Iron-Chelating Agents – Deferasirox Prior Authorization Criteria - Medicare Part D

Initial Evaluation

Deferasirox tablets for oral suspension (generic Exjade) and deferasirox oral tablets and sprinkle granules (generics for Jadenu) will be approved when BOTH of the following are met:

1. ONE of the following: 
   1. The patient has a diagnosis of chronic iron overload due to a non-transfusion dependent thalassemia syndrome AND ONE of the following: 
      1. A liver iron (Fe) concentration (LIC) of at least 5 mg Fe per gram of dry weight OR 
      2. A serum ferritin greater than 300 mcg/L OR 
      3. MRI confirmation of iron deposition OR 
   2. The patient has a diagnosis of chronic iron overload due to blood transfusions AND 
2. The patient is within the FDA labeled age for the requested medication for the requested indication AND 
3. The patient will NOT be using the requested medication in combination with another iron chelating agent (e.g., deferiprone) for the requested indication AND 
4. The patient does NOT have any FDA labeled contraindications to the requested medication

Length of Approval: 12 months

Renewal Evaluation

Deferasirox tablets for oral suspension (generic Exjade) and deferasirox oral tablets and sprinkle granules (generics for Jadenu) will be approved when ALL of the following are met:

1. The patient has been previously approved for the requested medication through the plan’s Prior Authorization criteria AND 
2. ONE of the following: 
   1. The patient has a diagnosis of chronic iron overload due to a non-transfusion dependent thalassemia syndrome OR 
   2. The patient has a diagnosis of chronic iron overload due to blood transfusions AND 
3. The patient is within the FDA labeled age for the requested medication for the requested indication AND 
4. The patient has had clinical benefit with the requested medication AND 
5. The patient will NOT be using the requested medication in combination with another iron chelating agent (e.g., deferiprone) for the requested indication AND 
6. The patient does NOT have any FDA labeled contraindications to the requested medication

Length of Approval: 12 months