CurrentNeighborhood Health Plan of Rhode IslandPolicy 1621-A

Deferiprone (Ferriprox) — Coverage Criteria for Transfusional Iron Overload and Hereditary Hemochromatosis

Defines prior authorization, coverage criteria, and documentation requirements for deferiprone (Ferriprox) for transfusional iron overload due to thalassemia, sickle cell disease/other anemias, and for hereditary hemochromatosis when phlebotomy is not an option; applies to members of Neighborhood Health Plan of Rhode Island governed by this policy.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyDeferiprone (Ferriprox) — Coverage Criteria for Transfusional Iron Overload and Hereditary Hemochromatosis

Policy CodePolicy 1621-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit prior authorization with pretreatment serum ferritin for initiation and current serum ferritin for continuation; up to 12 months may be authorized when criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization period

>1000pretreatment ferritin threshold

<500continuation lower limit

99 mg/kgmax daily dose

Coverage Criteria for Deferiprone (Ferriprox)

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Initial therapy — Transfusional iron overload

Covered when ALL of the following are met for transfusional iron overload (initial authorization):

Transfusional iron overload initial criteria: 1) Transfusional iron overload is due to thalassemia syndromes OR sickle cell disease or other anemias; 2) Member does not have transfusional iron overload due to myelodysplastic syndrome or Diamond Blackfan anemia; 3) Pretreatment serum ferritin level is consistently greater than 1000 mcg/L; 4) Dose will not exceed 99 mg/kg per day.see nodes

Authorization of 12 months may be granted when all criteria met.

Continuation therapy — Transfusional iron overload

Covered when ALL of the following are met for continued treatment (reauthorization) of transfusional iron overload:

Transfusional iron overload continuation criteria: 1) Member is experiencing benefit from therapy as evidenced by a decrease in serum ferritin levels compared to pretreatment baseline; 2) Serum ferritin level is not consistently below 500 mcg/L.see nodes

Authorization of 12 months may be granted when both criteria met.

Hereditary hemochromatosis

Covered when ALL of the following are met for hereditary hemochromatosis:

Hereditary hemochromatosis initial and continuation: 1) Phlebotomy is not an option (e.g., poor venous access or poor candidate due to underlying medical disorders) OR the member had an unsatisfactory response to phlebotomy; 2) For continuation: member is experiencing benefit from therapy as evidenced by a decrease in serum ferritin levels compared to pretreatment baseline.none

Authorization of 12 months may be granted.

Use of deferiprone (Ferriprox) for transfusional iron overload in patients with myelodysplastic syndrome or Diamond Blackfan anemia is not established. Safety and effectiveness have not been demonstrated for these specific conditions, and such use is therefore excluded or limited under this policy.

All indications not explicitly listed as covered in this policy are considered experimental/investigational and not medically necessary, with the single exception of hereditary hemochromatosis when covered as noted (including compendial use for hereditary hemochromatosis).

Any request for deferiprone for indications other than those specified in the coverage criteria is experimental/investigational and not medically necessary and will be denied per policy.

Drug and Test Coding

Covered drugNDC | mixedCovered

Ferriprox / deferiprone

Drug listed by brand and generic; all dosage forms and strengths unless otherwise stated

Serum ferritin — initiation and continuation thresholds

Initiation (pretreatment)Serum ferritin consistently >1000 mcg/L is required for initiation of therapy for transfusional iron overload.

Continuation (reauthorization)Serum ferritin must not be consistently below 500 mcg/L; member must show benefit (decrease from pretreatment baseline).

DocumentationInitial prior authorization must include a pretreatment serum ferritin level; continuation requests must include current serum ferritin level.

Maximum dose

Maximum daily doseDose must not exceed 99 mg/kg per day.

Authorization implicationRequests may be denied if the requested dose would exceed 99 mg/kg/day.

MonitoringDose information should be provided with prior authorization to verify compliance with the maximum allowable dose.

Provider Requirements and Authorization Rules

Prior Authorization

Prior Authorization Required

Prior authorization is required. Authorization up to 12 months may be granted when specified clinical criteria and documentation are met.

Authorization up to 12 months when clinical criteria met
Prior authorization required for initial and continuation requests

Prior Authorization

Phlebotomy Required First-line When Feasible

For hereditary hemochromatosis, deferiprone (oral iron chelation) should be used only when phlebotomy is not feasible or was unsatisfactory.

Use phlebotomy first-line when feasible
Deferiprone authorized only if phlebotomy not an option (e.g., poor venous access, poor candidate due to comorbidities) or if response to phlebotomy was unsatisfactory

Documentation Required

Required Documentation

Submission of the following documentation is necessary to initiate prior authorization review.

Transfusional iron overload — Initial requests: pretreatment serum ferritin level
Transfusional iron overload — Continuation requests: current serum ferritin level

Denial Risk

Denial Triggers

Requests may be denied if required clinical thresholds or documentation are not met, or if dosing exceeds program limits.

Denial may be triggered if pretreatment serum ferritin is not consistently > 1000 mcg/L for transfusional iron overload
Denial may be triggered if continuation serum ferritin is consistently < 500 mcg/L
Denial may be triggered if the requested dose would exceed 99 mg/kg per day
Denial may be triggered when transfusional iron overload is due to excluded diagnoses (e.g., myelodysplastic syndrome or Diamond Blackfan anemia)

Background

Deferiprone (Ferriprox) is an oral iron chelator indicated for treatment of transfusional iron overload in patients with thalassemia syndromes, sickle cell disease, or other anemias, and may be used for hereditary hemochromatosis when phlebotomy is not feasible or was ineffective. Monitoring of serum ferritin is used to assess treatment initiation and ongoing benefit. The safety and effectiveness of deferiprone have not been established for transfusional iron overload due to myelodysplastic syndrome or Diamond Blackfan anemia, and other nonlisted indications are considered experimental/investigational and not medically necessary.

Definitions

Transfusional iron overload — definition and relation to covered conditions

DefinitionTransfusional iron overload is iron accumulation resulting from repeated blood transfusions and is an indicated covered condition for deferiprone in thalassemia syndromes and in sickle cell disease or other anemias when criteria are met.

Covered conditionsIncludes thalassemia syndromes and sickle cell disease or other anemias as causes of transfusional iron overload.

Exclusions/limitationsUse is not established for transfusional iron overload due to myelodysplastic syndrome or Diamond Blackfan anemia (excluded/limited).

Authorization periodAuthorization of up to 12 months may be granted when all initial or continuation criteria are met.

Hereditary hemochromatosis — alternative therapy context

When deferiprone is allowedDeferiprone is covered for hereditary hemochromatosis only when phlebotomy is not an option (e.g., poor venous access or poor candidate) or when there was an unsatisfactory response to phlebotomy.

Continuation requirementFor continuation in hereditary hemochromatosis, member must demonstrate benefit with decreased serum ferritin compared to pretreatment baseline.

Authorization periodAuthorization of up to 12 months may be granted when criteria are met.