CurrentUnitedHealthcarePolicy 2024 P 3107-8

Solosec (secnidazole) step therapy program

UnitedHealthcare step therapy program requiring trial of specified alternative antibacterial agents before coverage of Solosec (secnidazole) for bacterial vaginosis or trichomoniasis in patients >=12 years. Authorization issued for one month; automated approval based on claims history may be used.

Policy Summary

PayerUnitedHealthcare

PolicySolosec (secnidazole) step therapy program

Policy CodePolicy 2024 P 3107-8

Change TypeAnnual review (no changes); historical additions

Effective DateNov 1, 2024

Next Review Date

Key ActionPrior to coverage of Solosec, document history of failure, contraindication, or intolerance to one of the listed alternative agents for the specific indication.

POLICY UPDATE CHANGES

8/2024 annual review with no changes.

Added Cleocin vaginal suppositories as a step agent (3/2019 historic change).

Added new indication for Trichomonas vaginalis (8/2022).

Added statement regarding use of automated approval process (3/2020).

2Covered Indications

6Alt agents for BV

2Alt agents for Trichomoniasis

Coverage Summary

UnitedHealthcare step therapy program requiring trial of specified alternative antibacterial agents before coverage of Solosec (secnidazole) for bacterial vaginosis or trichomoniasis in patients 12 years and older. Authorization will be issued for one month. UnitedHealthcare may use automated approval based on previous claim/medication history, diagnosis codes (ICD-10), and/or claim logic.

Initial Therapy Criteria

Bacterial vaginosis - Initial approval

Solosec will be approved when ALL of the following are met:

ALL of the following

Indication is bacterial vaginosis
Patient is 12 years of age or older
ONE of
- clindamycin capsules (generic Cleocin)
- clindamycin vaginal suppository (Cleocin)
- clindamycin vaginal cream (generic Cleocin, Clindesse)
- metronidazole tablets (generic Flagyl)
- tinidazole tablets (generic Tindamax)
- metronidazole vaginal gel (Metrogel-Vaginal)

Trichomonas vaginalis - Initial approval

Solosec will be approved when ALL of the following are met:

ALL of the following

Indication is trichomonas vaginalis (trichomoniasis)
Patient is 12 years of age or older
ONE of
- metronidazole tablets (generic Flagyl)
- tinidazole tablets (generic Tindamax)

Authorization, Automated Approvals, and Provider Requirements

Authorization duration

ALL of the following

Authorization will be issued for one month

Automated approvals / Additional rules

ANY of the following

UnitedHealthcare may approve initial and reauthorization based solely on previous claim/medication history, diagnosis codes (ICD-10) and/or claim logic
Supply limits may be in place
State mandates and member-specific benefit plan coverage may impact coverage criteria

Step Therapy

Step therapy requirement

Prior to coverage of Solosec, document a history of failure, contraindication, or intolerance to one of the listed alternative agents for the specific indication.

clindamycin capsules (generic Cleocin)
clindamycin vaginal suppository (Cleocin)
clindamycin vaginal cream (generic Cleocin, Clindesse)
metronidazole tablets (generic Flagyl)
tinidazole tablets (generic Tindamax)
metronidazole vaginal gel (Metrogel-Vaginal)

Prior Authorization

Authorization duration

Authorization for Solosec will be issued for one month.

Documentation Required

Support for automated approval

UnitedHealthcare may approve initial and reauthorization based solely on previous claim/medication history, diagnosis codes (ICD-10), and/or claim logic as part of automated approval processes. Provide previous claims or medication history and relevant diagnosis codes if available to support approval.

Applicable Codes / Referenced Drugs

Referenced drugs (alternatives listed for step therapy)mixed

	clindamycin capsules (generic Cleocin)
	clindamycin vaginal suppository (Cleocin)
	clindamycin vaginal cream (generic Cleocin, Clindesse)
	metronidazole tablets (generic Flagyl)
	tinidazole tablets (generic Tindamax)
	metronidazole vaginal gel (Metrogel-Vaginal)
	Solosec (secnidazole) - two gram oral granule single dose

Background

Solosec (secnidazole) is indicated for treatment of bacterial vaginosis and trichomoniasis in patients 12 years of age and older. Solosec is available as a single-dose two gram oral granule. The step therapy program encourages use of lower-cost alternative antibacterial agents prior to coverage of Solosec.

Step therapy: A utilization management program requiring trial of specified lower-cost alternatives before coverage of a preferred agent.

Revision History

3/2019added

Added Cleocin vaginal suppositories as a step agent (historic)

3/2020added

Added statement regarding use of automated approval process

8/2022added

Added new indication for Trichomonas vaginalis (Trichomoniasis) — material

8/2024revisedLatest

Annual review with no clinical policy changes

Policy Summary

PayerUnitedHealthcare

PolicySolosec (secnidazole) step therapy program

Policy CodePolicy 2024 P 3107-8

Change TypeAnnual review (no changes); historical additions

Effective DateNov 1, 2024

Next Review Date

Key ActionPrior to coverage of Solosec, document history of failure, contraindication, or intolerance to one of the listed alternative agents for the specific indication.

On This Page

OpenPayer

Solosec (secnidazole) step therapy program

Coverage Summary

Initial Therapy Criteria

Authorization, Automated Approvals, and Provider Requirements

Applicable Codes / Referenced Drugs

Clinical Evidence & References

Background

Revision History