CurrentAvMedPolicy N/A

Deferasirox (Exjade, Jadenu) prior authorization and step-edit

Form and criteria for prior authorization and step-edit requests for deferasirox formulations (Exjade, Jadenu) for AvMed members; applies to prescribers requesting coverage through AvMed specialty pharmacy processes.

Policy Summary

PayerAvMed

PolicyDeferasirox (Exjade, Jadenu) prior authorization and step-edit

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionFax a signed prescriber request form with complete member, prescriber, drug, dosing, diagnosis, and weight information to 1-305-671-0200.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 moInitial authorization duration

12 moReauthorization duration

≥2Min age (transfusional)

≥10Min age (NTDT)

Exjade 40 / Jadenu 28Dosing limits

Coverage Criteria for Deferasirox (Exjade, Jadenu)

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Initial: Transfusional iron overload

Covered when ALL of the following are met for transfusional iron overload (initial authorization 6 months):

Transfusional iron overload initial criteria: Member is ≥2 years of age; diagnosis of transfusional hemosiderosis (defined as transfusion of ≥100 mL/kg packed red blood cells, approximately 20 units for a 40 kg patient); serum ferritin levels consistently >1,000 mcg/L (submit ferritin labs within the last 30 days); medication will be dosed according to FDA recommendations for age, weight, eGFR and serum ferritin levels; member has an eGFR ≥40 mL/min/1.73 m2; baseline liver function labs (ALT, AST, bilirubin) have been evaluated; if requesting brand Jadenu or Exjade, documentation of trial and intolerable life‑endangering adverse event with generic deferasirox must be submitted.see text

All checked items must be supported by documentation

Initial: Non‑transfusion‑dependent thalassemia

Covered when ALL of the following are met for non‑transfusion‑dependent thalassemia (initial authorization 6 months):

Non-transfusion-dependent thalassemia initial criteria: Member is ≥10 years of age with a diagnosis of non‑transfusion‑dependent thalassemia syndrome; liver iron concentration (LIC) ≥5 mg Fe/g dry weight documented by current liver biopsy, MRI, or other FDA‑approved test; serum ferritin >300 mcg/L with two serum ferritin labs taken at least 1 month apart within the last 3 months; medication will be dosed according to FDA recommendations for age, weight, eGFR, LIC and serum ferritin levels; member has an eGFR ≥40 mL/min/1.73 m2; platelet count ≥50 x 10^9/L; baseline liver function labs (ALT, AST, bilirubin) have been evaluated; if requesting brand Jadenu or Exjade, documentation of trial and intolerable life‑endangering adverse event with generic deferasirox must be submitted; serum ferritin has decreased from baseline or last approval (submit current ferritin labs); if ferritin <500 mcg/L or LIC <3 mg Fe/g dw, therapy will be temporarily discontinued; if ferritin <300 mcg/L, therapy will be interrupted and LIC obtained.see text

All checked items must be supported by documentation

Reauthorization

Reauthorization criteria (12 months) — applies to all diagnoses:

Reauthorization criteria: Ongoing monitoring: liver function tests (ALT, AST, bilirubin) continue to be monitored; platelet levels remain ≥50 x 10^9/L; for non‑transfusion‑dependent thalassemia, liver iron concentration (LIC) continues to be monitored according to guideline recommendations; if requesting brand Jadenu or Exjade, documentation of prior trial and intolerable life‑endangering adverse event with generic deferasirox must be submitted; provide required current labs and documentation to support continued therapy.ongoing labs as specified

All checked items must be supported by documentation. Reauthorization period is 12 months.

Use of samples to initiate therapy does not satisfy the step-edit or prior authorization requirements and therefore cannot be used in lieu of documented trial history or formal authorization evidence. Requests relying on sample use as the start of therapy should include the required supporting documentation (labs, diagnostics, chart notes) described elsewhere in the form because sample use alone does not meet the plan's preauthorization criteria.

Initial Therapy Rules

Initial therapy

Initial therapy rules per indication (initial authorization 6 months):

Indication selection: Initial authorization is 6 months for indicated diagnoses (transfusional iron overload and non‑transfusion‑dependent thalassemia) with indication‑specific criteria as detailed in the policy. Medication must be dosed per FDA recommendations considering age, weight, eGFR, LIC (when applicable), and serum ferritin.6 months

See per‑indication initial criteria for required documentation

Continuation / Maintenance Therapy

Continuation therapy

Continuation/maintenance therapy requirements:

Continuation: Serum ferritin has decreased from baseline or last approval (submit current ferritin labs); ongoing monitoring of liver function tests and platelet counts per policy; LIC monitoring for non‑transfusion‑dependent thalassemia as recommended by guidelines; if ferritin or LIC fall below specified thresholds, therapy is paused or interrupted per protocol (see initial criteria for thresholds).see text

Reauthorization period is 12 months

Step Therapy Requirements

Step	Requirement	Failure criteria / exception
1	Mandatory trial of generic deferasirox (generic formulation) prior to approval of brand products (Jadenu or Exjade).	If prescriber documents an intolerable life‑threatening adverse event to generic deferasirox, brand product may be considered — documentation must be submitted.

Quantity Limits and Dosing Caps

inv-19: deferasirox (Exjade) — maximum dosing limit

Drugdeferasirox (Exjade)

Maximum daily dose40 mg/kg/day

ContextRecommended dosing limit per AvMed prior authorization form

inv-20: deferasirox (Jadenu) — maximum dosing limit

Drugdeferasirox (Jadenu)

Maximum daily dose28 mg/kg/day

ContextRecommended dosing limit per AvMed prior authorization form

Coding, Labs, and Diagnostic Criteria

Diagnosis codes (provider-entered)ICD-10

ICD code (provider to supply)

ICD-10 diagnosis code field on form - provider supplies applicable code

inv-06: Serum ferritin — thresholds for transfusional iron overload and non-transfusion-dependent thalassemia; submission requirements.

Transfusional iron overload thresholdSerum ferritin consistently >1,000 mcg/L (submit serum ferritin labs done within the last 30 days)

Non‑transfusion‑dependent thalassemia thresholdSerum ferritin >300 mcg/L (submit 2 serum ferritin labs taken at least 1 month apart from within the last 3 months)

Submission requirementFor non‑transfusion‑dependent thalassemia submit two ferritin labs at least 1 month apart within the last 3 months; for transfusional overload submit ferritin within 30 days

inv-07: Liver iron concentration (LIC) — threshold for initiation in non-transfusion-dependent thalassemia and monitoring guidance.

LIC threshold for initiation (NTDT)Liver iron concentration (LIC) ≥ 5 mg Fe/g dry weight (document with liver biopsy, MRI, or other FDA‑approved test)

Monitoring guidanceFor non‑transfusion‑dependent thalassemia, LIC continues to be monitored according to guideline recommendations; if LIC <3 mg Fe/g dw consider temporarily discontinuing therapy as specified

DocumentationSubmit current liver biopsy, MRI or other FDA‑approved test to document LIC

inv-08: eGFR — renal function requirement (≥40 mL/min/1.73 m2).

ParametereGFR

RequirementMember must have an eGFR ≥ 40 mL/min/1.73 m2

ContexteGFR requirement applies to both transfusional iron overload and non‑transfusion‑dependent thalassemia initial criteria

inv-09: Platelet count — hematologic threshold (≥50 x 10^9 /L).

ParameterPlatelet count

RequirementMember must have platelet levels ≥ 50 x 10^9 /L

ContextPlatelet threshold specified for non‑transfusion‑dependent thalassemia and reauthorization monitoring

Provider Submission, Documentation, and Billing Actions

Prior Authorization

Prior Authorization Required

Prior Authorization Required: The prescribing physician must sign and clearly print their name (preprinted stamps not valid) on the prior authorization request form. The completed form and all supporting documentation must be faxed to 1-305-671-0200. Office staff may complete other fields, but missing, incorrect, or illegible information (including phone/fax numbers) can delay processing.

Fax destination: 1-305-671-0200
Prescriber signature required (no preprinted stamps)
Include accurate phone and fax numbers

Denial Risk

Incomplete Documentation Risk

Incomplete or missing information on the request form or absent supporting documentation (labs, diagnostics, chart notes) may result in delays or denial of authorization. To avoid processing delays, ensure all required fields on the form are complete and legible and include the member AvMed ID, date of birth, prescriber NPI, contact information, and relevant clinical documentation.

Missing/incorrect/illegible information can delay authorization
Ensure member AvMed #, DOB, prescriber NPI, and contact info are included
Attach all relevant chart notes and diagnostics to support each checked criterion

Step Therapy

Brand Product Step/Edit Requirement

Brand Product Step/Edit Requirement: When requesting brand Jadenu or Exjade, submit documentation that the member has tried generic deferasirox and experienced an intolerable, life‑endangering adverse event (medical necessity for brand). If the brand is non‑formulary under the member's plan, additional medical necessity documentation may be required.

Documentation of trial with generic deferasirox and details of intolerable life‑threatening adverse event must be submitted when requesting Jadenu or Exjade (brand)
If drug is non‑formulary, include medical necessity justification

Documentation Required

Required Supporting Clinical Documentation

Required Supporting Clinical Documentation: Provide labs and diagnostics as specified for the indication and authorization type. For transfusional hemosiderosis: submit serum ferritin labs taken within the last 30 days showing consistently >1,000 mcg/L. For non‑transfusion‑dependent thalassemia initial requests: submit LIC documentation (liver biopsy, MRI or FDA‑approved test) showing LIC ≥ 5 mg Fe/g dw and two serum ferritin labs at least 1 month apart within the last 3 months; include current ferritin for trend assessment. For all requests include baseline and ongoing monitoring labs (ALT, AST, bilirubin), platelets, weight and date obtained, and eGFR. Failure to provide required labs (with dates) may result in denial.

Transfusional hemosiderosis: serum ferritin labs within 30 days (>1,000 mcg/L)
Non‑transfusion‑dependent thalassemia initial: LIC documentation (biopsy/MRI/FDA‑approved test) ≥5 mg Fe/g dw; two ferritin labs ≥1 month apart within 3 months
Include baseline and ongoing liver function tests (ALT, AST, bilirubin), platelets (≥50 x10^9/L where required), eGFR (≥40 mL/min/1.73 m2), weight and date obtained

Definitions

inv-15: transfusional hemosiderosis definition — transfusional iron overload defined (≥100 mL/kg packed RBCs, ~20 units for 40 kg).

DefinitionTransfusional hemosiderosis (transfusional iron overload)

Quantitative definitionTransfusion of ≥100 mL/kg of packed red blood cells

Approximate units exampleApproximately 20 units for a 40 kg patient

Background

Deferasirox is an oral iron chelator indicated to reduce iron overload from chronic blood transfusions (transfusional hemosiderosis) and to reduce iron burden in non‑transfusion‑dependent thalassemia syndromes. Therapy requires baseline and ongoing monitoring because of potential hepatic, renal, and hematologic toxicities; monitoring elements include serum ferritin, liver iron concentration (LIC), liver function tests (ALT, AST, bilirubin), renal function (eGFR), and platelet counts. Recommended maximum dosing limits are Exjade 40 mg/kg/day and Jadenu 28 mg/kg/day.

Site of Care and Dispensing

Note

Specialty pharmacy dispensing (Proprium Rx) and plan/formulary considerations

Deferasirox will be dispensed through AvMed's Specialty Pharmacy (Proprium Rx); plan benefit and formulary status may vary by plan and non‑formulary drugs may require medical necessity documentation.

Medication provided by Specialty Pharmacy - Proprium Rx.
If drug is non‑formulary under the member's plan, submit documentation of medical necessity.