Subject: deferoxamine-Desferal SGM 1620-A P2024a

Drug

DESFERAL  (deferoxamine mesylate)

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^1-4

Transfusional iron overload in patients with chronic anemia.

Compendial Uses

• Aluminum toxicity in patients undergoing dialysis^3,4,6
• Hereditary hemochromatosis^3,7,8

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:

Transfusional iron overload in chronic anemia:

• Initial requests: pretreatment serum ferritin level
• Continuation requests: current serum ferritin level

Coverage Criteria

Transfusional Iron Overload in Chronic Anemia^1,2,5,6

Authorization of 12 months may be granted for treatment of transfusional iron overload in members with chronic anemia when the pretreatment serum ferritin level is consistently greater than 1000 mcg/L.

Aluminum Toxicity in Members Undergoing Dialysis^3,4,6

Authorization of 12 months may be granted for treatment of aluminum toxicity in members undergoing dialysis.

Hereditary Hemochromatosis^3,7,8

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

Transfusional Iron Overload in Chronic Anemia^1-5

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

Aluminum Toxicity in Members Undergoing Dialysis³

Authorization of 12 months may be granted for continued treatment in members requesting reauthorization for aluminum toxicity while undergoing dialysis when the member is experiencing benefit from therapy as evidenced by either of the following:

• Decreased serum aluminum concentrations
• Symptomatic improvement (e.g., neurological symptom improvement, decreased bone pain)

Hereditary Hemochromatosis^7,8

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. Desferal [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; September 2022.
2. Deferoxamine mesylate [package insert]. Lake Forest, IL: Hospira, Inc.; November 2023.
3. AHFS Drug Information[database online]. American Society of Health-System Pharmacists, Inc. Bethesda, MD. Available at: http://online.lexi.com/lco/action/index/dataset/complete_ashp [available with subscription]. Accessed October 4, 2024.
4. Clinical Pharmacology [Internet]. Elsevier. Tampa (FL). Available from: http://www.clinicalpharmacology.com. October 4, 2024.
5. 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 January 30, 2025.
6. 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.
7. Adams P, Barton J, et al. How I Treat Hemochromatosis. Blood. 2010;116(3): 317-325.
8. 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 18, 2025