Add-on Payment to Reimburse Hospitals up to 75 Percent of the cost of FETROJA in Hospital Inpatient Setting
The NTAP will provide hospitals with a payment, in addition to the standard-of-care Diagnostic Related Group (DRG) reimbursement, of up to 75 percent of the average cost of FETROJA for a period of two to three years, effective in the new fiscal year starting on October 1, 2020. CMS has assigned a maximum payment of $7,919.86 for a patient treated with FETROJA.
“The NTAP designation for FETROJA underscores the need for new antimicrobial drugs for patients fighting drug-resistant infections and highlights FETROJA’s potential in filling an unmet medical need,” said Akira Kato, Ph.D., president and CEO at Shionogi Inc. “We believe the decision to include FETROJA in the NTAP program is an important step and will help increase access to this important antibiotic.”
The CMS NTAP program is designed to encourage the utilization of new medical technologies in the hospital inpatient setting to treat Medicare patients. “The pipeline of antibiotics that target antimicrobial resistance has greatly diminished. In addition to the CMS NTAP program, an urgent need exists for reimbursement reform and new economic incentives to encourage development and commercialization of antibiotics,” said Kato.
About FETROJA® (cefiderocol) for injection
Shionogi submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration for FETROJA and was granted Priority Review designation with a Prescription Drug User Fee Act (PDUFA) date of September 27, 2020. The company submitted the sNDA for the treatment of adult patients with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible Gram-negative pathogens.
Cefiderocol, under the brand name FETCROJA®, is approved by the European Commission for the treatment of infections due to aerobic Gram-negative bacteria in adults 18 years or older with limited treatment options.
Indication and Usage from USPI
Important Safety Information
Warnings and Precautions
An increase in all-cause mortality was observed in patients treated with FETROJA as compared to best available therapy (BAT) in a multinational, randomized, open-label trial in critically-ill patients with carbapenem-resistant Gram-negative bacterial infections (NCT02714595). Patients with nosocomial pneumonia, bloodstream infections, sepsis, or cUTI were included in the trial. BAT regimens varied according to local practices and consisted of 1 to 3 antibacterial drugs with activity against Gram-negative bacteria. Most of the BAT regimens contained colistin.
Clostridioides difficile-associated Diarrhea (CDAD)
Seizures and Other Central Nervous System (CNS) Adverse Reactions
Development of Drug-Resistant Bacteria
Shionogi’s commitment to fighting antimicrobial resistance
Forward Looking Statement
For further information, contact:
Lindsay Bohlander, Director, Advocacy & PR
- 1Antimicrobial Resistance Benchmark 2020. https://accesstomedicinefoundation.org/media/uploads/downloads/5f3f76733efaa_Antimicrobial_Resistance_Benchmark_2020.pdf Last accessed July 2020