Pharmacy Prior Authorization Criteria

Deferasirox products

Indications for Prior Authorization

Exjade (deferasirox), deferasirox tablet, Jadenu (deferasirox), Jadenu Sprinkle (deferasirox)

• For diagnosis of Chronic Iron Overload Due to Blood Transfusions (Transfusional Iron Overload)
  Indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older.

  Limitations of Use: The safety and efficacy of deferasirox when administered with other iron chelation therapy have not been established.

• For diagnosis of Treatment of Chronic Iron Overload in Non-Transfusion-Dependent Thalassemia Syndromes
  Indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT) syndromes and with a liver iron concentration (LIC) of at least 5 milligrams of iron per gram of liver dry weight (mg Fe/g dw) and a serum ferritin greater than 300 mcg/L.

  Limitations of Use: The safety and efficacy of deferasirox when administered with other iron chelation therapy have not been established.

• For diagnosis of Myelodysplastic syndrome (MDS)
  Low to intermediate risk myelodysplastic syndrome (MDS) for management of iron overload and in potential transplant patients who have received more than 20 red blood cell transfusions [11]

Criteria

Brand Jadenu, Brand Jadenu Sprinkle, Brand Exjade

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Chronic iron overload due to blood transfusions (transfusional hemosiderosis)

• Diagnosis of chronic iron overload due to blood transfusions (transfusional hemosiderosis)
AND
• Patient is 2 years of age or older
AND
• Patient has a baseline ferritin level more than 1,000 mcg/L
AND
• Patient has required the transfusion of at least 100 mL/kg packed red blood cells
AND
• Trial and failure of generic deferasirox

Generic deferasirox

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Chronic iron overload due to blood transfusions (transfusional hemosiderosis)

• Diagnosis of chronic iron overload due to blood transfusions (transfusional hemosiderosis)
AND
• Patient is 2 years of age or older
AND
• Patient has a baseline ferritin level more than 1,000 mcg/L
AND
• Patient has required the transfusion of at least 100 mL/kg packed red blood cells

Brand Jadenu, Brand Jadenu Sprinkle, Brand Exjade

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Myelodysplastic syndrome (MDS) [off-label]

• Diagnosis of myelodysplastic syndrome
AND
• Patient has Low or Intermediate-1 disease or is a potential transplant patient
AND
• Patient has received more than 20 red blood cell transfusions
AND
• Trial and failure of generic deferasirox

Generic deferasirox

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Myelodysplastic syndrome (MDS) [off-label]

• Diagnosis of myelodysplastic syndrome
AND
• Patient has Low or Intermediate-1 disease or is a potential transplant patient
AND
• Patient has received more than 20 red blood cell transfusions

Brand Jadenu, Brand Jadenu Sprinkle, Brand Exjade

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Chronic iron overload due to blood transfusions (transfusional hemosiderosis) & Myelodysplastic syndrome (MDS) [off-label]

• Patient experienced a reduction, from baseline, in serum ferritin level or liver iron concentration (LIC)
AND
• Trial and failure of generic deferasirox

Generic deferasirox

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Chronic iron overload due to blood transfusions (transfusional hemosiderosis) & Myelodysplastic syndrome (MDS) [off-label]

• Patient experienced a reduction, from baseline, in serum ferritin level or liver iron concentration (LIC)

Brand Jadenu, Brand Jadenu Sprinkle, Brand Exjade

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Chronic iron overload due to non-transfusion-dependent thalassemia (NTDT)

• Diagnosis of chronic iron overload due to non-transfusion-dependent thalassemia (NTDT)
AND
• Patient is 10 years of age or older
AND
• Liver iron concentration (LIC) 5 milligrams of iron per gram of liver dry weight (mg Fe/g dw) or higher
AND
• Serum ferritin level greater than 300 mcg/L
AND
• Trial and failure of generic deferasirox

Generic deferasirox

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Chronic iron overload due to non-transfusion-dependent thalassemia (NTDT)

• Diagnosis of chronic iron overload due to non-transfusion-dependent thalassemia (NTDT)
AND
• Patient is 10 years of age or older
AND
• Liver iron concentration (LIC) 5 milligrams of iron per gram of liver dry weight (mg Fe/g dw) or higher
AND
• Serum ferritin level greater than 300 mcg/L

Brand Jadenu, Brand Jadenu Sprinkle, Brand Exjade

Prior Authorization (Reauthorization)

Length of Approval: 6 Month(s)
For diagnosis of Chronic iron overload due to non-transfusion-dependent thalassemia (NTDT)

• Patient has liver iron concentration (LIC) 3 mg Fe/g dw or higher
AND
• Patient experienced a reduction, from baseline, in serum ferritin level or liver iron concentration (LIC)
AND
• Trial and failure of generic deferasirox

Generic deferasirox

Prior Authorization (Reauthorization)

Length of Approval: 6 Month(s)
For diagnosis of Chronic iron overload due to non-transfusion-dependent thalassemia (NTDT)

• Patient has liver iron concentration (LIC) 3 mg Fe/g dw or higher
AND
• Patient experienced a reduction, from baseline, in serum ferritin level or liver iron concentration (LIC)

P & T Revisions

2024-07-29, 2022-04-28, 2021-09-28, 2021-05-10, 2020-08-12, 2020-07-07, 2020-04-29, 2020-03-27, 2020-01-14, 2019-08-19

References

1. Exjade Prescribing Information. Novartis Pharmaceuticals Corporation. East Hanover, NJ. July 2020.
2. Cappellini MD, Cohen A, Piga A, et al. A Phase III study of deferasirox (ICL670), a once-daily oral iron chelator, in patients with [beta]-thalassemia. Blood. 2006;107(9):3455-62.
3. Cappellini MD. Iron-chelating therapy with the new oral agent ICL670 (Exjade). Best Pract Res Clin Haematol. 2005;18(2):289-98.
4. Galanello R, Piga A, Alberti D, Rouan MC, Bigler H, Sechaud R. Safety, tolerability, and pharmacokinetics of ICL670, a new orally active iron-chelating agent in patients with transfusion-dependent iron overload due to beta-thalassemia. J Clin Pharmacol. 2003;43(6):565-72.
5. Nisbet-Brown E, Olivieri NF, Giardina PJ, et al. Effectiveness and safety of ICL670 in iron-loaded patients with thalassaemia: a randomized, double-blind, placebo-controlled, dose-escalation trial. Lancet. 2003;361(9369):1597-602.
6. International Association of Sickle Cell Nurses and Physician Assistants. Nursing Practice Guidelines: Care of the Patient with Sickle Cell Disease and Iron Overload. 2008. http://www.iascnapa.org/guidelines/Guidelines_IronOverload.pdf. Accessed on April 8, 2021.
7. Ho PJ, Tay L, Linderman R, Catley L, Bowden DK. Australian guidelines for the assessment of iron overload and iron chelation in transfusion-dependent thalassaemia major, sickle cell disease and other congenital anaemias. Intern Med J. 2011;41(7):516-24.
8. Angelucci E, Barosi G, Camaschella C, et al. Italian Society of Hematology practice guidelines for the management of iron overload in thalassemia major and related disorders. Haematologica. 2008;93(5):741-52.
9. Porter JB and Shah FT. Iron overload in thalassemia and related conditions: therapeutic goals and assessment of response to chelation therapies. 2010 Dec;24(6):1109-30.
10. Jadenu, Jadenu Sprinkle Prescribing Information. Novartis Pharmaceuticals. East Hanover, NJ. July 2020.
11. AHFS Drug Information (Adult and Pediatric) [Internet database]. Bethesda, Maryland. Lexicomp, Inc. Updated periodically. Available by subscription at: http://online.lexi.com/. Accessed on April 8, 2021.
12. Deferasirox tablet Prescribing Information. Cipla USA, Inc. Warren, NJ. August 2020.

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Revision History

• 2024-07-29: Annual review - no changes to criteria
• 2022-04-28: Annual review: No changes to criteria
• 2021-09-28: Annual review: Updated background and added EHB formulary to the guideline.
• 2021-05-10: Annual review: Updated background and added EHB formulary to the guideline.
• 2020-08-12: Added new generic for Jadenu Sprinkle to guideline; no changes to criteria
• 2020-07-07: added new 180 mg deferasirox gpi to existing guideline no changes to criteria
• 2020-04-29: annual review no changes to clinical criteria references updated
• 2020-03-27: Updated formulary, products are now non-specialty.
• 2020-01-14: added generic Jadenu 90 & 360 mg tabs for treatment of chronic iron overload due to blood transfusions (transfusional iron overload) and for the treatment of chronic iron overload in non-transfusion-dependent thalassemia syndromes.
• 2019-08-19: removed (remove not in PI) from criteria

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