Subject: deferasirox-Exjade-Jadenu SGM 1622-A P2025

Drug

deferasirox–Exjade–Jadenu

EXJADE  (deferasirox)

JADENU  (deferasirox)

Policy:

Indications

The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.

FDA-approved Indications^1-5

·       Chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older.

·       Chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT) syndromes and with a liver iron (Fe) 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 micrograms per liter (mcg/L).

Compendial Uses^9-11

Hereditary hemochromatosis

All other indications are considered experimental/investigational and not medically necessary.

Documentation

Submission of the following information is necessary to initiate the prior authorization review:

·       Chronic iron overload due to blood transfusions (transfusional iron overload):

§  Initial requests: pretreatment serum ferritin level

§  Continuation requests: current serum ferritin level

·       Chronic iron overload in patients with non-transfusion dependent thalassemia syndromes:

§  Initial requests: pretreatment serum ferritin level or liver iron concentration (where applicable)

§  Continuation requests: current serum ferritin level

Prescriber Specialties

This medication must be prescribed by or in consultation with a hematologist.

Coverage Criteria

Chronic Iron Overload due to Blood Transfusions (Transfusional Iron Overload)^1-7

Authorization of 12 months may be granted for treatment of chronic iron overload due to blood transfusions when both of the following criteria are met:

·       Pretreatment serum ferritin level is greater than 1000 mcg/L.

·       Dose of deferasirox tablet for suspension or Exjade will not exceed 40 milligrams per kilogram per day (mg/kg/day), dose of deferasirox tablets/granules or Jadenu will not exceed 28 mg/kg/day.

Chronic Iron Overload in Patients with Non-Transfusion Dependent Thalassemia (NTDT) Syndromes^1-5,8

Authorization of 12 months may be granted for treatment of chronic iron overload in members with non-transfusion dependent thalassemia (NTDT) syndromes when both of the following criteria are met:

·       Member meets any of the following:

§  Pretreatment serum ferritin level is greater than or equal to 800 mcg/L.

§  Pretreatment liver iron concentration (LIC) is at least 5 milligrams of iron per gram of liver dry weight (mg Fe/g dw).

§  Pretreatment serum ferritin level is greater than 300 mcg/L to less than 800 mcg/L and member has clinical or laboratory measures indicative of iron overload (e.g., liver disease, renal disease).

·       Dose of deferasirox tablet for suspension or Exjade will not exceed 20 mg/kg/day, dose of deferasirox tablets/granules or Jadenu will not exceed 14 mg/kg/day.

Hereditary Hemochromatosis^9-11

Authorization of 12 months may be granted for treatment of hereditary hemochromatosis when phlebotomy is not an option (e.g., poor venous access, poor candidate due to underlying medical disorders) or the member had an unsatisfactory response to phlebotomy.

Continuation of Therapy

Chronic Iron Overload due to Blood Transfusions (Transfusional iron overload)^1-5

Authorization of 12 months may be granted for continued treatment in members requesting reauthorization for chronic iron overload due to blood transfusions (transfusional iron overload) when both of the following criteria are met:

·       Member is experiencing benefit from therapy as evidenced by a decrease in serum ferritin levels as compared to pretreatment baseline.

·       Serum ferritin level is not below 500 mcg/L.

Chronic Iron Overload in Patients with Non-Transfusion Dependent Thalassemia Syndromes^1-5,8

Authorization of 12 months may be granted for continued treatment in members requesting reauthorization for chronic iron overload with non-transfusion dependent thalassemia syndrome when both of the following criteria are met:

·       Member is experiencing benefit from therapy as evidenced by a decrease in serum ferritin levels as compared to pretreatment baseline.

·       Serum ferritin level is not below 300 mcg/L.

Hereditary Hemochromatosis

Authorization of 12 months may be granted for continued treatment in members requesting reauthorization for hereditary hemochromatosis when the member is experiencing benefit from therapy as evidenced by a decrease in serum ferritin levels as compared to pretreatment baseline.

Place of Service:

Outpatient

The above policy is based on the following references:

1.        Exjade [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; July 2020.

2.      Jadenu [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; July 2020.

3.      Deferasirox tablet for suspension [package insert]. Parsippany, NJ: Actavis Pharma, Inc; August 2021.

4.      Deferasirox tablet [package insert]. Piscataway, NJ: Camber Pharmaceuticals, Inc.; November 2024.

5.      Deferasirox granule [package insert]. Parsippany, NJ: Actavis Pharma, Inc.; January 2024.

6.      Taher AT, Farmakis D, Porter JB, et al. Guidelines for the management of transfusion dependent thalassaemia (TDT) 5th Edition [Internet]. Thalassaemia International Federation. 2025. Available at: https://thalassaemia.org.cy/publications/tif-publications/guidelines-for-the-management-of-transfusion-dependent-%ce%b2-thalassaemia-5th-edition-2025. Accessed October 14, 2025.

7.      Shah FT, Porter JB, Sadasivam N, et al. Guidelines for the monitoring and management of iron overload in patients with haemoglobinopathies and rare anemias. Br J Haematol. 2022;196(2):336-350.

8.      Taher A, Musallam K, Cappellini M, et al. Guidelines for the management of non-transfusion dependent β-thalassaemia 3rd Edition. Thalassaemia International Federation. 2023;1-132.

9.      European Association for the Study of the Liver. EASL Clinical practice guidelines on haemochromatosis. J Hepatol. 2022;77(2):479-502.

10.   Adams P, Barton J, et al. How I Treat Hemochromatosis. Blood. 2010;116(3): 317-325.

11.     Kowdley KV, Brown KE, et al. ACG Clinical Guideline: Hereditary Hemochromatosis. Am J Gastroenterol. 2019;114(8):1202-1218.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

June 06, 2026