Testosterone Cypionate denials in California external review

What the reviewers wrote

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for 100 mg per week of testosterone cypionate (Depo-testosterone) and if not 75 mg per week. Findings: The physician reviewer found that there is support in the medical literature for a portion of the requested medication dosage in this clinical setting. Specifically, testosterone cypionate (Depo-testosterone) is medically necessary. In 2016, the patient was noted to have an elevated hematocrit. However, it is unclear if this was calculated using the male reference range values. Based on the male reference range values, his hematocrit could be considered within the normal range. The standard typical doses for transgender or cisgender male with regards to testosterone intramuscular is 100 mg a week.

Nature of Statutory Criteria/Case Summary: The patient has been diagnosed with testicular hypofunction. Laboratory results dated 11/7/19 revealed a testosterone level of 251 ng/dL. The provider noted the patient has been treated with testosterone, and testosterone had helped his libido. In the Health Plan Prescription Drug Prior Authorization or Step Therapy Exception Request form, the provider noted that the patient has failed AndroGel and Androderm. The patient has requested authorization and coverage for testosterone cypionate 300 mg injected every two (2) weeks. The Health Plan denied the request and reported the requested medication is not medically necessary for the treatment of this patient. At issue in this case is whether testosterone cypionate 300 mg injected every two (2) weeks is medically necessary for the treatment of the patient’s medical condition.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for testosterone cypionate injections Findings: One study noted that, “The aim of testosterone replacement therapy (TRT) is to improve symptoms and signs of testosterone deficiency including decreased libido, erectile dysfunction, depressed mood, anaemia, loss of muscle and bone mass, by increasing serum testosterone levels to physiologic range.” Testosterone replacement therapy for hypogonadotropic hypogonadism is based upon laboratory documentation of below normal values on two serum testosterone levels drawn in the morning at least 24 hours apart. In patients receiving ongoing therapy, a pre-injection morning value in the low to low-to-normal range is also a clinical indication for continuation of therapy.

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Testosterone cypionate injections. Studies show that the aim of testosterone replacement therapy (TRT) is to improve symptoms and signs of testosterone deficiency including decreased libido, erectile dysfunction, depressed mood, anemia, loss of muscle and bone mass, by increasing serum testosterone levels to physiologic range a study showed. The records provided for review fail to document a recent assessment with prostate specific antigen (PSA) and rectal examination to assess the patient’s prostate cancer activity. In addition, there is a lack of report that the patient has undergone an assessment of muscle status, or the findings of a behavioral health examination. Moreover, the patient does not have evidence of muscle mass wasting.

These outcomes describe eligible cases completed through California DMHC’s Independent Medical Review program. They do not estimate the chance that an internal appeal, an external review in another jurisdiction, or your individual case will succeed. Use the record to identify evidence patterns involving Testosterone Cypionate, then check the rights and deadlines that apply to your plan.