CurrentHealth NetPolicy CP.CPA.155

Ivermectin (Soolantra)

Policy governs medical necessity, prior authorization criteria, and coverage conditions for topical ivermectin (Soolantra and generic) for treatment of inflammatory lesions of rosacea for commercial lines of business aligned with Centene-affiliated health plans.

Policy Summary

PayerHealth Net

PolicyIvermectin (Soolantra)

Policy CodePolicy CP.CPA.155

Change TypeClarified quantity limitgeneric redirectionreferences updated

Effective DateNov 16, 2016

Next Review Date

Key ActionProvider must submit office chart notes, lab results, or other clinical information supporting that member meets all approval criteria.

SourceLink

POLICY UPDATE CHANGES

Quantity limit of 45 g per month clarified (08.09.21).

Updated generic redirection language to require use of generic unless contraindicated or adverse effects (08.02.23).

Appendix B metronidazole topical formulations clarified (07.31.24).

References reviewed and updated (08.08.25; P&T Approval 11.25).

1Covered Indication(s)

45 g/moQuantity limit

≥18Minimum age (yrs)

6 wksRequired trial duration

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Coverage Summary

Policy scope: Topical ivermectin (brand Soolantra and generic) is covered for the treatment of inflammatory lesions of rosacea for commercial lines of business when the policy criteria are met and supporting documentation is provided. The policy aligns coverage with the FDA-approved indication. A generic-first approach is applied (brand Soolantra requires prior trial/use of generic ivermectin unless contraindicated or adverse effects occur). A monthly quantity limit of 45 g applies.

Thresholds

Age≥ 18 years

Failure duration≥ 6 consecutive weeks

Quantity limit≤ 45 g per month

Maximum daily dose1 g/day

Initial Therapy Criteria

Initial Approval Criteria

Provider must submit documentation supporting that member has met all approval criteria. Ivermectin and Soolantra are medically necessary when the following criteria are met:

ALL of the following

Diagnosis of rosacea
Age ≥ 18 years
Generic redirection: If request is for brand Soolantra cream, member must use generic ivermectin cream, unless contraindicated or clinically significant adverse effects are experienced
generic redirection
Failure of ≥ 6 consecutive weeks of one of the following at maximally tolerated doses, unless clinically significant adverse effects are experienced or all are contraindicated
- Oral doxycycline
- Oral minocycline

Other diagnoses/indications (Initial)

If requested use is not covered under rosacea criteria or recent label change exists

ANY of the following

If drug has had a label change within last 6 months not reflected in policy, refer to no coverage or non-formulary policy CP.CPA.190 (commercial) depending on formulary status
If requested use is not specifically listed in section III and criterion 1 above does not apply, refer to the off-label use policy CP.CPA.09 (commercial)

Continuation Therapy Criteria

Continued Therapy

Conditions required to continue coverage for rosacea

ALL of the following

Member eligibility
- Currently receiving medication via Centene benefit or member has previously met initial approval criteria
- Member is currently receiving medication and is enrolled in state/product with continuity of care regulations (refer to state specific addendums CC.PHARM.03A and CC.PHARM.03B)
Generic redirection: If request is for brand Soolantra cream, member must use generic ivermectin cream, unless contraindicated or clinically significant adverse effects are experienced
generic redirection

Unapproved Indications / Exclusions

Diagnoses/Indications Not Authorized

Coverage exclusions

Non-FDA approved indications which are not addressed in this policy are not authorized unless there is sufficient documentation of efficacy and safety per CP.CPA.09 or evidence of coverage documents

Provider Actions

Documentation Required

Submit supporting documentation

Providers must submit office chart notes, laboratory results, or other clinical information demonstrating that the member meets all approval criteria for topical ivermectin/Soolantra.

Office chart notes
Laboratory results
Other clinical information

Prior Authorization

Prior authorization may be required

Prior authorization may be required for ivermectin/Soolantra depending on the plan; providers should obtain prior authorization when applicable.

Applicable Codes

No procedure/drug codes listedmixed

No codes listed

Clinical Evidence & Indication

FDA indication: Treatment of inflammatory lesions of rosacea (Soolantra prescribing information). This policy aligns with the FDA label. References and policy language have been reviewed and updated over time (see summarized changes such as clarification of the 45 g/month quantity limit and updates to generic redirection language).

Background

Summary from background and applicability: Soolantra (ivermectin cream) is FDA-approved for treatment of inflammatory lesions of rosacea and this policy aligns coverage with the FDA indication. A generic-first (generic redirection) approach is required: if the request is for brand Soolantra, the member must use generic ivermectin cream unless contraindicated or clinically significant adverse effects are experienced. A monthly quantity limit of 45 g applies and approval requires documentation of trials of alternative therapies (failure of ≥ 6 consecutive weeks of one of the listed alternatives at maximally tolerated doses). The policy governs commercial lines of business and applies to Centene-affiliated health plans.

Quick Reference

Covered Indication(s)Treatment of inflammatory lesions of rosacea

Quantity limit45 g/month

Minimum age≥ 18 years

Required trial duration≥ 6 weeks of listed alternatives

Definitions

Definition — Generic redirection: Requirement to use the generic formulation before approving brand Soolantra unless the generic is contraindicated or clinically significant adverse effects are experienced.

Revision History

08.09.21clarified

Quantity limit of 45 g per month clarified.

04.26.22revised

Approval duration for Commercial line of business revised to 12 months or duration of request, whichever is less.

08.02.23revised

Generic redirection language updated: if request is for brand Soolantra cream, member must use generic ivermectin cream, unless contraindicated or clinically significant adverse effects are experienced.