CurrentCentenePolicy CP.PMN.103

Secnidazole (Solosec) (PDF)

Defines medical necessity criteria, prior authorization expectations, quantity and dosing limits, re-treatment timing, and exclusions for Secnidazole (Solosec) for commercial, HIM and Medicaid lines of business.

Policy Summary

PayerCentene

PolicySecnidazole (Solosec) (PDF)

Policy CodePolicy CP.PMN.103

Change Type1Q2026 annual review updates

Effective Date03.01.18

Next Review Date

Key ActionProvider must submit documentation supporting that member meets all approval criteria.

SourceLink

POLICY UPDATE CHANGES

Added allowable time elapsed for bacterial vaginosis and trichomoniasis retreatment to initial criteria (14 and 12 days respectively).

Added step therapy bypass for Illinois HIM per IL HB 5395.

Added 'request does not exceed health plan-approved quantity limit, if applicable' to initial criteria.

For bacterial vaginosis, tinidazole was added as an option to try/fail in prior reviews (1Q2022 onwards).

2FDA-approved indications covered

12Minimum age (years)

2 gSingle-dose maximum

14 / 12 daysRetreatment intervals (BV / Trich)

Coverage Summary

Scope summary: Defines medical necessity criteria, prior authorization expectations, quantity and dosing limits, re-treatment timing, and exclusions for Secnidazole (Solosec) for commercial, HIM and Medicaid lines of business.

Policy number: CP.PMN.103.

Coverage stance: covered_with_criteria — Solosec (secnidazole) is covered with specified initial approval criteria for bacterial vaginosis and trichomoniasis, including age, prior therapy requirements, single-dose maximum (2 g / 1 packet), re-treatment minimum intervals (14 days for BV and 12 days for trichomoniasis), and quantity/authorization requirements.

Key thresholds

Minimum age≥ 12 years

Maximum single dose2 g (1 packet)

BV retreatment interval≥ 14 days since previous Solosec claim

Trichomoniasis retreatment interval≥ 12 days since previous Solosec claim

Prior antibiotic trial window for BVAt least one of the two failed agents used within the last 6 months

Initial Therapy Criteria

Initial Approval Criteria - Bacterial Vaginosis

Solosec is medically necessary when ALL of the following are met:

Initial Approval - Bacterial Vaginosis

Diagnosis of bacterial vaginosis
Age ≥ 12 years≥ 12 years
Prior therapy: 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
Prior authorization may be required for tinidazole

Continuation / Re-authorization Criteria

Continuation / Re-authorization

Re-authorization rules:

BV re-authorization: Re-authorization is not permitted for bacterial vaginosis; members must meet the initial approval criteria and at least 14 days should have elapsed since the previous claim for Solosec≥ 14 days since prior Solosec claim
Approval duration: Not applicable
Trichomoniasis re-authorization: Re-authorization is not permitted for trichomoniasis; members must meet the initial approval criteria and at least 12 days should have elapsed since the previous claim for Solosec≥ 12 days since prior Solosec claim
Approval duration: Not applicable

Excluded Indications

Provider Actions

Documentation Required

Submit supporting documentation

Provider must submit documentation (office chart notes, lab results, or other clinical information) supporting that the member meets all approval criteria for Solosec.

Prior Authorization

Prior authorization for Solosec

Prior authorization is required for Solosec. Include documentation of prior treatment history (agents tried and timing) and the timing of any prior Solosec claims to demonstrate required retreatment intervals have been met.

Applicable Codes

Product availability / StrengthNDC|mixed

2 g	Oral granules: single dose 2 g packet (product strength/packaging noted)

Clinical Evidence & References

Primary reference: Solosec Prescribing Information (Lupin) October 2024.

Guidelines: CDC Sexually Transmitted Diseases Treatment Guidelines — Trichomoniasis (2022).

Guidelines: CDC Sexually Transmitted Diseases Treatment Guidelines — Bacterial Vaginosis (2021).

Background

Background: Secnidazole (Solosec) is an oral 5-nitroimidazole antimicrobial approved for the treatment of bacterial vaginosis and trichomoniasis in patients aged 12 years and older. The product is provided as oral granules: 2 g single-dose packet with an approved dosing regimen of a single 2 g oral dose for these indications.

Policy metadata

Policy numberCP.PMN.103

SubjectSecnidazole (Solosec) for bacterial vaginosis and trichomoniasis

StatusCURRENT

Effective date2018-03-01 (applies as of policy effective date)

Last review2026-02-26

Revision History

02.26.2026annual_reviewLatest

1Q2026 annual review (P&T Approval 02.26): added allowable time elapsed for retreatment with Solosec — at least 14 days for bacterial vaginosis and at least 12 days for trichomoniasis; added 'request does not exceed health plan-approved quantity limit, if applicable' to initial criteria; references reviewed and updated.

2026-01-01regulatory_effective_dateLatest

For Illinois Health Insurance Marketplace (HIM) requests, the step therapy requirement does not apply effective 1/1/2026 per IL HB 5395 (step therapy bypass added).

Policy Summary

PayerCentene

PolicySecnidazole (Solosec) (PDF)

Policy CodePolicy CP.PMN.103

Change Type1Q2026 annual review updates

Effective Date03.01.18

Next Review Date

Key ActionProvider must submit documentation supporting that member meets all approval criteria.

SourceLink

On This Page

IL HIM step therapy exception: For Illinois HIM requests, the step therapy requirement does not apply as of 1/1/2026 per IL HB 5395

applies only to Illinois HIM

Prior Solosec interval: If member has previously received Solosec, at least 14 days have elapsed since the previous claim for Solosec≥ 14 days since prior Solosec claim

Added allowable time elapsed for BV retreatment

Quantity limit: Request does not exceed health plan-approved quantity limit, if applicable

Dose limit: Dose does not exceed a single dose of 2 grams (1 packet)Maximum single dose = 2 g (1 packet)

Product availability: oral granules 2 g

Initial Approval Criteria - Trichomoniasis

Solosec is medically necessary when ALL of the following are met:

Initial Approval - Trichomoniasis

Diagnosis of trichomoniasis
Age ≥ 12 years≥ 12 years
Prior therapy: Failure of metronidazole and tinidazole, unless both are contraindicated or clinically significant adverse effects are experienced
Prior authorization may be required for tinidazole
IL HIM step therapy exception: For Illinois HIM requests, the step therapy requirement does not apply as of 1/1/2026 per IL HB 5395
applies only to Illinois HIM
Prior Solosec interval: If member has previously received Solosec, at least 12 days have elapsed since the previous claim for Solosec≥ 12 days since prior Solosec claim
Added allowable time elapsed for trichomoniasis retreatment
Quantity limit: Request does not exceed health plan-approved quantity limit, if applicable
Dose limit: Dose does not exceed a single dose of 2 grams (1 packet)Maximum single dose = 2 g (1 packet)
Product availability: oral granules 2 g

Initial Approval Criteria - Other diagnoses/indications

Coverage for other uses requires one of the following:

Initial Approval - Other diagnoses/indications

Recent label change guidance: If this drug has recently (within the last 6 months) undergone a label change that is not yet reflected in this policy, follow the formulary/no-coverage or non-formulary policy for the relevant line of business per guidancewithin 6 months
See policy references CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16
Off-label policy referral: If requested use is not listed under section III and criterion 1 does not apply, refer to the off-label use policy for the relevant line of business
See CP.CPA.09, HIM.PA.154, CP.PMN.53

Prior Authorization

Prior authorization may be required for tinidazole

Prior authorization may be required for tinidazole when used as a therapeutic alternative; this requirement may affect whether step therapy requirements are considered satisfied.

Billing Rule

Quantity and dose limits

Requests must not exceed any applicable health plan–approved quantity limit. Dose for Solosec must not exceed a single 2 g packet (single 2 g dose).

Denial Risk

Denial for non-FDA or undocumented off-label use

Claims for non‑FDA approved indications that are not addressed in this policy will not be authorized unless sufficient documentation of efficacy and safety is provided per the applicable off‑label use policies or evidence of coverage documents.

Added 'request does not exceed health plan-approved quantity limit, if applicable' to initial approval criteria for both bacterial vaginosis and trichomoniasis.

1Q2022non_material_note

Non-material historical note: tinidazole was added as an option to try/fail for bacterial vaginosis in prior reviews (1Q2022) and later noted that tinidazole may require prior authorization.