Sunflower Health Plan NUZYRA, Omadacycline Tosylate Form

Omadacycline (Nuzyra™) is a tetracycline class antibacterial. FDA Approved Indication(s) Nuzyra is indicated for the treatment of adult patients with the following infections caused by susceptible microorganisms: • Community-acquired bacterial pneumonia (CABP) o Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila pneumoniae • Acute bacterial skin and skin structure infections (ABSSSI) o Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Staphylococcus lugdunensis, Streptococcus pyogenes, Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus), Enterococcus faecalis, Enterobacter cloacae, and Klebsiella pneumoniae To reduce the development of drug-resistant bacteria and maintain the effectiveness of Nuzyra and other antibacterial drugs, Nuzyra should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible 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 Nuzyra is medically necessary when the following criteria are met: I. Initial Approval Criteria A. Acute Bacterial Skin and Skin Structure Infections, Community-Acquired Bacterial Pneumonia (must meet all): 1. Diagnosis of ABSSSI or 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): Page 1 of 7 CLINICAL POLICY Omadacycline i. Culture and sensitivity (C&S) report for the current infection shows isolated pathogen is an organism susceptible to omadacycline, 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; 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; 4. Dose does not exceed one of the following (a or b): a. ABSSSI: i. Loading dose: 200 mg IV (2 vials) on Day 1 or 450 mg PO (3 tablets) per day on Days 1 and 2; ii. Maintenance dose: 100 mg IV (1 vial) per day or 300 mg PO (2 tablets) per day; b. CABP: i. Loading dose: 200 mg IV (2 vials) or 600 mg PO (4 tablets) on Day 1; ii. Maintenance dose: 100 mg IV (1 vial) per day or 300 mg PO (2 tablets) per day. Approval duration: Up to 14 days of total treatment B. Other diagnoses/indications (must meet 1 or 2): 1. 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 2. 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. Page 2 of 7 CLINICAL POLICY Omadacycline II. Continued Therapy A. Acute Bacterial Skin and Skin Structure Infections, Community-Acquired Bacterial Pneumonia (must meet all): 1. 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 ≥ 14 days of therapy for current infection; 4. If request is for a dose increase, new dose does not exceed one of the following (a or b): a. 100 mg IV (1 vial) per day; b. 300 mg PO (2 tablets) per day. Approval duration: Up to 14 days of total treatment B. Other diagnoses/indications (must meet 1 or 2): 1. 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 2. 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. Page 3 of 7 CLINICAL POLICY Omadacycline IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key ABSSSI: acute bacterial skin and skin structure infections CABP: community-acquired bacterial pneumonia C&S: culture and sensitivity FDA: Food and Drug Administration 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 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. Dosing Regimen Appendix C: Contraindications/Boxed Warnings • Contraindication(s): known hypersensitivity to omadacycline, tetracycline-class antibacterial drugs or any of the excipients in Nuzyra • Boxed warning(s): none reported V. Dosage and Administration Indication Dosing Regimen CABP Loading dose: Day 1: 200 mg IV over 60 minutes OR 100 mg IV over 30 minutes twice OR 300 mg PO twice Maximum Dose See regimen Maintenance dose: 100 mg IV over 30 minutes QD OR 300 mg PO QD ABSSSI Total duration of treatment: 7-14 days Loading dose: Day 1: 200 mg IV over 60 minutes OR 100 mg IV over 30 minutes twice OR Day 1 and Day 2: 450 mg PO QD See regimen Maintenance dose: 100 mg IV over 30 minutes QD OR 300 mg PO QD Total duration of treatment: 7-14 days VI. Product Availability • Single dose vial: 100 mg omadacycline (equivalent to 131 mg omadacycline tosylate) • Tablet: 150 mg omadacycline (equivalent to 196 mg omadacycline tosylate) Page 4 of 7 CLINICAL POLICY Omadacycline VII.