Does Humana Cover AndroGel? Formulary, Prior Auth, Step Therapy, and Appeals
At a glance
- Drug / AndroGel, a topical testosterone gel available as 1% and 1.62%
- Controlled substance / Schedule III under the Controlled Substances Act [2]
- Who sets the tier / The individual Humana plan document for the benefit year
- Approved use / Low testosterone with an associated medical condition [1]
- Not an approved use / Age-related low testosterone without an associated condition [1]
- Required before starting / Morning serum testosterone below normal on at least two separate days [2]
Does Humana cover AndroGel?
Three questions get tangled together here: whether the plan lists the drug, what tier it sits on, and whether it wants prior authorization or a trial of another testosterone product first. Those are benefit design decisions written into each plan's formulary and utilization management documents. Two Humana members on different plans can get different answers about the same prescription, and the answer can change when the formulary resets for a new benefit year.
What is not plan-specific is the clinical gate: the diagnosis and the lab work. That part comes from the FDA-approved labeling.
The approved use, and the limitation FDA keeps pointing at
FDA says testosterone products are approved only for men who have low testosterone along with an associated medical condition, such as testicular failure from genetic problems or chemotherapy, or a problem in the hypothalamus or pituitary. None of the approved products are approved for low testosterone without such a condition [1].
The label for testosterone gel 1% splits it the same way. Primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism are the approved uses. Under Limitations of Use, the label states that safety and efficacy in age-related hypogonadism have not been established [2]. That is the label for testosterone gel 1%; the 1.62% gel has its own prescribing information and different dosing [2].
FDA said in June 2026 that it had requested removal of the age-related limitation, along with revisions to prostate cancer and benign prostatic hyperplasia safety information [1]. The testosterone gel 1% label effective September 2025 still carries the limitation [2].
The lab requirement on the label
The gel label says to confirm hypogonadism by ensuring serum testosterone has been measured in the morning on at least two separate days and that those concentrations are below the normal range [2]. The starting dose of the 1% gel is 50 mg once daily, applied to clean, dry, intact skin of the shoulders and upper arms and/or abdomen [2].
The label also directs periodic monitoring of serum testosterone, PSA, hemoglobin, hematocrit, liver function tests and lipid concentrations [2].
Step therapy and other testosterone products
A step therapy rule, where a plan has one, is a benefit rule written in the plan's utilization management document; it is not something the FDA label sets. Testosterone itself is a Schedule III controlled substance [2]. The gel label notes that topical testosterone products may have different doses, strengths or application instructions that may produce different systemic exposure, and that the application site and dose of testosterone gel 1% are not substitutable with other topical testosterone products [2].
What to pull from your own plan document
The checklist is short: the tier for AndroGel 1% and for AndroGel 1.62% separately, whether either needs prior authorization, whether a step through another testosterone product is required, any quantity limit, and whether the formulary changed for the new benefit year. Those answers decide what you pay and what paperwork the prescriber has to file.
Frequently asked questions
Does Humana cover AndroGel?
Will Humana pay for AndroGel for age-related low testosterone?
What documentation does the label require before AndroGel is started?
Does Humana require step therapy for AndroGel?
What tier is AndroGel on for Humana?
References
- Testosterone Information | FDA. Testosterone Information | FDA
- U.S. National Library of Medicine, DailyMed. Testosterone gel 1% topical, generic prescribing information. Testosterone gel 1% topical, generic label
- Original Medicare (Fee-for-service) Appeals | CMS. Original Medicare (Fee-for-service) Appeals | CMS