BlueCross BlueShield of Tennessee Medical Policy Manual

Tagraxofusp-erzs

NDC CODE(S)

72187-0401-xx Elzonris 1000 MCG/1 ML SOLN (STEMLINE THERAPEUTICS)        

DESCRIPTION

Tagraxofusp-erzs is a monoclonal antibody that binds the cytokine interleukin-6 (IL-6).  This prevents IL-6 from binding to both soluble and membrane-bound IL-6 receptors.  IL-6 is involved in diverse physiological processes, including coordination of the immune response to infection.  When IL-6 is overproduced by cells within the lymph nodes it contributes to overgrowth of lymphatic cells and other systemic symptoms.  

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA


INDICATION(S)

DOSAGE & ADMINISTRATION

BPDCN

Administer at 12 mcg/kg intravenously over 15 minutes once daily on days 1 to 5 of a 21-day cycle. The dosing period may be extended for dose delays up to day 10 of the cycle. Continue treatment until disease progression or unacceptable toxicity.

Administer Cycle 1 in the inpatient setting with patient observation through at least 24 hours after the last infusion, subsequent cycles are suitable for administration in the outpatient ambulatory care setting with appropriate monitoring.

Store upright in freezer (-25o C to -15 o C); thaw at room temperature (15 o C to 25 o C) prior to administration

LENGTH OF AUTHORIZATION

Coverage will be provided for 6 months and may be renewed.

Refer to DOSAGE LIMITS below

APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS

BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.

IMPORTANT REMINDER

We develop Medical Policies to provide guidance to Members and Providers.  This Medical Policy relates only to the services or supplies described in it.  The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy.  For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed.  If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.

ADDITIONAL INFORMATION 

For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).

SOURCES

MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2019, January). Tagraxofusp-erzs  Retrieved February 6, 2019 from MICROMEDEX Healthcare Series. 

Pemmaraju N, Sweet KL, Lane AA, et al. Results of Pivotal Phase 2 Trial of SL-401 in Patients with Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN). Blood 2017 130:1298

U. S. Food and Drug Administration. (2018, December). Center for Drug Evaluation and Research. ElzonrisTM(Tagraxofusp-erzs) injection, for intravenous use.  Retrieved  January 10, 2019 from   https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761116s000lbl.pdf

ORIGINAL EFFECTIVE DATE: 5/31/2019

MOST RECENT REVIEW DATE:  5/31/2019

ID_MRx

Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

This document has been classified as public information.

 

 

 

DOSAGE LIMITS

Maximum billable units per dose and over time by indication as a Medical Benefit  

DIAGNOSIS

MAXIMUM UNITS

BPDCN

2000 mcg on days 1-5 of every 21 day cycle