CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Elzonris (tagraxofusp) — Drug Coverage Criteria

Defines coverage, authorization, and clinical criteria for Elzonris (tagraxofusp) for treatment of cancer (notably BPDCN) for Neighborhood Health Plan of Rhode Island members; applies to UM reviewers and ordering providers requesting medication authorization.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyElzonris (tagraxofusp) — Drug Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateMay 31, 2024

Next Review DateMay 8, 2024

Key ActionObtain prior authorization from Evolent/UM and supply supporting evidence from FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2 yrsminimum patient age

12 mcg/kgsingle dose max

May 31, 2024effective

May 08, 2024committee approval

NCCN/ASCO/CMSevidence sources

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria for Elzonris (tagraxofusp)

Initial and continuation therapy for BPDCN

Covered when ALL of the following are met:

BPDCN indication: Member has Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) and Elzonris (tagraxofusp) will be used as a single agent for induction or continuation treatment for newly diagnosed or relapsed/refractory diseaseage >= 2 years

Applies to adults and pediatric members 2 years and older

Evidence support: Use is supported by FDA labeling, CMS-recognized compendia, NCCN or ASCO clinical guidelines, or acceptable peer-reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15

See PURPOSE section for acceptable sources

Dosing limit: Dosing does not exceed the single-dose limit for Elzonris<= 12 mcg/kg per single dose

Exceeding single dose limit is an exclusion

Continuation exemption criteria

Continuation requests exempt from full policy review when ALL of the following are met:

Recent use: The requested medication was used within the last yearwithin 1 year

No progression or intolerance: The member has not experienced disease progression and has not had intolerance to the requested medication

No added medications: No additional medication(s) are being added to the continuation request

Requests for Elzonris (tagraxofusp) will be excluded when any of the following apply: disease progression while receiving Elzonris; dosing that exceeds the single dose limit of 12 mcg/kg; or use that is investigational or for an off‑label indication without sufficient supporting evidence. The policy defines insufficient evidence as clinical reports that do not adequately represent the patient/cancer characteristics, the administered regimen, or clinically meaningful outcomes, as well as study designs that are inappropriate for the question under investigation. Case reports and abstracts without full peer‑reviewed publication are specifically noted as generally inadequate to support coverage.

Investigational or off‑label uses of Elzonris (tagraxofusp) are considered not medically necessary when they are not supported by CMS‑recognized compendia or acceptable peer‑reviewed literature. The policy enumerates specific evidence concerns that render a use investigational: inadequate representation of the treated patient population or cancer in the published evidence; lack of representation of the administered oncologic regimen; outcomes that do not meet established thresholds for clinical meaningfulness (for example ASCO‑recommended benchmarks); inappropriate experimental design for the clinical question; reliance on uncontrolled case reports; or dependence on abstracts without a full peer‑reviewed article.

Coding and Dose Limits

Single dose limit — 12 mcg/kg

Single dose maximum12 mcg/kg per single dose

ApplicabilityApplies to all Elzonris (tagraxofusp) dosing — requests exceeding this single dose will be excluded

Exclusion consequenceDosing that exceeds 12 mcg/kg is listed in the policy exclusion criteria and may result in denial

Prior Authorization, Documentation, and Denial Triggers

Prior Authorization

Prior authorization required and processed by Evolent/UM

Prior authorization is required for Elzonris (tagraxofusp) requests and is processed by Evolent/UM. Elzonris is authorized when used as a single agent for induction or continuation treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) in patients 2 years and older, when coverage criteria are met.

Step Therapy

Continuation requests may be exempt from review

Continuation requests may be exempt from full policy review when the requested medication was used within the last year, the member has not had disease progression or intolerance to the medication, and no additional medications are being added to the continuation request.

Requested medication used within the last year
No disease progression and/or no intolerance to the requested medication
No additional medication(s) are being added to the request

Initial Authorization Criteria

Initial therapy for BPDCN

Initial authorization allowed when ALL of the following are met:

Diagnosis: BPDCN diagnosis for induction or continuation in newly diagnosed or relapsed/refractory diseaseage >= 2 years

Single-agent use of Elzonris (tagraxofusp)

Supporting evidence: Use is supported by FDA approved product labeling, CMS-recognized compendia, NCCN or ASCO clinical guidelines, or acceptable peer-reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15

Per PURPOSE section

Continuation Authorization and Exemptions

Continuation therapy exemption

Continuation requests may be exempt from policy review if ALL of the following continuation conditions are met:

Continuation conditions: Requested medication was used within the last year; member has not experienced disease progression and/or intolerance; no additional medications are being added

See section A of policy for details

Key Definitions

BPDCN — definition and authorized use

DefinitionBlastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) is the hematologic malignancy for which Elzonris (tagraxofusp) is authorized as single‑agent therapy in this policy

Authorized useElzonris is authorized as a single agent for induction and continuation treatment of newly diagnosed or relapsed/refractory BPDCN

Eligible populationApplicable to adults and pediatric members 2 years of age and older

Duration of therapy contextTreatment is for induction/continuation until disease progression (unless previously used)

Background

Elzonris (tagraxofusp) is authorized in this policy for treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) as a single agent for induction and continuation in appropriate patients. The background intent of the policy is to ensure use aligns with FDA labeling and accepted evidence sources; uses that demonstrate disease progression on therapy, exceed the 12 mcg/kg single dose threshold, or lack adequate evidence from CMS compendia or peer‑reviewed literature will be excluded from coverage.