Appeal type: Medical Necessity
Decision: Upheld

Nature of Statutory Criteria/Case Summary: The patient has requested reimbursement and prospective authorization and coverage for Xyosted 100 mg/0.5 mL auto-injector. Lunenfeld and colleagues explain that male hypogonadism is defined by low levels of serum testosterone. Hypogonadism should be treated with testosterone therapy to induce and maintain secondary sex characteristics and to correct symptoms of testosterone deficiency, and if left untreated, may adversely affect multiple organ functions and quality of life. Testosterone treatment options include testosterone cypionate or testosterone enanthate by intramusclar injection, testosterone patch, topical transdermal gels, axillary foam, buccal testosterone tablets, testosterone pellets, injectable long-acting testosterone undecanoate in oil, and nasal testosterone gel. The most common options for treatment of hypogonadism in the United States are testosterone cypionate or testosterone enanthate by intramusclar injection, testosterone pellets, and topical transdermal gels. The type of preparation chosen for treatment will vary by clinician and patient preferences. After testosterone is initiated, it is important to monitor testosterone levels and aim to maintain serum testosterone concentrations during treatment in the mid-normal range for healthy young men, using timed laboratory monitoring at mid-dose intervals. Adjustments can be made in the dose of the testosterone, or the timing of the testosterone used to achieve mid-normal range testosterone levels. In this case, the patient has long-standing hypogonadism managed with testosterone cypionate by intramusclar injections. While the records show a fluctuation in the patients testosterone levels, this is not out of the norm for a patient taking testosterone cypionate, as it is typical for testosterone levels to fluctuate in response to when the last dose of testosterone was administered, so that a patient may have lower levels a few days prior to a dose and high levels for a few days following a dose. Xyosted, a weekly injectable, would cause similar fluctuations in testosterone levels throughout a given week, and dosage would need to be adjusted based on serum testosterone levels. There is a lack of evidence in current medical literature supporting the superior absorption for Xyosted over testosterone cypionate. The provider reported that the patient has a needle phobia. While Xyosted is unique in that it is available as a subcutaneous auto-injector, the records appear to reflect that the patient has been receiving testosterone by intramuscular injection, and continues to receive other subcutaneous injections including of Ozempic, Toujeo, and hCG. Therefore, Xyosted 100 mg/0.5 mL auto-injector was not and is not medically necessary for the treatment of this patient.Final Result: The reviewer determined that the medication at issue was not and is not medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be upheld.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.