CurrentClover HealthPolicy 4700-A

Deferoxamine (Desferal) Coverage

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This policy governs Medicare Part B coverage and authorization of deferoxamine mesylate (Desferal) for FDA-approved and compendial indications. Coverage applies when the applicable clinical criteria, documentation requirements, and continuation requirements are met.

Policy Summary

PayerClover Health

PolicyDeferoxamine (Desferal) Coverage

Policy CodePolicy 4700-A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionFor transfusional iron overload, submit a pretreatment serum ferritin level consistently greater than 1,000 mcg/L.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1Covered drugs

5Covered indications

12 monthsMost authorization duration

30 daysMalaria authorization

>1,000 mcg/LFerritin requirement

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CurrentClover HealthPolicy 4700-A

Deferoxamine (Desferal) Coverage

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Policy Summary

PayerClover Health

PolicyDeferoxamine (Desferal) Coverage

Policy CodePolicy 4700-A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionFor transfusional iron overload, submit a pretreatment serum ferritin level consistently greater than 1,000 mcg/L.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1Covered drugs

5Covered indications

12 monthsMost authorization duration

30 daysMalaria authorization

>1,000 mcg/LFerritin requirement

Coverage Criteria

Initial therapy: transfusional iron overload

Authorization of 12 months may be granted when the criterion is met.

Transfusional iron overload in chronic anemia: The member has transfusional iron overload in chronic anemia and the pretreatment serum ferritin level is consistently greater than 1000 mcg/L.>1000 mcg/L pretreatment serum ferritin

Initial therapy: aluminum toxicity

Authorization of 12 months may be granted when the criterion is met.

Aluminum toxicity in members undergoing dialysis: The member is undergoing dialysis and has aluminum toxicity.

Initial therapy: iron toxicity

Authorization of 12 months may be granted when the criterion is met.

Iron toxicity in members undergoing dialysis: The member is undergoing dialysis and has iron toxicity.

Initial therapy: malaria

Authorization of 30 days may be granted when the criterion is met.

Malaria: The member has malaria.

Initial therapy: porphyria

Authorization of 12 months may be granted when the criterion is met.

Porphyria: The member has porphyria and phlebotomy is contraindicated.

Initial therapy: hereditary hemochromatosis

Authorization of 12 months may be granted when the criterion is met.

Hereditary hemochromatosis: The member has hereditary hemochromatosis and phlebotomy is not an option, such as because of poor venous access or an underlying medical disorder, or the member had an unsatisfactory response to phlebotomy.

Continuation therapy: transfusional iron overload

Authorization for 12 months may be granted when all of the following criteria are met.

Transfusional iron overload continuation: The member is currently receiving therapy with the requested drug; the requested drug is being used to treat transfusional iron overload in a member with chronic anemia; and the member is receiving benefit from therapy.Decrease in serum ferritin compared with pretreatment baseline

Continuation therapy: aluminum toxicity

Authorization for 12 months may be granted when all of the following criteria are met.

Aluminum toxicity continuation: The member is currently receiving therapy with the requested drug; the requested drug is being used to treat aluminum toxicity in a member undergoing dialysis; and the member is receiving benefit from therapy.Decreased serum aluminum concentrations or symptomatic improvement, such as neurological symptom improvement or decreased bone pain

Continuation therapy: iron toxicity

Authorization for 12 months may be granted when all of the following criteria are met.

Iron toxicity continuation: The member is currently receiving therapy with the requested drug; the requested drug is being used to treat iron toxicity in a member undergoing dialysis; and the member is receiving benefit from therapy.Clinical benefit from therapy

Continuation therapy: porphyria

Authorization for 12 months may be granted when all of the following criteria are met.

Porphyria continuation: The member is currently receiving therapy with the requested drug; the requested drug is being used to treat porphyria; and the member is receiving benefit from therapy, such as symptomatic improvement.Symptomatic improvement or other benefit

Continuation therapy: dialysis-related iron toxicity

Authorization for 12 months may be granted when all of the following criteria are met.

Iron toxicity in members undergoing dialysis: The member is currently receiving therapy with the requested drug; the requested drug is being used to treat iron toxicity in members undergoing dialysis; and the member is receiving benefit from therapy.Clinical benefit from therapy

Continuation therapy: porphyria

Authorization for 12 months may be granted when all of the following criteria are met.

Porphyria: The member is currently receiving therapy with the requested drug; the requested drug is being used to treat porphyria; and the member is receiving benefit from therapy, such as symptomatic improvement.Symptomatic improvement or other benefit

Continuation therapy: hereditary hemochromatosis

Authorization for 12 months may be granted when all of the following criteria are met.

Hereditary hemochromatosis: The member is currently receiving therapy with the requested drug; the requested drug is being used to treat hereditary hemochromatosis; and the member is experiencing benefit from therapy.Decrease in serum ferritin compared with pretreatment baseline

Continuation therapy: malaria

All members, including new members, requesting authorization for continuation of therapy for malaria must meet all requirements in the coverage criteria.

Malaria continuation: All members, including new members, requesting authorization for continuation of therapy for malaria must meet all requirements in the coverage criteria.

Clinical Thresholds

Pretreatment Serum Ferritin

ThresholdConsistently greater than 1000 micrograms per liter (mcg/L)

Applies toPretreatment serum ferritin level

Clinical contextTransfusional iron overload in members with chronic anemia

Pretreatment Serum Ferritin

ThresholdAt least 1000 mcg/L

Applies toPretreatment serum ferritin

Clinical contextChronic iron overload due to transfusion-dependent anemias

Authorization and Documentation Requirements

Prior Authorization

Transfusional Iron Overload: Initial Authorization

Submit documentation supporting a pretreatment serum ferritin level consistently greater than 1000 mcg/L for members with chronic anemia and transfusional iron overload. Authorization may be granted for 12 months when this requirement is met.

Pretreatment serum ferritin must be consistently greater than 1000 mcg/L.
Indication: transfusional iron overload in a member with chronic anemia.
Authorization period: 12 months.

Prior Authorization

Aluminum Toxicity During Dialysis

Authorization may be granted for 12 months for treatment of aluminum toxicity in members undergoing dialysis.

Indication: aluminum toxicity.
The member must be undergoing dialysis.
Authorization period: 12 months.

Clinical Background

Deferoxamine mesylate (Desferal) is an iron and aluminum chelating agent used to remove or manage excess metal in specified clinical situations. Covered uses include acute iron intoxication as an adjunct to standard measures, transfusional iron overload in members with chronic anemia, and aluminum or iron toxicity in members undergoing dialysis.

The policy also recognizes coverage for selected compendial uses, including malaria, porphyria, and hereditary hemochromatosis. Coverage is subject to the indication-specific requirements; continuation therapy additionally requires current treatment with the requested drug and documented clinical benefit.

Policy Definitions

Benefit in Hereditary Hemochromatosis

DefinitionA treatment response demonstrated by a decrease in serum ferritin levels compared with the pretreatment baseline.

IndicationHereditary hemochromatosis

Response measureSerum ferritin levels compared with pretreatment baseline

Initial Therapy Criteria

Transfusional iron overload: initial therapy

Authorization of 12 months may be granted when the criterion is met.

Aluminum toxicity: initial therapy

Authorization of 12 months may be granted when the criterion is met.

Aluminum toxicity: The member is undergoing dialysis and has aluminum toxicity.

Iron toxicity: initial therapy

Authorization of 12 months may be granted when the criterion is met.

Continuation Therapy Criteria

Transfusional iron overload: continuation therapy

Authorization for 12 months may be granted when all of the following criteria are met.

Transfusional iron overload: The member is currently receiving therapy with the requested drug; the requested drug is being used to treat transfusional iron overload in a member with chronic anemia; and the member is receiving benefit from therapy.Decrease in serum ferritin compared with pretreatment baseline

Aluminum toxicity in members undergoing dialysis: continuation therapy

Authorization for 12 months may be granted when all of the following criteria are met.

Aluminum toxicity in members undergoing dialysis: The member is currently receiving therapy with the requested drug; the requested drug is being used to treat aluminum toxicity in a member undergoing dialysis; and the member is receiving benefit from therapy.Decreased serum aluminum concentrations or symptomatic improvement, such as neurological symptom improvement or decreased bone pain

Authorization Duration

Deferoxamine Mesylate Authorization

DrugDeferoxamine mesylate

Authorization period12 months

Covered indicationsTransfusional iron overload in chronic anemia; aluminum toxicity in members undergoing dialysis; iron toxicity in members undergoing dialysis; porphyria; and hereditary hemochromatosis

Deferoxamine Mesylate Authorization

DrugDeferoxamine mesylate

Authorization period30 days

Covered indicationMalaria

Policy Summary

PayerClover Health

PolicyDeferoxamine (Desferal) Coverage

Policy CodePolicy 4700-A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionFor transfusional iron overload, submit a pretreatment serum ferritin level consistently greater than 1,000 mcg/L.

SourceLink

On This Page

Prior Authorization

Iron Toxicity During Dialysis

Authorization may be granted for 12 months for treatment of iron toxicity in members undergoing dialysis.

Indication: iron toxicity.
The member must be undergoing dialysis.
Authorization period: 12 months.

Prior Authorization

Malaria Authorization

Authorization may be granted for 30 days for treatment of malaria.

Indication: malaria.
Authorization period: 30 days.

Prior Authorization

Porphyria When Phlebotomy Is Contraindicated

Authorization may be granted for 12 months for treatment of porphyria when phlebotomy is contraindicated.

Indication: porphyria.
Phlebotomy must be contraindicated.
Authorization period: 12 months.

Prior Authorization

Hereditary Hemochromatosis When Phlebotomy Is Not an Option

Authorization may be granted for 12 months for treatment of hereditary hemochromatosis when phlebotomy is not an option or the member had an unsatisfactory response to phlebotomy.

Phlebotomy is not an option, such as because of poor venous access or an underlying medical disorder, or the member had an unsatisfactory response to phlebotomy.
Authorization period: 12 months.

Documentation Required

Dialysis-Related Iron Toxicity: Continuation Documentation

For continuation authorization for iron toxicity in a member undergoing dialysis, document that the member is currently receiving the requested drug, that it is being used for the covered indication, and that the member is receiving benefit from therapy.

Current therapy with the requested drug is required.
Confirm treatment of iron toxicity in a member undergoing dialysis.
Document benefit from therapy.

Documentation Required

Porphyria: Continuation Documentation

For continuation authorization for porphyria, document current treatment with the requested drug, the diagnosis being treated, and symptomatic benefit from therapy.

Current therapy with the requested drug is required.
Confirm treatment of porphyria.
Document benefit, such as symptomatic improvement.

Documentation Required

Hereditary Hemochromatosis: Response Documentation

For continuation authorization for hereditary hemochromatosis, document current treatment with the requested drug, the diagnosis being treated, and a decrease in serum ferritin compared with the pretreatment baseline.

Current therapy with the requested drug is required.
Confirm treatment of hereditary hemochromatosis.
Document a decrease in serum ferritin compared with pretreatment baseline.

Documentation Required

Required Clinical Documentation

Clinical documentation must be available upon request for all submissions. For transfusional iron overload in members with chronic anemia, include the applicable pretreatment or current serum ferritin documentation.

Initial requests: pretreatment serum ferritin level.
Continuation requests: current serum ferritin level.

Documentation Required

Dialysis-Related Iron Toxicity Documentation

For dialysis-related iron toxicity continuation requests, provide documentation of the member’s current therapy, the indication, and supporting evidence that the member is receiving benefit.

Identify the requested drug and confirm the member is currently receiving therapy.
Document iron toxicity in a member undergoing dialysis.
Include supporting details demonstrating benefit from therapy.

Documentation Required

Porphyria Continuation Documentation

For porphyria continuation requests, provide documentation of current therapy, the diagnosis, and symptomatic benefit from treatment.

Identify the requested drug and confirm current therapy.
Document the porphyria diagnosis.
Describe symptomatic improvement or other benefit from therapy.

Documentation Required

Hereditary Hemochromatosis Response Documentation

For hereditary hemochromatosis continuation requests, provide documentation of current therapy, the diagnosis, and a decrease in serum ferritin compared with the pretreatment baseline.

Identify the requested drug and confirm current therapy.
Document the hereditary hemochromatosis diagnosis.
Provide serum ferritin results demonstrating a decrease from pretreatment baseline.

Denial Risk

Ferritin Threshold Not Met

Initial authorization for transfusional iron overload in chronic anemia may be denied when the pretreatment serum ferritin level is not consistently greater than 1000 mcg/L.

Required threshold: pretreatment serum ferritin consistently greater than 1000 mcg/L.

Denial Risk

Phlebotomy Requirement Not Met

Authorization for porphyria or hereditary hemochromatosis may be denied when the applicable phlebotomy requirement is not met.

Porphyria: phlebotomy must be contraindicated.
Hereditary hemochromatosis: phlebotomy must not be an option, or the member must have had an unsatisfactory response to phlebotomy.

Prior Authorization

Continuation Criteria Required

Continuation authorization requires the member to be currently receiving therapy, the requested drug to be used for the applicable covered indication, and documented benefit from therapy.

Applies to continuation requests, including new members requesting continuation.
Benefit must be documented for the applicable indication.
For aluminum toxicity, benefit is defined as decreased serum aluminum concentrations or symptomatic improvement; other indications have their specified benefit requirements.

Prior Authorization

Unlisted Indication Requires Compendial Support

Indications not listed in the coverage criteria are assessed individually. Submissions for unlisted indications must include supporting evidence from Medicare-approved compendia.

All other indications are subject to individual assessment.
Provide supporting evidence from Medicare-approved compendia.

Denial Risk

Dialysis-Related Iron Toxicity: Continuation Denial Risk

Continuation authorization for iron toxicity in a member undergoing dialysis may be denied when the member is not currently receiving the requested drug, the drug is not being used for the covered indication, or benefit from therapy is not documented.

Current therapy is required.
The indication must be iron toxicity in a member undergoing dialysis.
Benefit from therapy must be documented.

Denial Risk

Porphyria: No Documented Benefit

Continuation authorization for porphyria may be denied when benefit from therapy, such as symptomatic improvement, is not documented.

The member must be currently receiving the requested drug.
The drug must be used to treat porphyria.
Documented benefit, such as symptomatic improvement, is required.

Denial Risk

Hereditary Hemochromatosis: No Ferritin Response

Continuation authorization for hereditary hemochromatosis may be denied when a decrease in serum ferritin compared with the pretreatment baseline is not documented.

The member must be currently receiving the requested drug.
The drug must be used to treat hereditary hemochromatosis.
Serum ferritin must decrease compared with pretreatment baseline.

Iron toxicity: The member is undergoing dialysis and has iron toxicity.

Malaria: initial therapy

Authorization of 30 days may be granted when the criterion is met.

Malaria: The member has malaria.

Porphyria: initial therapy

Authorization of 12 months may be granted when the criterion is met.

Porphyria: The member has porphyria and phlebotomy is contraindicated.

Hereditary hemochromatosis: initial therapy

Authorization of 12 months may be granted when the criterion is met.

Iron toxicity in members undergoing dialysis: continuation therapy

Authorization for 12 months may be granted when all of the following criteria are met.

Iron toxicity in members undergoing dialysis: The member is currently receiving therapy with the requested drug; the requested drug is being used to treat iron toxicity in a member undergoing dialysis; and the member is receiving benefit from therapy.Clinical benefit from therapy

Porphyria: continuation therapy

Authorization for 12 months may be granted when all of the following criteria are met.

Iron toxicity in members undergoing dialysis: continuation therapy

Authorization for 12 months may be granted when all of the following criteria are met.

Porphyria: continuation therapy

Authorization for 12 months may be granted when all of the following criteria are met.

Hereditary hemochromatosis: continuation therapy

Authorization for 12 months may be granted when all of the following criteria are met.