Subject: deferasirox-Exjade-Jadenu 1622-A SGM P2024

Drug

EXJADE  (deferasirox)

JADENU  (deferasirox)

deferasirox

Policy:

      I.  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.

          A.  FDA-Approved Indications
               1.  Chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients
                    2 years of age and older
               2.  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

          B.  Compendial Use
               Hereditary hemochromatosis

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


    II.  DOCUMENTATION

          Submission of the following information is necessary to initiate the prior authorization review:
          A.  Chronic Iron Overload due to Blood Transfusions (transfusional iron overload):
               1.  Initial requests: pretreatment serum ferritin level
               2.  Continuation requests: current serum ferritin level
          B.  Chronic Iron Overload in Patients with Non-transfusion Dependent Thalassemia
                Syndromes:
               1.  Initial requests: pretreatment serum ferritin level or liver iron concentration (where
                    applicable).
               2.  Continuation requests: current serum ferritin level


   III.  CRITERIA FOR INITIAL APPROVAL

          A.  Chronic Iron Overload due to Blood Transfusions (transfusional iron overload)
               Authorization of 6 months may be granted for treatment of chronic iron overload due to
               blood transfusions when both of the following criteria are met:
               1.  Pretreatment serum ferritin level is consistently greater than 1000 mcg/L.
               2.  Dose of deferasirox tablet for suspension/Exjade will not exceed 40 mg/kg per day, dose
                    of deferasirox/Jadenu will not exceed 28 mg/kg per day.

          B.  Chronic Iron Overload in Patients with Non-transfusion Dependent Thalassemia
               Syndromes
               Authorization of 6 months may be granted for treatment of chronic iron overload in members
               with non-transfusion dependent thalassemia syndromes when both of the following criteria
               are met:
               1.  Member meets any of the following:
                    a.  Pretreatment serum ferritin level is greater than or equal to 800 mcg/L.
                    b.  Pretreatment liver iron concentration (LIC) is at least 5 milligrams of iron per gram of
                         liver dry weight (mg Fe/g dw).
                    c.  Pretreatment serum ferritin level is greater than 300 mcg/L to less than 800 mcg/L
                         and has clinical or laboratory measures indicative of iron overload (e.g., liver disease,
                         renal disease).
               2.  Dose of deferasirox tablet for suspension/Exjade will not exceed 20 mg/kg per day, dose
                    of deferasirox/Jadenu will not exceed 14 mg/kg per day.

          C.  Hereditary Hemochromatosis
               Authorization of 6 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.


   IV.  CONTINUATION OF THERAPY

          A.  Chronic Iron Overload due to Blood Transfusions (transfusional iron overload)
                Authorization of 6 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:
               1.  Member is experiencing benefit from therapy as evidenced by a decrease in serum
                    ferritin levels as compared to pretreatment baseline.
               2.  Serum ferritin level is not consistently below 500 mcg/L.

          B.  Chronic Iron Overload in Patients with Non-transfusion Dependent Thalassemia
               Syndromes
               Authorization of 6 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:
               1.  Member is experiencing benefit from therapy as evidenced by a decrease in serum
                    ferritin levels as compared to pretreatment baseline.
               2.  Serum ferritin level is not consistently below 300 mcg/L.

          C.  Hereditary Hemochromatosis
               Authorization of 6 months may be granted for continued treatment in members requesting
               reauthorization for hereditary hemochromatosis when 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]. North Wales, PA: Actavis Pharma, Inc; August 2021.
4. Deferasirox tablet [package insert]. Princeton, NJ: Dr. Reddy’s Laboratories Inc.; January 2021.
5. Deferasirox granule [package insert]. Bridgewater, NJ: Amneal Pharmaceuticals LLC; September 2022.
6. Cappellini MD, Cohen A, Porter J, et al. Guidelines for the management of transfusion dependent thalassaemia (TDT) 4th Edition [Internet]. Thalassaemia International Federation 2021;20:1-351.
7. Hoffbrand AV, Taher A, Cappellini MD. How I treat transfusional iron overload. Blood 2012;120(18):3657-69.
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. Phatak P, Brissot P, Bonkovsky H et al. A phase I/II, open-label, dose-escalation trial of once daily oral chelator deferasirox to treat iron overload in HFE-related hereditary hemochromatosis: Final Results of the Core Study. Blood 2009;114: 1514.
10. Adams P, Barton J, et al. How I Treat Hemochromatosis. Blood 2010;(116): 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.

April 11, 2024