ModifiedCentenePolicy CP PHAR.145

Deferasirox (Exjade, Jadenu) — Medical Necessity and Coverage Criteria

Policy governing medical necessity criteria, prior authorization, and coverage rules for deferasirox (Exjade, Jadenu) for treatment of chronic iron overload including transfusional hemosiderosis and non‑transfusion‑dependent thalassemia (NTDT) across Centene lines of business.

Policy Summary

PayerCentene

PolicyDeferasirox (Exjade, Jadenu) — Medical Necessity and Coverage Criteria

Policy CodePolicy CP PHAR.145

Change TypeMultiple material revisions (continuation response, cardiac T2* threshold, generic-use clarification)

Effective Date11.01.15

Next Review Date

Key ActionSubmit chart notes and recent lab results (serum ferritin and/or LIC) to document meeting approval criteria and response for continuation.

SourceLink

POLICY UPDATE CHANGES

Added Parkinson disease to section III (diagnoses/indications for which coverage is NOT authorized) with rationale in Appendix E.

For continuation of therapy in chronic transfusional iron overload added requirement that member is responding positively to therapy as evidenced by a decrease in serum ferritin compared to pretreatment baseline and clarified concurrent chelation allowed only with excess cardiac iron (cardiac T2* threshold) or iron-induced cardiomyopathy; added requirement to use generic deferasirox for continuation.

Specified dose maxima for Exjade and Jadenu for transfusional and NTDT indications and referenced Appendix D for dose rounding.

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

Policy is medically necessary for all deferasirox products not only Exjade/Jadenu.

Added Parkinson disease to section III with rationale in Appendix E.

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

Clarified continuation therapy template changes applied to other diagnoses/indications and continued therapy section.

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Coverage Criteria

Initial Therapy — Chronic Iron Overload due to Blood Transfusions

Covered when ALL of the following are met

Transfusional initial: 1) Diagnosis of chronic iron overload due to blood transfusions; 2) Age ≥ 2 years; 3) Member must use generic deferasirox unless contraindicated or clinically significant adverse effects are experienced; 4) Serum ferritin level > 1,000 mcg/L; 5) Estimated glomerular filtration rate (eGFR) ≥ 40 mL/min/1.73 m2; 6) Platelet count ≥ 50 x 10^9/L; 7) No severe hepatic impairment (Child‑Pugh C); 8) Therapy does not include concurrent use of other iron chelators unless member has excess cardiac iron as evidenced by cardiac T2* (mT2*) < 10 ms or iron‑induced cardiomyopathy; 9) Dose does not exceed Exjade 40 mg/kg/day or Jadenu 28 mg/kg/day (see Appendix D for dose rounding).see node text

Provider must submit supporting documentation

Initial Therapy — Chronic Iron Overload due to NTDT

Covered when ALL of the following are met

NTDT initial: 1) Diagnosis of chronic iron overload due to non‑transfusion‑dependent thalassemia (NTDT); 2) Age ≥ 10 years; 3) Documentation of serum ferritin level > 300 mcg/L; 4) Documentation of liver iron concentration (LIC) ≥ 5 mg Fe/g dry weight; 5) Member must use generic deferasirox unless contraindicated or clinically significant adverse effects are experienced; 6) Therapy does not include concurrent use of other iron chelators; 7) No severe hepatic impairment (Child‑Pugh C); 8) Platelet count ≥ 50 x 10^9/L; 9) Estimated glomerular filtration rate (eGFR) ≥ 40 mL/min/1.73 m2; 10) Dose does not exceed Exjade 20 mg/kg/day or Jadenu 14 mg/kg/day (see Appendix D for dose rounding).see node text

Provider must submit LIC and ferritin documentation

Continued Therapy — Chronic Iron Overload due to Blood Transfusions

Covered when ALL of the following are met for continued therapy

Transfusional continuation: 1) Member is currently receiving medication via Centene benefit or previously met initial approval criteria; 2) Member is responding positively to therapy as evidenced by a decrease in serum ferritin compared to pretreatment baseline; 3) Current documentation (within the past 30 days) shows serum ferritin ≥ 500 mcg/L; 4) Member must use generic deferasirox 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 cardiac T2* (mT2*) below threshold or iron‑induced cardiomyopathy; 6) Dose does not exceed Exjade 40 mg/kg/day or Jadenu 28 mg/kg/day;see node text

Approval duration: 12 months; documentation of ferritin trend vs pretreatment baseline required

Continued Therapy — Chronic Iron Overload due to NTDT

Covered when ALL of the following are met for continued therapy

NTDT continuation: 1) Member is currently receiving medication via Centene benefit or previously met initial approval criteria; 2) If member has received ≥ 6 months of deferasirox, current documentation shows either (a) serum ferritin ≥ 300 mcg/L (within past 30 days) OR (b) LIC ≥ 3 mg Fe/g dry weight (within past 90 days); 3) Member must use generic deferasirox unless contraindicated or clinically significant adverse effects are experienced; 4) Therapy does not include concurrent use of other iron chelators; 5) Dose does not exceed Exjade 20 mg/kg/day or Jadenu 14 mg/kg/day;see node text

Approval duration: 12 months

Continuation Therapy

Covered when ALL of the following are met for continuation therapy in chronic iron overload due to transfusions:

Response: Member is responding positively to therapy as evidenced by a decrease in serum ferritin levels compared to pretreatment baseline.serum ferritin decrease vs baseline

Added in 3Q 2023

Concurrent chelation bypass: Concurrent use of other iron chelators is allowable if member has excess cardiac iron as evidenced by cardiac T2* below threshold.mT2* < 10 ms

Threshold revised in 3Q 2025 per TIF guidelines

Product scope: Policy applies to all deferasirox products (not limited to brand formulations).

Clarified 3Q 2024

Parkinson's disease is specifically listed as a diagnosis for which coverage is NOT authorized under this policy. The rationale for this exclusion is documented in Appendix E and cites clinical trial data associating an iron chelator with worsening parkinsonism. Requests for treatment of Parkinson's disease with deferasirox should be denied unless there is sufficient supporting documentation as allowed under the applicable off‑label use policies or evidence‑of‑coverage documents.

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

For Medicaid members, state Medicaid coverage provisions take precedence when they conflict with the coverage provisions in this clinical policy. Providers should consult the relevant state Medicaid manual for any state‑specific coverage rules that supersede this policy.

Use of deferasirox for indications that are not FDA‑approved and are not specifically listed in this policy is considered not authorized unless the provider supplies sufficient documentation of efficacy and safety per the applicable off‑label use policies or evidence‑of‑coverage documents. Off‑label requests must be supported by the referenced off‑label policies and robust clinical evidence to be considered.

Continuation of deferasirox for chronic iron overload due to transfusions requires documented positive response to therapy. Specifically, failure to show a decrease in serum ferritin compared to the pretreatment baseline may render continuation of therapy not medically necessary and may result in denial of coverage.

Coding, Thresholds and Limits

Policy identifiermixed

CP PHAR.145

Policy reference number (internal)

Serum ferritin and LIC thresholds

Transfusional initial thresholdSerum ferritin >1000 mcg/L

NTDT initial thresholdsSerum ferritin >300 mcg/L AND LIC \u2265 5 mg Fe/g dry weight

NTDT continuation thresholdAfter \u22656 months, LIC \u2265 3 mg Fe/g dry weight OR serum ferritin \u2265 300 mcg/L (within specified windows)

Renal function threshold

Renal function contraindicationEstimated GFR <40 mL/min/1.73 m2

Required renal check for approvaleGFR must be >=40 mL/min/1.73 m2 at time of request for initial therapy

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required. Provider must submit documentation (such as chart notes, lab results, or other clinical information) supporting that the member meets all initial approval criteria prior to coverage.

Applies to all deferasirox products (generic and branded).
Prior authorization required for initial and continuation requests.

Denial Risk

Continuation Response Requirement

Provider must demonstrate positive response to therapy for continuation. For chronic iron overload due to blood transfusions, documentation must show a decrease in serum ferritin compared to the pretreatment baseline. Failure to show response (no decrease in serum ferritin) may preclude continuation of therapy.

Current documentation (within the past 30 days) of serum ferritin as specified in continuation criteria.

Background

Deferasirox is an oral iron chelator indicated for treatment of chronic iron overload due to repeated blood transfusions and for selected patients with non‑transfusion‑dependent thalassemia (NTDT). The policy defines laboratory thresholds and monitoring requirements for use: initial and continuation approvals depend on serum ferritin and liver iron concentration values, and safety monitoring includes renal and hepatic function and platelet counts. Boxed warnings and contraindications (for example, significantly reduced eGFR and severe hepatic impairment) are noted in the appendices and inform treatment eligibility and monitoring.

Definitions and Abbreviations

Liver iron concentration (LIC) definition

Definition (LIC)Liver iron concentration (LIC) expressed as mg Fe per g dry weight

Measurement contextLIC is used to assess hepatic iron burden for NTDT initial and continuation criteria

Referenced appendicesLIC abbreviation and units appear in Appendix A (Abbreviations) and are required in documentation

Non‑transfusion‑dependent thalassemia (NTDT) definition

Definition (NTDT)Non‑transfusion‑dependent thalassemia (NTDT): thalassemia syndromes not regularly requiring transfusions; policy applies to NTDT patients meeting age and LIC/ferritin thresholds

Age requirementInitial NTDT therapy limited to patients aged >=10 years

Initial Therapy

Initial therapy criteria per indication

Initial nodes: See individual indication-specific initial approval criteria: transfusional iron overload (age ≥2 years, serum ferritin >1,000 mcg/L, eGFR ≥40 mL/min/1.73 m2, platelet count ≥50 x10^9/L, no Child‑Pugh C, generic deferasirox required unless contraindicated, dose limits Exjade ≤40 mg/kg/day or Jadenu ≤28 mg/kg/day) and NTDT (age ≥10 years, serum ferritin >300 mcg/L, LIC ≥5 mg Fe/g dw, eGFR ≥40 mL/min/1.73 m2, platelet count ≥50 x10^9/L, no Child‑Pugh C, generic deferasirox required unless contraindicated, dose limits Exjade ≤20 mg/kg/day or Jadenu ≤14 mg/kg/day).

Continuation Therapy

Continuation therapy — per-indication continuation criteria

Continuation nodes: See indication-specific continuation criteria: transfusional continuation requires active therapy or prior initial approval, evidence of response (decrease in serum ferritin vs pretreatment baseline), current ferritin ≥500 mcg/L, generic deferasirox use unless contraindicated, cardiac iron criteria for concurrent chelation, dose limits Exjade ≤40 mg/kg/day or Jadenu ≤28 mg/kg/day; NTDT continuation requires active therapy or prior initial approval, after ≥6 months requires serum ferritin ≥300 mcg/L (within 30 days) OR LIC ≥3 mg Fe/g dw (within 90 days), generic deferasirox use unless contraindicated, no concurrent chelators, dose limits Exjade ≤20 mg/kg/day or Jadenu ≤14 mg/kg/day; approval duration 12 months for both.

Continuation Therapy for Chronic Iron Overload

Continuation of deferasirox therapy for chronic iron overload due to blood transfusions is covered when response and product-use requirements are met.

Response evidence: Documentation of decreased serum ferritin compared to pretreatment baseline is provided to demonstrate response to therapy.

Step Therapy and Product Use

Step	Requirement	Notes
1
Use generic deferasirox as the preferred initial agent
Member must use generic deferasirox unless contraindicated or clinically significant adverse effects occur; concurrent use of other iron chelators is generally not permitted

Step	Requirement	Notes
1
Continuation therapy must use the generic deferasirox product
For continued therapy members must be responding (decrease in serum ferritin vs pretreatment baseline) and use generic deferasirox unless contraindicated; added requirement for generic use for continuation

Step Therapy

Generic‑first and Concurrent Therapy Rules

Generic-first requirement: members must use generic deferasirox for initial and continued therapy unless contraindicated or the member experiences clinically significant adverse effects. Concurrent use of other iron chelators is not allowed except when member has excess cardiac iron or iron‑induced cardiomyopathy.

If contraindication or clinically significant adverse effect to generic product is documented, branded product may be considered.
Concurrent chelation is allowed only when cardiac T2* < 10 ms or documented iron‑induced cardiomyopathy (per 3Q 2025 update).