Prior Authorization Criteria for Approval

Initial Evaluation

Depo-Testosterone, testosterone cypionate and testosterone enanthate will be approved when ALL of the following are met:

1. The patient has ONE of the following diagnoses:
   1. The patient’s sex is male with AIDS/HIV-associated wasting syndrome AND BOTH of the following:
      1. ONE of the following:
         1. Unexplained involuntary weight loss (greater than 10% baseline body weight within 12 months, or 7.5% within 6 months)
            OR
         2. Body mass index less than 20 kg/m²
            OR
         3. At least 5% total body cell mass (BCM) loss within 6 months
            OR
         4. BCM less than 35% of total body weight and BMI less than 27 kg/m²
            AND
      2. All other causes of weight loss have been ruled out
         OR
   2. The patient’s sex is female with metastatic/inoperable breast cancer
      OR
   3. The patient’s sex is male with primary or secondary (hypogonadotropic) hypogonadism
      OR
   4. The patient’s sex is male and is an adolescent with delayed puberty
      AND
2. If the patient’s sex is male, ONE of the following:
   1. The patient is NOT currently receiving testosterone replacement therapy AND has ONE of the following pretreatment levels:
      1. Total serum testosterone level that is below the testing laboratory’s lower limit of the normal range or is less than 300 ng/dL
         OR
      2. Free serum testosterone level that is below the testing laboratory’s lower limit of the normal range
         OR
   2. The patient is currently receiving testosterone replacement therapy AND has ONE of the following current levels:
      1. Total serum testosterone level that is within OR below the testing laboratory’s lower limit of the normal range OR is less than 300 ng/dL
         OR
      2. Free serum testosterone level is within OR below the testing laboratory’s normal range
         AND
3. The patient does NOT have any FDA labeled contraindications to the requested medication
   AND
4. ONE of the following:
   1. The patient will NOT be using the requested medication in combination with another androgen or anabolic steroid
      OR
   2. The prescriber has provided information in support of therapy with more than one medication

Length of Approval:

6 months (delayed puberty only)

12 months (all other indications)