Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Testicular Hypofunction
Treatment: Xyosted
The insurer denied the Xyosted
The denial is upheld

This is a male diagnosed with testicular hypofunction. This request is for Xyosted. As reported; the patient is on Xyosted. He was on testosterone cypionate and tadalafil.  

The patient's testosterone was 523.74; sex hormone-binding globulin (SHBG) was 13.77 (14.55-94.64); free testosterone was 16.24 (3.06-15.2 median 9.13); and hematocrit (HCT) was 47.8,  The year prior, the patient's hematocrit  was 47; testosterone was 1320 (240-950 median 595); and free testosterone was 44.9 (4.65-18.1 median 11.375).  Two years prior, his prostate specific antigen (PSA) was 1.4; and hematocrit was 48.9.  Three years prior, the patient's testosterone was 883 (240-950 median 595); and free testosterone was 32.7 (4.85-19 median 11.925).  The patient's testosterone was 374 (240-950 median 595); and free testosterone was 12 (4.85-19 median 11.925). The patient's prostate specific antigen (PSA) was 1.3; and testosterone was 183 (280-880 median 580).  The patient's testosterone was 221 (280-880 median 580).  The patient's testosterone was 217 (280-880 median 580).  Four years prior the patient's testosterone was 302 (240-950 median 595); and free testosterone was 10.3 (4.85-19 median 11.925).

No, the proposed Xyosted is not medically necessary.
The American Association of Clinical Endocrinologists and the Endocrine Society recommendations require documentation of two low morning testosterone or free testosterone levels [1]. 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), or 2-functional (hyperprolactinemia, hypercortisolism, obesity, chronic systemic disease) [4]. Since the majority of causes involve abnormalities of the pituitary or hypothalamus, a magnetic resonance image (MRI) is indicated to rule out structural lesions in these patients [2]. Magnetic resonance image is indicated in this group of patients when they are less than 50 for all patients with a low testosterone and a normal luteinizing hormone (LH) or an elevated prolactin [5, [6, [7, [8]. In older men a magnetic resonance image (MRI) is indicated when there is a very low testosterone, less than 150 nanograms per deciliter (ng/dl), and a normal luteinizing hormone (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 luteinizing hormone (LH) and follicular stimulating hormone (FSH) (primary) or low or normal luteinizing hormone (secondary) [9]. 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 does not have low morning testosterone or low morning free testosterone levels. Based on this, the patient does not meet accepted criteria for treatment with testosterone. The request is not in accordance with generally accepted standards of medical practice and so the request does not meet the Summary Plan Description definition of medically necessary.

Yes, the health plan acted reasonably, with sound medical judgment, and in the best interest of the patient, as the request is not medically necessary as described above.