Subject: Testosterone Products TGC PA 1210-A P03-2026

Drug

TESTOSTERONE PRODUCTS

ANDROGEL  (testosterone)

AZMIRO  (testosterone cypionate)

Testosterone enanthate (generic Delatestryl – brand unavailable)  (testosterone enanthate)

DEPO-TESTOSTERONE  (testosterone cypionate)

FORTESTA  (testosterone)

JATENZO  (testosterone undecanoate)

KYZATREX  (testosterone undecanoate)

NATESTO  (testosterone)

TESTIM  (testosterone)

TESTOPEL  (testosterone)

testosterone (all brands)  (testosterone)

TLANDO  (testosterone undecanoate)

UNDECATREX  (testosterone undecanoate)

VOGELXO  (testosterone)

XYOSTED  (testosterone enanthate)

Policy:

Indications

FDA-approved Indications

Androgel, Fortesta, Natesto, Testim, Testosterone Topical Gel, Testosterone Topical Solution, Vogelxo

Topical and nasal testosterone products are indicated 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 conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter’s 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 testosterone serum concentrations but have gonadotropins in the normal or low range.

Limitations of Use:

·        Safety and efficacy of topical and nasal testosterone products in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established.

·        Safety and efficacy of topical and nasal testosterone products 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.

Azmiro

Azmiro is indicated for testosterone replacement therapy in males in conditions associated with a deficiency or absence of endogenous testosterone:

•       Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchiectomy, Klinefelter’s syndrome, or toxic damage from alcohol or heavy metals, 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 testosterone serum concentrations but have gonadotropins in the normal or low range.

Limitations of Use:

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

•       Safety and efficacy of Azmiro in pediatric patients below the age of 12 years have not been established.

Depo-Testosterone

Depo-Testosterone Injection is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone.

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

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

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

Jatenzo, Kyzatrex, Tlando, Undecatrex

Testosterone undecanoate is indicated for 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 conditions such as 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 testosterone serum concentrations but have gonadotropins in the normal or low range.

Limitations of Use:

·        Safety and efficacy of testosterone undecanoate in males less than 18 years old have not been established.

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

Testopel

Males

Androgens are indicated for replacement therapy in conditions associated with a deficiency or absence of endogenous testosterone.

·        Primary hypogonadism (congenital or acquired) - testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testes syndrome; or orchiectomy.

·        Hypogonadotropic hypogonadism (congenital or acquired) - gonadotropic LHRH deficiency, or pituitary - hypothalamic injury from tumors, trauma or radiation.

If the above conditions occur prior to puberty, androgen replacement therapy will be needed during the adolescent years for development of secondary sex characteristics. Prolonged androgen treatment will be required to maintain sexual characteristics in these and other males who develop testosterone deficiency after puberty.

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

·        Androgens may be used to stimulate puberty in carefully selected males with clearly delayed puberty. These patients usually have a familial pattern of delayed puberty that is not secondary to a pathological disorder; puberty is expected to occur spontaneously at a relatively late date. Brief treatment with conservative doses may occasionally be justified in these patients if they do not respond to psychological support. The potential adverse effect on bone maturation should be discussed with the patient and parents prior to androgen administration. An x-ray of the hand and wrist to determine bone age should be taken every 6 months to assess the effect of treatment on epiphyseal centers.

Testosterone Enanthate Injection

Males

Testosterone enanthate injection (generic Delatestryl) is indicated for replacement therapy in 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, or orchidectomy.

Hypogonadotropic hypogonadism (congenital or acquired) - Gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. (Appropriate adrenal cortical and thyroid hormone replacement therapy are still necessary, however, and are actually of primary importance).

If the above conditions occur prior to puberty, androgen replacement therapy will be needed during the adolescent years for development of secondary sexual characteristics. Prolonged androgen treatment will be required to maintain sexual characteristics in these and other males who develop testosterone deficiency after puberty.

Safety and efficacy of testosterone enanthate injection (generic Delatestryl) in men with age-related hypogonadism have not been established.

Delayed puberty - Testosterone enanthate injection (generic Delatestryl) may be used to stimulate puberty in carefully selected males with clearly delayed puberty. These patients usually have a familial pattern of delayed puberty that is not secondary to a pathological disorder; puberty is expected to occur spontaneously at a relatively late date. Brief treatment with conservative doses may occasionally be justified in these patients if they do not respond to psychological support. The potential adverse effect on bone maturation should be discussed with the patient and parents prior to androgen administration. An X-ray of the hand and wrist to determine bone age should be obtained every six months to assess the effect of treatment on the epiphyseal centers.

Females

Metastatic mammary cancer - Testosterone enanthate injection (generic Delatestryl) may be used secondarily in women with advancing inoperable metastatic (skeletal) mammary cancer who are one to five years postmenopausal. Primary goals of therapy in these women include ablation of the ovaries. Other methods of counteracting estrogen activity are adrenalectomy, hypophysectomy, and/or antiestrogen therapy. This treatment has also been used in premenopausal women with breast cancer who have benefited from oophorectomy and are considered to a have a hormone-responsive tumor. Judgment concerning androgen therapy should be made by an oncologist with expertise in this field.

Xyosted

Xyosted (testosterone enanthate) injection is an androgen indicated for 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’s 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 testosterone serum concentrations but have gonadotropins in the low or normal range.

Limitations of Use:

·        Safety and efficacy of Xyosted in men with “age-related hypogonadism” has not been established.

·        Safety and efficacy of Xyosted in males less than 18 years old have not been established.

Compendial Uses

Gender dysphoria^20,22-24 (also known as transgender and gender diverse (TGD) persons)

Coverage Criteria

Breast Cancer (Hormone-Responsive Tumor)

Authorization may be granted when the requested drug is being prescribed for a premenopausal patient with breast cancer who has benefited from oophorectomy AND is considered to have a hormone-responsive tumor when ALL of the following criteria are met:

·        The requested drug is NOT being prescribed for age-related hypogonadism (also referred to as late-onset hypogonadism). [NOTE: Safety and efficacy of testosterone products in patients with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established.]

·        The request is for intramuscular testosterone enanthate injection (generic Delatestryl).

Delayed Puberty

Authorization may be granted when the requested drug is being prescribed for delayed puberty when ALL of the following criteria are met:

·        The requested drug is NOT being prescribed for age-related hypogonadism (also referred to as late-onset hypogonadism). [NOTE: Safety and efficacy of testosterone products in patients with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established.]

·        The request is for intramuscular testosterone enanthate injection (generic Delatestryl) OR testosterone propionate implant pellet (Testopel).

Gender Dysphoria

Authorization may be granted when the requested drug is being prescribed for gender-affirming care in a patient who is able to make an informed decision to engage in hormone therapy when ALL of the following criteria are met:

·        The requested drug is NOT being prescribed for age-related hypogonadism (also referred to as late-onset hypogonadism). [NOTE: Safety and efficacy of testosterone products in patients with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established.]

·        The patient’s comorbid conditions are reasonably controlled.

·        The patient has been educated on ANY contraindications AND side effects to therapy.

·        Before the start of therapy, the patient has been informed of fertility preservation options.

·        If the patient is less than 18 years of age, then ALL of the following criteria are met:

§  The requested drug is prescribed by, or in consultation with, a provider specialized in the care of transgender youth (e.g., pediatric endocrinologist, family or internal medicine physician, obstetrician-gynecologist), that has collaborated care with a mental health provider.

§  The patient has reached, or has previously reached, Tanner stage 2 of puberty or greater.

Inoperable Metastatic Breast Cancer

Authorization may be granted when the requested drug is being prescribed for inoperable metastatic breast cancer in a patient who is 1 to 5 years postmenopausal AND had an incomplete response to other therapy for metastatic breast cancer when ALL of the following criteria are met:

·        The requested drug is NOT being prescribed for age-related hypogonadism (also referred to as late-onset hypogonadism). [NOTE: Safety and efficacy of testosterone products in patients with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established.]

·        The request is for intramuscular testosterone enanthate injection (generic Delatestryl).

Primary or Hypogonadotropic Hypogonadism

Authorization may be granted when the requested drug is being prescribed for primary or hypogonadotropic hypogonadism when ALL of the following criteria are met:

·        The requested drug is NOT being prescribed for age-related hypogonadism (also referred to as late-onset hypogonadism). [NOTE: Safety and efficacy of testosterone products in patients with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established.]

·        Before the start of testosterone therapy, the patient has at least TWO confirmed low morning testosterone levels according to current practice guidelines or your standard lab reference values.

Continuation of Therapy

Breast Cancer (Hormone-Responsive Tumor), Delayed Puberty, Gender Dysphoria, Inoperable Metastatic Breast Cancer

All patients (including new patients) requesting authorization for continuation of therapy must meet all requirements in the coverage criteria section.

Primary or Hypogonadotropic Hypogonadism

Authorization may be granted when the requested drug is being prescribed for primary or hypogonadotropic hypogonadism when ALL of the following criteria are met:

·        The requested drug is NOT being prescribed for age-related hypogonadism (also referred to as late-onset hypogonadism). [NOTE: Safety and efficacy of testosterone products in patients with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established.]

·        Before the patient started testosterone therapy, the patient had a confirmed low morning testosterone level according to current practice guidelines or your standard lab reference values.

Duration of Approval (DOA)

·        1210-A: DOA: 36 months

Place of Service:

Outpatient

The above policy is based on the following references:

1.      Androgel 1.62% [package insert]. Morristown, NJ: Ascend Therapeutics US, LLC; October 2025.

2.     Azmiro [package insert]. Woburn, MA: Azurity Pharmaceuticals, Inc.; July 2025.

3.     Depo-Testosterone [package insert]. New York, NY: Pharmacia & Upjohn Co; June 2025.

4.     Fortesta [package insert]. Malvern, PA: Endo Pharmaceuticals Inc.; July 2025.

5.     Jatenzo [package insert]. Fort Collins, CO: Tolmar Inc.; September 2025.

6.     Kyzatrex [package insert]. Raleigh NC: Marius Pharmaceuticals LLC; October 2025.

7.     Natesto Nasal Gel [package insert]. Mississauga, ON: Acerus Pharmaceutical Corporation; July 2025.

8.     Testim [package insert]. Malvern, PA: Endo USA; July 2025.

9.     Testopel (testosterone pellets) [package insert]. Malvern, PA: Endo USA; July 2025.

10.  Testosterone Enanthate [package insert]. E. Windsor, NJ: Eugia US LLC; July 2025.

11.    Testosterone Gel 1% [package insert]. Durham, NC: Encube Ethicals, Inc.; October 2025.

12.   Testosterone Topical Gel [package insert]. Parsippany, NJ: Actavis Pharma, Inc.; August 2025.

13.   Testosterone Topical Solution [package insert]. Bedminster, NJ: Alembic Pharmaceuticals, Inc.; July 2025.

14.   Tlando [package insert]. Ewing, NJ: Verity Pharmaceuticals, Inc.; July 2025.

15.   Undecatrex [package insert]. San Antonio, TX: Trifluent Pharma LLC; September 2022.

16.   Vogelxo [package insert]. Maple Grove, MN: Upsher-Smith Laboratories, LLC; July 2025.

17.   Xyosted [package insert]. Ewing, NJ: Antares Pharma, Inc.; July 2025.

18.   Lexicomp Online, AHFS DI (Adult and Pediatric) Online. Waltham, MA: UpToDate, Inc.; 2026. https://online.lexi.com. Accessed  January 22, 2026.

19.   Lexicomp Online, Lexi-Drugs Online. Waltham, MA: UpToDate, Inc.; 2026. https://online.lexi.com. Accessed January 22, 2026.

20. Micromedex® (electronic version). Merative, Ann Arbor, Michigan, USA. Available at: https://www.micromedexsolutions.com/ (cited: 01/22/2026).

21.   Bhasin S, Brito JP, Cunningham GR, et al. Testosterone Therapy in Men with Hypogonadism: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2018;103(5):1715-1744.

22.  Coleman E, Radix AE, Bouman WP, et al. Standards of Care for the Health of Transgender and Gender Diverse People, Version 8. Int J Transgend Health. 2022;23(S1):S1-S258.

23.  Hembree WC, Cohen-Kettenis PT, Gooren L, et al. Endocrine Treatment of Gender Dysphoric/Gender-Incongruent Persons: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2017;102(11):3869-3903.

24.  Health Care for Transgender and Gender Diverse Individuals. ACOG Committee Opinion No. 823. American College of Obstetricians and Gynecologists. Obstet Gynecol. 2021;137:e75-88.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

August 20, 2026