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    Xenleta™

    Drug - Xenleta™ (lefamulin) [Nabriva Therapeutics US, Inc.]

    April 2020

    Therapeutic Area  - Pleuromutilins

    Approval criteria

    • Be ≥ 18 years of age AND
    • Have a diagnosis of community-acquired bacterial pneumonia (CABP) AND
    • CABP is thought to be due to organisms susceptible to lefamulin and patient is not at risk for multidrug resistant organisms (e.g., Pseudomonas aeruginosa, methicillin-resistant Staphylococcus aureus) AND
    • Not have known sensitivity to lefamulin, its excipients, or another pleuromutilin agents AND
    • Not be pregnant AND
    • Be advised (prescriber attestation) to use effective contraception during treatment and for 2 days following treatment completion if patient is female of reproductive potential AND
    • Not have QT prolongation or ventricular arrhythmias AND
    • Not be taking concomitant agents that prolong the QT interval that are considered sensitive substrates of cytochrome p450 3A4 (CYP3A4) (e.g., pimozide) AND
    • Not be taking any Class IA or Class III antiarrhythmic drugs (e.g., quinidine, procainamide, amiodarone, sotalol) or other agents known to prolong the QT interval (e.g., antipsychotics, erythromycin, moxifloxacin, tricyclic antidepressants) AND
    • Treatment duration is in compliance with product labeling (5 to 7 days intravenous [IV], 5 days oral, and, IV to oral switch, total duration does not exceed 7 days) AND
    • If patient has severe hepatic impairment, oral lefamulin will not be used and the IV formulation is prescribed with a decreased dosing interval (every 24 hours) as per product labeling AND
    • Not be a candidate (based on patient history, risk factors, comorbidities, or local antibiogram) for current treatment-guideline recommended first-line agents for CABP (e.g., macrolide, doxycycline, beta-lactam plus doxycycline or macrolide) OR
    • Patient is continuing treatment to complete a treatment course initiated in an inpatient setting (e.g., hospital) to facilitate transition to an outpatient setting; and the following documentation is provided:
      • Number of doses administered in the inpatient setting as substantiated by medication administration record
      • Number of doses (IV and/or oral doses) that will be administered in an outpatient setting

    Renewal criteria

    • Not renewable for current CABP episode

    Quantity limits

    • 14 vials/7 days (if initiated on IV formulation and switched to oral, total duration should not exceed 7 days)
    • 10 tablets/5 days

    Billing for Xenleta

    • Doses (IV or oral formulation) administered in an inpatient setting is not eligible for outpatient reimbursement
    • Doses (IV or oral formulation) administered by a healthcare provider in an outpatient setting must be submitted as a medical claim
    • Doses (oral formulation) dispensed by a pharmacy must be submitted as a pharmacy claim

    Questions?

    MHCP Provider Call Center 651-431-2700 or 800-366-5411

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