Subject: deferasirox-Exjade-Jadenu 1622-A SGM P2022
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EXJADE
(deferasirox; tablets for suspension)
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JADENU
(deferasirox; tablets, sprinkle granules)
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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.
3. Member’s renal function has been evaluated.
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.
4. Member’s renal function has been evaluated.
C. Hereditary Hemochromatosis
Authorization of 6 months may be granted for treatment of hereditary hemochromatosis when both of
the following criteria are met:
1. 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.
2. Member’s renal function has been evaluated.
IV. CONTINUATION OF THERAPY
Authorization of 6 months may be granted for continued treatment in members requesting reauthorization for an indication listed in Section III when the following criteria are met:
A. Chronic Iron Overload due to Blood Transfusions (transfusional iron overload)
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.
3. Member’s renal function has been evaluated.
B. Chronic Iron Overload in Patients with Non-transfusion Dependent Thalassemia Syndromes
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.
3. Member’s renal function has been evaluated.
C. Hereditary Hemochromatosis
1. Member is experiencing benefit from therapy as evidenced by a decrease in serum ferritin levels as
compared to pretreatment baseline.
2. Member’s renal function has been evaluated.
Place of Service:
Outpatient
The above policy is based on the following references:
- Exjade [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; July 2020.
- Jadenu [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; July 2020.
- 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.
- Hoffbrand AV, Taher A, Cappellini MD. How I treat transfusional iron overload. Blood 2012;120(18):3657-69.
- 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.
- 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.
- Adams P, Barton J, et al. How I Treat Hemochromatosis. Blood 2010;(116): 317-325.
- 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
- Deferasirox tablet for suspension [package insert]. North Wales, PA: Actavis Pharma, Inc; January 2020.
- Deferasirox tablet [package insert]. Princeton, NJ: Dr. Reddy’s Laboratories Inc.; June 2020.
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 17, 2022
