Appeal type: Formulary Exception
Decision: Overturned

Diagnosis:  Hypogonadism.
Treatment:  Formulary exception for Testosterone 30mg/actuation solution.

The insurer is denied coverage of a formulary exception for Testosterone 30mg/actuation solution.  The denial is overturned.

This male patient has a diagnosis of hypogonadism. The patient's testosterone level was 135 ng/dL and then 67.1 ng/dL on the next test.  He was prescribed testosterone transdermal gel 50 mg/5 gm packet (1%) daily, with a maximum dose 100 mg. However, this medication regimen did not treat his testosterone levels or symptoms. The patient's total testosterone level was between 200 to 300 ng/dL and he continued to have symptoms of hypogonadism. His treating providers changed the prescription to testosterone topical solution 30 mg/actuation with 4 pumps per day, at a maximum dose of 120 mg. The patient has been doing well with this regimen with optimal testosterone levels and has resolved symptoms.

The insurer denied coverage for testosterone 30 mg/actuation solution stating the patient first needs to try and fail all the preferred medications that are covered, such as testosterone cypionate injection, testosterone enanthate injection, testosterone transdermal gel 10 mg/actuation (2%), and testosterone transdermal gel 25 mg/2.5 g(1%).

The treating endocrinologist states the patient had tried and failed testosterone transdermal gel 50 mg/5 g packet (1%). The patient is fearful of needles and the testosterone topical solution is a more physiologic and safer alternative to injections.  The patient has been on testosterone topical solution 30 mg/actuation.

Based on the documentation submitted, the formulary drugs, specifically testosterone cypionate or enanthate may potentially cause anxiety or acute phobia to the patient who has needle phobia. The patient has failed transdermal gel in the past, and had uncontrolled hypogonadism on this form of therapy, which leads to symptoms of uncontrolled hypogonadism such as fatigue, low energy, low mood and low motivation.      

The patient has tried and failed transdermal gel, and he has needle phobia; thus the intramuscular (IM) forms of testosterone would be ineffective.     

The requested drug would be more effective than the formulary drug. The patient has documented good testosterone levels and good clinical response to the requested drug, testosterone topical solution.

Per Burns, P. R., Kim, E. D., Ruff, D. D., & Seftel, A. D., "The current study was designed to replicate clinical practice with topical TRT by evaluating the effect of axillary administration of 2% testosterone solution in HGN men who had had a suboptimal response after previous treatment with a topical testosterone gel.  This study demonstrated that treatment of these men with 2% testosterone solution resulted in their achieving testosterone levels in the normal range and in improvements in their energy levels and sexual drives."

Per Shoskes, J. J., Wilson, M. K., & Spinner, M. L., "Since 2002, several testosterone gels and liquids have been developed for transdermal TRT.  Due to the concern for testosterone gel or liquid being transferred to females and children who come into contact with a patient's skin after use, these formulations have received a USA Boxed Warning. Patients should be reminded to wash their hands after application and to avoid skin contact with others. Recommended sites of application for these agents are areas that will be covered by clothing to minimize transfer. The potential advantages of testosterone transdermal gels and liquids include ease of application, less skin irritation than patches, and more consistent serum testosterone levels than other formulations, such as IM testosterone."

The health plan did not act reasonably with sound medical judgment, and in the best interest of the patient.

The carrier's denial of Request for Formulary Exception for Testosterone 30mg/actuation solution is overturned.