ModifiedMass General Brigham Health PlanPolicy N/A

Xenleta (lefamulin) Oral Tablets

Outlines prior authorization criteria, limitations, and quantity limits for outpatient pharmacy benefit coverage of Xenleta (lefamulin) oral tablets for adults with community-acquired bacterial pneumonia (CABP). Includes allowance for members new to plan and transitions from inpatient therapy.

Policy Summary

PayerMass General Brigham Health Plan

PolicyXenleta (lefamulin) Oral Tablets

Policy CodePolicy N/A

Change TypeRevised criteria (includes inpatient-to-outpatient transition); removed age requirement

Effective DateApr 1, 2025

Next Review Date

Key ActionPrior authorization is required under the pharmacy benefit for Xenleta oral tablets; authorization may be granted for members new to the plan within 90 days who are currently receiving treatment or when criteria for inpatient initiation/transition or CABP with prior use/contraindication/resistance to at least one alternative generic antibiotic are met.

SourceLink

POLICY UPDATE CHANGES

Updated verbiage for new members and added criteria to allow approval if member was started in the inpatient setting and is transitioning to outpatient treatment; removed age requirement.

Separated MassHealth vs Commercial/Exchange in 11/16/2022 review; no clinical changes at that time.

1 monthInitial Approval Duration

90 daysNew-member continuity window

10 tabs/5 daysQuantity Limit (600 mg)

Coverage Summary

Scope: Outlines prior authorization criteria, limitations, and quantity limits for outpatient pharmacy benefit coverage of Xenleta (lefamulin) oral tablets for adults with CABP. Coverage stance: covered_with_criteria; authorization may be granted for members new to the plan within 90 days who are actively on medication, or when inpatient-to-outpatient transition criteria or diagnosis-and-alternative-antibiotic criteria are met. Xenleta is available as intravenous infusion or oral tablets and indicated for adults with CABP per the background.

Policy metadata

Effective date04/01/2025

Last review01/08/2025

StatusMODIFIED

SubjectXenleta (lefamulin) Oral Tablets

New-member continuity window90 days

Initial approval duration1 month

Quantity limit (600 mg)10 tablets per 5 days

Authorization Criteria

Authorization may be granted when ONE of the following is met:

ANY of the following

ALL of the following
- Member meets ONE of the following
  - Member is new to the plan within the past 90 days and is currently receiving treatment with the requested medication (excluding when product obtained as samples or via manufacturer's patient assistance programs).
    Applies to members new to plan within 90 days who are actively on medication.
  - ONE of
    ALL of
    Member initiated Xenleta IV or tablets in the inpatient setting and is transitioning to outpatient treatment.

Provider Actions & Requirements

Prior Authorization

Prior authorization required

Prior authorization is required under the pharmacy benefit for Xenleta oral tablets; authorization may be granted for members new to the plan within 90 days who are currently receiving treatment or when criteria for inpatient initiation/transition or CABP with prior use/contraindication/resistance to at least one alternative generic antibiotic are met.

Pharmacy benefit (not medical) applies.
Members new to plan within 90 days may be approved if actively receiving medication.
Approval pathway includes member initiated in inpatient setting and transitioning to outpatient treatment.

Documentation Required

New member continuity documentation

For members new to plan within 90 days, documentation must show the member is currently receiving the medication and that the product was not obtained as samples or via manufacturer's patient assistance programs.

Applicable Codes

NDC / Drug productNDCCovered

No codes listed

Clinical Evidence & References

Prescribing Information: Xenleta (lefamulin) prescribing information, Nabriva Therapeutics US Inc., June 2021.

Indication: Xenleta is indicated for treatment of adults with community-acquired bacterial pneumonia (CABP) caused by specified susceptible microorganisms; available as intravenous infusion or oral tablets.

Background

Xenleta (lefamulin) is indicated for treatment of adults with community-acquired bacterial pneumonia (CABP). It is available as an intravenous infusion or oral tablets.

Revision History

2025-04-01material_revisedLatest

Updated criteria to allow inpatient-to-outpatient transition as an approval pathway and removed prior age restriction; updated verbiage for new members. (Effective 04/01/2025)

2022-11-16administrative_clarification

Administrative separation of plan populations: MassHealth (MH) was separated from Commercial/Exchange in the 11/16/2022 review; no clinical changes were made at that time.

Policy Summary

PayerMass General Brigham Health Plan

PolicyXenleta (lefamulin) Oral Tablets

Policy CodePolicy N/A

Change TypeRevised criteria (includes inpatient-to-outpatient transition); removed age requirement

Effective DateApr 1, 2025

Next Review Date

SourceLink

On This Page

Diagnosis of community-acquired bacterial pneumonia (CABP) caused by a susceptible microorganism: Streptococcus pneumoniae; Staphylococcus aureus (methicillin-susceptible isolates); Haemophilus influenzae; Legionella pneumophila; Mycoplasma pneumoniae; or Chlamydophila pneumoniae.

Member has had previous use, contraindication, or resistance to at least one alternative generic antibiotic (example: moxifloxacin).

At least one alternative generic antibiotic must have prior use, documented contraindication, or documented resistance.

Excludes coverage when product was obtained as samples or via manufacturer's patient assistance programs.

Billing Rule

Initial approval duration

Requests will be approved for 1 month (authorization duration = 1 month).

Prior Authorization

Reauthorization requirement

Requests for reauthorization must meet the same initial criteria.

Billing Rule

Quantity limit

Quantity limit applies as specified.

Xenleta 600 mg — 10 tablets per 5 days