Appeal type: Formulary Exception
Decision: Overturned

Diagnosis:  Testicular hypofunction
Treatment:  Formulary exception for testosterone gel
The health plan should cover the Formulary exception for Testosterone gel.

The patient is a male diagnosed with Hypogonadism.  This request is for Testosterone gel.  As reported, he used testosterone 1 % in the past and had treatment failure.  He had Pituitary adenoma s/p (status post) resection in the past.  In past he has blurry vision and headache diagnosed with Tolosa Hunt syndrome.  He completed testosterone XRT.  The formulary alternatives include testosterone transdermal gel 10 mg per actuation 2% and testosterone cypionate and testosterone enanthate.  He also tried Fortesta transdermal gel 10 mg per actuation.  He benefited from the requested formulation testosterone 1% 50mg/5g.

The patient's testosterone was 141 (264-916, median 590); free testosterone was 6.4 (6.6-18.1, median 12.35).

Previously the patient's testosterone was 232 (264-916, median 590); Estradiol was 34.6. 

Previous to the above, the patient's testosterone was 444.33 (300-1080, median 690); PSA (prostate specific antigen) was 1.74 (0-4).

Previous to that the patient's testosterone was 211.74 (300-1080, median 690); SHBG (Sex Hormone Binding Globulin) was 27; LH (luteinizing hormone) was <0.50; IGF1 (insulin-like growth factor 1) was 125; GH (growth hormone) was 0.08; FSH (follicle stimulating hormone) was 0.6; ACTH (adrenocorticotropic hormone) was 113; Free testosterone was 5.1 (4-29 median 16); testosterone Bioavailable was 96 (77-367, median 222) .

The American association of clinical endocrinologists and the Endocrine society recommendations require documentation of two low morning testosterone or free testosterone levels (1, 2).  The diagnosis of hypogonadotropic or primary hypogonadism is made with a low testosterone, or free testosterone (2, 3).  The causes of acquired hypogonadotropic hypogonadism are the following:  1)  structural (tumors, infiltrative lesions, infarction, head trauma), and 2)  functional (hyperprolactinemia, hypercortisolism, obesity, chronic systemic disease) (4). 
Since the majority of causes involve abnormalities of the pituitary or hypothalamus, an MRI is indicated to rule out structural lesions in these patients (3).  MRI is indicated in this group of patients when they are <50 for all patients with a low testosterone and a normal LH or an elevated prolactin (5-8).  In older men, an MRI is indicated when there is a very low testosterone <150ng/dl and a normal LH or an elevated prolactin or with visual changes or headaches.  Obesity is a known cause of hypogonadotropic hypogonadism (5).  The diagnosis of hypogonadism is made using a low testosterone and an elevated LH and FSH (primary) or low or normal LH (secondary). 

The endocrine society criteria recommend adjusting testosterone dosing to keep the testosterone level in the middle of the normal range. 

"We suggest aiming at achieving serum testosterone levels during treatment in the mid-normal range." 

The endocrine society criteria also recommend that testosterone be adjusted with the patient symptoms in mind.

This patient has two documented low testosterone levels, with non-elevated LH levels in the setting of a history of pituitary surgery.  Based on this, he meets accepted criteria for treatment with testosterone.

The patient failed 1% testosterone gel and Fortesta.  He has benefited from the requested formulation.  Given the fact that the patient already failed two forms of testosterone gel, and the fact that he benefited from the requested formulation, the health plan should cover the requested treatment.