September 10, 2020 at 8:39 AM EDT
-NTAP designation highlights need for novel antibiotics to fight drug-resistant infections and advance antimicrobial stewardship
-CONTEPO first Qualified Infectious Disease Product to receive NTAP conditional approval prior to FDA approval
DUBLIN, Ireland, Sept. 10, 2020 (GLOBE NEWSWIRE) — Nabriva Therapeutics plc (NASDAQ: NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, announced today that the Centers for Medicare & Medicaid Services (CMS) has granted a new technology add-on payment (NTAP) for XENLETA (lefamulin) for injection when administered in the hospital inpatient setting. XENLETA is a pleuromutilin antibacterial indicated for the treatment of adults with community-acquired bacterial pneumonia (CABP). Both the IV and oral formulations of XENLETA were granted Qualified Infectious Disease Product (QIDP) and Fast Track designation by the FDA.
Beginning on October 1, 2020, CMS will provide an additional maximum payment of $1,275.75 for XENLETA when used in the inpatient hospital setting for fiscal year 2021. The U.S. Food and Drug Administration (FDA) approved the IV and oral versions of XENLETA for the treatment of adult patients with CABP in August 2019.
Nabriva also announced today that CMS has granted an NTAP for CONTEPO (fosfomycin), making CONTEPO the first QIDP to be granted conditional NTAP approval prior to receiving FDA approval. CONTEPO was granted QIDP and Fast Track Designation by the FDA for the treatment of complicated urinary tract infections (cUTI), including acute pyelonephritis. If CONTEPO receives FDA approval prior to July 1, 2021, the maximum add-on payment for a case involving the administration of CONTEPO is $2,343.75 for fiscal year 2021, which would become effective beginning in the first quarter after FDA approval is granted.
The NTAP will provide hospitals with a payment on top of the standard-of-care Diagnostic Related Group (DRG) reimbursement. This additional payment is provided to offset some of the costs of new drugs and devices when certain criteria are met. For the fiscal year 2021, add-on payments for QIDPs are limited to the lesser of 75 percent of the average cost of the product, or 75 percent of the amount by which the costs of the case exceeds the standard DRG payment. NTAP designation lasts no more than three years for a specific indication.
“The NTAP designation highlights the potential of XENLETA and CONTEPO to address the urgent need for novel, first-in-class antibiotics for patients fighting drug-resistant infections,” said Ted Schroeder, Chief Executive Officer of Nabriva Therapeutics. “Importantly, the decision to grant conditional NTAP approval to CONTEPO is unprecedented and we believe should enable more rapid access to this innovative antimicrobial following FDA approval. We applaud CMS for taking the initial policy steps that will enable patients in need to be prescribed innovative antibacterial agents and help reverse the consequences of antimicrobial resistance.”
The NTAP program for antimicrobial resistance (AMR) is intended to encourage the use of new medical technologies in the hospital inpatient setting and help reduce barriers to antibiotic innovation.
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