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Androgens and Anabolic Steroids Prior Authorization with Quantity Limit 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 does not apply to MN BPI.
This program will apply only to the Oral and Topical Androgen and Anabolic Steroids.
POLICY REVIEW CYCLE
Effective Date |
Date of Origin |
07-01-2024 |
|
FDA APPROVED INDICATIONS AND DOSAGE
Agent(s) |
FDA Indication(s) |
Notes |
Ref# |
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:
|
|
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:
|
*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:
|
*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:
|
|
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:
|
|
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:
|
|
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:
|
|
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:
|
*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:
|
*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:
|
|
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) Limitations of use:
|
*generic available |
9 |
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:
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)
|
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:
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)
Aveed carries a black box warning concerning serious pulmonary oil microembolism (POME) reactions and anaphylaxis.(20)
Danazol carries a black box warning for several reasons.(14,15)
Jatenzo, Kyzatrex, and Xyosted carry a black box warning for blood pressure increases.(12,17,43)
|
REFERENCES
Number |
Reference |
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 |
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. |
POLICY AGENT SUMMARY PRIOR AUTHORIZATION
Target Brand Agent(s) |
Target Generic Agent(s) |
Strength |
Targeted MSC |
Available MSC |
Final Age Limit |
Preferred Status |
|
||||||
|
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 |
|
|
POLICY AGENT SUMMARY QUANTITY LIMIT
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
QL Amount |
Dose Form |
Day Supply |
Duration |
Addtl QL Info |
Allowed Exceptions |
Targeted NDCs When Exclusions Exist |
|
|||||||||
|
|
|
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 |
|
|
|
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 |
|
|
|
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 |
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 |
|
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 CLINICAL CRITERIA FOR APPROVAL
Module |
Clinical Criteria for Approval |
||||||
Prior Authorization with Quantity Limit - Through Generic |
TARGET AGENT(S) Androderm (testosterone patch) * generic available 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. *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:
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: Initial: up to 6 months (delayed puberty only), up to 12 months (all other indications). Renewal: up to 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.
ALBP _ Commercial _ CS _ Androgens_and_Anabolic_Steroids_PAQL _ProgSum_ 07-01-2024 _ © Copyright Prime Therapeutics LLC. May 2024 All Rights Reserved