Effective Date

Date of Origin   

07-01-2024           

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

1

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   

2,3

danazol*

Capsule

Endometriosis amenable to hormone management

Prevention of attacks of angioedema of all types (cutaneous, abdominal, laryngeal) in males and females

*generic available

14

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     

5

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.

12

Kyzatrex™

(testosterone undecanoate)

Capsules

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.  These men usually have low serum testosterone concentrations and gonadotropins (follicle stimulating hormone (FSH), luteinizing hormone (LH)) above the normal range

Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation.  These men have low serum testosterone concentrations but have gonadotropins in the normal or low range.

Limitations of use:

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

43

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

Limitation of use:

• Safety and efficacy of methyltestosterone in men with "age-related hypogonadism" (also referred to as "late-onset hypogonadism") have not been established.

11

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

10

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

6

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
• Topical testosterone products may have different doses, strengths, or application instructions that may result in different systemic exposure

*generic available     

8

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

4

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.

44

Vogelxo®, Testosterone Gel*

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)

Limitations of use:

• Safety and efficacy of Vogelxo in men with "age-related hypogonadism" (also referred to as "late-onset hypogonadism") have not been established.
• Safety and efficacy of Vogelxo in males less than 18 years old have not been established.
• Topical testosterone products may have different doses, strengths, or application instructions that may result in different systemic exposure.

*generic available    

9

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:

• 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.(21)

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.(22)

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.(23)

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.(21) 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(36), testosterone enanthate(37-39), and testosterone cypionate.(41) Up to 60% of women suffering from AIDS wasting are androgen deficient.(24) The use of transdermal testosterone to treat AIDS wasting in women is supported by literature.(25,26)

The diagnosis of HIV wasting requires one of the following:(27)

• 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/m^2
• In men: BCM less than 35% of total body weight and BMI less than 27 kg/m^2
• In women: BCM less than 23% of total body weight and BMI less than 27 kg/m^2

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.(29)

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 (ED). 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.(32)

Off Label Use: Myeloproliferative Neoplasms

Danazol, immunomodulatory agents (lenalidomide or thalidomide) with or without prednisone or luspatercept are recommended for the treatment of anemia in patients with serum epoetin levels greater than or equal to 500 mU/mL. Patients with a serum EPO less than 500mU/mL that have had no or loss of reqponse with erythropoetin stimulating agents should be managed as a patient with an EPO level greater than or equal to 500 mU/mL.(34)

Off Label Use : Gender Identity Disorder / Gender Dysphoria / Gender Incongruence

The Endocrine Society states the following for the diagnosis and treatment of gender identity disorder (GID) / gender dysphoria / gender incongruence:

• Recommend that a diagnosis be made by a mental health professional (MHP) and/or trained physicians. For children and adolescents, the MHP must also have training in child and adolescent developmental psychopathology
• Recommend all transsexual individuals should be informed and counseled regarding option for fertility preservation prior to initiating puberty suppression in adolescents and prior to treating with hormonal therapy of the affirmed gender in both adolescents and adults
• For the treatment of adolescents
  • Recommend for adolescents initiating treatment with sex hormones that the individual have sufficient mental capacity to give informed consent, which most adolescents have by age 16
  • Recognize that there may be compelling reasons to initiate sex hormone treatment prior to the age of 16 years in some adolescents even though there are limited studies of gender-affirming hormone treatment administered before age 13.5 -14 years of age
  • Suggest monitoring of clinical pubertal development every 3-6 months and laboratory parameters every 6-12 months during sex hormone treatment
  • Criteria for treatment with gender-affirming sex hormone therapy
    • A qualified mental health professional has confirmed:
      • The persistence of gender dysphoria
      • 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 sex hormone treatment
      • The adolescent has sufficient mental capacity (which most adolescents have by age 16 year) to estimate the consequences of this (partly) irreversible treatment, weight the benefits and risks, and give informed consent to this (partly) irreversible treatment
    • The adolescent:
      • Has been informed of the (irreversible) effects and side effects of treatment (including potential loss of fertility) and options to preserve fertility)
      • Has given informed consent and (particularly when the adolescent has not reached the age of legal medical consent, depending on applicable legislation) the parents or other caretakers or guardians have consented to the treatment and are involved in supporting the adolescent throughout the treatment process
    • A pediatric endocrinologist or other clinician experience in pubertal induction:
      • Agrees with the indication for sex hormone treatment
      • Has confirmed that there are no medical contraindications to sex hormone treatment
• For the treatment of adults
  • Recommend clinicians evaluate and address medical conditions that can be exacerbated by hormone depletion and treatment with sex hormones before beginning treatment
  • Suggest clinicians measure hormone levels during treatment to ensure that endogenous sex steroids are suppressed and administered sex hormones are maintained in the normal physiologic range for the affirmed gender
  • Suggest regular clinical evaluation for physical changes and potential adverse changes in response to sex steroid hormones and laboratory monitoring of sex hormone levels every 3 months during the first year of hormone therapy for transgender males and females and then once or twice yearly
  • Criteria for treatment with gender-affirming hormone therapy
    • Persistent, well-documented gender dysphoria/gender incongruence
    • The capacity to make a fully informed decision and to consent for treatment
    • The age of majority in a given country
    • Mental health concerns, if present, must be reasonably well controlled

Clinical studies have demonstrated the efficacy of several different androgen preparations to induce masculinization in transgender males, including parenteral testosterone enanthate, cypionate, and undecanoate, as well as transdermal testosterone.(33)

Safety

AndroGel testosterone solution, Fortesta, Testim, and Vogelxo carry a boxed warning about secondary exposure to testosterone.(2,4,5,8,9)

• 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.

Aveed carries a black box warning concerning serious pulmonary oil microembolism (POME) reactions and anaphylaxis.(20)

• Serious POME reactions, involving urge to cough, dyspnea, throat tightening, chest pain, dizziness, and syncope; and episodes of anaphylaxis, including life-threatening reactions, have been reported to occur during or immediately after the administration of testosterone undecanoate injection. These reactions can occur after any injection of testosterone undecanoate during the course of therapy, including after the first dose.
• Following each injection of Aveed, observe patients in the healthcare setting for 30 minutes in order to provide appropriate medical treatment in the event of serious POME reactions or anaphylaxis.
• Aveed is available only through a restricted program called the Aveed REMS Program.

Danazol carries a black box warning for several reasons.(14,15)

• 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.

Jatenzo, Kyzatrex, and Xyosted carry a black box warning for blood pressure increases.(12,17,43)

• Can cause blood pressure (BP) increases that can increase the risk of major adverse cardiovascular events (MACE), including non-fatal myocardial infarction, non-fatal stroke and cardiovascular death.
• Before initiating, consider the patient’s baseline cardiovascular risk and ensure blood pressure is adequately controlled.
• Periodically monitor for and treat new-onset hypertension or exacerbations of pre-existing hypertension and re-evaluate whether the benefits outweigh its risks in patients who develop cardiovascular risk factors or cardiovascular disease on treatment.
• Due to this risk, use only for the treatment of men with hypogonadal conditions associated with structural or genetic etiologies.

1

Androderm prescribing information. Allergan, Inc. May 2020.

2

AndroGel 1% prescribing information. Encube Ethicals Private Limited November 2021

3

AndroGel 1.62% prescribing information. AbbVie Inc. November 2020.

4

Testosterone solution pump prescribing information. Cipla USA, Inc. August 2020.

5

Fortesta prescribing information. Endo Pharma, Inc. January 2022.

6

Natesto Gel prescribing information. Acerus Pharmaceuticals Corporation. December 2022.

7

Reference no longer used.

8

Testim prescribing information. Endo Pharmaceuticals, Inc. August 2021.

9

Vogelxo prescribing information. Upsher-Smith Laboratories, Inc. December 2022.

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

Reference no longer used.

14

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

15

Reference no longer used. 

16

Testosterone enanthate prescribing information. Hikma Pharmaceuticals USA, Inc. November 2021.

17

Xyosted prescribing information. Antares Pharma, Inc. November 2019.

18

Depo-Testosterone prescribing information. Pharmacia and Upjohn Company LLC. August 2020.

19

Testopel prescribing information. Endo Pharmaceuticals, Inc. August 2018.

20

Aveed prescribing information. Endo Pharmaceutical Solutions Inc. August 2021.

21

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

22

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.  https://www.aafp.org/afp/2017/1101/p590.html#sec-5

23

Maurer M, Magerl M, Ansotegui, et.al.  The International WAO/EAACI guideline for the management of hereditary angioedema – the 2021 revision and update.  European Journal of Allergy and Clinical Immunology. 77, 7(2022).  July 2022. https://onlinelibrary.wiley.com/doi/full/10.1111/all.15214 

24

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. https://academic.oup.com/cid/article/36/Supplement_2/S69/351477  

25

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 https://academic.oup.com/jcem/article/83/8/2717/2660479

26

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. https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/216981 

27

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

28

Reference no longer used.

29

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

30

Reference no longer used.

31

Reference no longer used.

32

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

33

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  https://academic.oup.com/jcem/article/102/11/3869/4157558
Correction: Journal of Clinical Endocrinology and Metabolism.  July 2018, 103(7): 2758-2759.  https://academic.oup.com/jcem/article/103/7/2758/5036711

34

Myeloproliferative Neoplasms. NCCN Clinical Practice Guidelines in Oncology. Version 1.2024, pages MF-3, MS-25-28.

35

Reference no longer used. 

36

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.

37

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.

38

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.

39

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

40

Reference no longer used. 

41

Primary Care of Veterans with HIV.  Androgen Deficiency. US Department of Veteran Affairs. Page 331. 2019. https://www.hiv.va.gov/pdf/pcm-manual.pdf

42

Reference no longer used.

43

Kyzatrex prescribing information.  Marius Pharmaceuticals.  September 2022.

44

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

danazol cap

100 MG ; 200 MG ; 50 MG

Y

Y

danazol cap

100 MG ; 200 MG ; 50 MG

M ; N ; O

Y

methyltestosterone cap

10 MG

M ; N ; O

Y

methyltestosterone cap

10 MG

Y

Y

Methitest

Methyltestosterone Oral Tab 10 MG

10 MG

Y

N

Methitest

Methyltestosterone Oral Tab 10 MG

10 MG

M ; N ; O

N

oxandrolone tab

10 MG ; 2.5 MG

M ; N ; O ; Y

N ; Y

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

Y

M ; N ; O ; Y

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

M ; N ; O ; Y

Androderm

testosterone td patch

2 MG/24HR ; 4 MG/24HR

Y

N

Androderm

testosterone td patch

2 MG/24HR ; 4 MG/24HR

M ; N ; O

N

testosterone td soln

30 MG/ACT

Y

Y

testosterone td soln

30 MG/ACT

M ; N ; O

Y

Jatenzo ; Kyzatrex ; Tlando

testosterone undecanoate cap

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

Y

N

Jatenzo ; Kyzatrex ; Tlando

testosterone undecanoate cap

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

M ; N ; O

N

60

Systems

30

DAYS

Methyltestosterone Cap 10 MG

10 MG

600

Capsules

30

DAYS

testosterone td soln

30 MG/ACT

2

Bottles

30

DAYS

Androderm

testosterone td patch

2 MG/24HR ; 4 MG/24HR

30

Patches

30

DAYS

Androgel

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

20.25 MG/1.25GM

30

Packets

30

DAYS

Androgel

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

25 MG/2.5GM

60

Packets

30

DAYS

Androgel

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

40.5 MG/2.5GM

60

Packets

30

DAYS

Androgel ; Testim ; Vogelxo

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

1 % ; 50 MG/5GM

60

Packets

30

DAYS

Androgel ; Testim ; Vogelxo

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

1 % ; 50 MG/5GM

60

Tubes

30

DAYS

Androgel ; Testim ; Vogelxo

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

1 % ; 50 MG/5GM

60

Packets

30

DAYS

Androgel pump

Testosterone TD Gel 20.25 MG/ACT (1.62%)

1.62 %

2

Bottles

30

DAYS

Fortesta

Testosterone TD Gel 10MG/ACT (2%)

10 MG/ACT

2

30

DAYS

Jatenzo

Testosterone Undecanoate Cap 158 MG

158 MG

120

Capsules

30

DAYS

Jatenzo

Testosterone Undecanoate Cap 198 MG

198 MG

120

Capsules

30

DAYS

Jatenzo

Testosterone Undecanoate Cap 237 MG

237 MG

60

Capsules

30

DAYS

Kyzatrex

Testosterone Undecanoate Cap

100 MG

60

Capsules

30

DAYS

Kyzatrex

Testosterone Undecanoate Cap

150 MG

120

Capsules

30

DAYS

Kyzatrex

Testosterone Undecanoate Cap

200 MG

120

Capsules

30

DAYS

Methitest

Methyltestosterone Oral Tab 10 MG

10 MG

600

Tablets

30

DAYS

Natesto

Testosterone Nasal Gel 5.5 MG/ACT

5.5 MG/ACT

3

30

DAYS

Tlando

Testosterone Undecanoate Cap

112.5  ; 112.5 MG

120

Capsules

30

DAYS

Vogelxo pump

Testosterone TD Gel 12.5 MG/ACT (1%)

1 %

4

Bottles

30

DAYS

Vogelxo pump

Testosterone TD Gel 12.5 MG/ACT (1%)

1 %

4

Bottles

30

DAYS

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

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

danazol cap

100 MG ; 200 MG ; 50 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

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

testosterone td soln

30 MG/ACT

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

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

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

Jatenzo ; Kyzatrex ; Tlando

testosterone undecanoate cap

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

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

Jatenzo ; Kyzatrex ; Tlando

testosterone undecanoate cap

100 MG ; 112.5  ; 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

Methitest

Methyltestosterone Oral Tab 10 MG

10 MG

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

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

testosterone td soln

30 MG/ACT

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

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

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

Androgel pump

Testosterone TD Gel 20.25 MG/ACT (1.62%)

1.62 %

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

Natesto

Testosterone Nasal Gel 5.5 MG/ACT

5.5 MG/ACT

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

Tlando

Testosterone Undecanoate Cap

112.5  ; 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

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

TARGET AGENT(S)

Androderm (testosterone patch)
Androgel (testosterone gel)
danazol*
Fortesta (testosterone gel)
Jatenzo (testosterone undecanoate)
Kyzatrex (testosterone undecanoate)
Methitest (methyltestosterone)
Natesto (testosterone)
Testim (testosterone gel)
TLANDO (testosterone undecanoate)
Voxelgo (testosterone gel)

* generic available

Initial Evaluation

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

1. ONE of the following:
   1. A requested agent is eligbile for continuation of therapy AND ONE of the following:

1. 1. 1. The patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days OR
      2. The prescriber states the patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed OR
   2. BOTH of the following:
      1. ONE of the following:
         1. If the request is for Androderm, Androgel, Testosterone gel, testosterone solution, Fortesta, Natesto, 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 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
         3. If the request is for Jatenzo, Kyzatrex or Tlando, the patient has a diagnosis of primary or secondary (hypogonadotropic) hypogonadism OR
         4. 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. There is support 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. There is support 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. There is support 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.  prolonged administration of corticosteroids AND
2. The patient does NOT have any FDA labeled contraindications to the requested agent AND
3. 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. There is support for 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.

*Step therapy requirement may not apply if a prior health plan paid for the medication - documentation of a paid claim may be required.

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 [Note: patients not previously approved for the requested agent will require initial evaluation review] 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. There is support for 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 for the requested indication OR
   2. There is support for 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) exceeds 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) exceeds the program quantity limit AND
   2. The requested quantity (dose) exceeds the maximum FDA labeled dose for the requested indication AND
   3. There is support of therapy with a higher dose for the requested indication

Length of Approval: Initial: up to 6 months (delayed puberty only), up to 12 months (all other indications). Renewal: up to 12 months