Exjade (deferasirox) — Blue Cross Blue Shield of Oklahoma

Preferred products

• Generic deferasirox

Initial criteria

• If patient has been treated with a deferasirox agent within past 90 days, patient’s current (within last 30 days) serum ferritin >500 mcg/L OR
• For chronic iron overload due to non-transfusion dependent thalassemia syndrome: BOTH of the following:
• - ONE of baseline liver iron concentration ≥5 mg FE/g dry weight OR serum ferritin >300 mcg/L OR MRI confirmation of iron deposition AND
• - If treated with deferasirox agent within past 90 days, LIC >3 mg FE/g dry weight OR
• Patient has another FDA approved indication or one supported in compendia for requested agent and route of administration AND
• If the patient has an FDA approved indication: ONE of the following:
• - Patient’s age within FDA labeling for requested indication OR there is support for use for the patient’s age for the requested indication AND
• If request is for a brand agent (Exjade or Jadenu) with available generic equivalent, ONE of the following:
• - Both of the following: (1) Patient has stage four advanced, metastatic cancer and requested agent used to treat the cancer or associated condition [chart notes required]; AND (2) Use is consistent with best practices and FDA approved OR
• - Patient currently stable on requested agent [chart notes required] OR
• - Tried and had inadequate response to generic equivalent [chart notes required] OR
• - Generic equivalent discontinued due to lack of efficacy, diminished effect, or adverse event [chart notes required] OR
• - Intolerance or hypersensitivity to generic equivalent not expected with brand [chart notes required] OR
• - FDA labeled contraindication to generic equivalent not expected with brand [chart notes required] OR
• - Generic equivalent expected ineffective or cause adherence barrier or worsen comorbidity or functional ability or cause harm [chart notes required] OR
• - Generic equivalent not in best interest of patient based on medical necessity [chart notes required] OR
• - Tried another drug in same class that was discontinued due to lack of efficacy or adverse event [chart notes required] OR
• - There is support for the use of requested brand agent over generic equivalent
• Patient does NOT have severe hepatic impairment (Child-Pugh-Turcotte C) AND
• Prescriber is specialist (e.g., hematologist) or has consulted with one AND
• Requested agent will NOT be used in combination with another iron chelating agent targeted in this program AND
• Patient does NOT have any FDA labeled contraindications to requested agent

Reauthorization criteria

• Patient previously approved for requested agent through plan’s PA process AND
• ONE of the following:
• - Diagnosis of chronic iron overload due to blood transfusions AND BOTH of: decrease in serum ferritin from baseline AND current serum ferritin >500 mcg/L OR
• - Diagnosis of non-transfusional iron overload due to thalassemia syndromes AND current serum ferritin >300 mcg/L OR
• - Another diagnosis and has had clinical benefit with requested agent AND
• Patient does NOT have severe hepatic impairment (Child-Pugh-Turcotte C) AND
• Prescriber is specialist (e.g., hematologist) or has consulted with one AND
• Agent will NOT be used in combination with another iron chelating agent targeted in this program AND
• Patient does NOT have any FDA labeled contraindications to requested agent

Approval duration

12 months