MHN deferoxamine coverage & prior auth update

Coverage Criteria

inv-01: Acute Iron Intoxication — Covered when ALL of the following are met

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).dose ≤ 6000 mg/24 hr

Approval duration: 1 month

inv-02: Chronic Transfusion-Dependent Iron Overload (Initial) — Covered when ALL of the following are met

Covered when ALL of the following are met

Chronic transfusional iron overload initial: 1. Diagnosis of chronic iron overload due to transfusion-dependent anemia (e.g., congenital/acquired anemias including thalassemia, sickle cell anemia, aplastic anemia, myelodysplasia); 2. Transfusion history of ≥ 100 mL/kg of packed red blood cells; 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 as evidenced by mT2* ≤ 10 ms or iron-induced cardiomyopathy; 6. Dose does not exceed SC: 2,000 mg/day; IV: 40 mg/kg/day (children) or 60 mg/kg/day (adults); IM: 1,000 mg/day.ferritin > 1000 mcg/L; transfusion ≥100 mL/kg

inv-03: Chronic Transfusion-Dependent Iron Overload (Continuation) — Covered when ALL of the following are met

Covered when ALL of the following are met

Chronic transfusional iron overload continued: 1. Member currently receiving medication via Centene benefit or previously met initial approval criteria, or continuity of care per state rules; 2. Member is responding positively to therapy as evidenced by a decrease in serum ferritin compared to pretreatment baseline; 3. Current documentation within the 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 as evidenced by mT2* ≤ 10 ms or iron-induced cardiomyopathy; 6. If request is for a dose increase, new dose does not exceed SC: 2,000 mg/day; IV: 40 mg/kg/day (children) or 60 mg/kg/day (adults); IM: 1,000 mg/day.ferritin ≥500 mcg/L for continuation

Approval duration: 12 months

inv-04: Other Indications — Covered only if one of the following applies

Covered only if one of the following applies

Other diagnoses/indications: 1. If the drug has had a label change within the last 6 months that is not yet reflected in this policy, follow the referenced formulary/non-formulary policies for the applicable line of business (see CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16); OR 2. If the requested use (diagnosis, age, dosing) is not listed under the 'Diagnoses/Indications for which coverage is NOT authorized' section and criterion 1 does not apply, refer to the off-label use policy for the relevant line of business (see CP.CPA.09, HIM.PA.154, CP.PMN.53).

See referenced policies

inv-05: Coverage criteria highlights — Key policy coverage rules and updates noted in annual reviews

Key policy coverage rules and updates noted in annual reviews

Generic product requirement: Member must use generic deferoxamine when required by the plan.

Added 3Q 2022

Continuation response for chronic iron overload: Continuation requires evidence of a decrease in serum ferritin compared to pretreatment baseline.

Added 3Q 2023

Concurrent iron chelator allowance: Concurrent use of other iron chelators is not allowed for chronic iron overload unless member has excess cardiac iron as demonstrated by mT2* ≤ 10 ms.mT2* ≤ 10 ms

Revised 3Q 2025 per TIF guidelines

The policy explicitly lists diagnoses/indications for which coverage is NOT authorized. Specifically, Primary hemochromatosis and Parkinson's disease are named in the exclusion list and requests for deferoxamine for these diagnoses should be considered non‑authorized under this policy.

Non‑FDA approved indications that are not addressed in this policy are excluded unless the provider submits sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies (for example, CP.CPA.09 for commercial, HIM.PA.154 for marketplace, and CP.PMN.53 for Medicaid) or relevant evidence of coverage documents.

Inclusion or exclusion of billing or procedure codes in this policy does not guarantee coverage. Providers must follow the plan's coding guidance and consult current professional coding sources prior to claim submission to reduce risk of denial.

Use of deferoxamine for primary hemochromatosis or for Parkinson's disease is listed in Section III as conditions for which coverage is not authorized; requests for these indications are subject to denial under this policy.

This document fragment does not enumerate additional specific 'not medically necessary' (NMN) conditions beyond those listed in Section III. For a complete set of NMN statements and any other exclusion details, refer to the full policy text and appendices.

Initial Therapy Criteria

inv-28: Initial Therapy Criteria — 2 top-level nodes

Initial therapy acute: See Acute Iron Intoxication criteria: diagnosis of acute iron intoxication; brand-to-generic requirement unless contraindicated; dose ≤ 6,000 mg/24 hr; approval duration 1 month.

Initial therapy chronic: See Chronic Transfusion-Dependent Iron Overload (Initial) criteria: diagnosis of chronic transfusion-dependent iron overload; transfusion history ≥ 100 mL/kg; serum ferritin > 1,000 mcg/L; brand-to-generic requirement unless contraindicated; no concurrent chelators unless excess cardiac iron (mT2* ≤ 10 ms) or iron-induced cardiomyopathy; route-specific dose limits apply (SC ≤ 2,000 mg/day; IV 40 mg/kg/day children or 60 mg/kg/day adults; IM ≤ 1,000 mg/day).

inv-29: Initial therapy scope — Clarified to apply to all deferoxamine products

Initial therapy coverage statements clarified to apply to all deferoxamine products

Product scope:

Continuation Therapy Criteria

inv-30: Continuation Therapy Criteria — 1 top-level node

Covered when ALL of the following are met

Continuation: 1. Member currently receiving medication via Centene benefit or previously met initial criteria or has continuity of care per state rules; 2. Member is responding positively to therapy as evidenced by a decrease in serum ferritin compared to pretreatment baseline; 3. Current documentation within the 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 as evidenced by mT2* ≤ 10 ms or iron-induced cardiomyopathy; 6. If request is for a dose increase, new dose does not exceed SC: 2,000 mg/day; IV: 40 mg/kg/day (children) or 60 mg/kg/day (adults); IM: 1,000 mg/day.

inv-31: Continuation criteria for chronic iron overload — Continuation requirements added/clarified in annual reviews

Continuation requirements added/clarified in annual reviews

Response evidence: Member must be responding positively to therapy as evidenced by a decrease in serum ferritin levels compared to pretreatment baseline for continuation in chronic iron overload.

Coding

HCPCS CodesHCPCS

J0895

Injection, deferoxamine mesylate, 500 mg

HCPCS Codes (informational)HCPCS

J0895

Injection, deferoxamine mesylate, 500 mg

inv-13: Serum ferritin — Initiation > 1,000 mcg/L; continuation documentation ≥ 500 mcg/L within last 30 days

Serum ferritin — initiation> 1,000 mcg/L

Serum ferritin — continuationDocumentation of serum ferritin ≥ 500 mcg/L within last 30 days

ContextApplies to chronic transfusional iron overload initial and continuation criteria

inv-14: Transfusion history — ≥ 100 mL/kg packed RBCs (e.g., ≥ 20 units for a 40 kg person)

Transfusion history threshold≥ 100 mL/kg packed red blood cells

Example≈ ≥ 20 units packed RBCs for a 40 kg person

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Providers must submit documentation demonstrating the member meets the specific clinical criteria outlined in the Policy/Criteria (e.g., diagnosis, transfusion history, serum ferritin, dosing limits, and evidence supporting use of generic deferoxamine when applicable). Approval durations vary by indication (see policy criteria for Acute vs Chronic indications).

Prior authorization required for requests for deferoxamine (Desferal and generics).
Approval durations: Acute iron intoxication — 1 month; Chronic transfusion-dependent iron overload — 12 months.

Documentation Required

Required Clinical Documentation

Provider must submit clinical documentation (such as office chart notes, lab results, serum ferritin values, transfusion history, mT2* cardiac iron assessment when applicable, and any information supporting contraindication to generic product) to support that the member meets all approval criteria. For continuation/renewal requests include recent (within 30 days) serum ferritin demonstrating response to therapy and documentation of current dosing.

Step Therapy / Substitution Requirements

Step	Requirement
1	Brand-to-generic substitution required for requests for brand Desferal unless contraindicated or clinically significant adverse effects are experienced.

Step	Requirement
1	Member must use generic deferoxamine prior to coverage of brand Desferal when the generic requirement applies; exemptions allowed for contraindication or clinically significant adverse effects.

Quantity Limits / Dosing

inv-34: deferoxamine dosing limits — varies by route: SC ≤ 2000 mg/day; IV ≤ 40 mg/kg/day (children) or 60 mg/kg/day (adults); IM ≤ 1000 mg/day; acute max 6000 mg/24 hr

SC (subcutaneous) maximum≤ 2,000 mg per day

IV (intravenous) maximumChildren: ≤ 40 mg/kg/day; Adults: ≤ 60 mg/kg/day

IM (intramuscular) maximum≤ 1,000 mg per day

Acute intoxication maximum (IM or IV)Up to 6,000 mg per 24 hours

Site of Care

Note

Site of care: IV limited to cardiovascular collapse; IM if not in shock

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

SC infusion is an appropriate site-of-care option outside of cardiovascular collapse.
Follow route-specific dosing and maximums when selecting site of care.

Definitions

inv-26: mT2* — myocardial T2 (used to assess cardiac iron load)

mT2* termMyocardial T2 (used to assess cardiac iron load)

ModalityDerived from cardiac magnetic resonance (T2) imaging

PurposePolicy uses mT2* to evaluate cardiac iron burden and guide chelation decisions

inv-27: mT2* — Cardiac magnetic resonance-derived metric (millisecond) used to assess cardiac iron; policy uses mT2* thresholds to guide concurrent chelation

Metric descriptionCardiac magnetic resonance‑derived metric reported in milliseconds (mT2*)

Clinical useUsed in policy thresholds to determine excess cardiac iron and allow concurrent iron chelator use

Background

Background: Deferoxamine is an iron‑chelating agent indicated for treatment of acute iron intoxication and for management of transfusional iron overload in chronic anemias. The policy notes that certain diagnoses (see Section III) are not authorized indications for its use.

OpenPayer

Deferoxamine (Desferal) coverage

Coverage Criteria

Initial Therapy Criteria

Continuation Therapy Criteria

Coding

Provider Actions & Requirements

Step Therapy / Substitution Requirements

Quantity Limits / Dosing

Site of Care

Definitions

Background