Asset Publisher
Androgens and Anabolic Steroids Prior Authorization with Quantity Limit Through Generic Program Summary
Policy Number: PH-1000
This program applies to Blue Partner, Commercial, GenPlus, NetResults A series, SourceRx and Health Insurance Marketplace formularies.
This program will apply only to the Oral and Topical Androgen and Anabolic Steroids.
Quantity limits only apply to Topical Androgen Agents.
POLICY REVIEW CYCLE
Effective Date |
Date of Origin |
4/1/2023 |
|
FDA APPROVED INDICATIONS AND DOSAGE
Agent(s) |
FDA Indication(s) |
Notes |
Ref# |
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 |
|
See package insert for FDA prescribing information: https://dailymed.nlm.nih.gov/dailymed/index.cfm
CLINICAL RATIONALE
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)
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)
|
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.
Anadrol-50 and Oxandrin, carry a black box warning for several reasons.
Danazol carries a black box warning for several reasons.
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:
|
REFERENCES
Number |
Reference |
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. |
POLICY AGENT SUMMARY PRIOR AUTHORIZATION
Target Brand Agent(s) |
Target Generic Agent(s) |
Strength |
Targeted MSC |
Available MSC |
Preferred Status |
Effective Date |
|
||||||
|
|
|
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 |
|
|
POLICY AGENT SUMMARY QUANTITY LIMIT
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
QL Amount |
Dose Form |
Days Supply |
Duration |
Addtl QL Info |
Allowed Exceptions |
Targeted NDCs When Exclusions Exist |
Effective Date |
|
||||||||||
|
|
|
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 |
|
|
|
|
CLIENT SUMMARY – PRIOR AUTHORIZATION
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
Client Formulary |
|
|
|
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 |
CLIENT SUMMARY – QUANTITY LIMITS
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
Client Formulary |
|
|
|
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 CLINICAL CRITERIA FOR APPROVAL
Module |
Clinical Criteria for Approval |
||||
Prior Authorization with Quantity Limit - Through Generic |
Initial Evaluation Target Agent(s) will be approved when ALL of the following are met:
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:
Length of Approval: 12 months NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria. |
QUANTITY LIMIT CLINICAL CRITERIA FOR APPROVAL
Module |
Clinical Criteria for Approval |
QL with PA |
Quantity Limit for the Target Agent(s) will be approved when ONE of the following is met:
Length of Approval: 12 months |
This pharmacy policy is not an authorization, certification, explanation of benefits or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All pharmacy policies are based on (i) information in FDA approved package inserts (and black box warning, alerts, or other information disseminated by the FDA as applicable); (ii) research of current medical and pharmacy literature; and/or (iii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.
The purpose of Blue Cross and Blue Shield of Alabama’s pharmacy policies are to provide a guide to coverage. Pharmacy policies are not intended to dictate to physicians how to practice medicine. Physicians should exercise their medical judgment in providing the care they feel is most appropriate for their patients.
Neither this policy, nor the successful adjudication of a pharmacy claim, is guarantee of payment.
Commercial _ CS _ Androgens and Anabolic Steroids Prior Authorization with Quantity Limit _ProgSum_ 4/1/2023