Subject: Ferriprox 1621-A SGM P2022
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.
FDA-Approved Indications
A. Transfusional Iron Overload due to Thalassemia Syndromes
1. Ferriprox oral solution is indicated for the treatment of transfusional iron overload in adult and pediatric
patients 3 years of age and older with thalassemia syndromes.
2. Ferriprox tablets are indicated for treatment of transfusional iron overload in adult and pediatric patients
8 years of age and older with thalassemia syndromes.
B. Transfusional Iron Overload due to Sickle Cell Disease or Other Anemias
1. Ferriprox oral solution is indicated for the treatment of transfusional iron overload in adult and pediatric
patients 3 years of age and older with sickle cell disease or other anemias.
2. 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.
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:
1. Initial requests: pretreatment serum ferritin level
2. Continuation requests: current serum ferritin level
III. CRITERIA FOR INITIAL APPROVAL
Transfusional Iron Overload
Authorization of 6 months may be granted for treatment of transfusional iron overload when all of the following criteria are met:
A. Transfusional iron overload is due to either of the following:
1. Thalassemia syndromes
2. Sickle cell disease or other anemias
B. Member does not have transfusional iron overload due to myelodysplastic syndrome or Diamond Blackfan anemia
C. Pretreatment serum ferritin level is consistently greater than 1000 mcg/L.
D. Dose of Ferriprox will not exceed 99 mg/kg per day.
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 both of the following criteria are met:
A. Member is experiencing benefit from therapy as evidenced by a decrease in serum ferritin levels as
compared to pretreatment baseline.
B. Serum ferritin level is not consistently below 500 mcg/L.
Place of Service:
Outpatient
The above policy is based on the following references:
- Ferriprox [package insert]. Rockville, MD: ApoPharma USA, Inc.; April 2021.
- Micromedex Solutions [database online]. Truven Health Analytics, Inc. Ann Arbor, MI. Available at: www.micromedexsolutions.com. Accessed October 7, 2020.
- 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.
- 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..
- Hoffbrand AV, Taher A, Cappellini MD. How I treat transfusional iron overload. Blood 2012;120(18):3657-69
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
