SOLOSEC, Secnidazole Form

Secnidazole (Solosec ™) is a 5-nitroimidazole antimicrobial. FDA Approved Indication(s) Solosec is indicated for the treatment of:
• Bacterial vaginosis in female patients 12 years of age and older • Trichomoniasis in patients 12 years of age and older Limitation(s) of use: To reduce the development of drug-resistant bacteria and maintain the effectiveness of Solosec and other antibacterial drugs, Solosec 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 Solosec is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Bacterial Vaginosis (must meet all):

1. Diagnosis of bacterial vaginosis;
2. Age ≥ 12 years;
3. Failure of two of the following agents, with at least one of the agents used within the last 6 months, unless clinically significant adverse effects are experienced or all are contraindicated: metronidazole, clindamycin, tinidazole (see Appendices B and D for regimens);
   Prior authorization may be required.
   
   4. Dose does not exceed a single dose of 2 grams (1 packet). Approval duration: 7 days (1 packet total)
      B. Trichomoniasis (must meet all):
4. Diagnosis of trichomoniasis;
5. Age ≥ 12 years;

6. Failure of metronidazole and tinidazole, unless both are contraindicated or clinically significant adverse effects are experienced (see Appendix B);
   Prior authorization may be required.

   4. Dose does not exceed a single dose of 2 grams (1 packet). Page 1 of 7

   CLINICAL POLICY Secnidazole Approval duration: 7 days (1 packet total)
   C. 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.
      II. Continued Therapy A. Bacterial Vaginosis
   3. Re-authorization is not permitted. Members must meet the initial approval criteria and at least 14 days should have elapsed since the previous claim for Solosec.
      Approval duration: Not applicable B. Trichomoniasis
   4. Re-authorization is not permitted. Members must meet the initial approval criteria and at least 12 days should have elapsed since the previous claim for Solosec.
      Approval duration: Not applicable C. 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: 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
   6. 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 Page 2 of 7

   CLINICAL POLICY Secnidazole 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 CDC: Centers for Disease Control 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 Bacterial vaginosis clindamycin (Clindesse® vaginal cream, Cleocin®) Intravaginal 2% cream in adults: 1 applicatorful (100 mg clindamycin/5 g cream) intravaginally at bedtime for 7 days • The FDA-approved regimen for most products is 1 applicatorful (100 mg clindamycin/5 g cream) intravaginally at bedtime for 3 or 7 consecutive days in non-pregnant patients and for 7 days in pregnant patients. The dose for Clindesse vaginal cream is 1 applicatorful (100 mg clindamycin/5 g cream) intravaginally as a single dose at any time of the day. See dosing regimen Intravaginal 2% cream in post-menarchal adolescents†: 1 applicatorful (100 mg clindamycin/5 g cream) intravaginally as a single dose Intravaginal ovules/suppositories in adults and post- menarchal adolescents: 1 ovule (100 mg clindamycin) inserted intravaginally at bedtime for 3 days Oral in adults† and adolescents†: 300 mg PO BID for 7 days 0.75% vaginal gel (MetroGel-vaginal): 1 applicatorful (5 g of 0.75% metronidazole gel) intravaginally 1 to 2 times daily for 5 days in adults; metronidazole (Flagyl®, MetroGel- See dosing regimen Page 3 of 7

   CLINICAL POLICY Secnidazole Drug Name Dosing Regimen Vaginal®, Nuvessa®, Vandazole®) One applicatorful (5 g of 0.75% metronidazole gel) intravaginally once daily for 5 days in post- menarchal adolescents†
   Dose Limit/ Maximum Dose 0.75% vaginal gel (Vandazole): One applicatorful (5 g of 0.75% metronidazole gel) intravaginally once daily for 5 days in adults and post-menarchal adolescents† 1.3% vaginal gel: One applicator (5 g of 1.3% gel containing 65 mg of metronidazole) administered intravaginally as a single dose at bedtime in adult women, and adolescents 12-17 years† Regular-release tablet†: 500 mg PO BID for 7 days for adults, children > 45 kg and adolescents; 15 to 25 mg/kg/day PO TID for 7 days in children weighing < 45 kg Adults and adolescents†: 2 g PO QD for 2 days or 1g PO QD for 5 days* Children weighing < 45 kg†: 45 mg/kg/day PO TID for 7 days Female children weighing ≥ 45 kg and adolescents†: 500 mg PO BID for 7 days. Male children weighing ≥ 45 kg and adolescents†: A single 2-g dose PO Adults: A single 2-g dose PO or 500 mg PO BID for 7 days Adults and adolescents†: A single 2-g dose PO
   tinidazole (Tindamax®) Trichomoniasis metronidazole (Flagyl®) See dosing regimen See dosing regimen tinidazole (Tindamax®) 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. †Off-label indication *Recommended regimen per CDC in adults Alternative regimen per CDC in adults See dosing regimen Appendix C: Contraindications/Boxed Warnings • Contraindication(s): history of hypersensitivity to secnidazole, or other nitroimidazole derivatives; patients with Cockayne syndrome • Boxed warning(s): none reported Appendix D: CDC Treatment Regimens for Bacterial Vaginosis • Metronidazole 500 mg orally twice a day for 7 days Page 4 of 7

   CLINICAL POLICY Secnidazole • Metronidazole gel 0.75%, one full applicator (5 g) intravaginally, once a day for 5 days • Clindamycin cream 2%, one full applicator (5 g) intravaginally at bedtime for 7 days • Clindamycin 300 mg orally twice daily for 7 days • Clindamycin ovules 100 mg intravaginally once at bedtime for 3 days • Tinidazole 2 g orally once daily for 2 days, or 1 g orally once daily for 5 days • Solosec 2 g oral granules in a single dose V. Dosage and Administration
   Indication Bacterial vaginosis, trichomoniasis Dosing Regimen 2 g PO as a single dose Maximum Dose 2 g as a single dose VI. Product Availability
   Oral granules: 2 g VII.