CurrentCignaPolicy N/A

Ophthalmology - Dry Eye Disease - Tryptyr Prior Authorization Policy

Defines prior authorization requirements and coverage criteria for Tryptyr (acoltremon ophthalmic solution) for treatment of dry eye disease under Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyTryptyr (acoltremon) ophthalmic solution prior authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateApr 1, 2026

Next Review DateApr 1, 2026

Key ActionObtain prior authorization and approve for 1 year when FDA-approved criteria for dry eye disease are met for patients ≥18 years.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥18Min age

1 yearApproval length

ExcludedConcomitant use

2References

Coverage Criteria for Tryptyr (acoltremon)

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Concomitant use of Tryptyr with an ophthalmic cyclosporine product (examples: Cequa, Restasis/generic, Vevye), Tyrvaya (varenicline nasal solution), or Xiidra (lifitegrast 5% ophthalmic solution) is declared not medically necessary. The policy states there are no data to support concomitant use of Tryptyr with these agents.

Tryptyr is considered not medically necessary for any use other than the FDA‑approved indication for dry eye disease. This includes requests that seek concomitant administration of Tryptyr with ophthalmic cyclosporine products (Cequa, Restasis/generic, Vevye), Tyrvaya (varenicline nasal solution), or Xiidra (lifitegrast 5% ophthalmic solution), because there are no data to support such combined use.

Provider Actions, Authorization, and Billing

Prior Authorization

Prior Authorization Required

Prior authorization required — Approve when criteria for the FDA-approved indication are met. Approval duration: 1 year for adult patients (≥ 18 years) when used for dry eye disease (dry eye syndrome, keratoconjunctivitis sicca).

Tryptyr (acoltremon ophthalmic solution) — Prior authorization recommended for prescription benefit coverage.
Approval duration: 1 year for FDA‑approved indication in patients ≥ 18 years.

Note

Guideline Context — No Mandated Step Requirement

Guideline context: The AAO Dry Eye Syndrome Preferred Practice Pattern (2024) describes a four-step staged management approach but indicates therapies may be chosen from any step based on provider judgment and patient preference; there is no mandated step-therapy requirement. Tryptyr is not specifically addressed in the AAO guideline. Other FDA‑approved therapies (e.g., ophthalmic cyclosporine products, Miebo, Tyrvaya, Xiidra) are noted as Step 2 options and may be considered alternative therapies.

No step-therapy sequence is mandated — providers may select therapies from any step based on clinical judgment and patient preference.
AAO notes no head-to-head trials showing superiority of one FDA‑approved agent over another.

Documentation Required

Billing and Documentation Expectations

Billing and documentation expectations: Coverage determinations must be consistent with the member's applicable benefit plan and supported by clinical documentation of the covered diagnosis. When submitting claims, use the most appropriate diagnosis and procedure codes as of the date of service; services billed for conditions or diagnoses not covered under the applicable coverage policy will be denied.

Ensure documentation supports diagnosis of dry eye disease (e.g., dry eye syndrome, keratoconjunctivitis sicca).
Use appropriate ICD‑10/CPT/HCPCS codes current on date of service; claims lacking covered codes will be denied.

Denial Risk

Not Medically Necessary Uses

Not medically necessary uses — Requests for Tryptyr for any use other than the FDA‑approved indication (dry eye disease) are considered not medically necessary. Concomitant use with an ophthalmic cyclosporine product, Tyrvaya (varenicline nasal solution), or Xiidra (lifitegrast ophthalmic solution) is not supported by data and is considered not medically necessary.

Concomitant use with ophthalmic cyclosporine products (Cequa, Restasis/generic, Vevye), Tyrvaya, or Xiidra is not medically necessary.
This list may not be exhaustive; criteria will be updated as new published data become available.

Background on Tryptyr and Dry Eye Disease

Tryptyr (acoltremon ophthalmic solution) is a TRPM8 thermoreceptor agonist indicated for the treatment of the signs and symptoms of dry eye disease. Dry eye disease (also called dry eye syndrome or keratoconjunctivitis sicca) is a disorder classified by symptoms and signs and is managed using a staged approach outlined in AAO guidance. Prior authorization is recommended for Tryptyr; approvals for the FDA‑approved indication are for 1 year and limited to patients aged ≥ 18 years. The policy also specifies that concomitant use with ophthalmic cyclosporine products, Tyrvaya, or Xiidra is considered not medically necessary because supporting data are lacking.

Definitions

inv-09: Dry eye disease — alternate names, classification by symptoms/signs and severity

Alternate namesAlso known as dry eye syndrome or keratoconjunctivitis sicca.

Core definitionA disorder of the ocular surface characterized by signs and symptoms of ocular surface dryness; Tryptyr is indicated for treatment of the signs and symptoms of dry eye disease.

Classification by symptoms and signsGenerally classified as mild, moderate, or severe based on symptoms and clinical signs; emphasis is placed on symptoms over signs.

Management approachManaged using a staged (four-step) approach per AAO Preferred Practice Pattern, with specific therapies selectable from any step based on provider judgment and patient preference.

Pediatric useSafety and efficacy in pediatric patients have not been established (adult indication only).