CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Xenleta (lefamulin) for community-acquired bacterial pneumonia — Coverage Criteria

This policy governs coverage and authorization criteria for Xenleta (lefamulin) for treatment of adults with community-acquired bacterial pneumonia (CABP) for Neighborhood Health Plan of Rhode Island members, including Medical and Pharmacy benefit provisions.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyXenleta (lefamulin) for community-acquired bacterial pneumonia — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJan 1, 2021

Next Review DateN/A

Key ActionSubmit prior authorization with chest radiograph confirmation, culture/sensitivity results, age ≥18, and evidence of trial and failure or intolerance to at least one alternative antibiotic.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥18minimum age for coverage

10tablets per course

5-10 daysIV dosing duration

J0691HCPCS (injectable)

1 monthoral coverage duration

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Coverage and Authorization Criteria

Initial Authorization Criteria

Covered when ALL of the following are met

Primary coverage criteria

Clinical presentation and diagnostic confirmation
- Symptoms: At least 3 of the 4 symptoms consistent with community-acquired bacterial pneumonia (CABP): cough, sputum production, chest pain and/or dyspnea.
- Radiographic confirmation: Diagnosis of CABP confirmed by chest radiograph.
Microbiologic documentation: Documentation of culture and sensitivity results.
Age eligibility: Patient is at least 18 years of age.
Prior therapy requirement
- Alternative antibiotic trial: Member has tried and failed, or had intolerance to, at least one alternative antibiotic to which the organism is susceptible (examples: moxifloxacin, levofloxacin, beta-lactam plus macrolide, or beta-lactam plus doxycycline).
- MMP exception: For Medicaid Medicare Plan (MMP) members who received this medication within the past 365 days, the prior therapy requirement does not apply.
Oral formulation continuation (when applicable): For Xenleta (lefamulin) tablet requests, therapy must have been initiated in the hospital and the request is for continuation upon discharge when applicable.

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This clinical medical policy governs coverage for Xenleta (lefamulin) only in the absence of a National Coverage Determination (NCD) or Local Coverage Determination (LCD) for INTEGRITY (Medicare‑Medicaid Plan) members, per 42 CFR 422.101. If an applicable NCD or LCD exists, those determinations supersede this policy for affected members.

Requests will be considered not medically necessary and may be denied when required diagnostic or eligibility information is missing. Specifically, denials may result if the submission does not document: diagnostic confirmation of CABP by chest radiograph; at least 3 of 4 CABP symptoms (cough, sputum production, chest pain and/or dyspnea); culture and sensitivity results; evidence that the patient is ≥18 years of age; or documentation of trial and failure or intolerance to at least one alternative antibiotic to which the organism is susceptible. For oral tablet requests, documentation that therapy was initiated in the hospital (when applicable) is also required.

Documentation, Prior Authorization, and Step Therapy Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Requests must demonstrate diagnostic confirmation of Community Acquired Bacterial Pneumonia (CABP), confirm member age ≥ 18 years, and document a trial and failure or intolerance to an alternative antibiotic (unless member is MMP and meets exception).

Authorization precondition: Diagnostic confirmation including chest radiograph
Age requirement: Member is ≥ 18 years
Step therapy: Trial and failure or intolerance to at least one alternative antibiotic to which the organism is susceptible (e.g., moxifloxacin, levofloxacin, beta-lactam + macrolide, beta-lactam + doxycycline)
MMP (Medicare-Medicaid Plan) exception: MMP members who received this medication within the past 365 days are not subject to the step therapy requirement
Xenleta tablets special case: For tablet requests intended as hospital-to-home continuation, documentation that therapy was initiated in the hospital is required

Step Therapy

Step Therapy / Alternative Trial Requirement

Billing Codes and Billable Units

HCPCS / CPT codes listedHCPCS

J0691

Injectable, lefamulin, 1mg

IV Dosing and Billing Thresholds

Maximum billable units (IV)3000 billable units every 10 days

Dose interval (IV)150 mg IV every 12 hours

Minimum IV duration before oral transitionMinimum of 3 days of IV before transitioning to oral

Key Definitions

Early Clinical Response (trial definition)

DefinitionImprovement in clinical signs and symptoms of pneumonia within 72 hours of treatment initiation as used in clinical trials.

ContextEndpoint used in LEAP 1 and LEAP 2 trials comparing lefamulin to moxifloxacin.

Clinical implicationEarly improvement (within 72 hours) was the trial primary measure of response to therapy.

CABP Diagnostic Confirmation

Required symptom countAt least 3 of the following 4 symptoms: cough, sputum production, chest pain, and/or dyspnea.

Radiographic confirmationChest radiograph confirming a diagnosis of community-acquired bacterial pneumonia (CABP).

Clinical Background

Lefamulin (Xenleta) is a pleuromutilin antibacterial agent indicated for the treatment of adults with community‑acquired bacterial pneumonia (CABP). Clinical evidence from pivotal trials demonstrated non‑inferiority to moxifloxacin for early clinical response and overall clinical success. Common adverse reactions observed in trials include gastrointestinal events such as nausea, vomiting, and diarrhea.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyXenleta (lefamulin) for community-acquired bacterial pneumonia — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJan 1, 2021

Next Review DateN/A

SourceLink

On This Page

Member must have tried and failed or had an intolerance to one alternative antibiotic to which the isolated organism is susceptible prior to approval, unless the MMP exception applies or the request is for a hospital-initiated continuation of therapy.

Required alternative trial examples: moxifloxacin, levofloxacin, beta-lactam + macrolide, beta-lactam + doxycycline
Exception: Prior alternative trial not required for MMP members who received the medication within the past 365 days
Exception: Prior trial not required when the request documents continuation of hospital-initiated therapy

Documentation Required

Required Clinical Documentation

Clinical documentation must be submitted with the authorization request. This documentation should confirm the diagnosis and support medical necessity.

Documentation of ≥ 3 of the 4 CABP symptoms (cough, sputum production, chest pain and/or dyspnea)
Chest radiograph confirming CABP
Culture and sensitivity results demonstrating organism susceptibility
For Xenleta tablets, documentation that therapy was initiated during hospitalization if request is for continuation upon discharge
Member age documentation (date of birth)

Denial Risk

Denial Risks for Missing Required Documentation

Requests lacking required documentation are at high risk for denial. Ensure all required diagnostic, microbiology, and trial information is provided to avoid delays or denials.

Missing chest radiograph or documentation of ≥3 CABP symptoms may result in denial
Absent culture and sensitivity results showing organism susceptibility may result in denial
Failure to document trial and failure or intolerance to an alternative antibiotic (when required) may result in denial
Missing proof of member age (≥18 years) may result in denial
For tablet continuation requests, lack of documentation that therapy was initiated in the hospital may result in denial

Additional documentationDocumentation of culture and sensitivity results is required along with symptom and radiograph confirmation.