CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Deferiprone (Ferriprox) for transfusional iron overload and hereditary hemochromatosis

Defines prior authorization criteria, documentation requirements, initial and continuation authorization conditions, limitations of use, dosing cap, and covered indications for deferiprone (Ferriprox) oral solution and tablets for transfusional iron overload (thalassemia, sickle cell disease/other anemias) and compendial use for hereditary hemochromatosis when phlebotomy is not an option.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyDeferiprone (Ferriprox) for transfusional iron overload and hereditary hemochromatosis

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionSubmit prior authorization with pretreatment serum ferritin for initial requests and current serum ferritin for continuation; authorizations granted up to 6 months when criteria are met.

POLICY UPDATE CHANGES

No material clinical/coverage changes

2FDA-Approved Indications Covered

1Compendial Indication (conditional)

2Excluded Indications

Coverage Summary

This policy covers deferiprone (Ferriprox) oral solution and tablets for the treatment of transfusional iron overload in patients with thalassemia syndromes and with sickle cell disease or other anemias, and provides compendial coverage for hereditary hemochromatosis when phlebotomy is not feasible or was unsuccessful. The policy excludes use for transfusional iron overload due to myelodysplastic syndrome (MDS) and Diamond Blackfan anemia, for which safety and effectiveness have not been established. Overall coverage stance: covered_with_criteria.

Initial Therapy Criteria

Initial Authorization - Transfusional Iron Overload (Ferriprox / deferiprone)

Authorization of 6 months may be granted when ALL of the following are met:

ALL of the following

Transfusional iron overload is due to either thalassemia syndromes or sickle cell disease or other anemias
Member does not have transfusional iron overload due to myelodysplastic syndrome or Diamond Blackfan anemia
pretreatment serum ferritin: Pretreatment serum ferritin level is consistently greater than 1000 mcg/L> 1000 mcg/L
dose cap: Dose of Ferriprox will not exceed 99 mg/kg per day<= 99 mg/kg/day
Dose cap applies to therapy

Initial Authorization - Hereditary Hemochromatosis (Compendial Use)

Authorization of 6 months may be granted when ALL of the following are met:

ALL of the following

Diagnosis of hereditary hemochromatosis (compendial use)
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
Phlebotomy not feasible or response unsatisfactory

Continuation / Reauthorization Criteria

Continuation/Reauthorization - Transfusional Iron Overload

Authorization of 6 months may be granted for continued treatment when ALL of the following are met:

ALL of the following

evidence of benefit: Member is experiencing benefit from therapy as evidenced by a decrease in serum ferritin levels compared to pretreatment baseline
continuation ferritin: Serum ferritin level is not consistently below 500 mcg/Lnot consistently < 500 mcg/L
Avoid continuation if ferritin consistently < 500 mcg/L

Continuation/Reauthorization - Hereditary Hemochromatosis

Authorization of 6 months may be granted for continued treatment when the following is met:

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

Provider Actions & Billing Rules

Prior Authorization

Prior authorization required

Submission of prior authorization is required. Initial and continuation authorizations may be granted for up to 6 months when the approval criteria are met.

Documentation Required

Required lab documentation

Include pretreatment serum ferritin level for initial requests and current serum ferritin level for continuation/reauthorization.

Billing Rule

Dose limit enforcement

Dose of Ferriprox (deferiprone) will not exceed 99 mg/kg per day; claims may be subject to review if the prescribed dose exceeds this limit.

Denial Risk

Excluded diagnoses

Requests for transfusional iron overload due to myelodysplastic syndrome or Diamond Blackfan anemia are not eligible because safety and effectiveness have not been established and such requests may be denied.

Clinical Evidence & References

Primary references include the Ferriprox and deferiprone package inserts (Ferriprox tablets and oral solution, Nov 2021; deferiprone generic inserts 2021–2022) and clinical guidelines cited for transfusion dependent thalassaemia and hereditary hemochromatosis (Thalassaemia International Federation 2021 guidelines; ACG Clinical Guideline: Hereditary Hemochromatosis, 2019). Safety and effectiveness statements note that use in myelodysplastic syndrome and Diamond Blackfan anemia is not established and such indications are excluded.

Background

Deferiprone (Ferriprox) oral solution and tablets are indicated and covered for transfusional iron overload in thalassemia syndromes and in sickle cell disease or other anemias per product labeling, and the policy includes compendial use for hereditary hemochromatosis when phlebotomy is not an option or response to phlebotomy was unsatisfactory. The policy specifies documentation and authorization criteria (e.g., pretreatment and current serum ferritin requirements) and notes that safety and effectiveness have not been established for transfusional iron overload due to myelodysplastic syndrome or Diamond Blackfan anemia.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyDeferiprone (Ferriprox) for transfusional iron overload and hereditary hemochromatosis

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionSubmit prior authorization with pretreatment serum ferritin for initial requests and current serum ferritin for continuation; authorizations granted up to 6 months when criteria are met.

On This Page

OpenPayer

Deferiprone (Ferriprox) for transfusional iron overload and hereditary hemochromatosis

Coverage Summary

Initial Therapy Criteria

Continuation / Reauthorization Criteria

Limitations / Not Covered

Provider Actions & Billing Rules

Applicable Codes

Clinical Evidence & References

Background