Subject: deferoxamine-Desferal 1620-A SGM P2023

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
          Chronic iron overload due to transfusion-dependent anemias

          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 transfusion-dependent anemias:
          A.  Initial requests: pretreatment serum ferritin level
          B.  Continuation requests: current serum ferritin level

 
  III.  CRITERIA FOR INITIAL APPROVAL

          A.  Chronic Iron Overload due to Transfusion-Dependent
               Anemias
              Authorization of 6 months may be granted for treatment of
              chronic iron overload due to transfusion-dependent anemias
              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 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 Transfusion-Dependent
               Anemias
              Authorization of 6 months may be granted for continued
              treatment in members requesting reauthorization for chronic
              iron overload due to transfusion-dependent anemias 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.; April 2021.
3. Micromedex Solutions [database online]. Truven Health Analytics, Inc. Ann Arbor, MI. Available at: www.micromedexsolutions.com. Accessed October 1, 2022.
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 1, 2022.
5. Clinical Pharmacology [Internet]. Elsevier. Tampa (FL). Available from: http://www.clinicalpharmacology.com. October 1, 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. Adams P, Barton J, et al. How I Treat Hemochromatosis. Blood 2010; (116): 317-325.
9. 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