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?
Coverage is set by the individual Humana plan's formulary and utilization management rules, so the tier and prior authorization requirements differ between plans. The clinical side is the same everywhere: testosterone is approved only for low testosterone with an associated medical condition [1].
Will Humana pay for AndroGel for age-related low testosterone?
FDA says none of the approved testosterone products are approved for men with low testosterone who lack an associated medical condition [1]. The testosterone gel 1% label lists age-related hypogonadism under Limitations of Use, stating safety and efficacy have not been established [2]. FDA said in June 2026 it had asked for that limitation to be removed, and the testosterone gel 1% label (effective September 2025) still carries it [1][2]. Whether a plan pays for it is set by that plan's own criteria.
What documentation does the label require before AndroGel is started?
The testosterone gel 1% label says to confirm hypogonadism by measuring serum testosterone in the morning on at least two separate days and confirming the values are below the normal range [2]. It also directs periodic monitoring of serum testosterone, PSA, hemoglobin, hematocrit, liver function tests and lipids [2].
Does Humana require step therapy for AndroGel?
Step therapy is a plan benefit rule rather than an FDA rule, so whether it applies depends on the individual Humana plan document for the benefit year. Testosterone itself is a Schedule III controlled substance [2].
What tier is AndroGel on for Humana?
Tier placement is part of each plan's formulary for the benefit year, so it has to be checked against your specific plan document, and the 1% and 1.62% gels can sit differently. The label notes topical testosterone products may differ in dose, strength and application instructions and may produce different systemic exposure [2].

References

  1. Testosterone Information | FDA. Testosterone Information | FDA
  2. U.S. National Library of Medicine, DailyMed. Testosterone gel 1% topical, generic prescribing information. Testosterone gel 1% topical, generic label
  3. Original Medicare (Fee-for-service) Appeals | CMS. Original Medicare (Fee-for-service) Appeals | CMS
Evidence overview for Does Humana Cover AndroGel? Formulary, Prior Auth, Step Therapy, and Appeals