sex hormone treatment, as well as the medical and social risks and benefits AND
      3. ONE of the following:
         1. The patient does not suffer from psychiatric comorbidity that interferes with the diagnostic work-up or treatment OR
         2. If the patient has significant medical or mental health issues present, they must be reasonably well controlled and noted in the medical documentation submitted AND
      4. For patients new to therapy, the patient has completed at least 12 continuous months of living in a congruent gender role with his/her gender identity (real life experience) prior to cross-sex hormone treatment (this should be noted in medical documentation submitted including start/end dates)​​​ OR
   4. If the request is for delayed puberty in an adolescent, ONE of the following:
      1. The patient’s sex is male OR
      2. The prescriber has provided information that the requested agent is medically appropriate for the patient’s sex OR
   5. If the request is for metastatic/inoperable breast cancer, ONE of the following:
      1. The patient’s sex is female OR
      2. The prescriber has provided information that the requested agent is medically appropriate for the patient’s sex OR
   6. If the request is for anemia, the anemia is associated with ONE of the following:
      1. Deficient red cell production OR
      2. Acquired aplastic anemia OR
      3. Congenital aplastic anemia OR
      4. Myelofibrosis OR
      5. Hypoplastic anemia due to the administration of myelotoxic drugs OR
   7. The request is for fibrocystic breast disease OR
   8. The request is for endometriosis amenable to hormone management OR
   1. The request is for the prevention of attacks of angioedema OR
   10. If the request is for myeloproliferative neoplasms, ONE of the following:
       1. Patient has a serum EPO greater than or equal to 500 mU/mL OR
       2. Patient has a serum EPO less than 500 mU/mL and no response or loss of response to erythropoietic stimulating agents OR
   11. If the request is for Turner syndrome, the agent will be used in conjunction with growth hormone (GH) OR
   50. The request is for bone pain frequently accompanying osteoporosis OR
   1000. If the request is to promote weight gain, the patient has ONE of the following:
         1. Weight loss following extensive surgery OR
         2. Chronic infections OR
         3. Severe trauma OR
         4. Failure to gain or maintain normal weight without definite pathophysiologic reasons OR
         5. A prolonged administration of corticosteroids AND
3. The patient does NOT have any FDA labeled contraindications to the requested agent AND
4. If the request is for one of the following brand agents, then ONE of the following:
   1. The patient has tried and had an inadequate response to a generic androgen or anabolic steroid agent that is supported for use for the requested indication OR
   2. The patient has an intolerance or hypersensitivity to a generic androgen or anabolic steroid agent that is supported for use for the requested indication that is not expected to occur with the brand agent OR
   3. The patient has an FDA labeled contraindication to ALL generic androgen or anabolic steroid agents that is supported for use for the requested indication that is not expected to occur with the brand agent AND

5. ONE of the following:
   1. The patient will NOT be using the requested agent in combination with another androgen or anabolic steroid agent OR
   2. The prescriber has provided information in support of therapy with more than one androgen or anabolic steroid agent

Length of Approval: 12 months 

NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria.

Renewal Evaluation

Target Agent will be approved when ALL of the following are met:

1. The patient has been previously approved for the requested agent through the plan’s Prior Authorization process AND
2. The patient has had clinical benefit with the requested agent AND
3. ONE of the following:
   1. The patient has a diagnosis of primary or secondary hypogonadism and the patient’s current testosterone level is ONE of the following:
      1. Total serum testosterone level that is within OR below the testing laboratory’s normal range OR is less than 300 ng/dL OR
      2. Free serum testosterone level that is within OR below the testing laboratory’s normal range OR
   2. The patient has a diagnosis of gender identity disorder (GID), gender dysphoria, or gender incongruence AND BOTH of the following:
      1. The patient is being monitored at least once per year AND
      2. ONE of the following:
         1. The patient's current testosterone level is ONE of the following:
            1. Total serum testosterone level that is within OR below the testing laboratory's normal range OR is less than 300 ng/dL OR
            2. Free serum testosterone level that is within OR below the testing laboratory's normal range OR
         2. The prescriber has provided information in support of continuing therapy with the patient's current testosterone level OR
   3. The patient has a diagnosis other than primary or secondary hypogonadism, gender identity disorder (GID), gender dysphoria, or gender incongruence AND
4. The patient does NOT have any FDA labeled contraindications to the requested agent AND
5. If the request is for one of the following brand agents, then ONE of the following:
   1. The patient has tried and had an inadequate response to a generic androgen or anabolic steroid agent that is supported for use for the requested indication OR
   2. The patient has an intolerance or hypersensitivity to a generic androgen or anabolic steroid agent that is supported for use for the requested indication that is not expected to occur with the brand agent OR
   3. The patient has an FDA labeled contraindication to ALL generic androgen or anabolic steroid agents that is supported for use for the requested indication that is not expected to occur with the brand agent AND

6. ONE of the following:
   1. The patient will NOT be using the requested agent in combination with another androgen or anabolic steroid agent OR
   2. The prescriber has provided information in support of therapy with more than one androgen or anabolic steroid agent

Length of Approval: 12 months

NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria.

QL with PA

Quantity Limit for the Target Agent(s) will be approved when ONE of the following is met:

1. The requested agent does NOT have a program quantity limit OR
2. The requested quantity (dose) does NOT exceed the program quantity limit OR
3. ALL of the following:
   1. The requested quantity (dose) is greater than the program quantity limit AND
   2. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication AND
   3. The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does not exceed the program quantity limit OR
4. ALL of the following:
   1. The requested quantity (dose) is greater than the program quantity limit AND
   2. The requested quantity (dose) is greater than the maximum FDA labeled dose for the requested indication AND
   3. The prescriber has provided information in support of therapy with a higher dose for the requested indication

Length of Approval: 12 months