CurrentNeighborhood Health Plan of Rhode IslandPolicy 1621-A

Deferiprone-Ferriprox solution

Defines coverage and prior authorization criteria for deferiprone (Ferriprox) oral solution and tablets for transfusional iron overload (due to thalassemia syndromes, sickle cell disease, or other anemias) and for hereditary hemochromatosis when phlebotomy is not an option or unsuccessful. Specifies documentation requirements, dosing limit, exclusions, and reauthorization criteria.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyDeferiprone-Ferriprox solution

Policy CodePolicy 1621-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit pretreatment serum ferritin for initial requests and current serum ferritin for continuation requests to initiate prior authorization review.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes.

3Covered indications

2Explicit exclusions

12Auth duration (months)

99 mg/kg/dayMax dose

Coverage Summary

Coverage: Covered with criteria for deferiprone (Ferriprox) oral solution and tablets for treatment of transfusional iron overload when due to thalassemia syndromes or sickle cell disease/other anemias, and for hereditary hemochromatosis when phlebotomy is not feasible or was unsuccessful. Authorization duration is 12 months. Dosing for authorization is capped at ≤ 99 mg/kg/day.

Key thresholds and quick facts

Pretreatment serum ferritin threshold> 1000 mcg/L

Continuation (reauthorization) ferritin requirementSerum ferritin not consistently below 500 mcg/L

Maximum authorized dose<= 99 mg/kg per day

Authorization duration12 months

Covered indication categories (count)3 (thalassemia syndromes; sickle cell disease/other anemias; hereditary hemochromatosis)

Explicit exclusions (count)2 (myelodysplastic syndrome; Diamond Blackfan anemia)

Documentation requiredPretreatment ferritin for initial; current ferritin for continuation

Initial Therapy Criteria

Initial Authorization — Transfusional Iron Overload due to Thalassemia Syndromes or Sickle Cell Disease/Other Anemias

Authorization of 12 months may be granted when ALL of the following criteria are met:

Transfusional iron overload is due to thalassemia syndromes OR due to sickle cell disease or other anemias

Either thalassemia syndromes OR sickle cell disease/other anemias must be the cause

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

Exclusion: MDS or Diamond Blackfan anemia

Pretreatment serum ferritin level is consistently greater than 1000 mcg/Lserum ferritin > 1000 mcg/L

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

Dosing cap for authorization

Initial Authorization — Hereditary Hemochromatosis

Authorization of 12 months may be granted when ALL of the following criteria are met:

Diagnosis of hereditary hemochromatosis

Use when phlebotomy is not an option (e.g., poor venous access, poor candidate due to underlying medical disorders) OR member had an unsatisfactory response to phlebotomy

Continuation / Reauthorization Criteria

Continuation / Reauthorization — Transfusional Iron Overload

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

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

Serum ferritin level is not consistently below 500 mcg/Lnot consistently < 500 mcg/L

Continuation / Reauthorization — Hereditary Hemochromatosis

Authorization of 12 months may be granted for continued treatment when the following criterion is met:

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

Limitations of Use / Not Covered Indications

The following are considered not medically necessary (experimental/investigational) or not established:

Treatment of transfusional iron overload in patients with myelodysplastic syndrome

Safety and effectiveness not established

Treatment of transfusional iron overload in patients with Diamond Blackfan anemia

Safety and effectiveness not established

All other indications not listed (except compendial use: hereditary hemochromatosis)

All other indications considered experimental/investigational and not medically necessary

Provider Actions

Prior Authorization

Prior authorization required with documentation

Submit pretreatment serum ferritin level for initial requests and current serum ferritin level for continuation requests to initiate prior authorization review.

Documentation Required

Document benefit for reauthorization

For reauthorization, document a decrease in serum ferritin from the pretreatment baseline to demonstrate benefit, and ensure serum ferritin is not consistently below 500 mcg/L for transfusional iron overload.

Billing Rule

Dosing limit

Dose must not exceed 99 mg/kg per day for authorization.

Clinical Evidence & References

Primary evidence sources include the Ferriprox (deferiprone) package inserts and relevant clinical guidelines listed in references. The policy notes that safety and effectiveness have not been established for treatment of transfusional iron overload in patients with myelodysplastic syndrome (MDS) or Diamond Blackfan anemia.

Background & Definitions

Indications and background: Ferriprox (deferiprone) is indicated for treatment of transfusional iron overload in patients with thalassemia syndromes and in patients with sickle cell disease or other anemias. The oral solution formulation is indicated for patients aged 3 years and older; tablets are indicated for patients aged 8 years and older. Ferriprox may be used for hereditary hemochromatosis when phlebotomy is not an option or the member had an unsatisfactory response to phlebotomy. Safety and effectiveness have not been established for transfusional iron overload due to myelodysplastic syndrome or Diamond Blackfan anemia.

Definitions: Transfusional iron overload — a clinical condition resulting from chronic transfusions that leads to excess body iron. This policy ties treatment eligibility to specific serum ferritin thresholds (for example, pretreatment serum ferritin consistently > 1000 mcg/L for initial authorization and serum ferritin not consistently 500 mcg/L for continuing authorization).