DELATESTRYL (testosterone cypionate 100mg/ml; 200mg/ml)

DELATESTRYL (testosterone cypionate) 

OFFICE ADMINISTRATION / SELF ADMINISTRATION

Testosterone cypionate 200 mg/mL, 1 ML vial does not require prior authorization, but does have a quantity limit of 4 ML every 28 days.  Prior authorization is required for any request above 4 ML every 28 days.

Testosterone cypionate 100 mg/mL, 10 ML vial requires prior authorization including medical rationale for exceeding 4 ML quantity limit.

Indications for Prior Authorization:

• Replacement therapy in males in conditions associated with symptoms of deficiency or absence of endogenous testosterone
  • Primary hypogonadism (congenital or acquired) - testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, age-related hypogonadism; or orchidectomy
  • Hypogonadotropic hypogonadism (congenital or acquired) - gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumor, trauma, or radiation
  • Hormone therapy for transgender males (female-to-male)

Prior authorization criteria:

• Diagnosis of hypogonadism or hormone therapy for transgender males is confirmed by medical record documentation including lab documentation of morning serum testosterone concentrations; AND
• For hypogonadism: Other reasons for androgen deficiency have been ruled out (e.g. adrenal insufficiency, hypopituitarism); AND
• For age-related hypogonadism: patient has documented symptoms of sexual dysfunction including at least one of the following:
  • Reduced sexual libido and activity.
  • Decreased morning erection
  • Disturbances in potency

Dosing:

• For replacement in the hypogonadal male, 50-400 mg should be administered every two to four weeks.
• Quantity limit is a 30 day supply per fill.

Coverage Duration:

• One year

Additional Information:

• Testosterone cypionate is contraindicated in men with carcinomas of the breast or prostate