Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Tagraxofusp-erzs (Elzonris™)

Policy #:08.01.55c

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract. The Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition.

Tagraxofusp-erzs (Elzonris™) is considered medically necessary and, therefore, covered for the treatment of blastic plasmacytoid dendritic neoplasm (BPDCN) in individuals two years and older when used as a single agent for one of the following criteria:
  • treatment induction in individuals for intensive remission therapy
  • treatment until progression if complete response (CR) achieved after induction
  • relapsed/refractory BPDCB (if not already used as first line)

EXPERIMENTAL/INVESTIGATIONAL

All other uses for tagraxofusp-erzs (Elzonris™) are considered experimental/investigational and, therefore, not covered unless the indication is supported as an accepted off-label use, as defined in the Company medical policy on off-label coverage for prescription drugs and biologics.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the drug.
Guidelines

According to the FDA-approved label, initiation and subsequent cycles of therapy with tagraxofusp-erzs (Elzonris™) should be performed in a facility equipped with appropriate monitoring for individuals with hematopoietic malignancies. The individual should be monitored for at least 24 hours following the initial infusion. For subsequent cycles, the individual should be monitored for at least four hours following each infusion.

PEDIATRIC USE

The safety and effectiveness of tagraxofusp-erzs (Elzonris™) in pediatric patients below the age of two years have not been established.

BLACK BOX WARNINGS

Refer to the specific manufacturer's prescribing information for any applicable Black Box Warnings.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, tagraxofusp-erzs (Elzonris™) is covered under the medical benefits of the Company’s products when the medical necessity criteria listed in this medical policy are met.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

Tagraxofusp-erzs (Elzonris™) was approved by the FDA in December 21, 2018 for the treatment of blastic plasmacytoid dendritic cell neoplasm in individuals two years and older.

Description

Blastic plasmacytoid dendritic cell neoplasm (BPDCN), previously known as blastic natural killer cell leukemia/lymphoma, is a rare aggressive hematologic malignancy derived from plasmacytoid dendritic cells. BPDCN characterized by expression of CD4, CD56, and CD123. BPDCN commonly presents with cutaneous lesions and possible involvement of the lymph nodes and bone marrow.

Tagraxofusp-erzs (Elzonris™), a CD123-directed cytotoxin, is a fusion protein composed of a recombinant human interleukin-3 and truncated diphtheria toxin administered by intravenous infusion. Tagraxofusp-erzs (Elzonris™) inhibits protein synthesis and causes cell death in CD123- expressing cells. On December 21, 2018, tagraxofusp-erzs (Elzonris™) was approved by the US Food and Drug Administration (FDA) as an orphan drug (a drug used to treat, prevent, or diagnose a rare disease) for the treatment of BPDCN in individuals two years and older.

CLINICAL TRIALS

The safety and efficacy of tagraxofusp-erzs (Elzonris™) was evaluated in a multi-stage, multicenter, open-label, single-arm Phase 2 clinical trial. The trial consisted of 13 treatment-naive individuals and 15 refractory or relapsed individuals with BPDCN. The primary endpoint was clinical complete response. In the treatment-naive cohort, the clinical complete response was 53.8% (7/13) with a complete response duration range of 3.9 to 12.2 months. Median duration of complete response was not reached. In the relapsed or refractory cohort, the clinical complete response of the was 13.3% (2/15).
References


Alkharabsheh O, Frankel AE. Clinical activity and tolerability of SL-401 (tagraxofusp): Recombinant diphtheria toxin and interleukin-3 in hemoatologic malignancies. Biomedicines. 2019;7(1).

Arber D, Orazi A, Hasserjian R, et. al. The 2016 revision to the World Health Organization classification of myeloid neoplasms and acute leukemia. Blood. 2016.127(20):2391-2405.

Lexi-Drugs Compendium. Elzonris™. 04/07/2020. [Lexicomp Online Web site]. Available at: http://online.lexi.com/lco/action/home [via subscription only]. Accessed April 10, 2020.

National Comprehensive Cancer Network (NCCN). NCCN Drugs & Biologics Compendium™.[NCCN Web site]. 2020. Available at: https://www.nccn.org/professionals/drug_compendium/content/ [via subscription only]. Accessed April 10, 2020.

Owczarczyk-Saczonek A, Sokolowksa-Wojdylo M, Olszewska B, et.al. Clinicopathologic retrospective analysis of blastic plasmacytoid dendritic cell neoplasms. Postepy Dermatol Alergol. 2018.35(2):128-138.

Safaei A, Monabati A, Mokhtari M, et. al. Blastic plasmacytoid dendritic cell neoplasm: a report of three cases. IJMS. 2019.44(1):74-78.

Truven Health Analytics. Micromedex® DrugDex® Compendium. Elzonris™. 11/06/2019. Greenwood Village, CO. [Micromedex® Solutions Web site]. Available at: http://www.micromedexsolutions.com/micromedex2/librarian [via subscription only]. Accessed April 10, 2020.

US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Approval letter. tagraxofusp-erzs (Elzonris™). [FDA Web site]. 12/21/2018. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761116Orig1s000Approv.pdf. Accessed on April 10, 2020.

US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. tagraxofusp-erzs (Elzonris™) drug label [FDA Web site]. 12/2018. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761116s000lbl.pdf. Accessed April 10, 2020.



Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

C86.4 Blastic NK-cell lymphoma



HCPCS Level II Code Number(s)



J9269 Injection, tagraxofusp-erzs, 10 micrograms




Revenue Code Number(s)

N/A

Coding and Billing Requirements



Policy History

REVISIONS FROM 08.01.55c:
06/08/2020This version of the policy will become effective 06/08/2020.

This policy has been updated in consideration of revisions within the National Comprehensive Cancer Network (NCC) 2020.

Coverage was added for the condition of blastic plasmacytoid dendritic neoplasm.

REVISIONS FROM 08.01.55b:
10/01/2019This policy has been identified for the HCPCS code update, effective 10/01/2019.

The following HCPCS codes have been removed from this policy and are replaced by the following HCPCS code:
    REMOVED:
      C9049 Injection, tagraxofusp-erzs, 10 mcg
      J3590 Unclassified biologics
    REPLACED WITH: J9269 Injection, tagraxofusp-erzs, 10 micrograms

REVISIONS FROM 08.01.55a:
07/01/2019This policy has been identified for the HCPCS code update, effective 07/01/2019.

The following NOC code has been removed from this policy and is replaced by the following HCPCS code:
    REMOVED: C9399 Unclassified drugs or biologicals
    REPLACED WITH: C9049 Injection, tagraxofusp-erzs, 10 mcg

REVISIONS FROM 08.01.55:
04/15/2019The following new policy has been developed to communicate the Company's coverage criteria for Tagraxofusp-erzs (Elzonris™).
Version Effective Date: 06/08/2020
Version Issued Date: 06/08/2020
Version Reissued Date: N/A

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