CurrentMass General Brigham Health PlanPolicy N/A

Exjade (deferasirox) / Jadenu (deferasirox) prior authorization

Defines prior authorization requirements for deferasirox products (Exjade, Jadenu, generics) under the pharmacy benefit for Mass General Brigham Health Plan commercial/exchange members; applies to specialty pharmacy dispensing. Affects prescribers and pharmacists requesting coverage.

Policy Summary

PayerMass General Brigham Health Plan

PolicyExjade (deferasirox) / Jadenu (deferasirox) prior authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJan 1, 2024

Next Review DateN/A

Key ActionSubmit prior authorization with diagnosis and pretreatment labs (serum ferritin and LIC for NTDT) and ensure specialty pharmacy dispensing.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsApproval duration

>=1000Ferritin threshold (transfusional)

>=300Ferritin threshold (NTDT)

>=5LIC requirement (NTDT)

SpecialtyDispensing

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Coverage Criteria for Deferasirox (Exjade, Jadenu)

Initial Therapy

Authorization may be granted when ALL of the following are met for the indicated condition:

New-to-plan continuation: Member new to the plan currently receiving the requested medication (excluding samples or manufacturer patient assistance programs)

Allows continuation for members already on therapy

Transfusional iron overload initial: Member has a diagnosis of chronic iron overload due to blood transfusions AND submission of documentation that shows pretreatment serum ferritin level is consistently greater than 1000 mcg/L AND dose will not exceed Exjade (deferasirox tablet for suspension) 40 mg/kg/day or Jadenu (deferasirox) 28 mg/kg/daypretreatment serum ferritin >1000 mcg/L; dose limits as stated

NTDT initial: Member has a diagnosis of non-transfusion dependent thalassemia syndromes AND submission of documentation that shows pretreatment serum ferritin level is greater than 300 mcg/L AND submission of documentation that shows pretreatment liver iron concentration (LIC) >= 5 mg Fe/g dry weight AND dose will not exceed Exjade 20 mg/kg/day or Jadenu 14 mg/kg/daypretreatment ferritin >300 mcg/L; LIC >=5 mg Fe/g dw; dose limits as stated

Hereditary hemochromatosis initial: Member has a diagnosis of hereditary hemochromatosis AND phlebotomy is not an option (e.g., poor venous access, poor candidate due to underlying medical disorders) OR member had an unsatisfactory response to phlebotomy

Allows chelation when phlebotomy unsuitable or ineffective

Reauthorization / Continued Treatment

Reauthorization criteria — ALL must be met:

Clinical benefit: Member is experiencing benefit from therapy as evidenced by a decrease in serum ferritin levels compared to pretreatment baseline

Ferritin floor for transfusional overload: For chronic iron overload due to blood transfusions (transfusional iron overload), serum ferritin level is not consistently below 500 mcg/L>= 500 mcg/L (not consistently below)

Prevents oversuppression of iron stores

Ferritin floor for NTDT: For chronic iron overload in patients with non-transfusion dependent thalassemia syndromes, serum ferritin level is not consistently below 300 mcg/L>= 300 mcg/L (not consistently below)

Prevents oversuppression of iron stores

For members who are not currently receiving deferasirox, prior authorization will only be considered when the request meets the policy’s specified initial clinical criteria for the indicated condition. Members new to the plan who are already receiving the requested medication may be authorized to continue therapy provided the drug was not obtained solely as samples or through a manufacturer patient assistance program; document current outpatient therapy when submitting the request.

Deferasirox will not be authorized for uses outside the listed, indication-specific criteria. Specifically, coverage for non-transfusion dependent thalassemia (NTDT) requires pretreatment laboratory confirmation of serum ferritin > 300 mcg/L and a pretreatment liver iron concentration (LIC) ≥ 5 mg Fe/g dry weight. Requests that do not document these thresholds, or that propose use for indications not described in the FDA-approved criteria, do not meet the policy’s authorization requirements.

Coding, Lab Thresholds, and Dosing

Neutral — no specific codes providedmixed

NDC/CPT not specified

The document designates pharmacy benefit specialty dispensing but does not list specific billing codes.

Serum ferritin thresholds — transfusional and NTDT values

Transfusional iron overload pretreatment ferritinConsistently >1000 mcg/L (documentation of pretreatment serum ferritin >1000 mcg/L required)

NTDT pretreatment ferritin>300 mcg/L (documentation of pretreatment serum ferritin >300 mcg/L required)

Reauthorization ferritin floor — transfusionalSerum ferritin not consistently below 500 mcg/L for continued treatment

Reauthorization ferritin floor — NTDTSerum ferritin not consistently below 300 mcg/L for continued treatment

Liver iron concentration (LIC) requirement for NTDT

LIC requirement for NTDT initial authorizationAt least 5 mg Fe/g dry weight (LIC >= 5 mg Fe/g dw) required for NTDT patients

Provider Actions, Documentation, and Authorization

Prior Authorization

Prior authorization and specialty pharmacy dispensing required

Prior authorization is required under the pharmacy benefit for deferasirox products (Exjade, Jadenu); this medication is designated specialty and must be filled at a contracted specialty pharmacy. Authorization may be granted for members new to the plan who are currently receiving the medication (excluding samples or manufacturer patient assistance) or for new starts who meet the clinical criteria for an indicated condition.

Medication designated specialty — must be filled at a contracted specialty pharmacy.
Prior authorization required under the pharmacy benefit.
Continuation allowed for members new to the plan who are currently receiving the medication (excluding samples or manufacturer patient assistance).

Step Therapy

Step therapy — none required

No step therapy requirements are listed in this policy.

Definitions

NTDT — Non-transfusion-dependent thalassemia definition and policy implications

DefinitionNon-transfusion-dependent thalassemia (NTDT): thalassemia syndromes not requiring regular transfusions but with iron overload

Pretreatment requirements for coverageDiagnosis of NTDT plus pretreatment serum ferritin >300 mcg/L and LIC >=5 mg Fe/g dw required for authorization

Age criterionFDA indication applies to patients 10 years of age and older

DocumentationSubmit pretreatment ferritin values and LIC in mg Fe/g dry weight to support request

Transfusional iron overload — definition and pretreatment requirements

DefinitionTransfusional iron overload (transfusional hemosiderosis): chronic iron accumulation due to repeated blood transfusions

Background

Deferasirox is an oral iron chelator approved for treatment of chronic iron overload. The policy aligns coverage with the FDA‑approved indications: for transfusional iron overload (patients ≥2 years) and for chronic iron overload in non‑transfusion dependent thalassemia (NTDT) (patients meeting age and LIC/ferritin criteria). For transfusional iron overload the policy requires documentation of a diagnosis of chronic iron overload due to transfusions and a pretreatment serum ferritin consistently >1000 mcg/L; dosing limits are set (Exjade ≤ 40 mg/kg/day, Jadenu ≤ 28 mg/kg/day). For NTDT the policy requires a pretreatment serum ferritin >300 mcg/L and LIC ≥ 5 mg Fe/g dry weight, with maximum doses (Exjade ≤ 20 mg/kg/day, Jadenu ≤ 14 mg/kg/day).