Subject: deferasirox-Exjade-Jadenu 1622-A SGM P2023

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 and
                    liver iron concentration
               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 all 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 all of the following
          criteria are met:
          1.  Pretreatment serum ferritin level is greater than 300 mcg/L.
          2.  Pretreatment liver iron concentration (LIC) is at least 5
               milligrams of iron per gram of liver dry weight (mg Fe/g dw).
          3.  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 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 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; August 2021
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 thalassaemia (NTDT) 2nd Edition. Thalassaemia International Federation 2018;1-117.
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, Kris V. MD, FACG1; Brown, Kyle E. MD, MSc2,3,4; Ahn, Joseph MD, MS, MBA, FACG (GRADE Methodologist)5; Sundaram, Vinay MD, MSc6 ACG Clinical Guideline: Hereditary Hemochromatosis, The American Journal of Gastroenterology: August 2019 - Volume 114 - Issue 8 - p 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, 2023