CurrentViva HealthPolicy IC-0426

Elzonris (tagraxofusp-erzs) — intravenous therapy for BPDCN

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Prior authorization and coverage criteria for intravenous tagraxofusp-erzs (Elzonris) for treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) and related administration, dosing, and monitoring requirements for Viva Health members.

Policy Summary

PayerViva Health

PolicyElzonris (tagraxofusp-erzs) — intravenous therapy for BPDCN

Policy CodePolicy IC-0426

Change TypeNo material change

Effective Date

Last ReviewMay 5, 2026

Next Review DateMay 5, 2026

Key ActionObtain prior authorization; initial approval granted for 6 months (180 days) and may be renewed every 6 months.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsinitial prior authorization duration

1000

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CurrentViva HealthPolicy IC-0426

Elzonris (tagraxofusp-erzs) — intravenous therapy for BPDCN

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Policy Summary

PayerViva Health

PolicyElzonris (tagraxofusp-erzs) — intravenous therapy for BPDCN

Policy CodePolicy IC-0426

Change TypeNo material change

Effective Date

Last ReviewMay 5, 2026

Next Review DateMay 5, 2026

Key ActionObtain prior authorization; initial approval granted for 6 months (180 days) and may be renewed every 6 months.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsinitial prior authorization duration

1000

Coverage Criteria for Elzonris (tagraxofusp-erzs)

inv-01: Initial Therapy for BPDCN

Covered when ALL of the following are met

Age: Member is at least 2 years of age>=2 years

From initial approval criteria

Disease biomarker: Member has CD123-positive/expressing diseaseCD123 positive

Universal criterion

Therapy setting: Used as single agent therapysingle agent

Universal criterion

Albumin: Member has a serum albumin level of at least 3.2 g/dL prior to initiating therapy and will be monitored throughout therapy>=3.2 g/dL

Universal criterion

Cardiac status: Member does not have significant cardiovascular disease (examples: uncontrolled or NYHA Class 3–4 heart failure, uncontrolled angina, myocardial infarction or stroke within 6 months, uncontrolled hypertension, clinically significant arrhythmias not controlled by medication, or low baseline left ventricular ejection fraction)no significant cardiovascular disease

Universal criterion

CNS disease: Member does not have active or suspected central nervous system (CNS) leukemiano active/suspected CNS leukemia

Universal criterion

Indication-specific for BPDCN: Member has a definitive diagnosis of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in peripheral blood, bone marrow, spleen, lymph nodes, skin, and/or other sites; AND one of the following intents applies: used as induction therapy in members who are candidates for intensive therapy; OR used as treatment until progression if a complete response (CR) was achieved after induction; OR used as treatment for relapsed/refractory disease if not already useddefinitive BPDCN diagnosis with one of listed therapy intents

BPDCN-specific criterion

inv-02: Renewal / Continuation Therapy

Renewal covered when ALL of the following are met

Continuation of baseline criteria: Member continues to meet universal and other indication-specific relevant criteria such as concomitant therapy requirements (not including prerequisite therapy), performance status, and laboratory thresholds identified in initial criteriacontinuing eligibility

Renewal requirement

Toxicity: Absence of unacceptable toxicity from the drug (examples include capillary leak syndrome, severe hypersensitivity reactions, severe hepatotoxicity)no unacceptable toxicity

Renewal requirement

Response: Disease stabilization or improvement as evidenced by a complete response (CR: morphologic, cytogenetic, or molecular complete response) or a clinical complete response (CRc: complete response with residual skin abnormality not indicative of active disease)

Regimen	Dose & Schedule	Setting & Observation	Duration/Discontinuation
Tagraxofusp-erzs for BPDCN	12 mcg/kg IV over 15 minutes once daily on days 1-5 of a 21-day cycle; dosing period may be extended for dose delays up to day 10 of the cycle.	Cycle 1: administer inpatient with observation through at least 24 hours after the last infusion. Subsequent cycles: may be given in an outpatient/ambulatory care setting equipped for monitoring; observe member for a minimum of 4 hours following each infusion.	Continue treatment until disease progression or unacceptable toxicity.

Coverage initiation is exclusionary when the member has significant cardiovascular disease, active or suspected central nervous system (CNS) leukemia, or insufficient serum albumin prior to starting therapy. Specifically, the policy requires a baseline serum albumin >= 3.2 g/dL and ongoing monitoring during treatment. Examples of cardiovascular conditions that exclude initiation include uncontrolled or NYHA Class 3 or 4 congestive heart failure, uncontrolled angina, a history of myocardial infarction or stroke within the prior 6 months, uncontrolled hypertension, clinically significant arrhythmias not controlled by medication, or a baseline left ventricular ejection fraction below the institutional lower limit of normal. Active or suspected CNS leukemia is also an exclusionary condition for starting therapy.

This policy describes coverage only for treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN). Use of tagraxofusp-erzs for other indications or disease states is not described as covered by this policy. For BPDCN the member must have a definitive diagnosis (site documentation may include peripheral blood, bone marrow, spleen, lymph nodes, skin, or other involved sites) and the drug may be used as induction in candidates for intensive therapy, as treatment until progression after a complete response, or for relapsed/refractory disease if not previously used.

Coding and Billing

Covered HCPCS CodesHCPCSCovered

J9269

Injection, tagraxofusp-erzs, 10 micrograms; 1 billable unit = 10 mcg

NDCNDC

72187-0401-xx

Elzonris 1000 mcg/1 mL single-dose vial NDC (format shown)

Covered Diagnosis Codes (ICD-10)ICD-10Covered

C86.40

Blastic NK-cell lymphoma not having achieved remission

Serum albumin requirement — numeric threshold for treatment eligibility

Serum albumin threshold>= 3.2 g/dL prior to initiating therapy; monitored throughout therapy

PurposeRequired baseline laboratory parameter for initiation of tagraxofusp-erzs in BPDCN

Consequence of low valueSerum albumin below 3.2 g/dL is an exclusionary condition for initiation and may be a trigger for denial

Provider Actions, Documentation, and Prior Authorization

Prior Authorization

Prior authorization validity

Prior authorization is required. Initial approval is provided for 6 months (180 days) and may be renewed every 6 months (180 days) thereafter.

Step Therapy

Therapy sequencing for BPDCN

No prerequisite therapy is required for use in BPDCN. The drug may be used as induction therapy in candidates for intensive therapy, as treatment until progression if a CR was achieved after induction, or as treatment for relapsed/refractory disease if not previously used.

Documentation Required

Required documentation to support medical necessity

Permitted Lines of Therapy

inv-16: first-line | continuation | salvage

Induction: Used as induction therapy in members who are candidates for intensive therapyinduction candidates

Line-of-therapy option

Post-CR continuation: Used as treatment until progression if a complete response (CR) was achieved after inductionpost-CR use

Continuation/maintenance option

Relapsed/Refractory: Used as treatment for relapsed or refractory disease if not previously usedrelapsed/refractory setting

Biomarker and Response Definitions

CD123 — positive/expression required for eligibility

BiomarkerCD123 expression (CD123-positive disease) is required for eligibility

Testing implicationDocumented CD123-positive/expressing disease must be included in the medical record prior to initiation

Relation to coverageAbsence of CD123 expression is a trigger for potential denial

CD123-positive disease — disease expressing the CD123 antigen, required for therapy eligibility

DefinitionDisease expressing the CD123 antigen (CD123-positive disease) — required for therapy eligibility

Clinical contextApplies to blastic plasmacytoid dendritic cell neoplasm (BPDCN) and must be documented in diagnostic sites such as peripheral blood, bone marrow, spleen, lymph nodes, skin, or other sites

Background

Tagraxofusp-erzs (Elzonris) is an intravenous CD123-directed cytotoxin indicated for blastic plasmacytoid dendritic cell neoplasm (BPDCN). The policy requires that members have CD123-positive disease and meet universal eligibility criteria — including use as a single agent and a baseline serum albumin >= 3.2 g/dL — before initiating therapy. For BPDCN dosing, the regimen in the policy is administered per the indication intent: it may be used as induction in candidates for intensive therapy, continued until progression after a complete response, or used for relapsed/refractory disease if not previously given. Providers should note the safety profile summarized in the policy (including risks that inform the cardiac and albumin exclusions) and follow monitoring and administration guidance described for initial and subsequent cycles.

Revision History

05/05/2026policy reviewLatest

Last review of the clinical policy document (IC-0426) completed on 05/05/2026; document status updated with review date.

05/2025annual review

Policy reviewed in May 2025 as part of routine scheduled reviews (dates reviewed listed through 05/2025).

04/2024annual review