Lefamulin (Xenleta) Form

Lefamulin (Xenleta™) is a systemic pleuromutilin antibacterial drug. FDA Approved Indication(s) Xenleta is indicated for the treatment of adults with community-acquired bacterial pneumonia (CABP) caused by the following susceptible microorganisms: Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae, Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila pneumoniae. To reduce the development of drug resistant bacteria and maintain the effectiveness of Xenleta and other antibacterial drugs, Xenleta should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Xenleta is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Community-Acquired Bacterial Pneumonia (must meet all):

1. Diagnosis of CABP;

   2. Age ≥ 18 years;
   3. Member meets one of the following (a or b): a. Request is for continuation of therapy initiated in an acute care hospital from which member was discharged; b. Both of the following (i and ii): i. Culture and sensitivity (C&S) report for the current infection shows isolated pathogen is susceptible to Xenleta, unless provider submits documentation that obtaining a C&S report is not feasible; ii. Member meets one of the following (a, b, or c): a) Failure of ≥ 2 formulary antibiotics to which the isolated pathogen is susceptible (if available) per C&S report, unless clinically significant adverse effects are experienced or all are contraindicated;
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   CLINICAL POLICY Lefamulin b) C&S report shows resistance or lack of susceptibility of the isolated pathogen to all formulary antibiotics FDA-approved for member’s diagnosis;
   c) If provider documents that obtaining a C&S report is not feasible: Failure of ≥ 2 formulary antibiotics indicated for member’s diagnosis (if available), unless clinically significant adverse effects are experienced or all are contraindicated;

2. Dose does not exceed 1,200 mg PO (2 tablets) or 300 mg IV (2 vials) per day. Approval duration: Duration of request or up to 7 days of total treatment, whichever is less B. Other diagnoses/indications (must meet 1 or 2):
3. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or
4. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid. II. Continued Therapy A. Community-Acquired Bacterial Pneumonia (must meet all):

5. Member meets one of the following (a, b, or c): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B); c. Request is for continuation of therapy initiated in an acute care hospital from which member was discharged;

   2. Member is responding positively to therapy;
   3. Member has not received ≥ 7 days of therapy for current infection;
   4. If request is for a dose increase, new dose does not exceed 1,200 mg PO (2 tablets) or 300 mg IV (2 vials) per day.
      Approval duration: Up to 7 days of total treatment
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   CLINICAL POLICY Lefamulin B. Other diagnoses/indications (must meet 1 or 2):

6. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

7. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid. III. Diagnoses/Indications for which coverage is NOT authorized:
   A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid or evidence of coverage documents
   IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key FDA: Food and Drug Administration CABP: community-acquired bacterial pneumonia C&S: culture and sensitivity
   Appendix B: Therapeutic Alternatives
   This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent for all relevant lines of business and may require prior authorization.
   Drug Name Dosing Regimen Dose Limit/ Maximum Dose Therapeutic alternatives include formulary antibiotics that are indicated for member’s diagnosis and have sufficient activity against the offending pathogen at the site of the infection. Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic. Appendix C: Contraindications/Boxed Warnings • Contraindication(s): known hypersensitivity to lefamulin, pleuromutilin class drugs, or any of the components of Xenleta; concomitant use of Xenleta tablets with CYP3A substrates that prolong the QT interval Page 3 of 6

   CLINICAL POLICY Lefamulin • Boxed warning(s): none reported V. Dosage and Administration
   Indication Dosing Regimen CABP PO: 600 mg (1 tablet) PO q12h for 5 days. Maximum Dose PO: 1,200 mg/day IV: 300 mg/day IV: 150 mg (1 vial) q12h IV over 60 minutes (with the option to switch to Xenleta 600 mg tablets PO q12h to complete the treatment course) for 5 to 7 days.
   VI. Product Availability
   • Tablets: 600 mg • Vial for injection: 150 mg VII.