CurrentCignaPolicy N/A

Metabolic Disorders - Cysteamine Ophthalmic Solution Prior Authorization Policy

Defines prior authorization requirements for Cystadrops and Cystaran ophthalmic cysteamine solutions for treatment of corneal cystine crystal deposits in cystinosis patients; applies to prescriptions under Cigna health benefit plans.

Policy Summary

PayerCigna

PolicyCysteamine Ophthalmic Solution Prior Authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateMar 4, 2026

Key ActionObtain prior authorization and ensure the medication is prescribed by or in consultation with an ophthalmologist or metabolic disease specialist.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2brand formulations covered

1 yrapproval duration (FDA)

Nationalapplicability

Nonerecent annual revisions

Coverage Criteria

FDA-Approved Indication: Corneal cystine crystal deposits: A) Patient has corneal cysteine crystal deposits confirmed by slit-lamp examination; AND B) The medication is prescribed by or in consultation with an ophthalmologist or a metabolic disease specialist (or specialist who focuses in the treatment of metabolic diseases).

Approval duration: 1 year

Cystadrops (cysteamine 0.37% ophthalmic solution) and Cystaran (cysteamine 0.44% ophthalmic solution) are covered with criteria only for the FDA‑approved indication of treatment of corneal cystine crystal deposits in patients with cystinosis. Use of these products for any other condition is considered not medically necessary. This policy reflects current criteria and will be updated as new published data become available.

Use of Cystadrops or Cystaran for indications other than corneal cystine crystal deposits associated with cystinosis is considered not medically necessary. Providers should document the diagnosis of corneal cystine crystal deposition when seeking coverage; claims submitted for non‑covered indications will be denied as not covered.

Provider Actions / Authorization Requirements

Prior Authorization

Prior Authorization Recommended

Prior authorization recommended for prescription benefit coverage of Cystadrops (0.37%) and Cystaran (0.44%) for treatment of corneal cystine/cysteine crystal deposits. Approvals are provided for the duration noted in the policy.

Cystadrops (cysteamine 0.37% ophthalmic solution) — Recordati Rare Diseases
Cystaran (cysteamine 0.44% ophthalmic solution) — Leadiant Biosciences

Documentation Required

Prescriber Specialty Documentation

Because of the specialized skills required for evaluation, diagnosis, monitoring of adverse events, and assessment of long-term efficacy, approval requires the medication to be prescribed by or in consultation with a physician who specializes in the condition being treated.

Prescriber must be an ophthalmologist or a metabolic disease specialist (or specialist who focuses in the treatment of metabolic diseases).

Denial Risk

Coding / Claim Denial Risk

Claims submitted for services that are not accompanied by covered diagnosis and/or procedure code(s) under the applicable coverage policy will be denied as not covered. When billing, providers must use the most appropriate codes as of the effective date of the submission.

Claims without covered diagnosis/procedure codes will be denied.
Ensure use of covered ICD-10/CPT/HCPCS codes consistent with this policy and the member's benefit plan.

Note

Provider Action

Providers should include documentation of slit-lamp confirmation of corneal cystine/cysteine crystal deposits and specialty consultation or prescription in the prior authorization request.

Approval criteria require: 1) slit-lamp examination confirming corneal cysteine crystal deposits; and 2) prescription by or consultation with an ophthalmologist or metabolic disease specialist.
Approvals are authorized for 1 year when criteria are met.

Definitions

Cysteamine ophthalmic solution — definition and indication

Drug classCystine-depleting topical agent

IndicationTreatment of corneal cystine crystal accumulation in patients with cystinosis

Typical formulations referencedCystadrops (cysteamine 0.37%) and Cystaran (cysteamine 0.44%) — topical ophthalmic solutions

Therapeutic rationaleTopical cysteamine is required because oral cysteamine does not achieve therapeutic corneal concentrations to dissolve corneal cystine crystals

Affected tissueCornea (corneal cystine crystals causing photophobia and ocular manifestations)

Background

Cystinosis is a rare inherited metabolic disorder in which cystine accumulates in lysosomes and deposits as crystals in multiple tissues, including the cornea. Corneal cystine crystal accumulation can cause photophobia and visual disturbance. Oral cysteamine does not reliably achieve therapeutic concentrations in the cornea, so topical cysteamine ophthalmic solutions (Cystadrops and Cystaran) are used specifically to reduce corneal cystine crystals.