Jadenu (deferasirox) — Blue Cross Blue Shield of Montana

Preferred products

• Generic deferasirox

Initial criteria

• If patient has been treated with a deferasirox agent within the past 90 days, current (within the last 30 days) serum ferritin is greater than 500 mcg/L OR
• Diagnosis of chronic iron overload due to a non-transfusion dependent thalassemia syndrome AND BOTH: (1) baseline liver iron concentration (LIC) ≥ 5 mg FE/g dry weight OR serum ferritin > 300 mcg/L OR MRI confirmation of iron deposition AND (2) if previously treated with a deferasirox agent within 90 days, LIC > 3 mg FE/g dry weight OR
• Other FDA approved indication for requested agent and route of administration OR
• Other indication supported in compendia for requested agent and route of administration
• If FDA approved indication, patient's age is within FDA labeling for the indication OR there is support for using requested agent for patient's age for the indication
• If request is for one of the following brand agents with generic equivalent (Exjade, Jadenu), then ONE of: (A) advanced metastatic cancer criteria met; OR (B) patient currently stable on agent; OR (C) tried and had inadequate response to generic equivalent; OR (D) generic discontinued due to lack of efficacy or adverse event; OR (E) intolerance or hypersensitivity to generic; OR (F) FDA labeled contraindication to generic not expected with brand; OR (G) generic expected to be ineffective, cause adherence barrier, worsen comorbid condition, reduce functional ability, or cause harm; OR (H) generic not in best interest of patient based on medical necessity; OR (I) tried another drug in same class/mechanism discontinued due to lack of efficacy or adverse event; OR (J) support for use of brand over generic
• Patient does NOT have severe hepatic impairment (Child-Pugh-Turcotte C)
• Prescriber is a specialist in the area of the patient’s diagnosis (e.g., hematologist) or has consulted a specialist
• Patient will NOT be using the requested agent in combination with another iron chelating agent targeted in this program
• Patient does NOT have any FDA labeled contraindications to the requested agent

Reauthorization criteria

• Patient previously approved for requested agent through plan’s Prior Authorization process
• ONE of: (A) Chronic iron overload due to blood transfusions AND both a decrease in serum ferritin from baseline 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 and has had clinical benefit with requested agent
• Patient does NOT have severe hepatic impairment (Child-Pugh-Turcotte C)
• Prescriber is a specialist in the area of the patient’s diagnosis (e.g., hematologist) or has consulted a specialist
• Patient will NOT be using the requested agent in combination with another iron chelating agent targeted in this program
• Patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

12 months