Testosterone Formulations Billing & Prior-Auth Playbook

Who the labels say qualifies

For testosterone replacement in men, FDA-approved use generally requires low or absent testosterone together with an associated medical condition — testicular failure from causes such as genetic problems or chemotherapy, or hypothalamus or pituitary disease [1]. None of the approved products is approved for men with low testosterone who lack an associated medical condition [1]. Intramuscular testosterone enanthate also carries labeled uses for delayed puberty in carefully selected boys and, secondarily, metastatic breast cancer in postmenopausal women [3]. The Depo-Testosterone and intramuscular enanthate labels still state that safety and efficacy in age-related hypogonadism have not been established [2][3]. In June 2026 FDA asked companies to remove that limitation of use and to revise prostate cancer and benign prostatic hyperplasia safety information; the injectable labels checked had not yet changed [1].

What has to be documented before the first prescription?

Both intramuscular labels require the diagnosis to be confirmed with morning serum testosterone measured on at least two separate days, both results below the normal range [2][3]. The Endocrine Society guideline says the same in its own terms: diagnose only men with symptoms and signs consistent with deficiency and unequivocally and consistently low serum testosterone, measured fasting in the morning and repeated to confirm [7]. TRAVERSE, the trial behind the 2025 label changes, enrolled men with two fasting levels below 300 ng/dL — a trial entry rule, not a coverage threshold [8].

Which products have separate labels?

Depo-Testosterone (testosterone cypionate) and intramuscular testosterone enanthate have separate prescribing labels [2][3]. For replacement in hypogonadal men, the intramuscular labels give 50 to 400 mg every 2 to 4 weeks [2][3], and the cypionate label gives an intramuscular half-life of about 8 days [2]. Aveed, the testosterone undecanoate injection, appears on FDA's approved REMS table [5].

Monitoring that appears in labeling

The Depo-Testosterone label calls for hemoglobin and hematocrit checks periodically during long-term use, and for periodic blood pressure monitoring, especially in men with hypertension; testosterone products are not recommended in uncontrolled hypertension [2].

In February 2025, FDA requested that TRAVERSE results be added to testosterone labeling, that a blood pressure warning be added for products that lacked one, that product-specific blood pressure data be included for products with completed ambulatory blood pressure studies, and that boxed-warning language about increased adverse cardiovascular outcomes be removed [6]. The Depo-Testosterone and intramuscular enanthate labels cited here do not describe TRAVERSE [2][3]. FDA's action followed ambulatory blood pressure studies that it says confirmed a blood pressure increase with all testosterone products [6].

TRAVERSE randomized 5,246 men aged 45 to 80 with existing or high cardiovascular risk to 1.62% testosterone gel or placebo gel; the primary cardiovascular endpoint occurred in 7.0% with testosterone and 7.3% with placebo [1][8]. It tested a gel, not an injection, and no outcome trial of that size exists for injectable testosterone [8].

Controlled substance status

Testosterone is a Schedule III controlled substance; the Depo-Testosterone and intramuscular enanthate labels each state Schedule III [2][3].