72187-0401-xx Elzonris 1000 MCG/1 ML SOLN (STEMLINE THERAPEUTICS)
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.
Tagraxofusp-erzs for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Tagraxofusp-erzs for the treatment of other conditions/diseases is considered investigational.
Tagraxofusp-erzs is considered medically appropriate if ALL of the following criteria are met:
Individual has CD-123 positive/expressing disease
Base-line serum albumin level of at least 3.2 g/dL
Individual does not have significant cardiovascular disease (e.g., uncontrolled or any NYHA Class 3 or 4 congestive heart failure, uncontrolled angina, history of myocardial infarction or stroke within 6 months prior to initiation of therapy, uncontrolled hypertension or clinically significant arrhythmias not controlled by medication, baseline left ventricular ejection fraction ≤ 40%)
Individual does not have active or suspected CNS leukemia
Diagnosis of Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) and ALL of the following:
Individual is 2 years of age or older
Individual must have a definitive diagnosis of BPDCN in the peripheral blood, bone marrow, spleen, lymph nodes, skin, and/or other sites
Individual is treatment-naïve or has persistent/recurrent disease
Tagraxofusp-erzs is considered medically appropriate for renewal if ALL of the following criteria are met:
Individual continues to meet initial approval criteria
Absence of unacceptable toxicity from the drug. Examples include any of the following: capillary leak syndrome (i.e. hypoalbuminemia, edema/weight gain, pulmonary edema, hypotension, etc.), severe hypersensitivity, severe hepatotoxicity (e.g., AST/ALT > 5 times the upper limit of normal), nephrotoxicity (e.g., serum creatinine > 1.8 mg/dL or creatinine clearance ≤ 60 mL/minute), cardiovascular effects (e.g., systolic blood pressure ≥ 160 mmHg or ≤ 80 mmHg; or heart rate ≥ 130 bpm or ≤ 40 bpm), etc.
Disease stabilization or improvement as evidenced by a complete response [CR] (i.e.,morphologic, cytogenetic or molecular complete response CR) or clinical complete response [CRc] (i.e., complete response with residual skin abnormality not indicative of active disease)
DOSAGE & ADMINISTRATION
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
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.
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.
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).
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
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.
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Maximum billable units per dose and over time by indication as a Medical Benefit