Appeal type: Medical Necessity
Decision: Overturned Decision of Health Plan

Nature of Statutory Criteria/Case Summary: The patient has been diagnosed with primary hypogonadism and Rosai Dorfman syndrome. Laboratory results revealed a total testosterone level of 289 ng/dL and a free testosterone level of 52 pg/mL. His luteinizing hormone level was elevated at 10.1 mIU/mL. The provider noted the patient had been treated with high dose prednisone for one year but had since tapered off the prednisone. A scrotal ultrasound was noted to be normal. The patient reported a significant lack of libido with erectile dysfunction. The patient also reported a severe needle phobia and did not feel able to perform syringe/vial injections. Thus, Xyosted 75 mg/ 0.5mL, an autoinjector was chosen over the intramuscular injections. The patient has requested authorization and coverage for the brand name medication Xyosted 75 mg/ 0.5mL autoinjector. 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 brand name medication Xyosted 75mg/ 0.5mL autoinjector is medically necessary for the treatment of this patient. Bhasin and colleagues reported, We suggest that when clinicians institute testosterone (T) therapy, they aim at achieving T concentrations in the mid-normal range during treatment with any of the approved formulations, taking into consideration patient preference, pharmacokinetics, formulation-specific adverse effects, treatment burden, and cost. The authors also noted multiple approved formulations of T therapy, including injections, transdermal gels, transdermal patches, and tablets. Qaseem and colleagues reported, Both intramuscular and transdermal testosterone applications have been associated with improvements in sexual function. Evidence from indirect comparisons suggests no substantial differences in clinical effectiveness, benefits, or harms between intramuscular and transdermal testosterone applications, although very little evidence exists from direct comparisons of the two formulations. In this case, the patient has low testosterone levels with symptoms of decreased libido and erectile dysfunction. He has hypogonadal symptoms due to low testosterone levels and would benefit from testosterone treatment. Given that evidence suggests similar effectiveness across preparations, and patient preference should be considered, the requested medication is a reasonable alternative for testosterone replacement therapy. Therefore, the brand name medication Xyosted 75 mg/ 0.5mL autoinjector is medically necessary for the treatment of this patient. Final Result: The reviewer determined that the requested medication is medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be overturned.Credentials/Qualifications: The reviewer is board certified in internal medicine with sub-specialty certification in endocrinology, diabetes and metabolism and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.