CurrentCentenePolicy CP PMN.270

Pilocarpine (Qlosi, Vuity) for Presbyopia — Coverage Criteria

Defines medical necessity and prior authorization criteria for Qlosi and Vuity for treatment of presbyopia in adult members across Centene line(s) of business. Affects prescribers (optometrists/ophthalmologists) and pharmacy/medical benefit reviewers.

Policy Summary

PayerCentene

PolicyPilocarpine (Qlosi, Vuity) for Presbyopia — Coverage Criteria

Policy CodePolicy CP PMN.270

Change TypeAdded Qlosidosing clarifications

Effective DateDec 1, 2021

Next Review Date

Key ActionSubmit prior authorization with documentation that member meets initial or continued therapy criteria including diagnosis, prescriber specialty, age limits, failure of corrective lenses or intolerance, absence of glaucoma/ocular hypertension, and dosing within specified limits.

SourceLink

POLICY UPDATE CHANGES

Added newly approved agent Qlosi to criteria.

Updated maximum dosing language for Vuity per prescriber information: an initial drop in each eye daily followed by an additional dose 3 to 6 hours after first dose.

Updated maximum dosing language for Qlosi per prescriber information: initial drop in each eye daily followed by an additional dose 2 to 3 hours after first dose.

2FDA-approved products addressed (Qlosi, Vuity)

6 monthsInitial approval duration

12 monthsContinued therapy approval duration

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Age restrictions differ by agent

HypersensitivityContraindication

Coverage Criteria

Initial Therapy

Covered when ALL of the following are met:

Initial Approval

Age and product specific: If Vuity: age 40-55 years; if Qlosi: age 45-64 years.
Dosing limits: Vuity: 1 drop per eye per day, with an additional dose in each eye administered 3 to 6 hours after the first dose; OR Qlosi: 1 drop per eye per day, with an additional dose in each eye administered 2 to 3 hours after the first dose (maximum 2 drops per eye/day).

Prescriber and documentation: Prescribed by or in consultation with an optometrist or ophthalmologist and supporting documentation submitted (e.g., office chart notes) demonstrating presbyopia and prior corrective-lens failure or contraindication/intolerance to corrective lenses.

Continuation Therapy

Covered for continuation when ALL of the following are met:

Continuation: Member is currently receiving the medication via the Centene benefit or has previously met initial approval criteria, OR member is under continuity of care per applicable state/product provisions; member is responding positively to therapy (stability or improvement in near vision); dosing remains within product-specific maximums; if a dose increase is requested, the new dose does not exceed the specified maximum for the requested product.

Not Medically Necessary / Not Authorized

Non-FDA indications and exclusions: Non–FDA-approved indications are not authorized unless sufficient documentation of efficacy and safety is provided per applicable off‑label use policies (e.g., CP.CPA.09, HIM.PA.154, CPPMN.53). Requests for members with known hypersensitivity to pilocarpine or any excipient, or for members with glaucoma or ocular hypertension, are not authorized and may be denied.

Known hypersensitivity to pilocarpine or any excipient is a contraindication and excludes coverage for pilocarpine ophthalmic products.

Use of pilocarpine ophthalmic products for non–FDA‑approved indications that are not addressed in this policy is not authorized unless the provider submits sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies (see CP.CPA.09, HIM.PA.154, CPPMN.53 or other evidence of coverage documents).

Coding and Dosing

Codes referencedmixed

N/A	No procedure or billing CPT/HCPCS codes specified in policy document

Maximum dosing per product — Vuity and Qlosi

Vuity — daily dosing1 drop in each eye once daily; one additional drop in each eye may be administered 3 to 6 hours after the first dose (maximum 2 drops per eye/day)

Qlosi — daily dosing1 drop in each eye once daily; one additional drop in each eye may be administered 2 to 3 hours after the first dose (maximum 2 drops per eye/day)

Per-prescriber maximumBoth products: maximum of 2 drops per eye per day (initial drop plus a single permitted additional drop within product-specific interval)

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required and coverage is criteria-based. Provider must document that the member meets initial or continued therapy criteria, including diagnosis and relevant clinical information.

Prior authorization required — Policy number CP PMN.270
Coverage is criteria-based; approval granted only when all applicable clinical criteria are met
Approval duration (when authorized): 6 months

Documentation Required

Required Supporting Documentation

Provider must submit supporting documentation with the PA request (e.g., office chart notes, ophthalmologic exam findings, vision testing results, and lab results when applicable) demonstrating that the member meets all approval criteria.

Examples of acceptable documentation: office chart notes, visual acuity testing, refraction results, prior use of corrective lenses, and notes from an optometrist or ophthalmologist

Background

Pilocarpine ophthalmic solutions (marketed as Vuity and Qlosi) are cholinergic muscarinic receptor agonists approved to treat presbyopia in adults by improving near vision. These products are prescribed by optometrists or ophthalmologists and require attention to product‑specific age limits, dosing limits, and contraindications such as glaucoma and known hypersensitivity.

Definitions

Presbyopia — definition and age-related note

DefinitionPresbyopia: age-related decline in near vision for which Qlosi and Vuity are FDA-approved treatments.

Clinical noteAgents addressed (Qlosi, Vuity) are pilocarpine ophthalmic solutions — cholinergic muscarinic agonists used to improve near vision in adults.

Age-related considerationPolicy includes product-specific age ranges for eligibility (see coverage criteria): Vuity and Qlosi intended for adult presbyopia patients.

Policy Summary

PayerCentene

PolicyPilocarpine (Qlosi, Vuity) for Presbyopia — Coverage Criteria

Policy CodePolicy CP PMN.270

Change TypeAdded Qlosidosing clarifications

Effective DateDec 1, 2021

Next Review Date

SourceLink

On This Page

Note

Requests for Non–FDA‑Approved Indications / New Indications or Dosing

Requests for non–FDA-approved indications (off‑label uses), newly approved indications, age expansions, or dosing regimens not reflected in this policy must follow the applicable formulary/off‑label/non‑formulary procedures and policies.

If the requested use is a newly approved indication, age expansion, or dosing change not yet in this policy, follow the formulary or off‑label procedures for the relevant line of business
Commercial formulary/off‑label references: CP.CPA.190 and CP.CPA.09
Health insurance marketplace references: HIM.PA.33 and HIM.PA.154
Medicaid references: CP PMN.255 / CP PMN.16 and CP.PMN.53

Denial Risk

Non‑FDA Indications — Documentation and Denial Risk

Requests for non‑FDA indications that do not include sufficient documentation of efficacy and safety (per the off‑label use policies listed above) may be denied.

Non‑FDA indications require strong supporting evidence per off‑label use policies (CP.CPA.09, HIM.PA.154, CP.PMN.53)
Absence of adequate documentation increases risk of denial

Denial Risk

Denial Conditions / Contraindications

Requests will be denied when the member has contraindications listed in this policy (for example, glaucoma, ocular hypertension, or known hypersensitivity to pilocarpine or any excipients).

Do not request therapy for members with glaucoma or ocular hypertension — such requests may be denied
Known hypersensitivity to the active ingredient or any excipient is a contraindication and may result in denial