Exjade — Blue Cross Blue Shield of Alabama

Initial criteria

• ONE of the following:
• - The patient has a diagnosis of chronic iron overload due to blood transfusions (transfusional hemosiderosis) AND BOTH of the following: the patient’s baseline (pretreatment) serum ferritin is greater than 1,000 mcg/L AND if the patient has been treated with a deferasirox agent within the past 90 days, the patient’s current (within the last 30 days) serum ferritin is greater than 500 mcg/L
• - OR the patient has a diagnosis of chronic iron overload due to a non-transfusion dependent thalassemia syndrome AND BOTH of the following: ONE of the following: baseline (pretreatment) liver iron concentration (LIC) ≥ 5 mg FE/g dry weight OR serum ferritin > 300 mcg/L OR MRI confirmation of iron deposition AND if previously treated with a deferasirox agent within past 90 days, LIC > 3 mg FE/g dry weight
• - OR the patient has another FDA approved indication for the requested agent and route of administration OR another indication supported in compendia for the requested agent and route of administration
• AND if FDA approved indication: the patient’s age is within FDA labeling for the requested indication OR there is support for age use
• AND if request for brand with available generic (Exjade/Jadenu vs generic deferasirox): patient has intolerance or hypersensitivity to the generic equivalent, OR has an FDA labeled contraindication to the generic not expected with brand, OR there is support for use of brand over generic
• AND the patient does NOT have severe hepatic impairment (Child-Pugh-Turcotte C)
• AND the prescriber is a specialist in the area of the patient’s diagnosis or has consulted with one
• AND the patient will NOT be using the requested agent in combination with another iron chelating agent targeted in this program
• AND the patient does NOT have any FDA labeled contraindications to the requested agent

Reauthorization criteria

• The patient has been previously approved for the requested agent through the plan’s Prior Authorization process
• AND ONE of the following:
• - Patient has a diagnosis of chronic iron overload due to blood transfusions AND BOTH: decrease in serum ferritin from baseline AND current ferritin > 500 mcg/L
• - OR non-transfusional iron overload due to thalassemia syndromes AND current ferritin > 300 mcg/L
• - OR another diagnosis with clinical benefit from therapy
• AND patient does NOT have severe hepatic impairment (Child-Pugh-Turcotte C)
• AND prescriber is a specialist or has consulted with one
• AND patient will NOT be using in combination with another iron chelating agent targeted in this program
• AND patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

12 months