Acoltremon (Tryptyr) for dry eye disease
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This policy governs medical necessity and prior authorization criteria for Acoltremon (Tryptyr) when used to treat signs and symptoms of dry eye disease for affected health plan members across listed lines of business.
No material clinical or coverage changes in this revision.
Coverage Criteria
Initial Therapy (Dry Eye Disease)
Covered when ALL of the following are met:
Illinois HIM requests: step therapy requirements do not apply per IL HB 5395
Continuation Therapy (Dry Eye Disease)
Continued therapy covered when ALL of the following are met:
Approval duration: 12 months
Other Diagnoses/Indications
For diagnoses/uses not specified:
References to specific line-of-business policies for non-standard uses
Non–FDA approved indications for Acoltremon (Tryptyr) are not authorized unless the request includes sufficient documentation of safety and efficacy in accordance with the applicable off‑label use policies (see CP.CPA.09 for commercial, HIM.PA.154 for marketplace/ICHRA, and CP.PMN.53 for Medicaid) or as otherwise supported by evidence of coverage documents.
When state Medicaid coverage provisions conflict with this clinical policy, state Medicaid coverage provisions take precedence. Providers should consult the applicable state Medicaid manual for specific coverage requirements and follow those provisions for Medicaid members.
Use of Acoltremon for non‑FDA‑approved indications without submission of sufficient supporting documentation as required by the referenced off‑label use policies (CP.CPA.09, HIM.PA.154, CP.PMN.53) would be considered not authorized under this policy.
Product Coding and Limits
| NDC not listed | Product: Ophthalmic solution single-dose vial 0.003%, 0.4 mL; 60 vials/carton |
Provider Actions and Authorization
Prior authorization required
Prior authorization is required for Acoltremon (Tryptyr). Approval is granted when all listed initial or continued therapy criteria are met; approvals are issued for 12 months.
Prior authorization requirement
This clinical policy governs coverage decisions that may require prior authorization per the Health Plan; providers submitting claims and services are subject to the policy's terms and must follow the policy when requesting coverage.
Step therapy requirements
Step therapy requires documented failure of an artificial tears agent, an ophthalmic anti-inflammatory agent, and generic ophthalmic cyclosporine emulsion 0.05% (generic Restasis), unless contraindicated or clinically significant adverse effects occur.
- Illinois HIM requests are exempt from step therapy requirements per IL HB 5395.
Provider submission details
Submit prior authorization requests that clearly state diagnosis, age, prior therapies tried (including dates and agents), and the quantity requested to facilitate timely review.
- Include documentation of failures or contraindications to required step therapies.
- Ensure requested quantity does not exceed 60 vials (1 carton) per 30 days.
Required documentation
Provider must submit documentation (such as office chart notes, lab results, or other clinical information) supporting that the member has met all approval criteria.
- Documentation should include evidence of diagnosis, age, prior therapy trials and outcomes, and current response to therapy for continuation requests.
Provider contractual notice
Providers, members, and their representatives are bound to the terms and conditions expressed in this clinical policy through their contracts; by providing services or submitting claims they agree to be bound by the policy terms.
Denial triggers
Requests that do not document that the member has met all approval criteria for dry eye disease (including age ≥18 years, required prior therapy failures or documented contraindications, and quantity limits) may be denied.
- Requests exceeding 60 vials (1 carton) per 30 days may be denied.
- Use for non‑FDA‑approved indications without sufficient off‑label documentation may be denied.
State Medicaid precedence
When state Medicaid coverage provisions conflict with this clinical policy, state Medicaid coverage provisions take precedence; failure to follow state Medicaid manual provisions may result in denial.
- Refer to the applicable state Medicaid manual for coverage provisions.
Background
Acoltremon (Tryptyr) is a TRPM8 thermoreceptor agonist approved for treatment of signs and symptoms of dry eye disease (DED). Per American Academy of Ophthalmology guidance referenced in this policy, artificial tears are the standard initial therapy for DED; if inadequate, topical anti‑inflammatory agents (for example, cyclosporine or lifitegrast) are typical next steps prior to use of newer agents such as Acoltremon. Providers must follow the policy criteria for initial and continued therapy, including prior therapy requirements and documentation of clinical response.
Definitions
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