Subject: deferoxamine-Desferal 1620-A SGM P2022

Drug

DESFERAL  (deferoxamine)

deferoxamine mesylate (generic)

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 

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 Transfusion-Dependent Anemias
      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
      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
      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; October 2020.
2. Deferoxamine mesylate [package insert]. Lake Forest, IL: Hospira, Inc.; August 2020.
3. Micromedex Solutions [database online]. Truven Health Analytics, Inc. Ann Arbor, MI. Available at: www.micromedexsolutions.com. Accessed October 7, 2020.
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 7, 2020.
5. Clinical Pharmacology [Internet]. Elsevier. Tampa (FL). Available from: http://www.clinicalpharmacology.com. October 7, 2020.
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.

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