CurrentHealth NetPolicy CP PMN.219

Clinical Policy: Lefamulin (Xenleta)

Medical necessity criteria, dosing limits, and coverage guidance for lefamulin (Xenleta) in adults with community-acquired bacterial pneumonia for Health Net lines of business including Commercial, HIM, and Medicaid.

Policy Summary

PayerHealth Net

PolicyClinical Policy: Lefamulin (Xenleta)

Policy CodePolicy CP PMN.219

Change TypeStep therapy bypass added (IL HIM)

Effective DateMar 1, 2020

Next Review Date

Key ActionSubmit documentation (office notes, labs, C&S results when available) showing the member meets all approval criteria and dosing does not exceed PO 1,200 mg/day or IV 300 mg/day.

SourceLink

POLICY UPDATE CHANGES

Added step therapy bypass for Illinois HIM per IL HB 5395.

Adults with CABPIndication population

1,200 mg/dayPO max

300 mg/dayIV max

≤ 7 daysInitial approval length

C9399, J8499HCPCS

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Coverage Criteria for Lefamulin (Xenleta)

Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met

Initial Approval for CABP: 1. Diagnosis of community-acquired bacterial pneumonia (CABP) and age ≥ 18 years; 2. Request is for continuation of therapy initiated in an acute care hospital from which the member was discharged OR for outpatient initiation when applicable; 3. One of the following must be met: (a) Culture and sensitivity (C&S) report for the current infection shows the isolated pathogen is susceptible to lefamulin (Xenleta), unless the provider documents that obtaining a C&S is not feasible; OR (b) Failure of ≥ 2 formulary antibiotics to which the isolated pathogen is susceptible per C&S (if available), unless clinically significant adverse effects or contraindications prevent their use; OR (c) C&S demonstrates resistance or lack of susceptibility of the isolated pathogen to all formulary antibiotics FDA‑approved for the diagnosis. If C&S is not feasible, provider must document failure of ≥ 2 formulary antibiotics indicated for the diagnosis (if available) unless contraindicated or not tolerated; 4. Requested dose does not exceed either 1,200 mg PO per day (two 600 mg tablets per day) or 300 mg IV per day (two 150 mg vials per day).

Approval duration: up to 7 days total treatment

Continuation Therapy — Covered for continuation when ALL of the following are met

Covered for continuation when ALL of the following are met

Continued Therapy for CABP: 1. Member is currently receiving lefamulin via the Centene benefit or previously met initial approval criteria; 2. Request is for continuation of therapy initiated in an acute care hospital from which the member was discharged OR the member is enrolled in a state/product with continuity of care regulations permitting continuation; 3. Member is responding positively to therapy; 4. Member has not received > 7 days of therapy for the current infection; 5. If a dose increase is requested, the new dose does not exceed 1,200 mg PO per day or 300 mg IV per day.

Requests for lefamulin (Xenleta) to treat indications that are not FDA‑approved are not authorized under this policy unless the provider submits sufficient documentation of efficacy and safety per the applicable off‑label use policy. Acceptable documentation includes evidence aligning with off‑label use policies CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace), or CP.PMN.53 (Medicaid), or other evidence of coverage documents that demonstrate the proposed use is supported.

Requests for lefamulin (Xenleta) for non‑FDA approved indications that lack adequate supporting evidence or do not reference the appropriate off‑label use policy will be considered not authorized. Providers should include clinical rationale and relevant supporting documentation (per the off‑label use policies named above) when requesting coverage for an unapproved indication to avoid denial.

Provider Actions, Documentation & Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for Xenleta. Requests must include documentation that the approval criteria are met and that proposed dosing does not exceed policy limits.

Policy number: CP PMN.219
Dose limits: PO ≤ 1,200 mg/day; IV ≤ 300 mg/day
Approval duration: up to 7 days or duration of request, whichever is less

Documentation Required

Required Documentation

Provider must submit supporting clinical documentation such as office chart notes, culture & susceptibility (C&S) reports when available, and relevant lab results. Requests without adequate documentation will be denied as insufficient.

Examples of acceptable documentation: office notes, hospital discharge summary, C&S lab reports, radiology reports, progress notes
Insufficient documentation or requests for non‑covered/off‑label indications will be considered not covered

Documentation Required

C&S Recommended

Culture and susceptibility (C&S) results are recommended and should be submitted when available. If a C&S report shows the isolated pathogen is susceptible to Xenleta, include that report. If obtaining a C&S is not feasible, the provider must document why it could not be obtained.

When available, submit C&S showing susceptibility or resistance
If C&S is not feasible, document reasons and provide alternative supporting clinical information

Step Therapy

Step Therapy / IL Bypass

Step therapy applies: approval requires documentation of failure of two formulary antibiotics (or documented resistance per C&S) unless there is clinical intolerance or contraindication. Per Illinois HB 5395 / IL HIM requirements, a bypass is allowed when applicable and must be documented.

Document failure (lack of clinical response) of 2 formulary antibiotics indicated for CABP unless contraindicated or not tolerated
Alternatively, submit C&S demonstrating resistance or lack of susceptibility to all formulary antibiotics for the diagnosis
IL HIM bypass: if statutory bypass criteria apply, include documentation supporting bypass per IL HB 5395

Denial Risk

Insufficient Documentation / Non‑Covered Indication

Requests lacking required documentation, or for non‑FDA‑approved indications without sufficient evidence, will be considered not covered.

Non‑FDA indications require sufficient documentation of efficacy/safety per applicable off‑label use policies
Insufficient clinical information will result in denial

Definitions

inv-13: culture and sensitivity — C&S

Definition: C&SCulture and sensitivity (C&S)

PurposeLaboratory testing to identify causative pathogen(s) and determine antimicrobial susceptibility

Use in policyC&S results should be used when available to select or modify therapy and may support approval if showing susceptibility to Xenleta

inv-14: community-acquired bacterial pneumonia — CABP

Definition: CABPCommunity-acquired bacterial pneumonia (CABP)

Indicated populationAdults with CABP — policy applies to members age ≥ 18 years

Relevant dosingTreatment regimens include 600 mg PO q12h or 150 mg IV q12h (total daily maxima: PO 1,200 mg; IV 300 mg)

Role of C&SC&S results can confirm pathogen susceptibility for selecting lefamulin for CABP

OpenPayer

Clinical Policy: Lefamulin (Xenleta)

Coverage Criteria for Lefamulin (Xenleta)

Provider Actions, Documentation & Prior Authorization

Coding and Dosing Limits

Definitions

Background

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