testosterone enanthate intramuscular injection – Hikma, generic only — Cigna

Initial criteria

• For Hypogonadism (Primary or Secondary) in Males: Approve for 1 year if ONE of the following (A or B) is met:
• A) Initial Therapy. Approve in a patient with hypogonadism as confirmed by ALL of the following (i, ii, and iii):
• i. Patient has had persistent signs and symptoms of androgen deficiency (pre-treatment); AND
• ii. Patient has had two pre-treatment serum testosterone (total or bioavailable) measurements, each taken in the morning, on two separate days; AND
• iii. The two serum testosterone levels are both low, as defined by the normal laboratory reference values; OR
• B) Patient Currently Receiving Testosterone Therapy. Approve if BOTH of the following (i and ii) are met:
• i. Patient has had persistent signs and symptoms of androgen deficiency (pre-treatment); AND
• ii. Patient has had at least one pre-treatment serum testosterone (total or bioavailable) level, which was low, as defined by the normal laboratory reference values.
• For Delayed Puberty or Induction of Puberty in Males age ≥ 14 years: Approve Depo-Testosterone, Azmiro, testosterone enanthate intramuscular injection, or Testopel for 6 months.
• For Breast Cancer in Females: Approve testosterone enanthate intramuscular injection for 6 months if prescribed by or in consultation with an oncologist.
• For Gender-Dysphoric/Gender-Incongruent Persons or FTM Gender Reassignment: Approve for 1 year if prescribed by or in consultation with an endocrinologist or a physician who specializes in the treatment of transgender patients.

Approval duration

6–12 months depending on indication