Subject: deferoxamine-Desferal 1620-A SGM P2024

Drug

DESFERAL  (deferoxamine)

deferoxamine mesylate

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 Indication
               Transfusional iron overload in patients with chronic anemia

          B.  Compendial Uses
               1.  Aluminum toxicity in patients undergoing dialysis
               2.  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:
          Chronic Iron Overload due to Transfusional Iron Overload:
          A.  Initial requests: pretreatment serum ferritin level
          B.  Continuation requests: current serum ferritin level


   III.  CRITERIA FOR INITIAL APPROVAL

          A.  Transfusional Iron Overload in Members with Chronic Anemia
               Authorization of 6 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.

          B.  Aluminum Toxicity in Members Undergoing Dialysis
               Authorization of 6 months may be granted for treatment of aluminum toxicity in members
               undergoing dialysis.

          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.  Transfusional Iron Overload in Members with Chronic Anemia
               Authorization of 6 months may be granted for continued treatment in members requesting
               reauthorization for transfusional iron overload with chronic anemia when member is
               experiencing benefit from therapy as evidenced by a decrease in serum ferritin levels as
               compared to pretreatment baseline.

          B.  Aluminum Toxicity in Members Undergoing Dialysis
               Authorization of 6 months may be granted for continued treatment in members requesting
               reauthorization for aluminum toxicity while undergoing dialysis when member is
               experiencing benefit from therapy as evidenced by any of the following:
               1.  Decreased serum aluminum concentrations
               2.  Symptomatic improvement (e.g., neurological symptom improvement, decreased bone
                    pain)

          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. Desferal [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; September 2022.
2. Deferoxamine mesylate [package insert]. Lake Forest, IL: Hospira, Inc.; March 2023.
3. Micromedex Solutions [database online]. Truven Health Analytics, Inc. Ann Arbor, MI. Available at: www.micromedexsolutions.com. Accessed October 3, 2023.
4. AHFS DI (Adult and Pediatric) [database online]. Lexi-Comp, Inc. Hudson, OH. Available at: http://online.lexi.com/lco/action/index/dataset/complete_ashp [available with subscription]. Accessed October 3, 2023.
5. Clinical Pharmacology [Internet]. Elsevier. Tampa (FL). Available from: http://www.clinicalpharmacology.com. October 3, 2023.
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. Adams P, Barton J, et al. How I Treat Hemochromatosis. Blood 2010; (116): 317-325.
9. 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