CurrentCentenePolicy HIMPA.15

Brinzolamide/Brimonidine (Simbrinza) ophthalmic suspension

Policy governing medical necessity and coverage criteria for Simbrinza (brinzolamide 1% / brimonidine 0.2%) for reduction of elevated intraocular pressure in members, applicable to Centene-affiliated health plans.

Policy Summary

PayerCentene

PolicyBrinzolamide/Brimonidine (Simbrinza) ophthalmic suspension

Policy CodePolicy HIMPA.15

Change TypeNo material change

Effective DateSep 4, 2018

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results, or other clinical information) supporting that the member has met all approval criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1% / 0.2%active ingredient concentrations

TIDrecommended dosing frequency

12 monthsapproval duration

>=22minimum age

Coverage Criteria

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Initial Approval for Ocular Hypertension or Open-Angle Glaucoma: Member has a diagnosis of open-angle glaucoma or ocular hypertension; member is >= 22 years of age; member has failed a prostaglandin analog (e.g., latanoprost, travoprost, bimatoprost, tafluprost) in combination with a beta blocker (e.g., timolol) unless clinically significant adverse effects occur or both classes are contraindicated; requested dose does not exceed 1 bottle per 25 days; dosing is consistent with prescribing information (instill 1 drop in the affected eye(s) three times daily; maximum 3 drops/day per affected eye).

Continuation Therapy

Covered when ALL of the following are met

Continued Therapy for Ocular Hypertension or Open-Angle Glaucoma: Member is currently receiving the medication via the Centene benefit or previously met initial approval criteria; member is responding positively to therapy (clinical benefit documented); when applicable, members continuing therapy under continuity-of-care regulations meet state/product requirements; if the request is for a dose increase, the new dose does not exceed 1 bottle per 25 days.

Coverage under this clinical policy is subject to all terms, conditions, exclusions, and limitations specified in the member's coverage documents (for example, evidence of coverage, certificate of coverage, policy or contract). Where discrepancies exist between this clinical policy and applicable law, regulation, or the member's coverage documents, legal and regulatory requirements and the member's coverage documents govern.

Provider Actions and Prior Authorization

Prior Authorization

Prior Authorization Guidance

Prior authorization is required. This document is a clinical policy guide to medical necessity; however, prior authorization, coverage decisions, and approvals are governed by the member's contract, plan terms, and applicable Health Plan administrative policies.

Prior authorization required for requests unless otherwise exempt.
Approvals are granted for 12 months when criteria are met.

Documentation Required

Required Documentation and Insufficiency

Provider must submit supporting clinical documentation (e.g., office chart notes, lab results, and other relevant clinical information) demonstrating the member meets all approval criteria. Requests lacking required documentation may be delayed or denied.

Include recent office notes documenting diagnosis and prior therapies.
Include lab results or diagnostic testing when relevant.
Attach documentation of adverse effects or contraindications if claiming exceptions to step therapy.

Note

Provider Obligations

Providers submitting requests or claims are bound by the terms and conditions of the Health Plan and must comply with applicable administrative policies, contract provisions, and state/federal regulations. Providers are independent contractors and not agents of the Health Plan.

Comply with plan-level prior authorization processes and timelines.
Ensure documentation is retained and available upon request.
Follow state-specific continuity of care regulations when applicable.

Step Therapy

Step Therapy Requirement

Step therapy requirement: For approval, there must be documented failure of a prostaglandin analog in combination with a beta blocker (e.g., latanoprost, travoprost, bimatoprost, tafluprost plus timolol), unless all such agents are contraindicated or clinically significant adverse effects have occurred.

Examples of prostaglandin analogs: latanoprost, travoprost, bimatoprost, tafluprost.
Combination failure or intolerance must be documented in the medical record.

Background

Simbrinza is a fixed‑dose ophthalmic suspension containing brinzolamide 1% (a carbonic anhydrase inhibitor) and brimonidine tartrate 0.2% (an alpha‑2 adrenergic receptor agonist) indicated to reduce elevated intraocular pressure in patients with open‑angle glaucoma or ocular hypertension. The approved dosing regimen is one drop in the affected eye(s) three times daily (TID), with a maximum of 3 drops per day per affected eye.

Definitions

Simbrinza (brinzolamide/brimonidine) description

Active ingredients & concentrationsBrinzolamide 1% and brimonidine tartrate 0.2%

FormulationOphthalmic suspension, fixed‑dose combination

Indication (FDA)Reduction of elevated intraocular pressure in patients with open‑angle glaucoma or ocular hypertension

Clinical policy — definition

PurposeA guide to medical necessity used to assist in making coverage decisions and administering benefits

Not a contract or guaranteeDoes not constitute a contract or guarantee regarding payment or results

Clinical judgmentNot intended to dictate how providers practice; providers must exercise professional medical judgment