Baxdela®
Drugs - Baxdela® (delafloxacin) [Melinda Therapeutics]
July 2018
Therapeutic area - Quinolones
Approval criteria
- Patient must be 18 years of age or older AND
- Patient must have a diagnosis of an acute bacterial skin and skin structure infection (ABSSSI) that is proven or strongly suspected to be caused by bacteria susceptible to delafloxacin, based on the culture and sensitivity report (if available) AND
- Patient must have no known hypersensitivity to delafloxacin, any of its components, or any of the fluoroquinolone class of antibacterial drugs AND
- Patient must have no end stage renal disease (ESRD) (eGFR < 15 mL/min/1.73 m2) AND
- Patient must have no history of myasthenia gravis AND
- Baxdela is not ordered to treat the same infection for which it or another fluoroquinolone has already been used and treatment was insufficient (e.g., incomplete infection resolution/treatment failure) AND
- Patient is continuing therapy from an inpatient hospital stay (to facilitate transition to outpatient for completion of therapy) OR
- Patient has a contraindication, intolerance to, or failure of preferred antibiotics that are FDA-approved for ABSSSI (should not be approved if patient has failed another fluoroquinolone) OR
- The culture and sensitivity report (if available) or local antibiogram shows resistance of the suspected pathogen to all preferred antibiotics that are FDA-approved for the diagnosed infection
Quantity limits
Background
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Baxdela and other antibacterial drugs, Baxdela should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. Baxdela, when administered as an intravenous infusion, is not eligible for outpatient reimbursement.
Questions?
MHCP Provider Call Center 651-431-2700 or 800-366-5411
