Does Aetna (CVS Health) Cover AndroGel?
At a glance
- Aetna coverage / set by the individual plan's drug list and prior-authorization rules
- FDA on approved use / men with low testosterone and an associated medical condition [1]
- Label wording, generic testosterone gel 1% / primary or hypogonadotropic hypogonadism in adult men [2]
- Age-related hypogonadism / limitation of use still in the label; FDA asked in June 2026 for its removal [1][2]
- Diagnosis step in the label / morning testosterone on two separate days, both below normal, before treatment starts [2]
- Controlled substance / Schedule III [2]
Where Aetna coverage is decided
Whether Aetna pays for AndroGel, which strength, and under what prior-authorization or step requirements are stated in the individual plan's current drug list and coverage documents. AndroGel 1% and AndroGel 1.62% are separate strengths with their own dosing, and the generic gel 1% label says its dosing differs from the 1.62% gel [2].
Who testosterone gel is approved for
FDA states that none of the approved testosterone products is approved for men with low testosterone who lack an associated medical condition, for example genetic problems, chemotherapy effects, or hypothalamus or pituitary disorders [1].
As an example of label wording, the label for generic testosterone gel 1% (Teva) lists replacement therapy in adult men with primary hypogonadism, meaning testicular failure from causes such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter syndrome, chemotherapy, or toxic damage from alcohol or heavy metals, or with hypogonadotropic hypogonadism from gonadotropin or LHRH deficiency or pituitary or hypothalamic injury from tumors, trauma or radiation [2].
That label's limitation of use says safety and efficacy in age-related, or late-onset, hypogonadism have not been established, and neither have they in males under 18 [2]. In June 2026 FDA asked for that age-related hypogonadism limitation to be removed and for prostate cancer and benign prostatic hyperplasia safety information to be revised; a requested change is not a changed label [1].
The two-test diagnosis step
The generic testosterone gel 1% label says to confirm hypogonadism before treatment starts, with serum testosterone measured in the morning on at least two separate days and both values below the normal range [2]. The 2018 Endocrine Society guideline recommends fasting morning total testosterone as the first test and a repeat morning measurement to confirm the diagnosis [4]. The label states that testosterone gel 1% contains testosterone, a Schedule III controlled substance [2].
Frequently asked questions
Does Aetna cover AndroGel?
Is AndroGel approved for low testosterone caused by aging?
What does the testosterone gel 1% label say about diagnosis before treatment?
Is testosterone gel a controlled substance?
References
- Testosterone Information | FDA. Testosterone Information | FDA
- U.S. National Library of Medicine, DailyMed. Testosterone gel 1% topical (generic, Actavis Pharma for Teva) prescribing information. Testosterone gel 1% topical (generic, Actavis Pharma for Teva) label
- Lincoff AM, Bhasin S, Flevaris P, Mitchell LM, Basaria S, Boden WE, et al. Cardiovascular Safety of Testosterone-Replacement Therapy. N Engl J Med. 2023;389(2):107-117. Cardiovascular Safety of Testosterone-Replacement Therapy
- Bhasin S, Brito JP, Cunningham GR, Hayes FJ, Hodis HN, Matsumoto AM, et al. Testosterone Therapy in Men With Hypogonadism: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2018;103(5):1715-1744. Testosterone Therapy in Men With Hypogonadism: An Endocrine Society Clinical Practice Guideline
- FDA issues class-wide labeling changes for testosterone products | FDA. FDA issues class-wide labeling changes for testosterone products | FDA