CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Ophthalmic cysteamine (Cystaran, Cystadrops) — coverage criteria for corneal cystine crystal accumulation

Covers prior authorization and continuation requirements for Cystaran and Cystadrops to treat corneal cystine crystal accumulation in members with cystinosis; applies to prescribers and prior authorization reviewers for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyOphthalmic cysteamine (Cystaran, Cystadrops) — coverage criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionSubmit leukocyte cystine assay results or genetic testing results to support prior authorization for ophthalmic cysteamine.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization period

2covered products

1diagnostic required

Coverage Criteria

Initial Authorization

Covered when ALL of the following are met:

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Continuation of Therapy / Reauthorization

Continuation of therapy covered when ANY of the following are met:

Continuation authorization for ophthalmic cysteamine: A. Member has experienced a decrease in corneal cystine crystal accumulation; or B. Member did not experience an increase in corneal cystine crystal accumulation.12 months authorization

Reauthorization duration stated as 12 months

Provider Actions & Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required for Cystadrops may be granted for up to 12 months when diagnosis is confirmed by leukocyte cystine assay or genetic testing and the member has corneal cystine crystal accumulation.

Authorization duration: up to 12 months
Condition: corneal cystine crystal accumulation present
Diagnostic confirmation: leukocyte cystine assay OR genetic testing

Documentation Required

Submit leukocyte cystine assay results or genetic testing results that support the diagnosis of cystinosis with the prior authorization request.

Acceptable documentation: assay detecting increased cystine concentration in leukocytes
Acceptable documentation: genetic testing confirming cystinosis

Denial Risk

Indications — Covered vs Not Covered

Cystadrops is indicated only for treatment of corneal cystine crystal deposits in patients with cystinosis. Use for any other indication is considered experimental/investigational and not covered.

Indication covered: corneal cystine crystal deposits in adults and children with cystinosis
Not covered: all other indications (experimental/investigational)

Note

Provider Action — Required Evidence

(Provider action) Ensure the prior authorization submission includes positive diagnostic confirmation and documentation of corneal cystine crystal accumulation to avoid denial.

Failure to provide required assay or genetic test results and evidence of corneal involvement may result in denial

Definitions

Cystaran — definition / indication

Generic nameCysteamine ophthalmic solution

Indication (per product label)Treatment of corneal cystine crystal accumulation in patients with cystinosis.

Covered authorization periodUp to 12 months when initial criteria met (prior authorization).

Diagnostic requirementDiagnosis of cystinosis confirmed by increased leukocyte cystine concentration or genetic testing required for authorization.

Cystadrops — definition / indication

Generic nameCysteamine ophthalmic solution (Cystadrops)

Indication (per product label)Treatment of corneal cystine crystal deposits in adults and children with cystinosis.

LimitationsUse for indications other than corneal cystine crystal deposits in cystinosis is considered experimental/investigational and not medically necessary.

Covered authorization periodUp to 12 months for initial or continued therapy when criteria met (prior authorization).

Background

Cystinosis is an inherited metabolic disorder in which cystine accumulates within cells and can form crystals in multiple tissues, including the cornea. This corneal cystine crystal accumulation can impair vision and cause ocular surface symptoms. Topical cysteamine ophthalmic solutions — specifically Cystaran and Cystadrops — are indicated to reduce corneal cystine crystal deposits in patients with cystinosis.

Prior authorization for ophthalmic cysteamine may be granted when the member has a confirmed diagnosis of cystinosis (by increased leukocyte cystine concentration or genetic testing) and has corneal cystine crystal accumulation; initial and continuation authorizations are typically issued for 12 months. Providers should submit diagnostic documentation (leukocyte cystine assay results or genetic testing) to support the request for treatment.