AVEED (testosterone undecanoate)

AVEED (testosterone undecanoate)

OFFICE ADMINISTRATION  [MEDICAL BENEFIT]

Indications for Prior Authorization: 

• Indicated for testosterone replacement in adult males for conditions associated with a deficiency or absence of endogenous testosterone (primary hypogonadism (congenital or acquired), and hypogonadotropic hypogonadism (congenital or acquired).

The following criteria must be met for coverage:

• Patient is 18 years of age or older, AND
• Diagnosis of hypogonadism confirmed by medical record documentation including lab documentation of morning serum testosterone concentrations below normal range, AND
• Patient has persistent signs and symptoms (e.g., depressed mood, decreased energy, progressive decrease in muscle mass, osteoporosis, loss of libido) of androgen deficiency (pre-treatment), AND
• Other reasons for androgen deficiency have been ruled out (e.g. adrenal insufficiency, hypopituitarism), AND
• Medical justification is provided why patient cannot use both topical testosterone (gel and patch), and testosterone for IM injection, AND
• Limited to a 30 day supply per fill
• Contraindicated in men with carcinomas of the breast or prostate
• Warnings include serious pulmonary oil microembolism (POME) reactions and anaphylaxis

Dosing:

• The recommended dose of Aveed is 3 mL (750 mg) injected intramuscularly, followed by 3 mL (750 mg) injected after 4 weeks, then 3 mL (750 mg) injected every 10 weeks thereafter.

Approval: 

• 1 year