CurrentCentenePolicy CP PMN.219

Lefamulin (Xenleta) - Clinical Policy

Policy governing medical necessity and prior authorization criteria for lefamulin (Xenleta) use in adults with community-acquired bacterial pneumonia (CABP) for Centene lines of business, including Commercial, HIM, and Medicaid.

Policy Summary

PayerCentene

PolicyLefamulin (Xenleta) - Clinical Policy

Policy CodePolicy CP PMN.219

Change TypeNo material change

Effective DateMar 1, 2020

Next Review Date

Key ActionSubmit prior authorization with supporting documentation showing diagnosis of CABP and that approval criteria for initial or continued therapy are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Adults (≥18)Age population indicated in criteria

5-7 daysTypical treatment duration

PO ≤1200mg; IV ≤300mgMax daily dosing

C9399, J8499Referenced HCPCS

Coverage Criteria for Lefamulin (Xenleta)

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Coding and Dosing Limits

Referenced HCPCS CodesHCPCS

C9399	Unclassified drugs or biologicals
J8499	Prescription drug, oral, non-chemotherapeutic, NOS

Maximum Daily Dose — inv-06

Oral (PO) maximum≤ 1,200 mg per day (600 mg PO every 12 hours; max 2 tablets/day)

Intravenous (IV) maximum≤ 300 mg per day (150 mg IV every 12 hours; max 2 vials/day)

Source dosing regimensTypical dosing: PO 600 mg q12h for 5–7 days; IV 150 mg q12h IV over 60 minutes (with option to switch to PO to complete course)

Treatment Duration Limit — inv-07

Maximum authorized durationUp to 7 days total treatment (approval duration = duration of request or up to 7 days, whichever is less)

Typical treatment courseUsual PO course: 5–7 days; IV to PO switch may be used to complete 5–7 day course

Continuation limitMember must not have received more than 7 days of therapy for the current infection to qualify for continuation

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required. Provider must document a diagnosis of community-acquired bacterial pneumonia (CABP) and show that the member meets the plan's initial or continuation criteria for Xenleta. Requests for continuation of therapy initiated in an acute care hospital must be specified.

Affected drug: Xenleta
Make sure request specifies diagnosis and whether therapy was initiated in an acute care hospital

Documentation Required

Supportive Documentation Required

Provider must submit supporting clinical documentation with the prior authorization request. Acceptable documentation includes, but is not limited to, office chart notes, hospital discharge summary, culture and sensitivity (C&S) reports, laboratory results, prior medication history, and notes documenting adverse reactions or contraindications to alternative antibiotics.

Include C&S report when available showing pathogen susceptibility to Xenleta or documentation why C&S is not feasible
If C&S is not available, supply prior antibiotic treatment history and reasons for failure or contraindication

Denial Risk

Provider Action / Denial Risk

Requests that do not include required documentation or that do not meet the specified approval criteria (including failure to document required prior antibiotic trials, C&S results, or hospital-initiated therapy status) may be denied. Requests for non‑FDA indications require sufficient off‑label documentation per applicable off‑label use policies.

Non‑FDA indications: include supporting evidence per CP.CPA.09, HIM.PA.154, or CP.PMN.53 as applicable
Incomplete clinical documentation increases likelihood of denial

Background

Lefamulin (Xenleta) is a systemic pleuromutilin antibacterial indicated for adults with community‑acquired bacterial pneumonia (CABP) caused by susceptible organisms. Dosing options include oral and intravenous formulations (typical regimens include oral 600 mg every 12 hours or IV 150 mg every 12 hours), and use should be limited to proven or strongly suspected bacterial infections with consideration of culture and susceptibility data when available.

Definitions

community-acquired bacterial pneumonia (CABP) — inv-13

DefinitionCommunity-acquired bacterial pneumonia (CABP): pneumonia acquired outside of the hospital or healthcare setting (abbreviated as CABP)

Indication in policyCABP is the required diagnosis for initial approval of lefamulin (Xenleta)

Age requirementPolicy applies to adults 18 years of age or older with CABP

culture and sensitivity (C&S) — inv-14

DefinitionCulture and sensitivity (C&S): laboratory testing to identify the pathogen and determine its susceptibility to antimicrobial agents (abbreviated C&S)

Role in approvalA C&S report showing the isolated pathogen is susceptible to Xenleta satisfies microbiology requirement for initial approval, unless obtaining C&S is not feasible

Alternate when not feasibleIf C&S cannot be obtained, provider must document infeasibility and demonstrate failure of 2 formulary antibiotics for the diagnosis