CurrentEmblemHealthPolicy N/A

Elzonris (tagraxofusp) for Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

Defines accepted indications, coverage criteria, and authorization requirements for Elzonris (tagraxofusp) for members of the payer network, including adults and pediatric patients aged 2 years and older with Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN).

Policy Summary

PayerEmblemHealth

PolicyElzonris (tagraxofusp) for BPDCN

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain prior authorization through Evolent with supporting documentation that the member has BPDCN and will receive Elzonris as single-agent induction or continuation therapy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

J9269HCPCS code listed

2 yrsminimum pediatric age

12 mcg/kgsingle dose max

CLSboxed warning

Medicare Advantagelines of business

Coverage Criteria for Elzonris (tagraxofusp)

Initial or Continuation Therapy for BPDCN

Covered when ALL of the following are met

BPDCN indication and age: Member has Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) and Elzonris (tagraxofusp) will be used as a single agentage >= 2 years

Applies to adults and pediatric members 2 years and older for induction or continuation treatment of newly diagnosed or relapsed/refractory disease until disease progression (if not used previously)

Exclusions to coverage include any of the following: disease progression that occurs while the member is receiving Elzonris (tagraxofusp); dosing that exceeds the single‑dose limit of 12 mcg/kg; and investigational or off‑label uses of Elzonris that are not supported by sufficient evidence as defined in this policy (for example, uses not supported by CMS‑recognized compendia or acceptable peer‑reviewed literature and evidence that does not meet the policy’s criteria for clinical relevance and study design).

Use of Elzonris is considered not medically necessary when prescribed for investigational or off‑label indications that lack adequate supporting evidence per the policy definitions (for example, indications unsupported by CMS‑recognized compendia or acceptable peer‑reviewed literature, evidence that does not represent the relevant patient or regimen, or reports limited to case reports or abstracts without full peer‑reviewed publication).

Policy Summary

PayerEmblemHealth

PolicyElzonris (tagraxofusp) for BPDCN

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain prior authorization through Evolent with supporting documentation that the member has BPDCN and will receive Elzonris as single-agent induction or continuation therapy.

SourceLink

On This Page

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Regimen	Indication / Line of therapy	Coverage status
Elzonris (tagraxofusp) — single agent	Induction or continuation treatment for Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) in adults and pediatric members ≥2 years; for newly diagnosed or relapsed/refractory disease (until disease progression)	Covered with criteria

Coding and Dose Limits

Covered HCPCS CodesHCPCSCovered

J9269

Injection, tagraxofusp-erzs, 10 micrograms

Single dose limit — Elzonris (tagraxofusp) — dosing threshold

Single dose maximum12 mcg/kg per single dose

Related exclusionRequests exceeding this single dose limit may be excluded/denied

Relevant code contextLimit applies to Elzonris (tagraxofusp) dosing per policy exclusions

Provider Requirements and Authorization

Prior Authorization

Prior authorization required

Evolent (on behalf of the payer) must process and approve prior authorization requests for Elzonris (tagraxofusp); medications not authorized by Evolent may be deemed not approvable and not reimbursable. Approval must be supported by FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature meeting CMS requirements.

Covered HCPCS code: J9269

Step Therapy

Continuation exemption for active authorizations

Continuation requests can be processed without a new application when the member has not experienced disease progression on Elzonris, the prior authorization was active within the last year with no lapse greater than 30 days, and no additional medications are being added.

No disease progression on the requested medication
Prior authorization active within the last year with no lapse >30 days
No additional medications being added to the request

Documentation Required

Required clinical documentation

Provide clinical documentation confirming the member has a diagnosis of Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) and that Elzonris will be used as a single agent for induction or continuation in adults and pediatric members aged ≥2 years; support must reference FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature that meets CMS requirements.

Diagnosis of BPDCN
Planned use of Elzonris as a single agent for induction/continuation
Member age ≥ 2 years (when applicable)
Supporting references: FDA label, CMS compendia, NCCN/ASCO, or acceptable peer-reviewed literature

Denial Risk

Exclusion-based denial triggers

Requests may be denied if the member experienced disease progression while receiving Elzonris, if dosing exceeds the single dose limit of 12 mcg/kg, or if use is investigational/off‑label without sufficient supporting evidence per the policy's evidence standards.

Disease progression while receiving Elzonris
Dosing exceeds single dose limit of 12 mcg/kg
Investigational or off‑label use not supported by CMS‑recognized compendia or acceptable peer‑reviewed literature

Line of Therapy

first-line | later-line

Line of therapy: Elzonris may be used for induction or continuation treatment of newly diagnosed or relapsed/refractory BPDCN (if not used previously)

Key Definitions and Safety Warnings

Capillary leak syndrome (CLS) — key safety definition

DefinitionCapillary leak syndrome (CLS) — a potentially life‑threatening or fatal adverse event associated with tagraxofusp, involving fluid shift from the intravascular to interstitial space

Regulatory warningUS Boxed Warning — CLS is included in the boxed warning for tagraxofusp

Clinical actionMonitor for signs and symptoms of CLS and take actions as recommended in labeling

Background

Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) is an aggressive hematologic malignancy. Elzonris (tagraxofusp) is indicated as single‑agent therapy for induction or continuation treatment in adults and pediatric patients aged 2 years and older with newly diagnosed or relapsed/refractory BPDCN. Tagraxofusp carries a boxed warning for capillary leak syndrome (CLS) and requires monitoring during treatment per the product labeling.