CurrentEmblemHealthPolicy N/A

Elzonris (tagraxofusp-erzs) intravenous therapy for BPDCN — Coverage Criteria

Defines medical necessity, dosing, coding, and authorization requirements for Elzonris (tagraxofusp-erzs) to treat blastic plasmacytoid dendritic cell neoplasm (BPDCN) for EmblemHealth members.

Policy Summary

PayerEmblemHealth

PolicyElzonris (tagraxofusp-erzs) intravenous therapy for BPDCN — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateApr 3, 2025

Key ActionPrior authorization is required with submission of clinical documentation demonstrating that the patient meets the medical necessity criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsinitial length of authorization

12 mcg/kgrecommended dose

J9269HCPCS

C86.4ICD-10

>=3.2 g/dLalbumin threshold

Coverage Criteria for Elzonris (tagraxofusp-erzs)

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inv-01: Initial Approval Criteria

Covered when ALL of the following are met:

Initial criteria for Elzonris

Patient criteria: A. Patient is > 2 years of age; B. Clinically diagnosed BPDCN involving peripheral blood, bone marrow, spleen, lymph nodes, skin, and/or other sites; C. Adequate cardiac function and serum albumin > 3.2 g/dL prior to every course of therapy; D. No active or suspected CNS leukemia; E. Must be used as a single agent; F. Elzonris is prescribed by or in consultation with an oncologist.
Treatment intent (ONE of): i. Induction therapy in patients who are candidates for intensive remission therapy; OR ii. Continued treatment until progression if a complete response (CR) was achieved after induction; OR iii. Treatment for relapsed/refractory disease if not previously used.

inv-02: Renewal Criteria

Renewal is allowed when the following is met:

Renewal criteria: Patient continues to meet Initial Approval Criteria and has lack of adverse reactions or toxicities to medication (e.g., capillary leak syndrome).

Coverage is not recommended for circumstances not listed in the Initial Approval Criteria. Requests that do not meet the specific Initial Approval Criteria should be considered not covered unless additional supporting clinical documentation demonstrates medical necessity consistent with the criteria set forth in this policy.

Regimen	Dose / Schedule	Max per dose & billing units
Elzonris (tagraxofusp-erzs) for Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)	12 mcg/kg IV over 15 minutes once daily on Days 1–5 of each 21-day cycle	Maximum 2000 mcg on days 1–5 of every 21-day cycle (200 billable units on days 1–5)

Provider Requirements and Submission Instructions

Prior Authorization

Prior Authorization Required

Prior Authorization Required — The treating physician or primary care provider must submit clinical evidence demonstrating that the member meets the medical necessity criteria for the requested treatment. Without this documentation, EmblemHealth will not be able to properly review the preauthorization or post-payment request.

Submit clinical records that document diagnosis, relevant staging or disease involvement (e.g., peripheral blood, bone marrow, spleen, lymph nodes, skin, other sites for BPDCN), prior treatments and responses, cardiac function, and serum albumin levels (> 3.2 g/dL) prior to each course as applicable.
Indicate intended use (induction for candidates for intensive remission therapy; treatment until progression if CR achieved after induction; or treatment for relapsed/refractory disease).
Document that Elzonris will be used as a single agent and is prescribed by or in consultation with an oncologist.
State patient age (> 2 years) and absence of active or suspected CNS leukemia when applicable.

Documentation Required

Clinical Evidence Submission

Clinical Evidence Submission — Treating clinicians must submit supporting clinical evidence with the preauthorization or for post-payment review to allow EmblemHealth to assess medical necessity. Failure to provide the requested clinical documentation will prevent proper review of the request and may result in denial.

Include all relevant clinical notes, pathology reports, diagnostic test results, imaging, laboratory results (including serum albumin and cardiac assessment), and consultation notes.
For BPDCN, include documentation of diagnostic sites (eg, skin, blood, marrow), prior therapies, response status (complete response, relapsed/refractory), and intended treatment role (induction, maintenance until progression, or relapsed/refractory therapy).
If clinical information is incomplete, EmblemHealth may request additional records or deny the request if information is not provided.

Note

Single-Agent Requirement

Single-Agent Requirement — Document that Elzonris will be administered as a single agent. Prior authorization will be contingent on confirmation that no concurrent anti-neoplastic agents are planned unless specifically justified and approved.

If combination therapy is being considered, provide rationale and supporting evidence; authorization may be denied if the single-agent requirement is not met.

Denial Risk

Documentation Submission Required

Documentation Submission Required — Failure to submit the required clinical evidence will prevent proper review of the preauthorization or post-payment request.

Ensure timely submission of requested records to avoid delays or adverse coverage determinations.
Clinical review criteria reflect EmblemHealth's determination of medical necessity but do not guarantee coverage; benefit plan terms determine final coverage.

Key Definitions

Elzonris (tagraxofusp-erzs) — definition and mechanism

Drug name (generic/brand)tagraxofusp-erzs (Elzonris)

Mechanism of actionCD123-directed cytotoxin: recombinant human interleukin-3 (IL-3) fused with truncated diphtheria toxin that inhibits protein synthesis and causes cell death in CD123-expressing cells

Indication age rangeApproved for treatment of BPDCN in adults and pediatric patients > 2 years of age

ManufactureProduced by recombinant DNA technology in Escherichia coli cells

BPDCN — definition

DefinitionBlastic plasmacytoid dendritic cell neoplasm (BPDCN) diagnosed in peripheral blood, bone marrow, spleen, lymph nodes, skin, and/or other sites

Age considerationOccurs in patients including those > 2 years of age for purposes of this policy

Treatment contextBPDCN is the labeled indication for Elzonris per the policy's initial approval criteria

OpenPayer

Elzonris (tagraxofusp-erzs) intravenous therapy for BPDCN — Coverage Criteria

Coverage Criteria for Elzonris (tagraxofusp-erzs)

Billing Codes and Clinical Thresholds

Provider Requirements and Submission Instructions

Key Definitions

Line of Therapy

Background