CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Deferiprone (Ferriprox) — Coverage Criteria for Iron Overload

Covers medical necessity and prior authorization criteria for deferiprone (Ferriprox) for transfusional iron overload and hereditary hemochromatosis when phlebotomy is not an option; applies to members of Neighborhood Health Plan of Rhode Island as referenced by the payer policy.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyDeferiprone (Ferriprox) — Coverage Criteria for Iron Overload

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization documentation including pretreatment or current serum ferritin levels and ensure dosing does not exceed 99 mg/kg per day.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization duration

>=1000initiation ferritin

>=500continuation ferritin floor

99 mg/kg/daymax daily dose

≥3 / ≥8minimum ages (solution/tablet)

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Coverage Criteria

Initial Therapy - Transfusional Iron Overload

Authorization of 12 months may be granted for treatment of transfusional iron overload when ALL of the following are met:

Transfusional iron overload indication: Transfusional iron overload is due to either sickle cell disease/other anemias or thalassemia syndromes

supported by indications

Excluded etiologies: Member does not have transfusional iron overload due to myelodysplastic syndrome or Diamond Blackfan anemia

limitation of use

Dose limit: Dose will not exceed 99 mg/kg per day<=99 mg/kg/day

safety limit

Ferritin threshold: Pretreatment serum ferritin level is consistently greater than 1000 mcg/L>1000 mcg/L

lab requirement

Continuation Therapy - Transfusional Iron Overload

Authorization of 12 months may be granted for continued treatment when ALL of the following are met:

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

response requirement

Ferritin floor: Serum ferritin level is not consistently below 500 mcg/L>=500 mcg/L (not consistently below)

to avoid overtreatment

Therapy - Hereditary Hemochromatosis

Authorization of 12 months may be granted for treatment of hereditary hemochromatosis when ALL of the following are met:

Phlebotomy contraindication or failure: Phlebotomy is not an option (eg, poor venous access or poor candidate due to underlying medical disorders) OR member had an unsatisfactory response to phlebotomy

alternative to first-line therapy

Clinical benefit for reauthorization: Member is experiencing benefit as evidenced by a decrease in serum ferritin levels compared to pretreatment baseline

same as transfusional continuation

Use of deferiprone (Ferriprox) is not established for the treatment of transfusional iron overload when the etiology is myelodysplastic syndrome or Diamond‑Blackfan anemia.

Coding and Clinical Thresholds

Serum ferritin

Initiation thresholdPretreatment serum ferritin level is consistently greater than 1000 mcg/L

Continuation thresholdSerum ferritin level is not consistently below 500 mcg/L

ContextApplies to authorization of 12 months for transfusional iron overload when other criteria are met

Maximum daily dose

Maximum daily doseDose will not exceed 99 mg/kg per day

ApplicabilityLimit applies to initial authorization for transfusional iron overload

Authorization duration

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for treatment of transfusional iron overload and hereditary hemochromatosis. Authorization of up to 12 months may be granted when specified clinical criteria are met (see documentation requirements and applicable clinical criteria). Requests exceeding 99 mg/kg per day will not be authorized.

Authorization term: up to 12 months
Dose limit: will not exceed 99 mg/kg per day

Documentation Required

Required Documentation

Submit the following documentation with the prior authorization request to initiate review. Failure to provide required documentation may result in denial or delay.

Transfusional iron overload – Initial requests: pretreatment serum ferritin level
Transfusional iron overload – Continuation requests: current serum ferritin level (and evidence of benefit: decrease in ferritin compared to pretreatment baseline; ferritin not consistently below 500 mcg/L)

Background

Deferiprone (Ferriprox) is an oral iron chelator indicated for treatment of transfusional iron overload in patients with thalassemia syndromes, sickle cell disease, and other anemias requiring chelation therapy. Safety and effectiveness have not been established for treatment of transfusional iron overload in patients with myelodysplastic syndrome or Diamond‑Blackfan anemia.

Definitions

Transfusional iron overload

DefinitionTransfusional iron overload due to thalassemia, sickle cell disease, or other anemias requiring chelation therapy

Age/formulation notesOral solution indicated for patients ≥3 years (thalassemia, sickle cell, other anemias); tablets indicated for patients ≥8 years (thalassemia, sickle cell, other anemias)

Exclusion noteNot established for transfusional iron overload due to myelodysplastic syndrome or Diamond Blackfan anemia

Note

Clinical & Eligibility Notes

For transfusional iron overload, authorization is granted only when transfusional iron overload is due to sickle cell disease/other anemias or thalassemia syndromes, and not for transfusional iron overload due to myelodysplastic syndrome or Diamond Blackfan anemia. For hereditary hemochromatosis, authorization is for when phlebotomy is not an option or was unsatisfactory. Pretreatment serum ferritin must be consistently >1000 mcg/L for initial transfusional iron overload authorization.

Transfusional iron overload – qualifying diagnoses: sickle cell disease or other anemias, thalassemia syndromes
Exclusions: transfusional iron overload due to myelodysplastic syndrome or Diamond Blackfan anemia are not eligible
Transfusional iron overload – Initial ferritin threshold: consistently >1000 mcg/L
Transfusional iron overload – Continued therapy: member must show benefit (decreased ferritin vs pretreatment) and ferritin not consistently <500 mcg/L
Hereditary hemochromatosis – authorization only when phlebotomy is contraindicated or ineffective