CurrentColorado Rocky Mountain Health PlansPolicy N/A

Prior Authorization/Medical Necessity - Qlosi, Vizz, Vuity (topical ophthalmic solutions) for Presbyopia

Defines prior authorization and medical necessity stance for Qlosi (pilocarpine 0.4%), Vizz (aceclidine 1.44%), and Vuity (pilocarpine 1.25%) ophthalmic solutions for treatment of presbyopia in adults; applies to UnitedHealthcare Pharmacy Clinical Pharmacy Programs members covered under the payer.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyPrior Authorization/Medical Necessity - Qlosi, Vizz, Vuity for Presbyopia

Policy CodePolicy N/A

Change TypeNo material change

Effective DateDec 1, 2025

Next Review DateSep 1, 2025

Key ActionSubmit prior authorization requests for Qlosi, Vizz, or Vuity knowing the policy deems them not medically necessary and authorization requests will be denied unless overridden by state mandate or member benefit.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3products addressed

Deniedcoverage outcome

12/1/2025effective

2022-2025P&T history

Coverage Criteria

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Treatment of Presbyopia

Not covered for presbyopia when used as pharmacologic treatment:

Denial for presbyopia: Qlosi (pilocarpine 0.4%), Vizz (aceclidine 1.44%), and Vuity (pilocarpine 1.25%) are not considered medically necessary for the treatment of presbyopia and all authorization requests will be denied.

State mandates, federal regulatory requirements, and member-specific benefit plans may impact coverage.

This policy explicitly states that Qlosi (pilocarpine 0.4%), Vizz (aceclidine 1.44%), and Vuity (pilocarpine 1.25%) are not considered medically necessary when used as pharmacologic treatment for presbyopia. Consequently, all authorization requests for these products for the indication of presbyopia will be denied. Note that state mandates, federal regulatory requirements, or the member’s specific benefit plan may alter coverage for an individual member.

Per the policy definition of medically necessary health care services in the certificate of coverage, Qlosi, Vizz, and Vuity are not medically necessary for the treatment of presbyopia and therefore are not covered for that indication. All requests for authorization for these agents to treat presbyopia will be denied, subject to any overriding state or member benefit provisions.

Provider Actions & Authorization

Denial Risk

Prior Authorization Requirement and Denial

Prior authorization is required; however, Qlosi, Vizz, and Vuity are not considered medically necessary for the treatment of presbyopia under the member certificate of coverage. All requests for authorization will be denied. State mandates, federal requirements, and individual benefit plan terms may affect coverage.

All authorization requests for Qlosi, Vizz, or Vuity for presbyopia will be denied.
Check member-specific benefits and applicable state or federal mandates for exceptions.

Note

Standard Therapy Context

The standard of therapy for presbyopia is corrective lenses (glasses, contact lenses) or refractive surgery. Pharmacologic therapy with topical pilocarpine formulations is considered nonstandard relative to these established treatments.

Corrective lenses and refractive surgery are the primary standard therapies for presbyopia.
Topical pilocarpine products are informationally noted but not standard first-line therapy.

Prior Authorization

Automated Approval and Supply Limits

Automated approval and re-approval processes may occur despite the coverage criteria. UnitedHealthcare (programs may vary) may approve initial or reauthorization requests based solely on prior claim/medication history, diagnosis codes (ICD-10), and/or claim logic. Supply limits may also be applied.

Automated approvals can be granted based on prior claims or medication history.
Supply limits may be enforced on dispensed product quantities.

Denial Risk

Denial Policy

All requests for authorization will be denied per the medical necessity determination for treatment of presbyopia with these products.

Denial applies to Qlosi, Vizz, and Vuity for presbyopia.
Member-specific plan language and regulatory mandates may alter applicability.

Initial Therapy

Indication and coverage stance for initial therapy

Initial therapy denial: Use of Qlosi, Vizz, or Vuity for initial treatment of presbyopia is not considered medically necessary and will be denied.

Clinical trial age ranges (informational): Qlosi 45–64 years; Vizz 45–75 years; Vuity 40–55 years. Standard therapy remains corrective lenses or refractive surgery.

Definitions

Presbyopia (Definition and management)

DefinitionPresbyopia — age-related reduction in near focusing ability.

Typical managementCorrective lenses (glasses or contact lenses) or refractive surgery.

Clinical trial age ranges (informational)Qlosi: 45–64 years; Vizz: 45–75 years; Vuity: 40–55 years.

ScopeApplies to topical ophthalmic agents addressed in this policy (Qlosi, Vizz, Vuity).

Most actionable pointPresbyopia is managed with corrective lenses or refractive surgery; pharmacologic treatment with Qlosi, Vizz, or Vuity is not considered medically necessary for presbyopia under this policy.

Background

Background: Qlosi (pilocarpine 0.4%), Vizz (aceclidine 1.44%), and Vuity (pilocarpine 1.25%) are topical ophthalmic agents developed for the pharmacologic treatment of presbyopia in adults. Although these products have been studied for improving near vision, this policy addresses their coverage specifically for presbyopia and determines that use for that indication is not medically necessary under the certificate of coverage.