Sarecycline (Seysara) Form

Sarecycline (Seysara™) is a tetracycline-class drug. FDA Approved Indication(s) Seysara is indicated for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older. Limitation(s) of use:
• Efficacy of Seysara beyond 12 weeks and safety beyond 12 months have not been established. Seysara has not been evaluated in the treatment of infections. • To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, Seysara should be used only as indicated. 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 Seysara is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Acne Vulgaris (must meet all):

1. Diagnosis of acne vulgaris;
2. Age ≥ 9 years;

3. Failure of two preferred oral tetracycline antibiotics (e.g., immediate-release minocycline, doxycycline), each used for 4 weeks, unless clinically significant adverse effects are experienced or all are contraindicated;

   4. Dose does not exceed 150 mg (1 tablet) per day. Approval duration: 12 weeks
      B. Other diagnoses/indications (must meet 1 or 2):
   5. 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: Page 1 of 6

   CLINICAL POLICY Sarecycline 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.
      II. Continued Therapy A. Acne Vulgaris (must meet all):
   3. Member meets one of the following (a or b): 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);
4. Member is responding positively to therapy;

5. If request is for a dose increase, new dose does not exceed 150 mg (1 tablet) per day. Approval duration: 12 weeks 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 – Page 2 of 6

   CLINICAL POLICY Sarecycline 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 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.
   Dosing Regimen Drug Name Dose Limit/ Maximum Dose Varies doxycycline (Vibramycin) doxycycline, extended- release (Doryx) minocycline (Minocin)
   tetracycline
   Adults, adolescents, and children ≥ 8 years old weighing ≥ 45 kg: 100 mg PO every 12 hours on day 1, then 100 mg PO QD Children ≥ 8 years old and adolescents weighing < 45 kg: 2.2 mg/kg/dose PO every 12 hours on day 1, then 2.2 mg/kg/dose PO QD Adults, adolescents, and children ≥ 8 years old weighing ≥ 45 kg: 120 mg PO every 12 hours on day 1, then 120 mg PO daily Children ≥ 8 years old and adolescents weighing < 45 kg: 5.3 mg/kg PO in 2 divided doses on day 1, followed by 2.6 mg/kg PO once daily Adults: 200 mg PO initially, then 100 mg PO every 12 hours as adjunctive therapy. Alternatively, if more frequent oral doses are preferred, 100 to 200 mg PO initially, then 50 mg PO every 6 hours Children ≥ 8 years and adolescents: 4 mg/kg PO (max: 200 mg) initially, then 2 mg/kg/dose PO every 12 hours (max: 100 mg/dose) as adjunctive therapy Adults: 1 g/day PO in divided doses, then decrease slowly to 125 to 500 mg PO daily or every other day Children ≥ 9 years and adolescents: 1 g/day PO in divided doses, then decrease slowly to 125 to 500 mg PO QD or QOD Varies 200 mg/day Varies 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): hypersensitivity to any of the tetracyclines • Boxed warning(s): none reported Page 3 of 6

   CLINICAL POLICY Sarecycline V. Dosage and Administration
   Indication Dosing Regimen Acne vulgaris Weight-based dosing according to the following: • 33-54 kg: 60 mg
   • 55-84 kg: 100 mg
   • 85-136 kg: 150 mg Maximum Dose 150 mg/day Each dose is taken PO QD without regard to food intake. VI. Product Availability
   Tablets: 60 mg, 100 mg, 150 mg VII.