CurrentAnthemPolicy CC-0088

Elzonris (tagraxofusp-erzs) — coverage criteria for BPDCN

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.

Policy Summary

PayerAnthem

PolicyElzonris (tagraxofusp-erzs) — coverage criteria for BPDCN

Policy CodePolicy CC-0088

Change TypeRevised — wording/formattingprior material change removed ECOG requirement

Effective Date03/26/2026

Next Review Date

Key ActionObtain prior authorization and document baseline serum albumin >= 3.2 g/dL and evidence of BPDCN when requesting Elzonris as monotherapy per NCCN 2A.

SourceLink

POLICY UPDATE CHANGES

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.

53%CLS incidence

3.2 g/dLBaseline albumin

NCCN 2ACompendia category

J9269HCPCS

Coverage and Medical Necessity Criteria

Approval Criteria

Requests for Elzonris (tagraxofusp-erzs) may be approved if the following criteria are met:

Age or Diagnosis: I. Individual is under 19 years of age; OR II. Individual has a diagnosis of blastic plasmacytoid dendritic cell neoplasm (BPDCN)

Either pediatric age <19 OR diagnosis of BPDCN qualifies to proceed to further criteria

Place in therapy: III. Using in one of the following ways (NCCN 2A): A. For intensive remission induction therapy; OR B. Treatment until progression if complete response (CR) achieved after induction; OR C. Relapsed/refractory disease, if not already used

Place in therapy aligned with NCCN 2A

Monotherapy: IV. Individual is using as monotherapy

Single-agent use required

Policy Summary

PayerAnthem

PolicyElzonris (tagraxofusp-erzs) — coverage criteria for BPDCN

Policy CodePolicy CC-0088

Change TypeRevised — wording/formattingprior material change removed ECOG requirement

Effective Date03/26/2026

Next Review Date

Key ActionObtain prior authorization and document baseline serum albumin >= 3.2 g/dL and evidence of BPDCN when requesting Elzonris as monotherapy per NCCN 2A.

SourceLink

On This Page

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Laboratory prerequisite: V. At initial therapy, individual has a baseline serum albumin of 3.2 g/dL or higher>= 3.2 g/dL

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

HCPCSHCPCS

J9269

Injection, tagraxofusp-erzs, 10 micrograms [Elzonris]

ICD-10 DiagnosisICD-10

C86.40	Blastic NK-cell lymphoma not having achieved remission
Z51.11	Encounter for antineoplastic chemotherapy

Baseline serum albumin

Required baseline serum albumin>= 3.2 g/dL prior to initial Elzonris (tagraxofusp-erzs) therapy

Monitoring frequencyMeasure serum albumin prior to each dose and as clinically indicated during treatment

Purpose of thresholdMitigates risk of capillary leak syndrome (CLS) and aligns with NCCN 2A and product safety guidance

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

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

Step 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.

Documentation Required

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 Risk

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

Capillary Leak Syndrome (CLS)

DefinitionTreatment-emergent Capillary Leak Syndrome (CLS) characterized by hypoalbuminemia, edema, weight gain, hypotension, hepatic injury and potential fatality as reported with Elzonris

Incidence in trialsOverall incidence 53% (Grade 1–2: 43%; Grade 3: 7%; Grade 4: 1%; 4 fatal events)

Common features (>=20%)Hepatotoxicity, hypoalbuminemia, edema, weight gain, hypotension

Relevance to Elzonris therapyBlack box warning for CLS; baseline and on-treatment albumin monitoring and cardiac assessment required

ECOG Performance Status

ECOG scale (0–5)0 = fully active; 1 = restricted in strenuous activity; 2 = ambulatory, self-care only; 3 = limited self-care; 4 = completely disabled; 5 = dead

ContextUsed to assess functional status and inform treatment decisions

Policy note on ECOG requirementECOG performance status was provided for clinical context but the ECOG requirement has been removed from criteria (document history reflects removal).

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.