CurrentUnitedHealthcarePolicy N/A

Prior Authorization / Medical Necessity — Qlosi (pilocarpine) and Vuity (pilocarpine) ophthalmic solutions for presbyopia

Prior authorization and medical necessity policy for Qlosi (pilocarpine 0.4%) and Vuity (pilocarpine 1.25%) ophthalmic solutions for treatment of presbyopia in adults; affects prescribers and UnitedHealthcare pharmacy authorization reviewers.

Policy Summary

PayerUnitedHealthcare

PolicyPrior Authorization / Medical Necessity — Qlosi & Vuity for presbyopia

Policy CodePolicy N/A

Change TypeAnnual review (no material clinical changes)

Effective DateApr 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization for Qlosi; note that all requests for Vuity for presbyopia will be denied.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2medications in program

45-64; 40-55trial age ranges

DeniedVuity stance

2025-04-01effective

Coverage Criteria

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Treatment of Presbyopia — Vuity

Covered when ALL of the following are met

Vuity coverage: Vuity is not considered medically necessary for the treatment of presbyopia based on the definition of medically necessary health care services in the certificate of coverage.

All requests for authorization will be denied.

Initial Therapy / Trial Context

Initial therapy / trial context — clinical trial populations and policy stance

Clinical trial populations and policy stance

Clinical trial ages: Efficacy of Qlosi established in patients 45 to 64 years; Vuity in patients 40 to 55 years.

Coverage stance: Vuity requests for presbyopia will be denied per policy.

State mandates and member-specific benefit plans may alter coverage.

Provider Actions & Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization required for Qlosi and Vuity. All requests for Vuity for presbyopia will be denied per policy (not medically necessary for presbyopia). State mandates and member-specific benefit plans may affect coverage.

Applies to Qlosi (pilocarpine) 0.4% ophthalmic solution and Vuity (pilocarpine) 1.25% ophthalmic solution.
Vuity: all requests for treatment of presbyopia will be denied (not medically necessary).
Check state mandates and member benefit plan for exceptions.

Note

Standard Therapy Context

Corrective lenses (glasses, contact lenses) or refractive surgery are considered standard therapy for presbyopia and are the preferred treatments before considering pharmacologic options.

Standard therapy: corrective lenses or refractive surgery are first-line for presbyopia.

Billing Rule

Automated Approval / Reauthorization & Supply Limits

UnitedHealthcare may use automated approval/reauthorization workflows based on previous claims, medication history, diagnosis codes (ICD-10), and claim logic. Supply limits may apply; check program-specific quantity limits and automated criteria when submitting requests.

Automated approval/reauthorization may be granted using prior claim/medication history and ICD-10 diagnosis codes.
Supply limits may be enforced; review applicable quantity/supply constraints.

Step	Standard therapy requirement	Notes
1	Corrective lenses (glasses or contact lenses) or refractive surgery must be considered prior to pharmacologic treatment for presbyopia	These are considered the standard of care prior to consideration of topical pilocarpine formulations

Definitions

Presbyopia — definition and trial age ranges / management options

DefinitionPresbyopia: age-related near-vision impairment commonly managed with corrective lenses, contact lenses, or refractive surgery.

Clinical trial age range — QlosiEfficacy established in patients 45 to 64 years of age.

Clinical trial age range — VuityEfficacy established in patients 40 to 55 years of age.

Standard management optionsCorrective lenses (glasses, contact lenses) or refractive surgery; these are considered the standard of therapy prior to pharmacologic treatment.

Background

Pilocarpine ophthalmic solutions are topical cholinergic agonists used to treat presbyopia. Qlosi is formulated as pilocarpine 0.4% ophthalmic solution and Vuity as pilocarpine 1.25% ophthalmic solution; these products were evaluated in clinical trials for near-vision improvement in adults. Standard management options for presbyopia remain corrective lenses or refractive surgery.

Quantity Limits

Qlosi / Vuity — supply limits and automated approvals

Quantity limits policySupply limits may be in place for Qlosi and Vuity.

Automated approvalUnitedHealthcare may approve initial and reauthorization requests based solely on previous claim/medication history, diagnosis codes (ICD-10), and/or claim logic; use of automated processes varies by program.

Unit of measureLimits described as supply-based (per month) may apply, specific quantities determined by program rules.