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NBRV

Nabriva Therapeutics

$0.57 /

+0.0321 (+6.02%)

08:45
09/10/20
09/10
08:45
09/10/20
08:45

Nabriva Therapeutics granted NTAP for XENLETA, CONTEPO by CMS

Nabriva Therapeutics announced that the Centers for Medicare & Medicaid Services has granted a new technology add-on payment for XENLETA 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. Both the IV and oral formulations of XENLETA were granted Qualified Infectious Disease Product 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 approved the IV and oral versions of XENLETA for the treatment of adult patients with CABP in August 2019. Nabriva also announced that CMS has granted an NTAP for CONTEPO, 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, 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 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.

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