CMS (Centers for Medicare & Medicaid Services) issued NTAP (new technology add on payment) for Nabriva Therapeutics PLC (NASDAQ:NBRV)’s XENLETA. NTAP is used for XENLETA injection for an inpatient setting in a hospital.
XENLETA to treat CABP
Pleuromutilin antibacterial – Xenleta is used for the treatment of adults with CABP (community-acquired bacterial pneumonia). The fast track designation and QIDP (Qualified Infectious Disease Product) for Xenleta’s IV and oral formulations are approved by the US Food and Drug Administration.
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Nabriva will qualify for additional payment
Nabriva will receive an additional payment of $1,275.75 from CMS when Xenleta is used in an inpatient setting for 2021 with effect from October 1, 2020. In August 2019, the Food and Drug Administration approved Xenleta to cure patients with CABP.
Nabriva receives NTAP for fosfomycin
Nabriva received NTAP for fosfomycin (Contepo) from CMS. Fosfomycin also received fast track designation and QIDP from the US FDA to cure cUTI (complicated urinary tract infections). It can also cure acute pyelonephritis. CMS will pay $2,343.75 in 2021 if the US FDA gives its nod for fosfomycin before July 1, 2021, for each case in a hospital inpatient setting.
What is the benefit for hospitals?
The hospitals engaged in providing treatment using Xenleta will also get additional payment with NTAP in addition to the standard of care DRG (Diagnostic Related Group). Additional payment will help the hospitals compensate for the cost incurred to buy new devices and drugs to satisfy certain criteria.
Additional payments for the QIDPs will be capped at 75% of the product’s average cost in 2021. NTAP designation is valid for up to 3 years for the specific indication. Ted Schroeder, CEO of Nabriva, said the new technology add-on payment designation demonstrates XENLETA and fosfomycin potential in addressing the immediate need for first in class and novel antibiotics the people who are fighting against the drug-resistant infections.
The therapeutics team of Nabriva formulated semi-synthetic pleuromutilin antibiotic – XENLETA. The drug is used for systemic administration on humans and prevents bacterial protein synthesis. Nabriva demonstrated the effectiveness of XENLETA in multinational, two multicenter, double-dummy, double-blind, and non-inferiority trials conducted on 1,289 people who are suffering from CABP. The side effects of XENLETA are nausea, diarrhea, elevated liver enzymes, reaction at the injected site, and vomiting.