Vogelxo — Blue Cross Blue Shield of Alabama

Initial criteria

• Patient is an adult male (age ≥ 18 years) with confirmed testosterone deficiency evidenced by consistently low serum total or free testosterone AND symptoms or signs of low testosterone.
• Diagnosis of primary hypogonadism (testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter’s syndrome, chemotherapy, or toxic damage from alcohol or heavy metals) OR hypogonadotropic hypogonadism (gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation).
• Safety and efficacy in men with age-related hypogonadism have not been established (not covered for age-related or late-onset hypogonadism).
• Safety and efficacy in males < 18 years old have not been established (except for use in carefully selected males with delayed puberty when clinically appropriate).

Reauthorization criteria

• Reauthorization may be granted if the patient continues to exhibit symptomatic improvement and serum testosterone levels are within the normal physiologic range (e.g., 450–600 ng/dL) and reassessment occurs every 6–12 months.

Approval duration

12 months