CurrentCignaPolicy N/A

Chelating Agents -Iron Chelators (Oral) Prior Authorization Policy

Defines prior authorization criteria, required documentation, prescriber specialty, approval durations, covered FDA indications and supported other uses for oral iron chelators Exjade/Jadenu (deferasirox) and Ferriprox (deferiprone) for Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyChelating Agents -Iron Chelators (Oral) Prior Authorization Policy

Policy CodePolicy N/A

Change TypeAnnual revision (verbiage update) & review date update

Effective Date

Next Review Date

Key ActionPrior Authorization is recommended; obtain documentation of pre-treatment serum ferritin and ensure the medication is prescribed by or in consultation with a hematologist; approvals are provided for 1 year.

POLICY UPDATE CHANGES

Annual Revision updated verbiage for 'Patients Currently Receiving an Oral Chelator' to 'Approve if the patient is benefiting from therapy, according to the prescriber.'

Review date updated to 01/29/2025.

2Primary drug classes covered (deferasirox, deferiprone)

3Covered indication groups

1Approval duration (years)

Coverage Summary

This policy covers oral iron chelators deferasirox (Exjade, Jadenu, Jadenu Sprinkle) and deferiprone (Ferriprox tablets and oral solution) for treatment of chronic iron overload from transfusions and select non‑transfusion‑dependent thalassemia, with age‑ and formulation‑specific indications and limits. Deferasirox is indicated for transfusional iron overload in patients ≥ 2 years and for non‑transfusion‑dependent thalassemia in patients ≥ 10 years with liver iron concentration ≥ 5 mg Fe/g dry liver weight and serum ferritin > 300 mcg/L. Deferiprone tablets are indicated for transfusional iron overload in patients ≥ 8 years, and the oral solution is indicated in patients ≥ 3 years. Prior authorization is recommended for Cigna‑administered health benefit plans; initial prescribing requires a specialist (hematologist or treating specialist), documentation of pre‑treatment ferritin thresholds, and approvals are provided for 1 year.

Deferasirox (Exjade, Jadenu, Jadenu Sprinkle) — Coverage Criteria

Deferasirox (Exjade, Jadenu, Jadenu Sprinkle) - Coverage Criteria

Covered as medically necessary for FDA-approved indications or other uses with supportive evidence when documentation provided; approvals for 1 year

I. Iron Overload, Chronic - Transfusion-Related

1.A Initial Therapy
- Patient is receiving blood transfusions at regular intervals for a chronic condition (examples: thalassemia syndromes, myelodysplastic syndrome, chronic anemia, sickle cell disease).
- Prior to starting chelating therapy, serum ferritin level was > 1,000 mcg/L.> 1,000 mcg/L
  [documentation required]
- Medication is prescribed by or in consultation with a hematologist.
1.B Patient Currently Receiving deferasirox
- Patient is currently receiving deferasirox.
- Patient is benefiting from therapy, according to the prescriber.
  Examples of benefit include reduction in serum ferritin levels, stable disease, and reduced organ iron load.

II. Iron Overload, Chronic - Non-Transfusion-Dependent Thalassemia Syndromes

2.A Initial Therapy
- Prior to starting chelating therapy, serum ferritin level was > 300 mcg/L.> 300 mcg/L
  [documentation required]
- Medication is prescribed by or in consultation with a hematologist.
2.B Patient Currently Receiving deferasirox
- Patient is currently receiving deferasirox.
- Patient is benefiting from therapy, according to the prescriber.
  Examples of benefit include reduction in serum ferritin levels, stable disease, and reduced organ iron load.

Documentation Required

Deferasirox documentation requirements

Documentation of pre-treatment serum ferritin is required for deferasirox: > 1,000 mcg/L for transfusion-related indications and > 300 mcg/L for non-transfusion-dependent thalassemia. Documentation may include chart notes, prescription claims records, prescription receipts, and/or other information.

Serum ferritin > 1,000 mcg/L for transfusion-related iron overload.
Serum ferritin > 300 mcg/L for non-transfusion-dependent thalassemia.
Acceptable documentation: chart notes, prescription claims records, prescription receipts, and/or other information.

Deferiprone (Ferriprox tablets and oral solution) — Coverage Criteria

Deferiprone (Ferriprox tablets and oral solution) - Coverage Criteria

Covered as medically necessary for FDA-approved indications and other uses with supportive evidence when documentation provided; approvals for 1 year

I. Iron Overload, Chronic - Transfusion-Related Due to Thalassemia Syndromes

1.A Initial Therapy
- Prior to starting chelating therapy, serum ferritin level was > 1,000 mcg/L.> 1,000 mcg/L
  [documentation required]
- Medication is prescribed by or in consultation with a hematologist.
1.B Patient Currently Receiving deferiprone
- Patient is currently receiving deferiprone.
- Patient is benefiting from therapy, according to the prescriber.
  Examples of benefit include reduction in serum ferritin levels, stable disease, and reduced organ iron load.

II. Iron Overload, Chronic - Transfusion-Related Due to Sickle Cell Disease or Other Anemias

2.A Initial Therapy
- Prior to starting chelating therapy, serum ferritin level was > 1,000 mcg/L.> 1,000 mcg/L
  [documentation required]
- Medication is prescribed by or in consultation with a hematologist.
2.B Patient Currently Receiving deferiprone
- Patient is currently receiving deferiprone.
- Patient is benefiting from therapy, according to the prescriber.
  Examples of benefit include reduction in serum ferritin levels, stable disease, and reduced organ iron load.

III. Other Uses with Supportive Evidence - Non-Transfusion-Dependent Thalassemia Syndromes

3.A Initial Therapy
- Prior to starting chelating therapy, serum ferritin level was > 300 mcg/L.> 300 mcg/L
  [documentation required]
- Medication is prescribed by or in consultation with a hematologist.
3.B Patient Currently Receiving deferiprone
- Patient is currently receiving deferiprone.
- Patient is benefiting from therapy, according to the prescriber.
  Examples of benefit include reduction in serum ferritin levels, stable disease, and reduced organ iron load.

Documentation Required

Deferiprone documentation requirements

Documentation of pre-treatment serum ferritin is required for deferiprone: > 1,000 mcg/L for transfusion-related indications and > 300 mcg/L for non-transfusion-dependent thalassemia. Documentation may include chart notes, prescription claims records, prescription receipts, and/or other information.

Serum ferritin > 1,000 mcg/L for transfusion-related indications.
Serum ferritin > 300 mcg/L for non-transfusion-dependent thalassemia.
Acceptable documentation: chart notes, prescription claims records, prescription receipts, and/or other information.

Conditions Not Covered / Experimental Uses

Conditions Not Covered

Experimental, investigational or unproven uses

ALL of the following

Exjade, Jadenu, Jadenu Sprinkle, and Ferriprox are considered experimental, investigational or unproven for ANY other use(s) not specified in the criteria.

Denial Risk

Denial risk for uses outside criteria

Use of Exjade, Jadenu, Jadenu Sprinkle, or Ferriprox for any indication not specified in the coverage criteria is considered experimental, investigational or unproven and may be denied.

Provider Actions and Prior Authorization Requirements

Prior Authorization

Prior authorization required

Prior Authorization is recommended for prescription benefit coverage. Approvals provided for 1 year.

Prior Authorization is recommended.
Approvals provided for 1 year.

Documentation Required

Documentation of ferritin required

Documentation of pre-treatment serum ferritin level is required; thresholds depend on indication: > 1,000 mcg/L for transfusion-related iron overload and > 300 mcg/L for non-transfusion-dependent thalassemia. Documentation may include chart notes, prescription claims records, prescription receipts, and/or other information.

Thresholds: > 1,000 mcg/L (transfusion-related) or > 300 mcg/L (non-transfusion-dependent).
Allowable documentation types: chart notes, prescription claims records, prescription receipts, and/or other information.

Documentation Required

Specialist prescribing requirement

Initial approval requires the medication to be prescribed by or in consultation with a hematologist or a physician who specializes in the condition being treated.

Medication must be prescribed by or in consultation with a hematologist or appropriate specialist.

Documentation Required

Evidence of benefit for continuing therapy

For patients currently receiving therapy, the prescriber must attest the patient is benefiting from therapy. Examples of benefit include reduction in serum ferritin levels, stable disease, and reduced organ iron load.

Prescriber attestation required for continuing therapy.
Examples of benefit: reduction in serum ferritin, stable disease, reduced organ iron load.

Background and Evidence

Oral iron chelators deferasirox and deferiprone are oral agents used to reduce iron burden from chronic transfusions or disease‑related iron accumulation to prevent organ damage. Therapy goals include lowering serum ferritin and liver/cardiac iron to reduce risk of organ dysfunction. Formulation‑ and age‑specific indications and limits: deferasirox (Exjade/Jadenu/Jadenu Sprinkle) is indicated for transfusional iron overload (patients ≥ 2 years) and non‑transfusion‑dependent thalassemia (patients ≥ 10 years with LIC ≥ 5 mg Fe/g dry weight and ferritin > 300 mcg/L); deferiprone (Ferriprox) tablets are indicated for transfusional iron overload in patients ≥ 8 years and the oral solution for patients ≥ 3 years. Limitations include unestablished safety/efficacy when combined with other chelators and specific exclusions (e.g., deferiprone not established for MDS or Diamond‑Blackfan anemia); initiation and continuation require specialist involvement and documentation of ferritin thresholds.

Prescribing information cited	Guidelines referenced
[{"text":"Exjade/Jadenu PI July 2024; Jadenu Sprinkle PI July 2024; Ferriprox tablets PI July 2023; Ferriprox oral solution PI Nov 2021","status":""},{"text":"Thalassemia International Federation (Transfusion‑dependent 2021; Non‑transfusion‑dependent 2023), American Heart Association 2013, NCCN MDS v2.2025","status":""}

Policy Summary

PayerCigna

PolicyChelating Agents -Iron Chelators (Oral) Prior Authorization Policy

Policy CodePolicy N/A

Change TypeAnnual revision (verbiage update) & review date update

Effective Date

Next Review Date

On This Page

Exjade	deferasirox tablets for suspension (Novartis, generic)
Jadenu	deferasirox tablets (Novartis, generic)
Jadenu Sprinkle	deferasirox oral granules (Novartis, generic)
Ferriprox (tablets)	deferiprone tablets (Chiesi, generic)
Ferriprox (oral solution)	deferiprone oral solution (Chiesi)

OpenPayer

Chelating Agents -Iron Chelators (Oral) Prior Authorization Policy

Coverage Summary

Deferasirox (Exjade, Jadenu, Jadenu Sprinkle) — Coverage Criteria

Deferiprone (Ferriprox tablets and oral solution) — Coverage Criteria

Conditions Not Covered / Experimental Uses

Coding

Provider Actions and Prior Authorization Requirements

Background and Evidence

Definitions

Revision History