Does TRICARE Cover AndroGel? Coverage Rules, Prior Auth, and Appeals

What did the DoD committee decide about testosterone gel?

The Department of Defense Pharmacy and Therapeutics Committee reviewed the testosterone replacement therapy class at its February 2024 meeting [1]. Under the resulting formulary status, 1% and 1.62% testosterone gel multi-dose pumps and gel packets (AndroGel and generics), 2% solution pumps (Axiron and generics) and 1% gel in unit-dose tubes (Testim, Vogelxo and generics) are Uniform Formulary and step-preferred [1]. Other products, including the 2% gel pump, brand-only Vogelxo, the Androderm patch, Natesto nasal gel and the Xyosted auto-injector, are Uniform Formulary but non-step-preferred and require a trial of preferred agents [1]. The minutes say branded products with generic equivalents, such as AndroGel, are subject to the mandatory generic policy [1].

What does prior authorization require?

The minutes say new users of all testosterone products must meet manual prior authorization criteria based on intended use [1]. For hypogonadism the criteria are: the patient is a male aged 18 or older; the diagnosis is confirmed by morning total serum testosterone below 300 ng/dL on at least two separate occasions, or the drug is prescribed by an endocrinologist or urologist who made the diagnosis from unequivocally and consistently low total or free testosterone; the patient has signs and symptoms of hypogonadism; and the provider has investigated the cause of the low level and assessed the risks and benefits of testosterone therapy [1].

The criteria also say testosterone is not approved for concomitant use with other testosterone products and will not be approved to enhance athletic performance [1]. Authorization expires in one year; renewal requires the initial TRICARE approval, and coverage is approved indefinitely for continuation if the patient has had a positive response and the risks of continued therapy do not outweigh the benefits [1]. These are the criteria in the February 2024 minutes.

What the AndroGel 1% label covers

The AndroGel 1% label covers replacement therapy in males for primary hypogonadism (testicular failure from causes such as Klinefelter syndrome, orchiectomy or chemotherapy) or hypogonadotropic hypogonadism (gonadotropin or LHRH deficiency, or pituitary or hypothalamic injury) [2]. It says to confirm the diagnosis with serum testosterone measured in the morning on at least two separate days and below the normal range [2]. It states that safety and efficacy in age-related hypogonadism have not been established [2]. FDA says none of the approved testosterone products are approved for low testosterone without an associated medical condition, and in June 2026 asked sponsors to remove the age-related hypogonadism limitation and revise prostate cancer and benign prostatic hyperplasia safety information [3].