Androgens Oral Prior Authorization Criteria - Medicare Part D

The following product is included in this PA program (formulary specific):

Enhanced formulary: methyltestosterone
MAPD Stars formulary: methyltestosterone

Prior Authorization Criteria for Approval

Methyltestosterone 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 cryptorchidism OR 
   2. The patient’s sex is male with hypogonadism OR 
   3. The patient’s sex is male and is an adolescent with delayed puberty OR 
   4. The patient’s sex is female with metastatic/inoperable breast cancer 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)