CurrentColorado Rocky Mountain Health PlansPolicy N/A

Prior Authorization: Deferasirox (Exjade, Jadenu) and Deferiprone (Ferriprox) — Iron Chelators

Prior authorization and reauthorization criteria for deferasirox (Exjade, Jadenu) and deferiprone (Ferriprox) for treatment of chronic or transfusional iron overload; applies to members whose benefits require UnitedHealthcare Pharmacy Clinical Pharmacy Program prior authorization.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyPrior Authorization: Iron Chelators — Exjade, Jadenu, Ferriprox

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateSep 1, 2025

Next Review DateJun 1, 2025

Key ActionObtain prior authorization for Exjade, Jadenu, or Ferriprox; approvals issued for 12 months when criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3drugs covered

12auth period (months)

>=5LIC threshold

>300ferritin NTDT

Coverage Criteria

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Initial Therapy (Exjade/Jadenu transfusional)

Covered when ALL of the following are met:

Exjade/Jadenu initial (transfusional): (1) Diagnosis of chronic iron overload due to blood transfusion (e.g., sickle cell anemia, thalassemia, etc.); (2) Authorization will be issued for 12 months.

Reauthorization (Exjade/Jadenu)

Reauthorization covered when ANY of the following are met:

Exjade/Jadenu reauthorization: Documentation of positive clinical response to Exjade or Jadenu therapy

Authorization will be issued for 12 months.

Initial Therapy (Ferriprox)

Covered when ALL of the following are met:

Ferriprox initial: (1) Diagnosis of transfusional iron overload due to thalassemia syndromes, sickle cell disease or other anemias; (2) Ferriprox will not be used for treatment of transfusional iron overload due to myelodysplastic syndrome or Diamond Blackfan anemia (exclusion).

Authorization will be issued for 12 months.

Initial Therapy (Exjade/Jadenu NTDT)

Covered when ALL of the following are met:

Exjade/Jadenu initial (NTDT): (1) Diagnosis of chronic iron overload in non-transfusion dependent thalassemia (NTDT); (2) Patient has liver iron concentration (LIC) levels consistently >= 5 mg Fe/g dw prior to initiation of treatment with Exjade or Jadenu; (3) Patient has serum ferritin levels consistently > 300 mcg/L prior to initiation of treatment with Exjade or Jadenu.LIC >= 5 mg Fe/g dw; ferritin > 300 mcg/L

Authorization will be issued for 12 months.

Initial Therapy Rules

Initial therapy rules

Initial authorization criteria

Initial deferasirox transfusional: Diagnosis of chronic iron overload due to blood transfusion; authorization for 12 months.

Initial deferasirox NTDT: Diagnosis of NTDT; LIC >=5 mg Fe/g dw; ferritin >300 mcg/L; authorization for 12 months.LIC >=5 mg Fe/g dw; ferritin >300 mcg/L

Initial deferiprone: Diagnosis of transfusional iron overload due to thalassemia syndromes, sickle cell disease or other anemias; not for myelodysplastic syndrome or Diamond Blackfan anemia; authorization for 12 months.

Continuation / Reauthorization Criteria

Deferasirox continuation

Reauthorization rules

Continuation for deferasirox: Documentation of positive clinical response to therapy required for reauthorization; approvals issued for 12 months.

Deferiprone continuation

Reauthorization rules

Continuation for deferiprone: Documentation of positive clinical response to therapy required for reauthorization; approvals issued for 12 months.

Provider Actions & Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Exjade, Jadenu, and Ferriprox. Approvals are issued for 12 months for initial and reauthorization where applicable.

Affected products: Exjade (deferasirox), Jadenu (deferasirox), Ferriprox (deferiprone)
Approval duration: 12 months for initial and reauthorization

Documentation Required

NTDT Baseline Labs Required

For the NTDT indication when initiating Exjade or Jadenu, document baseline liver iron concentration (LIC) and serum ferritin. LIC must be measured prior to initiation and documented as ≥ 5 mg Fe/g dry weight; serum ferritin must be consistently > 300 mcg/L.

Indication: Non‑transfusion dependent thalassemia (NTDT)
Required labs: LIC ≥ 5 mg Fe/g dw (measured prior to start); serum ferritin consistently > 300 mcg/L

Denial Risk

Ferriprox Exclusion — Denial Risk

Ferriprox is approved only for transfusional iron overload due to thalassemia syndromes, sickle cell disease, or other anemias. Do not use Ferriprox for transfusional iron overload due to myelodysplastic syndrome or Diamond Blackfan anemia — use in those conditions will trigger denial.

Ferriprox indication: transfusional iron overload from thalassemia syndromes, sickle cell disease, or other anemias
Explicit exclusion: myelodysplastic syndrome; Diamond Blackfan anemia — documentation will be required and claims may be denied if used for these conditions

Step Therapy

Step Therapy & Automated Approvals

Step therapy and automated approvals may apply. Some members may receive automated initial approval or re-authorization based on prior claim/medication history, relevant diagnosis codes (ICD‑10), and claim logic. Verify member history and ensure documentation supports clinical criteria to avoid manual review or denial.

Step therapy: may be in place for the therapeutic class
Automated approvals: may be granted based on previous claims/medication history and diagnosis codes (ICD‑10)

Key Clinical Thresholds & Coding

LIC threshold

LIC threshold (NTDT)>= 5 mg Fe per gram dry weight (mg Fe/g dw)

Measurement contextLIC must be consistently >= 5 mg Fe/g dw prior to initiation of Exjade or Jadenu for NTDT patients

Unitsmg Fe per gram of dry weight (mg Fe/g dw)

Serum ferritin (NTDT)

Serum ferritin threshold (NTDT)> 300 mcg/L

Measurement contextSerum ferritin must be consistently > 300 mcg/L prior to initiation of Exjade or Jadenu for NTDT patients

Relation to LICUsed together with LIC >= 5 mg Fe/g dw to determine NTDT treatment eligibility

Serum ferritin (transfusional overload)

Serum ferritin threshold (transfusional overload)> 1000 mcg/L (example guidance for transfusional iron overload)

Measurement contextRecommended trigger for initiating Exjade/Jadenu in transfusional iron overload based on transfusion history and ferritin

Age/contextApplies in context of chronic transfusional iron overload (e.g., ~100 mL/kg transfused) as described in labeling

Step	Requirement	Notes
1	Step therapy may be in place (unspecified).	Automated approval or re-approval may occur based on prior claim/medication history, diagnosis codes (ICD-10), and program-specific logic.

Background

Deferasirox (Exjade, Jadenu) and deferiprone (Ferriprox) are oral iron chelators indicated to treat chronic or transfusional iron overload arising from repeated blood transfusions or certain anemias. Exjade and Jadenu are indicated for transfusional iron overload and for non‑transfusion dependent thalassemia (NTDT) patients meeting LIC ≥ 5 mg Fe/g dw and serum ferritin > 300 mcg/L thresholds. Ferriprox is indicated for transfusional iron overload in patients with thalassemia, sickle cell disease, or other anemias, with age‑based labeling for formulation (tablets and oral solution) as specified in product labeling.

Definitions

NTDT

DefinitionNon-transfusion dependent thalassemia (NTDT) syndromes

Use in policyNTDT is an indication for Exjade/Jadenu when LIC >= 5 mg Fe/g dw and ferritin > 300 mcg/L

Population noteApplies to patients ≥10 years of age per product labeling for deferasirox

LIC (definition)

DefinitionLiver iron concentration (LIC): amount of iron measured in mg Fe per gram of dry weight (mg Fe/g dw)

Clinical useLIC is used to determine eligibility for deferasirox in NTDT when consistently >= 5 mg Fe/g dw

Threshold unitsExpressed as mg Fe/g dry weight

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyPrior Authorization: Iron Chelators — Exjade, Jadenu, Ferriprox

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateSep 1, 2025

Next Review DateJun 1, 2025

Key ActionObtain prior authorization for Exjade, Jadenu, or Ferriprox; approvals issued for 12 months when criteria are met.

SourceLink

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