ModifiedCentenePolicy CP.PMN.192

Brimonidine Tartrate (Mirvaso) topical gel

Defines medical necessity and prior authorization criteria for brimonidine tartrate (Mirvaso and generic topical brimonidine) for treatment of persistent facial erythema of rosacea for Centene-affiliated health plans (Commercial, HIM/ICHRA, Medicaid).

Policy Summary

PayerCentene

PolicyBrimonidine Tartrate (Mirvaso) topical gel

Policy CodePolicy CP.PMN.192

Change TypeStep therapy bypass addeddosing and quantity clarified

Effective DateJun 1, 2019

Next Review Date

Key ActionSubmit prior authorization with supporting clinical documentation and confirm member meets all approval criteria including age ≥18 and dose ≤1 tube/month.

SourceLink

POLICY UPDATE CHANGES

Added step therapy bypass for generic and brand Mirvaso for Illinois HIM per IL HB 5395.

Added that plan-approved quantity limit may apply and clarified maximum dose is one tube per month.

Standardized approval duration language for Commercial to align with Medicaid/HIM and added ICHRA line of business.

1 tube/momaximum dose allowed

12 moapproval duration

≥18age requirement

0.33% gel

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Coverage Criteria

Initial Therapy

Covered when ALL of the following are met:

Diagnosis of persistent facial erythema associated with rosacea

Age ≥ 18 years

Brand-to-generic redirection: For brand Mirvaso requests, member must use generic topical brimonidine unless contraindicated or clinically significant adverse effects are experienced

Papules/pustules management: If papules or pustules are present, failure of, or concomitant treatment with, topical metronidazole, oral doxycycline, ivermectin cream, or azelaic acid (Finacea) unless clinically significant adverse effects are experienced or all are contraindicated

Step therapy bypass for Illinois HIM per IL HB 5395 (does not apply to IL HIM as of 1/1/2026)

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

Dose limit: Dose does not exceed 1 tube per month1 tube/month

Continuation Therapy

Covered when ALL of the following are met:

Continuation eligibility: Member is currently receiving medication via Centene benefit or previously met initial approval criteria OR member is currently receiving medication and is enrolled in a state/product with continuity of care regulations

Refer to state-specific continuity of care addendums

Clinical response: Member is responding positively to therapy

Brand-to-generic redirection: For brand Mirvaso requests, member must use generic topical brimonidine unless contraindicated or clinically significant adverse effects are experienced

Quantity/dose limits: Request does not exceed health plan-approved quantity limit; if request is for a dose increase, new dose does not exceed 1 tube per month

Requests for uses of brimonidine tartrate that are non‑FDA approved indications and are not specifically addressed in this policy are excluded from coverage unless the provider submits sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policy. See CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace/ICHRA, and CP.PMN.53 for Medicaid for the requirements and acceptable supporting evidence for off‑label requests.

When there is a conflict between this clinical policy and a state Medicaid coverage provision, the state Medicaid coverage provision takes precedence. Providers should consult the applicable state Medicaid manual for any state‑specific coverage rules that govern brimonidine tartrate.

Use of brimonidine tartrate for indications that are not FDA‑approved and are not described in this policy is considered not authorized unless adequate documentation is provided showing efficacy and safety as required by the applicable off‑label use policy. Absent that documentation, requests for non‑FDA indications may be denied.

Coding

Covered/Referenced Codesmixed

No CPT/HCPCS listed

Policy contains no specific procedure codes; therapeutic alternatives listed.

inv-07: Maximum supply — 1 tube per month

Maximum supplyDose limit does not exceed 1 tube per month (maximum 1 tube/month)

Dosing regimenApply a pea-size amount topically once daily to each of five facial areas (forehead, chin, nose, each cheek); one application/day

Product strengths/packagingGel 0.33% available in 30 g or 45 g tube/pump

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required and Approval Duration

Prior authorization is required. Approval duration: 12 months. Requests must not exceed any health plan‑approved quantity limit, if applicable, and dose for initial or continued therapy does not exceed 1 tube per month (or new dose limit for dose increase).

Approval duration: 12 months
Dose limit: ≤ 1 tube per month
Plan-approved quantity limits may apply

Documentation Required

Supportive Documentation Required

Provider must submit supporting documentation (such as office chart notes, lab results, or other clinical information) that demonstrates the member meets all approval criteria. Lack of adequate documentation may result in denial.

Examples: office chart notes, lab results, other clinical information

Background

Brimonidine tartrate topical gel is an alpha‑2 adrenergic agonist that produces vasoconstriction of superficial facial blood vessels to reduce erythema. The product is FDA‑approved for the topical treatment of persistent (nontransient) facial erythema of rosacea in adults ≥18 years and is supplied as a 0.33% gel in 30 g or 45 g tubes/pumps.

Definitions

inv-17: Facial erythema associated with rosacea — definition

DefinitionPersistent (nontransient) facial erythema of rosacea

Affected populationAdults 18 years of age or older (FDA-approved population)

Mechanism noteBrimonidine tartrate reduces erythema through direct vasoconstriction (alpha-2 adrenergic agonist)

inv-18: Clinical policy definition — Guide to medical necessity; not a guarantee of payment.

PurposeGuide to medical necessity to assist coverage decisions and benefit administration

Development basisDeveloped from medical literature, guidelines, agency approvals, and expert input