Subject: deferiprone-Ferriprox 1621-A SGM P2024

Drug

FERRIPROX  (deferiprone)

deferiprone

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.  Transfusional Iron Overload due to Thalassemia Syndromes
                    a.  Oral solution is indicated for treatment of transfusional iron overload in adult and
                         pediatric patients 3 years of age and older with thalassemia syndromes.
                    b.  Tablets are indicated for treatment of transfusional iron overload in adult and pediatric
                         patients 8 years of age and older with thalassemia syndromes.

               2.  Transfusional Iron Overload due to Sickle Cell Disease or Other Anemias
                    a.  Ferriprox oral solution is indicated for treatment of transfusional iron overload in adult
                         and pediatric patients 3 years of age and older with sickle cell disease or other
                         anemias.
                    b.  Ferriprox tablets are indicated for treatment of transfusional iron overload in adult and
                         pediatric patients 8 years of age and older with sickle cell disease or other anemias.

          Limitations of Use:
          Safety and effectiveness have not been established for the treatment of transfusional iron
          overload in patients with myelodysplastic syndrome or in patients with Diamond Blackfan
          anemia.

          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:
          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
               Authorization of 6 months may be granted for treatment of transfusional iron overload when
               all of the following criteria are met:
               1.  Transfusional iron overload is due to either of the following:
                    a.  Thalassemia syndromes
                    b.  Sickle cell disease or other anemias
               3.  Member does not have transfusional iron overload due to myelodysplastic syndrome or
                    Diamond Blackfan anemia
               4.  Pretreatment serum ferritin level is consistently greater than 1000 mcg/L
               5.  Dose will not exceed 99 mg/kg per day

          B.  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
               Authorization of 6 months may be granted for continued treatment in members requesting
               reauthorization for transfusion iron overload when both of the following criteria are met:
               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

          B.  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. Ferriprox tablets [package insert]. Cary, NC: Chiesi USA, Inc.; July 2023.
2. Ferriprox oral solution [package insert]. Cary, NC: Chiesi USA, Inc.; November 2021.
3. Deferiprone [package insert]. Hawthorne, NY: Taro Pharmaceuticals U.S.A., Inc.; November 2022.
4. Deferiprone [package insert]. Berkeley Heights, NJ: Hikma Pharmaceuticals USA Inc.; August 2023.
5. 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.
6. Hoffbrand AV, Taher A, Cappellini MD. How I treat transfusional iron overload. Blood 2012;120(18):3657-69.
7. Kowdley KV, Brown KE, et al. ACG Clinical Guideline: Hereditary Hemochromatosis. Am J Gastroenterol. 2019;114(8):1202-1218.
8. Porter J, Garbowski M. Consequences and management of iron overload in sickle cell disease. Hematology Am Soc Hematol Educ Program. 2013;2013:447-456.

 

 

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