CurrentUnitedHealthcarePolicy N/A

Immunomodulator Agents for Dry Eye — Prior Authorization Criteria and Dosing Limits

Prior authorization criteria and dosing limits for ophthalmic (and nasal) immunomodulator therapies used to treat dry eye syndrome/keratoconjunctivitis sicca; applies to members/providers requesting coverage of listed products.

Policy Summary

PayerUnitedHealthcare

PolicyImmunomodulator Agents for Dry Eye — Prior Authorization Criteria and Dosing Limits

Policy CodePolicy N/A

Change TypeAdded GCNs and updated dosing (annual review)

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization requests with a qualifying diagnosis code from Table 1 within the last 730 days and ensure requested quantity meets product-specific dosing limits.

SourceLink

POLICY UPDATE CHANGES

Added GCN for Cequa (45144) to the "Drugs Requiring Prior Authorization" table.

Updated dosing information for Xiidra.

Added criteria for Tyrvaya and dosing information.

8GCNs / products listed for prior authorization

730 daysdiagnosis look-back requirement

365 daysapproval duration when criteria met

16-18age thresholds vary by product

Coverage / Medical Necessity Criteria

Medical necessity criteria

Covered when the following flow logic is satisfied.

Top-level

Diagnosis: Member has a diagnosis of dry eye syndrome or keratoconjunctivitis sicca documented within the prior 730 days.
Age and product-specific minimums: Member meets the product-specific minimum age requirement: general requests require age ≥18 years; if the request is for Restasis, age ≥16 years; if the request is for Xiidra, age ≥17 years.
Dosing/Quantity: Requested quantity is less than or equal to the recommended dosing guidelines for the requested product (per product-specific limits).
If requested quantity exceeds the product dosing limits, deny as not medically necessary.

Policy Summary

PayerUnitedHealthcare

PolicyImmunomodulator Agents for Dry Eye — Prior Authorization Criteria and Dosing Limits

Policy CodePolicy N/A

Change TypeAdded GCNs and updated dosing (annual review)

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization requests with a qualifying diagnosis code from Table 1 within the last 730 days and ensure requested quantity meets product-specific dosing limits.

SourceLink

On This Page

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Requests for members who do not have a qualifying diagnosis of dry eye syndrome or keratoconjunctivitis sicca within the prior 730 days will be denied. The clinical flow requires at least one of the Table 1 diagnosis codes to be present in the member’s record during that look-back period.

Age minimums are applied by product. For most products the member must be ≥ 18 years of age. Exceptions: if the request is for Restasis the member must be ≥ 16 years, and if the request is for Xiidra the member must be ≥ 17 years. Requests for members below the applicable product-specific age threshold will be denied.

Coding, Products, and Quantity Limits

Required diagnosis codes (Table 1)ICD-10Covered

H04121	DRY EYE SYNDROME OF RIGHT LACRIMAL GLAND.
H04122	DRY EYE SYNDROME OF LEFT LACRIMAL GLAND.
H04123	DRY EYE SYNDROME BILATERAL LACRIMAL GLANDS.
H04129	DRY EYE SYNDROME UNSPECIFIED LACRIMAL GLAND.
H16221	KERATOCONJUNCTIVITIS SICCA, NOT SPECIFIED AS SJOGREN'S RIGHT EYE.
H16222	KERATOCONJUNCTIVITIS SICCA, NOT SPECIFIED AS SJOGREN'S LEFT EYE.
H16223	KERATOCONJUNCTIVITIS SICCA, NOT SPECIFIED AS SJOGREN'S BILATERAL.
H16229	KERATOCONJUNCTIVITIS SICCA, NOT SPECIFIED AS SJOGREN'S UNSPECIFIED EYE.
M3501	SICCA SYNDROME WITH KERATOCONJUNCTIVITIS.

Drugs Requiring Prior Authorization (GCNs)mixed

GCN: 45144	CEQUA 0.09% SOLUTION
GCN: 48834	EYSUVIS 0.25% EYE DROPS
GCN: 19216	RESTASIS 0.05% EYE EMULSION
GCN: 42588	RESTASIS MULTIDOSE 0.05%
GCN: 51384	TYRVAYA 0.03 MG NASAL SPRAY
GCN: 54237	VEVYE 0.1% EYE DROP
GCN: 41847	XIIDRA 5% EYE DROPS

Cequa, Restasis, Xiidra single-use containers — quantity / dosing limits summary

LimitCequa, Restasis (single-use), and Xiidra: 60 single-use vials/containers per 30 days

Restasis multidoseRestasis multidose bottle: 5.5 mL per 30 days

ScopeApplies to Cequa (0.09%), Restasis (0.05%), and Xiidra (5%) as listed in dosing table

Eysuvis dosing — 8.3 mL per 14 days

Recommended dosingEysuvis: 8.3 mL per 14 days

IntervalMeasured over a 14-day period

Source productEYSUVIS 0.25% eye drops (GCN listed)

Tyrvaya dosing — 2 spray bottles (60 sprays per bottle) per 30 days

Recommended dosingTyrvaya: 2 spray bottles (60 sprays per bottle) per 30 days

ProductTYRVAYA 0.03 mg nasal spray (GCN: 51384)

IntervalMeasured per 30-day period

Vevye dosing — 6 mL per 30 days

Recommended dosingVevye: 6 mL per 30 days

ProductVEVYE 0.1% eye drop (GCN: 54237)

IntervalMeasured per 30-day period

Provider Requirements and Actions

Prior Authorization

Prior Authorization Required

Prior authorization is required for the listed GCNs before dispensing. Submit PA requests per UnitedHealthcare procedures and confirm formulary coverage where applicable.

Prior authorization applies to the above GCNs; coverage may vary by formulary (verify current formulary status).
PA approvals are contingent on meeting clinical criteria and documentation requirements described below.

Documentation Required

Required Diagnosis Documentation

Ensure the medical record includes a qualifying diagnosis code from Table 1 documented within the past 730 days. Lack of an acceptable diagnosis entry within 730 days is a primary reason for denial.

Required: one qualifying Table 1 diagnosis documented in the last 730 days.
Examples of Table 1 descriptions: DRY EYE SYNDROME (right/left/bilateral/unspecified), KERATOCONJUNCTIVITIS SICCA (right/left/bilateral/unspecified), SICCA SYNDROME WITH KERATOCONJUNCTIVITIS.

Denial Risk

Denial Triggers and Age Restrictions

Be aware of explicit denial triggers and age-based restrictions. Requests that do not meet these conditions should not be submitted or will be denied on review.

Deny if no qualifying diagnosis in the last 730 days.
Deny if client is under minimum age for the requested product: general minimum <16 years leads to denial; Restasis requests require ≥16 years; Xiidra requests require ≥17 years; some branches require ≥18 years as noted in clinical logic.
Deny if requested quantity exceeds recommended dosing guidelines (see dosing limits per product in Table 8).

Billing Rule

Provider Billing and Quantity Rules

Follow dosing/quantity limits and billing rules when submitting PA and claims. Approvals are granted up to 365 days when all criteria are met.

Approved durations: up to 365 days when criteria met.
Confirm requested quantity does not exceed product-specific recommended dosing (Table 8) to avoid denial.

Key Definitions and Limits

Look-back timeframe — the period (730 days) during which a qualifying diagnosis must be present

Look-back period730 days — a qualifying diagnosis of dry eye syndrome or keratoconjunctivitis sicca must be present within this timeframe

Required evidenceAt least one required diagnosis code from Table 1 documented within the 730-day look-back

Consequence of absenceNo qualifying diagnosis within 730 days leads to denial per clinical criteria logic

Approval duration — when criteria are met, authorization is approved for 365 days

Approval durationWhen criteria are met, authorization is approved for 365 days

ConditionApproval contingent on meeting diagnosis, age, and dosing criteria

Denial triggerIf requested quantity exceeds recommended dosing guidelines, the request is denied (no approval period)

Background

Dry eye syndrome (keratoconjunctivitis sicca) is commonly managed with topical immunomodulator agents. This policy covers several such products that require prior authorization, including topical cyclosporine formulations, lifitegrast, and a varenicline nasal spray formulation. The intent is to link coverage decisions to documented diagnosis, age-appropriate use, and product-specific dosing limits to ensure appropriate utilization.

When criteria are met the policy authorizes therapy for up to 365 days. The policy uses a 730-day look-back to verify a qualifying diagnosis and enforces the dosing limits per product (see dosing table) as part of the medical necessity determination.