ModifiedMass General Brigham Health PlanPolicy N/A

Ferriprox (deferiprone)

Prior authorization and quantity-limit policy for Ferriprox (deferiprone) oral solution and tablets for treatment of transfusional iron overload and hereditary hemochromatosis under the pharmacy benefit; includes initial and continuation criteria, exclusions, dose cap, and authorization durations.

Policy Summary

PayerMass General Brigham Health Plan

PolicyFerriprox (deferiprone)

Policy CodePolicy N/A

Change TypeCriteria updated (baseline ferritin removal)

Effective DateMar 1, 2025

Next Review Date

Key ActionObtain prior authorization for Ferriprox and document diagnosis, dose (<=99 mg/kg/day), and monitoring (decrease in serum ferritin from baseline; ferritin not consistently <500 mcg/L for transfusional overload).

SourceLink

POLICY UPDATE CHANGES

Updated transfusional overload criteria to remove baseline ferritin requirement.

Policy switched from SGM to Custom effective 1/1/2024.

2Primary Indications Listed

99 mg/kg/dayMaximum Dose Threshold

6 monthsApproval Duration

Coverage Summary

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This policy status is covered_with_criteria. It applies to Ferriprox (deferiprone) oral solution and tablets as a prior-authorization and quantity-limit policy under the pharmacy benefit for treatment of transfusional iron overload and hereditary hemochromatosis. The product is available in tablets and oral solution formulations. Age-based indications specified in labeling are: oral solution for patients 3 years of age and older, and tablets for patients 8 years of age and older. The brief notes an effective date of 03/01/2025 and lists 2 primary indications.

Initial Therapy Criteria

Initial Authorization

Authorization may be granted for members new to the plan within the past 90 days who are currently receiving therapy OR when ALL of the following are met:

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

Allows continuity for recent plan entrants

Authorization criteria

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

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Hereditary Hemochromatosis Criteria

Hereditary Hemochromatosis

Authorization may be granted when ALL of the following are met:

Hereditary Hemochromatosis criteria

Diagnosis: Member has a diagnosis of hereditary hemochromatosis
Phlebotomy not an option or unsatisfactory response: Phlebotomy is not an option (e.g., poor candidate due to underlying medical disorders) OR member had an unsatisfactory response to phlebotomy

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Continuation Therapy Criteria / Reauthorization

Continuation of Therapy / Reauthorization

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

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

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

Provider Actions & Requirements

Prior Authorization

Prior authorization required

Obtain prior authorization for Ferriprox; members new to plan within 90 days may be approved if currently receiving therapy (excluding samples or manufacturer assistance).

Documentation Required

Diagnosis documentation

Document diagnosis specifying transfusional iron overload etiology (thalassemia syndromes OR sickle cell disease/other anemias) or hereditary hemochromatosis and, if hemochromatosis, evidence phlebotomy is not an option or was ineffective.

Documentation Required

Serum ferritin monitoring for continuation

For continuation, document decrease in serum ferritin from pretreatment baseline and that ferritin is not consistently < 500 mcg/L for transfusional overload patients.

Continuation requires ferritin not consistently < 500 mcg/L

Billing Rule

Dose limit enforcement

Ensure prescribed dose does not exceed 99 mg/kg per day; requests exceeding this will not meet criteria.

<= 99 mg/kg/day

Documentation Required

Authorization duration

Authorize initial and reauthorization requests for a maximum of 6 months; document expected duration and monitoring plan.

Maximum approval duration: 6 months

Clinical Evidence & References

Evidence sources cited include package inserts/product labeling from Chiesi USA, Taro, and Hikma (2021–2022) and the Thalassaemia International Federation 2021 guideline. The policy references product-specific labeling for Ferriprox oral solution and tablets and the TIF guideline for transfusion-dependent thalassemia management. The clinical definition of Transfusional iron overload (iron overload resulting from chronic blood transfusions, specified as due to thalassemia syndromes or sickle cell disease/other anemias) is noted as a relevant definition in the policy.

Background & Indications

Ferriprox (deferiprone) is an oral iron chelator available as tablets and oral solution. Labeling indicates the oral solution is for treatment of transfusional iron overload in adult and pediatric patients 3 years of age and older, while tablets are indicated for treatment in adult and pediatric patients 8 years of age and older. Indications include treatment of transfusional iron overload due to thalassemia syndromes, sickle cell disease, and other anemias, and treatment of hereditary hemochromatosis when phlebotomy is not an option or when the member had an unsatisfactory response to phlebotomy.

Definition

TermTransfusional iron overload

DefinitionIron overload resulting from chronic blood transfusions, specified in policy as due to thalassemia syndromes or sickle cell disease/other anemias (excludes myelodysplastic syndrome and Diamond Blackfan anemia).

Revision History

2025-03-01policy_revisionLatest

Updated transfusional overload criteria to remove the prior baseline ferritin requirement (change effective 03/01/2025).

2024-01-01administrative_change

Policy classification changed from SGM to Custom (noted in review history; effective 01/01/2024).

2025-03-01effective_date_coverageLatest

Ferriprox (deferiprone) policy effective date listed as 03/01/2025.

Policy Summary

PayerMass General Brigham Health Plan

PolicyFerriprox (deferiprone)

Policy CodePolicy N/A

Change TypeCriteria updated (baseline ferritin removal)

Effective DateMar 1, 2025

Next Review Date

SourceLink

On This Page

OpenPayer

Ferriprox (deferiprone)

Coverage Summary

Initial Therapy Criteria

Hereditary Hemochromatosis Criteria

Continuation Therapy Criteria / Reauthorization

Limitations

Provider Actions & Requirements

Applicable Codes

Clinical Evidence & References

Background & Indications

Revision History