The following products are included in this PA program (formulary specific):

Basic formulary: testosterone 1% gel, testosterone 1.62% gel

Enhanced formulary: testosterone 1% gel, testosterone 1.62% gel, testosterone 30 mg/act TD solution

MAPD Stars formulary: testosterone 1% gel, testosterone 1.62% gel, testosterone 30 mg/act TD solution

Prior Authorization and Quantity Limit Criteria for Approval

Formulary topical androgens will be approved when ALL of the following are met:

1. The patient has ONE of the following diagnoses:
   1. The patient has 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. In men: BCM less than 35% of total body weight and BMI less than 27 kg/m²
            OR
         5. . In women: BCM less than 23% 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 male with primary or secondary (hypogonadotropic) hypogonadism
      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 submitted information in support of therapy with more than one medication
      AND
5. ONE of the following:
   1. The requested quantity (dose) does NOT exceed the program quantity limit
      OR
   2. ALL of the following:
      1. The requested quantity (dose) is greater than the program quantity limit
         AND
      2. The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does not exceed the program quantity limit
         AND
      3. The prescriber has provided information in support of therapy with a higher dose for the requested indication

Length of Approval: 12 months