Does Kaiser Permanente Cover AndroGel?

At a glance

  • Kaiser coverage of AndroGel / Set by the member's plan drug list and coverage criteria
  • What to ask the plan / Whether AndroGel 1% is listed, at what tier, and whether prior authorization or step therapy applies
  • Drug / AndroGel 1% (testosterone gel), NDA 021015, approved 02/28/2000 [1]
  • FDA-approved use / Low testosterone with an associated medical condition [2]
  • Low testosterone without such a condition / Not an approved use [2]
  • Age-related hypogonadism / FDA asked sponsors in June 2026 to remove the label limitation of use [2]
  • Labeled forms / 25 mg/2.5 g and 50 mg/5 g packets, 12.5 mg/1.25 g metered gel [1]

What AndroGel is

AndroGel 1% is a topical testosterone gel applied to the skin. FDA's listing for NDA 021015 gives a first approval date of 02/28/2000 and shows three marketed prescription forms: 25 mg/2.5 g packets, 50 mg/5 g packets, and a 12.5 mg/1.25 g metered gel [1].

What use does FDA approve?

FDA says testosterone products are approved only for men who lack testosterone or have low testosterone in conjunction with an associated medical condition. The examples FDA gives are failure of the testicles to produce testosterone, from causes such as genetic problems or chemotherapy, and problems with the hypothalamus or pituitary, the brain structures that control testosterone production by the testicles. FDA also says none of the approved testosterone products is approved for men with low testosterone who lack an associated medical condition [2].

Age-related low testosterone, also called late-onset hypogonadism, has sat outside that approved use. FDA says that in June 2026 it asked sponsors of testosterone products to remove the label limitation of use stating that safety and efficacy in age-related hypogonadism have not been established, and to revise safety information on prostate cancer and benign prostatic hyperplasia [2].

What to check about AndroGel coverage

Whether a plan lists a brand-name drug, what tier it places it on, and whether it asks for prior authorization or a documented trial of another testosterone product first are terms written in the plan's own drug list and coverage criteria. The questions worth getting answered in writing for AndroGel 1% are:

  • Is AndroGel 1% on the plan's drug list, and at what cost tier?
  • Does the plan require prior authorization before it pays for it?
  • Does it require a documented trial of a different testosterone product first?
  • Are there quantity limits on gel pumps or packets?

The listing to check is the one for the exact product on the prescription. AndroGel 1% comes as packets and as a metered gel, and these are listed as separate products in FDA's approval record [1].

Frequently asked questions

Does Kaiser Permanente cover AndroGel?
That depends on the member's plan. The plan drug list and coverage criteria for the exact product on the prescription, AndroGel 1% packets or metered gel, say whether it is listed, at what tier, and whether prior authorization or step therapy applies.
What is AndroGel approved for?
FDA says testosterone products are approved only for men with low testosterone plus an associated medical condition, such as testicular failure or a hypothalamus or pituitary problem. None is approved for low testosterone without such a condition [2].
What is AndroGel and when was it approved?
AndroGel 1% is testosterone gel, NDA 021015, first approved 02/28/2000 and listed in Drugs@FDA as a marketed prescription product in packet and metered gel forms [1].
Did FDA change the age-related hypogonadism labeling?
FDA says in June 2026 it asked sponsors to remove the label limitation of use stating safety and efficacy in age-related hypogonadism have not been established, and to revise safety information on prostate cancer and benign prostatic hyperplasia [2].
What should I ask a plan about AndroGel coverage?
Ask whether AndroGel 1% is on the drug list, at what tier, whether prior authorization is required, whether a trial of a different testosterone product must come first, and whether quantity limits apply to gel pumps or packets.

References

  1. Drugs@FDA: FDA-Approved Drugs. Drugs@FDA: FDA-Approved Drugs
  2. Testosterone Information | FDA. Testosterone Information | FDA
Evidence overview for Does Kaiser Permanente Cover AndroGel?