Xenleta – NC Standard

Restricted Product(s)

• Xenleta™ (lefamulin)

FDA Approved Use

• For the treatment of adults with community-acquired bacterial pneumonia (CABP) caused by susceptible microorganisms: Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae, Legionella pneumophila, Mycoplasma pneumoniae and Chlamydophila pneumoniae.

Criteria for Approval of Restricted Product(s)

1. The patient has been stable on Xenleta (lefamulin) IV (inpatient) prior to transitioning to Xenleta (lefamulin) tablets; OR 
2. The prescriber is an infectious disease specialist; OR 
3. The patient is 18 years of age or older; AND 
4. The patient has been diagnosed with community-acquired bacterial pneumonia (CABP); AND 
5. The infection is caused by Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae, Legionella pneumophila, Mycoplasma pneumoniae, or Chlamydophila pneumoniae; AND 
   1. The patient has a history of fluoroquinolone or macrolide use in the past three months; OR 
   2. The infection has demonstrated resistance to the following antibiotics shown by a sputum culture/gram stain: amoxicillin, a macrolide antibiotic (azithromycin, clarithromycin, or erythromycin), doxycycline, fluoroquinolone (levofloxacin or moxifloxacin), and cefuroxime (medical record documentation required); AND 
6. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies (outlined below)*
   
   Duration of Approval: 30 days

*Non-formulary Exception Criteria

Non-Formulary Exception criteria applies on formularies which exclude requested product(s). Satisfactory completion of criteria points (above) may satisfy some, or all, portions of the Non-Formulary Exception Criteria. This criteria is summarized as:

1. Request must be for an FDA approved indication; AND
2. Patient must have a trial and failure of up to TWO formulary medications or a clinical contraindication/intolerance to those medications not tried.

References

All information referenced is from FDA package insert unless otherwise noted below.

Mandell LA, Wunderink RG, Anzueto A, et al. Infectious Diseases Society of America/American Thoracic Society consensus guidelines on the management of community-acquired pneumonia in adults. Clin Infect Dis 2007; 44 Suppl 2:S27.

Policy Implementation/Update Information

August 2021: Criteria update: Annual criteria review. No changes to policy.
September 2019: Original utilization management criteria issued. 

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Discrimination is Against the Law

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