Table Of Contents
Note:Most policies specifically exclude coverage of steroids for performance enhancement. For plans without this exclusion, androgens and anabolic steroids as well as other medical interventions for performance enhancement are not covered because performance enhancement of non-diseased individuals is not considered treatment of disease or injury. Please check benefit plan descriptions for details.
For gender dysphoria, the medication must be 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 for members less than 18 years of age.
Aetna considers intramuscular testosterone enanthate injection (generic Delatestryl) medically necessary for the following indications: (Note: The Delatestryl brand name has been discontinued in the U.S.; however, there is an FDA-approved generic equivalent available)
Aetna considers all other indications as experimental, investigational, or unproven.
Aetna considers continuation of intramuscular testosterone enanthate injection therapy medically necessary for members with any of the following indications:
For subcutaneous testosterone enanthate injection (Xyosted), see Pharmacy Clinical Policy BulletinTestosterone - Testosterone Enanthate TGC PA Policy 1368-A.
See also:
Testosterone Enanthate Injection, USP (generic Delatestryl) 200 mg/mL is available as 5 mL multiple dose vial, cartons of 1 vial, for deep gluteal intramuscular (IM) injection only.
Prior to initiating testosterone enanthate injection, diagnosis of hypogonadism should be confirmed by ensuring that serum testosterone concentrations have been measured in the morning on at least two separate days and that these serum testosterone concentrations are below the normal range.
Dosage and duration of therapy with testosterone enanthate injection will depend on age, sex, diagnosis, person's response to treatment, and appearance of adverse effects.
In general, total doses above 400 mg per month are not required because of the prolonged action of the preparation. Injections more frequently than every two weeks are rarely indicated.
For replacement in the hypogonadal male, the recommended dose is 50 mg to 400 mg administered every 2 to 4 weeks.
In males with delayed puberty: Various dosage regimens have been used; some call for lower dosages initially with gradual increases as puberty progresses, with or without a decrease to maintenance levels. Other regimens call for higher dosage to induce pubertal changes and lower dosage for maintenance after puberty. The chronological and skeletal ages must be taken into consideration, both in determining the initial dose and in adjusting the dose. Dosage is within the range of 50 to 200 mg every 2 to 4 weeks for a limited duration, for example, 4 to 6 months.
A dosage of 200 to 400 mg every 2 to 4 weeks is recommended. Women with metastatic breast carcinoma must be followed closely because androgen therapy occasionally appears to accelerate the disease.
Source: Eugia US LLC, 2024
Aetna considers intramuscular enanthate injections experimental, investigational, or unproven for the following indications (not an all-inclusive list) because the safety and efficacy for these indications has not been established:
Testosterone Enanthate Injection (generic Delatestryl - brand unavailable) is indicated for replacement therapy in conditions associated with a deficiency or absence of endogenous testosterone
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 anti-estrogen therapy. This treatment has also been used in pre-menopausal 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.
Intramuscular Testosterone Enanthate Injection, USP (Eugia USA LLC), a Schedule III controlled substance, is an FDA-approved generic equivalent of the brand, Delatestryl. Although Delatestryl was discontinued in the United States, a branded generic remains available.
Testosterone is an endogenous androgen which is responsible for normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. These effects include growth and maturation of the prostate, seminal vesicles, penis, and scrotum; the development of male hair distribution, such as facial, pubic, chest, and axillary hair; laryngeal enlargement, vocal cord thickening, alterations in body musculature and fat distribution. Low serum testosterone concentrations due to inadequate secretion of testosterone is associated with male hypogonadism. Symptoms include decreased sexual desire with or without impotence, fatigue, and mood disturbances. Male hypogonadism has two main etiologies, primary hypogonadism, which is caused by defects of the gonads, such as Klinefelter's Syndrome or Leydig cell aplasia, and secondary hypogonadism, which is the failure of the hypothalamus (or pituitary) to produce sufficient gonadotropins (FSH, LH).
Androgens are contraindicated in men with carcinomas of the breast or with known or suspected carcinomas of the prostate and in women who are or may become pregnant. When administered to pregnant women, androgens cause virilization of the external genitalia of the female fetus. This virilization includes clitoromegaly, abnormal vaginal development, and fusion of genital folds to form a scrotal-like structure. The degree of masculinization is related to the amount of drug given and the age of the fetus and is most likely to occur in the female fetus when the drugs are given in the first trimester. If the patient becomes pregnant while taking androgens, she should be apprised of the potential hazard to the fetus. This preparation is also contraindicated in patients with a history of hypersensitivity to any of its components.
Labeled warnings and precautions include the following:
