ModifiedCentenePolicy CP.PHAR.146

Deferoxamine (Desferal)

Covers medical necessity criteria, dosing limits, and authorization rules for deferoxamine (Desferal) for acute iron intoxication and chronic transfusional iron overload across Centene lines of business.

Policy Summary

PayerCentene

PolicyDeferoxamine (Desferal)

Policy CodePolicy CP.PHAR.146

Change TypeContent revisedmaterial coverage updates

Effective Date11.01.15

Next Review Date

Key ActionProvider must submit documentation (office notes, lab results) showing diagnosis, transfusion history, serum ferritin and dosing to support prior authorization.

SourceLink

POLICY UPDATE CHANGES

For continuation therapy in chronic iron overload, member must be responding to therapy as evidenced by a decrease in serum ferritin compared to pretreatment baseline; concurrent use of other chelators not allowed unless excess cardiac iron (mT2* ≤ 10 ms) or iron-induced cardiomyopathy.

Added requirement that member must use generic deferoxamine when request is for brand Desferal unless contraindicated or adverse effects are experienced.

Added Parkinson disease to list of diagnoses/indications for which coverage is NOT authorized with rationale in Appendix D.

For chronic iron overload, concurrent iron chelator bypass threshold revised from cardiac T2* < 20 ms to mT2* ≤ 10 ms per TIF guidelines.

Policy is medically necessary for all deferoxamine products not only Desferal.

Added requirement that member must use generic deferoxamine.

For continuation of therapy in chronic iron overload, added requirement that member is responding positively to therapy as evidenced by a decrease in serum ferritin compared to pretreatment baseline.

6,000 mgmax 24-hr dose (acute)

≥100 mL/kg

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Coverage Criteria

inv-01: Acute Iron Intoxication (Initial)

Covered when ALL of the following are met

Acute Iron Intoxication Initial: 1) Diagnosis of acute iron intoxication; 2) If request is for brand Desferal, member must use generic deferoxamine unless contraindicated or clinically significant adverse effects are experienced; 3) Dose does not exceed 6,000 mg in 24 hours (IM or IV).max 6,000 mg/24 hr

Approval duration: 1 month

inv-02: Chronic Iron Overload due to Transfusion-Dependent Anemias (Initial)

Covered when ALL of the following are met

Chronic Iron Overload Initial: 1) Diagnosis of chronic iron overload due to transfusion-dependent anemia (e.g., thalassemia, sickle cell anemia, aplastic anemia, myelodysplasia); 2) Transfusion history of ≥ 100 mL/kg of packed red blood cells (e.g., ≥ 20 units for a 40 kg person); 3) Serum ferritin level > 1,000 mcg/L; 4) If request is for brand Desferal, member must use generic deferoxamine unless contraindicated or clinically significant adverse effects are experienced; 5) Therapy does not include concurrent use of other iron chelators unless member has excess cardiac iron evidenced by mT2* ≤ 10 ms or iron-induced cardiomyopathy; 6) Dose does not exceed: a) SC 2,000 mg/day; b) IV 40 mg/kg/day (children) or 60 mg/kg/day (adults); c) IM 1,000 mg/day.ferritin >1,000 mcg/L; transfusion history ≥100 mL/kg; dosing limits as listed

Approval duration: 12 months per continuation rules

inv-03: Chronic Iron Overload due to Transfusion-Dependent Anemias (Continuation)

Covered when ALL of the following are met

Chronic Iron Overload Continuation: 1) Member currently receiving medication via Centene benefit or previously met initial approval criteria, or is receiving medication under continuity of care provisions; 2) Member is responding positively to therapy as evidenced by a decrease in serum ferritin compared to pretreatment baseline; 3) Current documentation (within last 30 days) shows serum ferritin ≥ 500 mcg/L; 4) If request is for brand Desferal, member must use generic deferoxamine unless contraindicated or clinically significant adverse effects are experienced; 5) Therapy does not include concurrent use of other iron chelators unless member has excess cardiac iron evidenced by mT2* ≤ 10 ms or iron-induced cardiomyopathy; 6) If request is for a dose increase, new dose does not exceed: a) SC 2,000 mg/day; b) IV 40 mg/kg/day (children) or 60 mg/kg/day (adults); c) IM 1,000 mg/day.serum ferritin ≥500 mcg/L for continuation documentation

Approval duration: 12 months

inv-04: Continuation Therapy (Chronic Iron Overload)

Continuation therapy for chronic iron overload is covered when ALL of the following are met

Response and restrictions: 1) Member is responding positively to therapy as evidenced by a decrease in serum ferritin compared to pretreatment baseline; 2) Therapy does not include concurrent use of other iron chelators unless member has excess cardiac iron with mT2* ≤ 10 ms or iron-induced cardiomyopathy; 3) Member must use generic deferoxamine when applicable unless contraindicated or clinically significant adverse effects are experienced.mT2* ≤ 10 ms

Added/updated per 3Q2023-3Q2025 reviews

The following diagnoses and indications are not authorized for coverage under this policy: Primary hemochromatosis and Parkinson's disease. In addition, non‑FDA approved indications are not addressed by this policy unless there is sufficient documentation of efficacy and safety consistent with the applicable off‑label use policies (CP.CPA.09 for commercial, HIM.PA.154 for marketplace, and CP.PMN.53 for Medicaid) or other evidence of coverage documents.

For chronic transfusional iron overload, concurrent use of other iron chelators is generally not permitted. An exception allowing concurrent chelation is limited to members with excess cardiac iron or iron‑induced cardiomyopathy as documented by cardiac MRI; the policy uses a cardiac T2* threshold of mT2* ≤ 10 ms to permit concurrent chelator therapy.

Use of deferoxamine is explicitly not authorized for primary hemochromatosis and for Parkinson's disease under this policy. Parkinson's disease was added to the list of non‑authorized indications following review (see policy history).

The lists of procedure and diagnosis codes presented in this policy are provided for informational purposes only. Inclusion or exclusion of any codes does not guarantee coverage; providers must follow current professional coding guidance when submitting claims because absence of prior authorization or presence/absence of a code in this document does not establish medical necessity or guarantee payment.

Initial Therapy

inv-25: Initial Therapy

Initial approval criteria per indication

Acute Initial: 1) Diagnosis of acute iron intoxication; 2) If request is for brand Desferal, member must use generic deferoxamine unless contraindicated or clinically significant adverse effects are experienced; 3) Dose does not exceed 6,000 mg in 24 hours (IM or IV).

Chronic Initial: 1) Diagnosis of chronic iron overload due to transfusion-dependent anemia; 2) Transfusion history of ≥ 100 mL/kg; 3) Serum ferritin level > 1,000 mcg/L; 4) If request is for brand Desferal, member must use generic deferoxamine unless contraindicated or clinically significant adverse effects are experienced; 5) Therapy does not include concurrent use of other iron chelators unless member has excess cardiac iron evidenced by mT2* ≤ 10 ms or iron-induced cardiomyopathy; 6) Dose limits: SC up to 2,000 mg/day; IV 40 mg/kg/day (children) or 60 mg/kg/day (adults); IM 1,000 mg/day.

Continuation Therapy

ALL of the following

Member meets one of the following: (a) currently receiving medication via Centene benefit or previously met initial approval criteria; OR (b) currently receiving medication and enrolled in a state/product with continuity of care regulations (see CC.PHARM.03A/03B).
Documentation of positive response to therapy: decrease in serum ferritin compared to pretreatment baseline.
Current serum ferritin within the last 30 days ≥ 500 mcg/L.
Brand-to-generic requirement: If request is for brand Desferal, member must use generic deferoxamine unless contraindicated or clinically significant adverse effects are experienced.
Added 3Q 2022

Coding and Clinical Thresholds

HCPCS CodesHCPCS

J0895

Injection, deferoxamine mesylate, 500 mg

Referenced HCPCS CodesHCPCS

J0895

Injection, deferoxamine mesylate, 500 mg

Transfusion history

ThresholdTransfusion history ≥ 100 mL/kg of packed red blood cells (e.g., ≥ 20 units for a 40 kg person)

ContextRequired for initial approval of chronic transfusion-dependent iron overload

Example useIncluded in criteria for chronic iron overload initial therapy

Serum ferritin

Initiation threshold> 1,000 mcg/L serum ferritin to initiate therapy

Continuation documentationCurrent documentation (within 30 days) showing serum ferritin ≥ 500 mcg/L required for continuation

Provider Actions & Authorization

Prior Authorization

Submit prior authorization with diagnosis, transfusion history, ferritin and dosing

Prior authorization is required for deferoxamine therapy; the request must include diagnosis, transfusion history, serum ferritin and dosing. Approval durations vary by indication (acute: 1 month; chronic continuation: 12 months).

Include diagnosis (acute intoxication or transfusion‑dependent chronic iron overload).
Provide transfusion history (≥ 100 mL/kg when applicable) and current serum ferritin.
List requested dose/route and ensure it does not exceed policy dosing limits.

Prior Authorization

Prior authorization covers deferoxamine injections (J0895) — policy applies to all deferoxamine products

Prior authorization applies to deferoxamine injections (HCPCS J0895 referenced) and the policy is clarified to be medically necessary for all deferoxamine products, not only Desferal.

HCPCS J0895 (Injection, deferoxamine mesylate, 500 mg) is referenced for billing but code inclusion is informational.

Step Therapy / Product Substitution

Step	Requirement	Notes
1	When request is for brand Desferal, member must trial generic deferoxamine unless contraindicated or clinically significant adverse effects are experienced.	Applies to acute and chronic indications (see criteria); added in 3Q2022 and reflected in continuation criteria; prior authorization required.

Step	Requirement	Policy Basis / Evidence
1	Member must use generic deferoxamine prior to use of brand Desferal unless there is a contraindication or clinically significant adverse effects.	Requirement added per 3Q2022 annual review and documented in coding/step therapy sections; reiterated in initial and continuation coverage criteria for chronic and acute indications.

Quantity Limits & Dosing

deferoxamine (Desferal) — dosing limits

SC (subcutaneous)Up to 2,000 mg/day

IV (intravenous)40 mg/kg/day (children) or 60 mg/kg/day (adults)

IM (intramuscular)1,000 mg/day; acute maximum 6,000 mg/24 hr

Site of Care

Note

IV infusion reserved for cardiovascular collapse; IM route if patient not in shock

IV infusion administration is limited to patients in cardiovascular collapse; use IM route if the patient is not in shock.

Applicable site settings include hospital outpatient, infusion center or office, but IV is reserved for cardiovascular collapse.

Background

Deferoxamine is an iron‑chelating agent indicated for management of acute iron intoxication and for treatment of transfusional iron overload in chronic anemias. It is not indicated for primary hemochromatosis. Because deferoxamine and its iron chelate are renally excreted, contraindications include known hypersensitivity to the active substance and severe renal disease or anuria. The policy requires prior authorization for deferoxamine products and documents specific dosing limits and monitoring thresholds for acute and chronic indications.

Definitions

myocardial T2 (mT2*)

Termmyocardial T2 (magnetic resonance measure of cardiac iron) = mT2*

PurposeUsed to quantify cardiac iron burden to guide therapy decisions

Policy useReferenced as evidence threshold for permitting concurrent chelator use

Cardiac MRI T2* threshold

ThresholdCardiac MRI T2* ≤ 10 ms permits concurrent iron chelator use or bypass of chelator restriction

Policy changeRevised from prior threshold (cardiac T2* < 20 ms) to mT2* ≤ 10 ms per 3Q2025 review and TIF guidelines

Application

Revision History

2025-05-14clinical_threshold_revisionLatest

Revised concurrent iron chelator bypass threshold for chronic iron overload from cardiac T2* < 20 ms to mT2* ≤ 10 ms per TIF guidelines.

2024-05-23clarification

Clarified that the policy is medically necessary for all deferoxamine products, not only Desferal; references reviewed and updated.

2023-04-14criteria_added

Added requirement for continuation therapy that member is responding to treatment as evidenced by decreased serum ferritin compared to pretreatment baseline and restricted concurrent use of other iron chelators unless excess cardiac iron; applied per competitor analysis and continuation criteria update.

Policy Summary

PayerCentene

PolicyDeferoxamine (Desferal)

Policy CodePolicy CP.PHAR.146

Change TypeContent revisedmaterial coverage updates

Effective Date11.01.15

Next Review Date

Key ActionProvider must submit documentation (office notes, lab results) showing diagnosis, transfusion history, serum ferritin and dosing to support prior authorization.

SourceLink

On This Page

Prior Authorization

Prior Authorization Required

Provider Action: Prior authorization is required for continuation of deferoxamine products under this policy. Ensure documentation submitted supports all continuation criteria (including recent serum ferritin results and evidence of prior authorization or continuity of care enrollment where applicable).

Prior authorization required for continuation requests.
Include serum ferritin result within 30 days and evidence of prior clinical response (decrease from baseline).
If requesting brand Desferal, include documentation of contraindication or adverse reaction to generic deferoxamine to justify brand use.

Denial Risk

Denial Triggers

Denial triggers and documentation risks: requests lacking evidence of positive response (no decrease in serum ferritin compared to pretreatment baseline), missing a serum ferritin ≥ 500 mcg/L within the last 30 days, requests for concurrent iron chelators without cardiac iron overload (mT2* ≤ 10 ms) or documentation of iron-induced cardiomyopathy, dose increases exceeding specified limits, or failure to trial generic deferoxamine when requesting brand Desferal (without documented contraindication/adverse effect) may be denied.

Denial triggers include: absent recent serum ferritin ≥ 500 mcg/L; no documented decrease from baseline; concurrent iron chelator use without qualifying cardiac iron criteria; dose over specified limits; brand Desferal request without generic trial or contraindication.