Does State Medicaid Cover AndroGel? Coverage, Prior Authorization, and Appeals by State

What AndroGel is

AndroGel appears in FDA's Drugs@FDA database under NDA 021015 as a transdermal gel, first approved 02/28/2000 and listed as 25 mg/2.5 g packets, 50 mg/5 g packets and a 12.5 mg/1.25 g metered gel [2]. FDA's testosterone page refers to AndroGel 1.62% when it describes the TRAVERSE cardiovascular trial [1].

Which patients fall inside the approved use

FDA states that testosterone products are approved only for use in men who lack or have low testosterone levels in conjunction with an associated medical condition, such as testicular failure from genetic problems or chemotherapy, or a hypothalamus or pituitary problem that controls testosterone production by the testicles [1]. FDA adds that none of the approved testosterone products is approved for men with low testosterone who lack an associated medical condition [1].

FDA says that in June 2026 it requested updates to testosterone prescribing information, including removing the limitation of use stating that safety and efficacy of testosterone replacement therapy in men with age-related hypogonadism have not been established, and revising safety information related to prostate cancer and benign prostatic hyperplasia [1]. FDA describes those as requested updates, not as a completed label change across products [1].

Does FDA approval tell you what Medicaid covers?

No. FDA approval and Medicaid coverage are separate decisions. FDA says testosterone products are approved for men whose low testosterone is associated with a medical condition [1], and AndroGel's FDA listing records the application number, approval date and product forms [2]. Whether a state program lists the drug, what prior authorization it asks for and how an appeal works are decided by that state.