CurrentMass General Brigham Health PlanPolicy N/A

Ferriprox (deferiprone)

Prior authorization policy for Ferriprox (deferiprone) under the pharmacy benefit for Commercial/Exchange members; defines indications, eligibility, dosing limit, exclusions, continuation and reauthorization criteria, and approval durations.

Policy Summary

PayerMass General Brigham Health Plan

PolicyFerriprox (deferiprone)

Policy CodePolicy N/A

Change TypeRevised (clinical) and Administrative

Effective DateMar 1, 2025

Next Review Date

Key ActionSubmit prior authorization under the pharmacy benefit with diagnosis and serum ferritin values (showing decrease from pretreatment baseline) or document member is new to plan within 90 days and currently receiving treatment.

SourceLink

POLICY UPDATE CHANGES

Updated transfusional overload criteria to remove baseline ferritin requirement.

Policy transitioned from SGM to Custom at 12/13/2023 review; effective 1/1/2024.

3Covered Indications (listed)

99 mg/kg/dayMax daily dose

6 monthsApproval duration

Coverage Summary

This policy applies to Commercial/Exchange members and requires prior authorization under the pharmacy benefit for Ferriprox (deferiprone). Coverage stance: covered_with_criteria. Authorization may be granted for members new to the plan within the past 90 days who are currently receiving treatment, or when the clinical criteria are met. Indicated conditions include transfusional iron overload due to thalassemia syndromes and transfusional iron overload due to sickle cell disease or other anemias; an alternative indication is hereditary hemochromatosis when phlebotomy is not an option or the member had an unsatisfactory response to phlebotomy. Dosing and limits: the requested dose must not exceed 99 mg/kg per day. Per product labeling, the oral solution is approved for ages ≥ 3 years and tablets are approved for ages ≥ 8 years for the transfusional iron overload indications.

Initial Authorization Criteria

Initial Authorization

Authorization may be granted when ALL of the following are met (or for members new to plan within past 90 days currently receiving treatment):

Member new to plan within past 90 days: Member is new to the plan within the past 90 days and is currently receiving treatment with the requested medication (excluding when product obtained as samples or via manufacturer's patient assistance programs).

Exclude samples or manufacturer's patient assistance programs

Or when clinical criteria are met

Transfusional iron overload diagnosis: Member has a diagnosis of transfusional iron overload due to either thalassemia syndromes or sickle cell disease or other anemias.
Exclusions: Member does not have transfusional iron overload due to myelodysplastic syndrome or Diamond Blackfan anemia.
Excluded per policy
Dose limit: Dose of Ferriprox will not exceed 99 mg/kg per day.<= 99 mg/kg per day

Hereditary hemochromatosis alternative indication: Member has a diagnosis of hereditary hemochromatosis AND phlebotomy is not an option (e.g., poor candidate due to underlying medical disorders) or the member had an unsatisfactory response to phlebotomy.

Continuation Therapy / Reauthorization Criteria

Continuation of Therapy / Reauthorization

Requests for reauthorization will be approved when ALL of the following criteria are met:

Evidence of benefit and ferritin requirement: Member is experiencing benefit from therapy as evidenced by a decrease in serum ferritin levels as compared to pretreatment baseline.

Transfusional overload ferritin threshold: For transfusional overload: serum ferritin level is not consistently below 500 mcg/L.not consistently < 500 mcg/L

Limitations

Approval duration: Initial approvals and reauthorizations will be granted for 6 months.

Provider Actions / Authorization Requirements

Prior Authorization

Prior authorization required

Prior authorization is required under the pharmacy benefit for Ferriprox. Authorization may be granted for members new to the plan within the past 90 days who are currently receiving treatment (excluding products obtained as samples or via the manufacturer's patient assistance programs), or when the clinical criteria in the policy are met.

Documentation Required

Documentation of diagnosis and ferritin

For initial and continuation requests provide the member's diagnosis (transfusional iron overload due to thalassemia syndromes or sickle cell disease/other anemias, or hereditary hemochromatosis when phlebotomy is not an option or had an unsatisfactory response) and serum ferritin values demonstrating a decrease from pretreatment baseline. For transfusional overload continuation, ensure serum ferritin is not consistently below 500 mcg/L.

Billing Rule

Approval duration

Initial approvals and reauthorizations are limited to 6 months per approval.

Clinical Evidence & References

References: Thalassaemia International Federation Guidelines for the management of transfusion dependent thalassaemia (TIF) 4th Edition 2021; ACG Clinical Guideline: Hereditary Hemochromatosis, The American Journal of Gastroenterology, August 2019; and multiple deferiprone/Ferriprox package inserts (Chiesi Ferriprox tablets and oral solution November 2021; Hikma December 2021; Taro August 2022).

Background

Ferriprox (deferiprone) is an oral iron chelator indicated for the treatment of transfusional iron overload due to thalassemia syndromes and due to sickle cell disease or other anemias. It is also indicated for hereditary hemochromatosis when phlebotomy is not an option or results are unsatisfactory. Per labeling for the transfusional iron overload indications, the oral solution is indicated for patients 3 years of age and older, and tablets are indicated for patients 8 years of age and older.

Definitions

Transfusional iron overload (definition)Iron overload resulting from chronic blood transfusions, associated with thalassemia syndromes, sickle cell disease, or other anemias (excluding MDS or Diamond Blackfan anemia per policy).