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Access | Reimbursement Support | Care
Stemline ARC provides access, reimbursement support, and care for eligible patients throughout treatment with ELZONRIS® (tagraxofusp-erzs) Injection for Intravenous (IV) Use
Permanent J-Code and NTAP designation for ELZONRIS Injection for IV Use, effective October 1, 2019
J-Code: J9269 Injection, tagraxofusp-erzs, 10 mcg
NTAP designation: XW033Q5 or XW043Q5*
Centers for Medicare & Medicaid Services (CMS) granted ELZONRIS Injection for IV Use a New Technology Add-On Payment (NTAP) designation for inpatient utilization†
For more information about Stemline ARC, call 1-833-4-STEMLINE (1-833-478-3654)
from 9:00 AM to 6:00 PM EST, Monday through Friday.
*Procedure code required to initiate NTAP payment.
†Medicare beneficiaries at qualified facilities that report an appropriate diagnosis code and ICD-10-PCS for the inpatient administration of ELZONRIS Injection for IV Use may be eligible for additional payment. NTAP as defined by CMS is issued to new technology meeting specific criteria and thresholds. The technology must be: 1) New: 2 or 3 years following FDA approval; 2) Existing MS-DRG must be inadequate; and 3) Technology must have substantial clinical improvement over existing services. The amount of payment is the lesser of 65% of the cost of ELZONRIS Injection for IV Use OR 65% of the amount by which the cost of the case exceeds the MS-DRG payment
‡In order to be eligible for the Stemline Commercial Co-Pay Program, the patient must not have government-funded health insurance (eg, Medicare, Medicaid, or any other federal or state program), must be taking ELZONRIS Injection for IV Use for an FDA-approved indication, and must confirm that they meet all of the eligibility criteria and agree to the rules set forth in the terms and conditions for the program. Patients and healthcare providers are responsible for completing and submitting enrollment forms and coverage or reimbursement documentation. Stemline Therapeutics, Inc. makes no representation or guarantee concerning coverage or reimbursement of any service or item.
§Dedicated Nurse Advocates are available to provide education and answer questions about treatment with ELZONRIS Injection for IV Use. Nurse Advocate support is not intended to replace discussions between patients and their healthcare providers.
Boxed WARNING: CAPILLARY LEAK SYNDROME
Capillary Leak Syndrome
Hypersensitivity Reactions
Hepatotoxicity
The most common adverse reactions in the clinical trials (incidence ≥ 30%) are capillary leak syndrome, nausea, fatigue, peripheral edema, pyrexia, and weight increase. The most common laboratory abnormalities (incidence ≥ 50%) are decreases in albumin, platelets, hemoglobin, calcium, sodium, and increases in glucose, ALT, and AST.
Please see full Prescribing Information, including Boxed WARNING.
To report SUSPECTED ADVERSE REACTIONS, contact Stemline Therapeutics, Inc. at 1-877-332-7961 or contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
IMPORTANT SAFETY INFORMATION
Boxed WARNING: CAPILLARY LEAK SYNDROME
Capillary Leak Syndrome
Hypersensitivity Reactions
Hepatotoxicity
The most common adverse reactions in the clinical trials (incidence ≥ 30%) are capillary leak syndrome, nausea, fatigue, peripheral edema, pyrexia, and weight increase. The most common laboratory abnormalities (incidence ≥ 50%) are decreases in albumin, platelets, hemoglobin, calcium, sodium, and increases in glucose, ALT, and AST.
Please see full Prescribing Information, including Boxed WARNING.
To report SUSPECTED ADVERSE REACTIONS, contact Stemline Therapeutics, Inc. at 1-877-332-7961 or contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.