Anabolic Steroids - Oxandrolone Prior Authorization Criteria – Medicare Part D

Prior Authorization Criteria for Approval

Oxandrolone will be approved when ALL of the following are met:

1. The patient has ONE of the following diagnoses:
   1. 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 female and is a child or adolescent with Turner syndrome AND is currently receiving growth hormone
      OR
   3. Patient has weight loss following extensive surgery, chronic infections, or severe trauma OR
   4. Patient has chronic pain from osteoporosis
      OR
   5. Patient is on long-term administration of oral or injectable corticosteroids
      AND
2. The patient does NOT have any FDA labeled contraindications to the requested medication
   AND
3. 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: 12 months