NEW YORK, Aug. 06, 2019 (GLOBE NEWSWIRE) -- Stemline Therapeutics, Inc. (NASDAQ:STML), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel oncology therapeutics, today announced that the Centers for Medicare & Medicaid Services (CMS) granted approval for a new technology add-on payment (NTAP) for ELZONRIS for the treatment of adult and pediatric patients, two years and older, with blastic plasmacytoid dendritic cell neoplasm (BPDCN).
As of October 1, 2019, the ELZONRIS NTAP will support Medicare beneficiaries' access to ELZONRIS. The NTAP program payment is in addition to the Diagnosis Related Group (DRG)-based reimbursement that hospitals receive under the Medicare's Inpatient Prospective Payment System (IPPS). The NTAP designation is expected to remain in effect for a period of at least two years but no more than three years to allow the cost of ELZONRIS to be included in CMS's recalibration of the DRG payment rate.
The NTAP program is only available to new technologies demonstrating substantial clinical improvement over existing therapies, meeting the definition of newness of the technology, and exceeding cost criterion thresholds. The NTAP approval for ELZONRIS ensures that Medicare beneficiaries have timely access to the novel therapy and provides an improved reimbursement landscape for additional facilities to adopt ELZONRIS into their treatment paradigm.
"We would like to thank CMS for granting the NTAP designation as it is an important step towards enhancing patient access to ELZONRIS and underscores its position as the standard of care for patients with BPDCN," said Robert Francomano, SVP and Global Head of Commercial at Stemline. "BPDCN is often diagnosed in older adults and the NTAP payment will help improve Medicare beneficiaries' access to ELZONRIS, the first and only FDA-approved treatment specifically for patients with BPDCN."
About ELZONRIS®
ELZONRIS® (tagraxofusp-erzs), a CD123-directed cytotoxin, is approved by the U.S. Food and Drug Administration (FDA) and commercially available in the U.S. for the treatment of adult and pediatric patients, two years or older, with blastic plasmacytoid dendritic cell neoplasm (BPDCN). For full prescribing information in the U.S., visit www.ELZONRIS.com. In Europe, a marketing authorization application (MAA) is under review by the European Medicines Agency (EMA). ELZONRIS is also being evaluated in additional clinical trials in other indications including chronic myelomonocytic leukemia (CMML), myelofibrosis (MF), and acute myeloid leukemia (AML).
About BPDCN
BPDCN is an aggressive hematologic malignancy with historically poor outcomes and an area of unmet medical need. BPDCN typically presents in the bone marrow and/or skin and may also involve lymph nodes and viscera. The BPDCN cell of origin is the plasmacytoid dendritic cell (pDC) precursor. The diagnosis of BPDCN is based on the immunophenotypic diagnostic triad of CD123, CD4, and CD56, as well as other markers. For more information, please visit the BPDCN disease awareness website at www.bpdcninfo.com.
About CD123
CD123 is a cell surface target expressed on a wide range of myeloid tumors including blastic plasmacytoid dendritic cell neoplasm (BPDCN), certain myeloproliferative neoplasms (MPNs) including chronic myelomonocytic leukemia (CMML) and myelofibrosis (MF), acute myeloid leukemia (AML) (and potentially enriched in certain AML subsets), myelodysplastic syndrome (MDS), and chronic myeloid leukemia (CML). CD123 has also been reported on certain lymphoid malignancies including multiple myeloma (MM), acute lymphoid leukemia (ALL), hairy cell leukemia (HCL), Hodgkin's lymphoma (HL), and certain Non-Hodgkin's lymphomas (NHL). In addition, CD123 has been detected on some solid tumors as well as autoimmune disorders including cutaneous lupus and scleroderma.
Contact:
Investor Relations
Stemline Therapeutics, Inc.
750 Lexington Avenue
Eleventh Floor
New York, NY 10022
Tel: 646-502-2307
Email: [email protected]
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