Exjade (deferasirox) — Blue Cross Blue Shield of New Mexico

Preferred products

• Generic deferasirox

Initial criteria

• If treated with a deferasirox agent within the past 90 days, current (within last 30 days) serum ferritin > 500 mcg/L OR
• 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 (FE) concentration (LIC) ≥ 5 mg FE/g dry weight OR serum ferritin > 300 mcg/L OR MRI confirmation of iron deposition AND
• If treated with a deferasirox agent within the past 90 days, LIC > 3 mg FE/g dry weight OR
• The patient has another FDA approved indication or a compendia-supported indication for the requested agent and route of administration AND
• If FDA approved indication, ONE of the following: (A) Age within FDA labeling for indication OR (B) Support for using agent for patient’s age for that indication AND
• If request is for brand Exjade or Jadenu (with available generic deferasirox), ONE of the following:
• A. BOTH of the following: (1) ONE of: patient has stage 4 advanced metastatic cancer and agent used to treat cancer or associated condition [chart notes required], AND (2) Use consistent with best practices, supported by peer-reviewed literature, and FDA approved OR
• B. Patient currently treated and stable on requested agent [chart notes required] OR
• C. Patient has tried and had inadequate response to generic equivalent [chart notes required] OR
• D. Generic equivalent discontinued due to lack of efficacy/effectiveness, diminished effect, or adverse event [chart notes required] OR
• E. Intolerance or hypersensitivity to generic not expected with brand [chart notes required] OR
• F. FDA labeled contraindication to generic not expected with brand [chart notes required] OR
• G. Generic expected ineffective or cause adherence barrier, worsen comorbidity, reduce function, or cause harm [chart notes required] OR
• H. Generic not in best interest of patient based on medical necessity [chart notes required] OR
• I. Tried another prescription drug in same pharmacologic class/mechanism and discontinued due to lack of efficacy/effectiveness or adverse event [chart notes required] OR
• J. Support for use of requested brand agent over generic equivalent AND
• Patient does NOT have severe hepatic impairment (Child-Pugh-Turcotte C) AND
• Prescriber is or has consulted with a hematologist or relevant specialist AND
• Patient will NOT use the requested agent in combination with another iron chelating agent targeted in this program AND
• Patient does NOT have any FDA labeled contraindications to the requested agent
• Alternative Ohio-specific approval: Member resides in Ohio AND plan is Fully Insured or HIM Shop (SG) AND both (A) No FDA labeled contraindications, AND (B) ONE of following: FDA labeled indication OR compendia-supported indication OR two peer-reviewed journal articles supporting proposed use (study design criteria as specified)

Reauthorization criteria

• Previously approved for requested agent through plan’s Prior Authorization process AND
• ONE of the following:
• A. Chronic iron overload due to blood transfusions AND BOTH of the following: decrease in serum ferritin from baseline (pretreatment) AND current serum ferritin > 500 mcg/L OR
• B. Non-transfusional iron overload due to thalassemia syndromes AND current serum ferritin > 300 mcg/L OR
• C. Another diagnosis with documented clinical benefit from requested agent AND
• Patient does NOT have severe hepatic impairment (Child-Pugh-Turcotte C) AND
• Prescriber is or has consulted with a relevant specialist AND
• Patient will NOT use with another iron chelating agent targeted in this program AND
• No FDA labeled contraindications to the requested agent

Approval duration

12 months