Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Low Testosterone. 
Treatment: Xyosted. 

The insurer denied the Xyosted. 
The determination is upheld. 

The patient was diagnosed with low testosterone. This request is for Xyosted. As reported, the patient was initially approved for testosterone cypionate for medulloblastoma and panhypopituitarism. The provider stated that the patient has difficulty drawing up the medication from a vial and has wide variation in testosterone levels, which is most likely due to dosing errors. For example, testosterone was 715, 529 (range 300-1080 median 690), 43 and free testosterone was 9.1, and it was 295 (185-886 median 535.5); follicle-stimulating hormone (FSH) was 9.65; luteinizing hormone (LH) was 3.27. At issue is the medical necessity of Xyosted. 

No, the requested health service/treatment of Xyosted is not medically necessary for this patient. The American Association of Clinical Endocrinology and the Endocrine Society recommendations require documentation of 2 low morning testosterone or free testosterone levels [1]. The diagnosis of hypogonadotropic or primary hypogonadism is made with a low testosterone, or free testosterone level [2, 3]. The causes of acquired hypogonadotropic hypogonadism are the following: structural (tumors, infiltrative lesions, infarction, head trauma) and functional (hyperprolactinemia, hypercortisolism, obesity, chronic systemic disease) [4]. 
Since most causes involve abnormalities of the pituitary or hypothalamus, magnetic resonance imaging (MRI) is indicated to rule out structural lesions in these patients [2]. Magnetic resonance imaging (MRI) is indicated in this group of patients when they are less than (< ) 50 years old for all patients with a low testosterone and a normal luteinizing hormone (LH) or an elevated prolactin [5-8]. In older men, magnetic resonance imaging (MRI) is indicated when there is a testosterone level less than (<) 150 nanograms per deciliter (ng/dl) and a normal luteinizing hormone (LH), an elevated prolactin or the presence of visual changes and/or headaches. 
Obesity is a known cause of hypogonadotropic hypogonadism [5, 9, 10]. The diagnosis of hypogonadism is made using a low testosterone and an elevated luteinizing hormone (LH) and follicle-stimulating hormone (FSH) (primary) or low or normal luteinizing hormone (LH) (secondary) [9]. The Endocrine Society criteria recommend adjusting testosterone dosing to keep the testosterone level in the middle of the normal range. The Endocrine Society also stated, "We suggest aiming at achieving serum testosterone levels during treatment in the mid-normal range." The Endocrine Society criteria also recommends that testosterone be adjusted with the patient's symptoms in mind.
This patient does not have 2 morning pretreatment low testosterone, low free testosterone, or bioavailable testosterone levels. Furthermore, the patient does not have low or elevated luteinizing hormone (LH) or magnetic resonance imaging (MRI) that documents hypogonadism. Based on the clinical information provided, the patient does not meet accepted criteria for treatment with testosterone. Lastly, the request is not in accordance with accepted standards of medical practice and therefore it is not medically necessary.