SIVEXTRO, Tedizolid Phosphate Form

Tedizolid (Sivextro®) is an oxazolidinone-class antibacterial agent. FDA Approved Indication(s) Sivextro is indicated in adult and pediatric patients 12 years of age and older for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following gram-positive microorganisms: • Staphylococcus aureus (including methicillin-resistant [MRSA] and methicillin-susceptible [MSSA] isolates)
• Streptococcus pyogenes • Streptococcus agalactiae • Streptococcus anginosus Group (including Streptococcus anginosus, Streptococcus intermedius, and Streptococcus constellatus) • Enterococcus faecalis To reduce the development of drug-resistant bacteria and maintain the effectiveness of Sivextro and other antibacterial drug, Sivextro should be used only to treat ABSSSI that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. 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 Sivextro is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Acute Bacterial Skin and Skin Structure Infections (must meet all):

1. Diagnosis of ABSSSI;

   2. Age ≥ 12 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; Page 1 of 6

   CLINICAL POLICY Tedizolid b. Both of the following (i and ii):
   i. Culture and sensitivity (C&S) report for the current infection shows isolated pathogen is a gram-positive bacteria susceptible to tedizolid, unless provider submits documentation that obtaining a C&S report is not feasible; ii. Member meets one of the following (1, 2, or 3): 1) 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;
   2) C&S report shows resistance or lack of susceptibility of the isolated pathogen to all formulary antibiotics FDA-approved for member’s diagnosis;
   3) 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 both of the following (a and b):
   a. 200 mg per day; b. 1 tablet or 1 vial per day;
   Approval duration: 6 days 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. Acute Bacterial Skin and Skin Structure Infections (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); Page 2 of 6

   CLINICAL POLICY Tedizolid 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 ≥ 6 days of therapy for current infection;
   4. Request does not exceed both of the following (a and b):
      a. 200 mg per day; b. 1 tablet or 1 vial per day. Approval duration: Up to 6 days or total treatment 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 ABSSSI: acute bacterial skin and skin structure infections C&S: culture and sensitivity FDA: Food and Drug Administration MRSA: methicillin-resistant Staphylococcus aureus MSSA: methicillin-susceptible Staphylococcus aureus 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.
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   CLINICAL POLICY Tedizolid 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): none reported • Boxed Warning(s): none reported V. Dosage and Administration
   Indication ABSSSI Dosing Regimen 200 mg once daily PO or IV over 1 hour for six days Maximum Dose 200 mg/day VI. Product Availability
   • Tablet: 200 mg • Single-use vial: 200 mg, sterile, lyophilized powder for reconstitution
   VII.