Elzonris (tagraxofusp-erzs) — coverage criteria for BPDCN
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Criteria governing medical-benefit coverage and prior authorization for Elzonris (tagraxofusp-erzs) for treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN), including eligibility, dosing prerequisites, and monitoring requirements for providers and payers.
Updated criteria to reflect NCCN 2A recommendations for place in therapy and removed ECOG score requirement.
Wording and formatting criteria updates; coding reviewed with no changes.
Coverage and Medical Necessity Criteria
Approval Criteria
Requests for Elzonris (tagraxofusp-erzs) may be approved if the following criteria are met:
Either pediatric age <19 OR diagnosis of BPDCN qualifies to proceed to further criteria
Place in therapy aligned with NCCN 2A
Single-agent use required
Per NCCN 2A and product safety guidance
Requests for Elzonris (tagraxofusp-erzs) will be declined when the specified coverage criteria are not met. Coverage requires that the individual either be <19 years of age or have a diagnosis of blastic plasmacytoid dendritic cell neoplasm (BPDCN), that the drug is used in one of the approved places in therapy (intensive remission induction; treatment until progression if a complete response is achieved after induction; or relapsed/refractory disease if not previously used), that it is administered as monotherapy, and that the individual has a baseline serum albumin of ≥ 3.2 g/dL prior to initial therapy. Requests that do not meet these conditions or that propose Elzonris for other indications will not be approved.
Elzonris coverage is limited to the scenarios described above. Use of Elzonris for indications other than pediatric patients (<19 years) or for diagnoses other than BPDCN does not meet the criteria. Additionally, coverage is limited to single-agent (monotherapy) use in the specified places in therapy per NCCN 2A (induction, maintenance until progression after CR, or relapsed/refractory if not previously used); combinations or unapproved places in therapy are excluded.
Covered Regimens and Place in Therapy
| Regimen | Indication / Place in Therapy | Monotherapy? | Baseline albumin requirement | Coverage status |
|---|---|---|---|---|
| Elzonris (tagraxofusp-erzs) monotherapy per NCCN 2A | ||||
| For intensive remission induction therapy; OR treatment until progression if complete response (CR) achieved after induction; OR relapsed/refractory BPDCN (if not previously used) | ||||
| Yes — single-agent use required | ||||
| Baseline serum albumin ≥ 3.2 g/dL prior to initial therapy | ||||
| Covered with criteria |
Billing and Diagnosis Codes
| J9269 | Injection, tagraxofusp-erzs, 10 micrograms [Elzonris] |
| C86.40 | Blastic NK-cell lymphoma not having achieved remission |
| Z51.11 | Encounter for antineoplastic chemotherapy |
Provider Requirements, Prior Authorization, and Documentation
Prior Authorization Required
Prior authorization is required for Elzonris (tagraxofusp-erzs). Submit a prior authorization request before initiating therapy when the patient is <19 years OR has a diagnosis of BPDCN and will receive Elzonris as monotherapy in an NCCN 2A–recommended place in therapy (induction for intensive remission, treatment until progression if CR achieved after induction, or for relapsed/refractory disease if not previously used).
- Affected product: Elzonris (tagraxofusp-erzs)
- Affected population: patients <19 years OR patients with BPDCN using Elzonris as monotherapy per NCCN 2A places in therapy
No Step Therapy Specified
No step therapy (prior step) requirements are specified beyond the clinical place in therapy and single‑agent (monotherapy) use required per NCCN 2A. There is no requirement to try an alternative agent before Elzonris when the listed coverage criteria are met.
Required Documentation
Document the following in the prior authorization submission: baseline serum albumin (>= 3.2 g/dL), evidence of BPDCN diagnosis (clinical notes, pathology report, or relevant ICD-10 codes), intent and place in therapy per NCCN 2A (induction for intensive remission, treatment until progression if CR achieved after induction, or relapsed/refractory disease if not previously used), and confirmation that Elzonris will be used as monotherapy. Include relevant baseline cardiac assessment and any prior treatments if applicable.
- Baseline serum albumin value (>= 3.2 g/dL)
- Documentation of BPDCN diagnosis (pathology report, clinical documentation, or ICD-10)
- Specify place in therapy/intent per NCCN 2A (induction, maintenance until progression after CR, or relapsed/refractory)
- Statement that Elzonris will be administered as monotherapy
- Baseline cardiac assessment and prior treatment history when applicable
Denial Trigger
Requests will be denied when the listed criteria are not fully met (patient not <19 years and no BPDCN diagnosis; not being used as monotherapy; not used in an NCCN 2A–recommended place in therapy; baseline serum albumin < 3.2 g/dL at initiation). Requests for indications other than those explicitly listed will not be approved.
Definitions and Clinical Terms
Background and Drug Information
Elzonris (tagraxofusp-erzs) is a CD123-directed fusion protein that links interleukin-3 to a truncated diphtheria toxin to target CD123-expressing malignant cells. It is indicated for treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN), an aggressive marrow/blood malignancy that often involves skin and lymph nodes and may present as or progress to acute leukemia. The product carries important safety considerations including a risk of capillary leak syndrome and requires baseline and on‑treatment monitoring, including verification of a baseline serum albumin of ≥ 3.2 g/dL prior to initial therapy.
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