Xyosted denials in California external review

What the reviewers wrote

Where the denial was overturned

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.

Xyosted (testosterone enanthate) is an FDA-approved medication for treatment of male hypogonadism. A clinical trial was done to evaluate the efficacy and safety of a subcutaneous testosterone enanthate auto-injector administered weekly to men with hypogonadism. The conclusion of the trial noted the dose adjusted subcutaneous testosterone enanthate auto-injector demonstrated a steady serum total testosterone pharmacokinetic profile with small peak and trough fluctuations. The clinical trial found that the device was safe, well tolerated and virtually painless, indicating that subcutaneous testosterone enanthate auto-injection offers a testosterone delivery system that is a convenient weekly option to treat testosterone deficiency.

Where the denial was 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.

Findings: The physician reviewer found that Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Xyosted. Male hypogonadism is a condition in which the testes do not make adequate levels of testosterone and/or sperm. Hypogonadism is treated with testosterone therapy to induce and maintain secondary sex characteristics and correct symptoms of testosterone deficiency. Hypogonadism, if untreated, may adversely affect multiple organ functions and quality of life. Options for treatment of hypogonadism with testosterone include testosterone cypionate or testosterone enanthate by intramuscular (IM) injection, testosterone patch, topical, transdermal gels, nasal gel, axial foam, buccal testosterone tablets, testosterone pellets, injectable long-acting testosterone undecanoate in oil, and nasal testosterone gel.

These outcomes describe eligible cases completed through California DMHC’s Independent Medical Review program. They do not estimate the chance that an internal appeal, an external review in another jurisdiction, or your individual case will succeed. Use the record to identify evidence patterns involving Xyosted, then check the rights and deadlines that apply to your plan.