CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Cystaran and Cystadrops (cysteamine ophthalmic solution) coverage

Defines prior authorization coverage criteria, documentation, prescriber specialty, and continuation criteria for Cystaran and Cystadrops for treatment of corneal cystine crystal accumulation/deposits in members with cystinosis. Excludes non-listed indications as experimental/investigational.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyCystaran and Cystadrops (cysteamine ophthalmic solution) coverage

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionPrior authorization is required; submission must include assay detecting increased cystine concentration in leukocytes or genetic testing results supporting the diagnosis.

POLICY UPDATE CHANGES

No material clinical or coverage changes.

2Drugs Listed

12Authorization Duration

1Required Diagnostic Evidence

Coverage Summary

Background: Cystaran and Cystadrops are cysteamine ophthalmic solutions indicated for the treatment of corneal cystine crystal accumulation/deposits in patients with cystinosis. Scope summary: coverage is limited to the FDA‑approved/compendial indication above; all other uses are considered experimental/investigational and not medically necessary.

Initial Therapy Criteria

Initial Authorization - Cystinosis

Authorization of 12 months may be granted for treatment of corneal cystine crystal accumulation when all of the following criteria are met:

ALL of the following

Diagnosis of cystinosis was confirmed by the presence of increased cystine concentration in leukocytes or by genetic testing
Member has corneal cystine crystal accumulation

Prior Authorization

Prior Authorization Required

Prior authorization is required. Submission for prior authorization must include an assay demonstrating increased cystine concentration in leukocytes or genetic testing results that support the diagnosis of cystinosis.

Documentation Required

Prescriber Specialty Requirement

This medication must be prescribed by or in consultation with an ophthalmologist or a physician who specializes in the treatment of metabolic disease and/or lysosomal storage disorders.

Billing Rule

Authorization Duration

Authorizations, both initial and for continuation, may be granted for a duration of 12 months.

Continuation Therapy Criteria

Continuation of Therapy

Authorization of 12 months may be granted for continued treatment in members requesting reauthorization for an indication listed in the Coverage Criteria section who are responding to therapy met by either of the following criteria:

ONE of

Member has experienced a decrease in corneal cystine crystal accumulation
Member did not experience an increase in corneal cystine crystal accumulation

Authorizations for continuation align with the 12‑month authorization duration and require documentation of response. For reauthorization, documentation must show the member is responding to therapy as defined by either a decrease in corneal cystine crystal accumulation or no increase in corneal cystine crystal accumulation. Prior authorization submission should include diagnostic documentation (assay detecting increased leukocyte cystine concentration or genetic testing results).

Unproven / Exclusions

Indications Not Covered

ALL of the following

All other indications (other than treatment of corneal cystine crystal accumulation/deposits in cystinosis) are considered experimental/investigational and not medically necessary

Coverage reiteration: Only the FDA‑approved/compendial uses listed (treatment of corneal cystine crystal accumulation/deposits in cystinosis) are covered. All other indications are considered experimental/investigational and not medically necessary.

Provider Actions

Prior Authorization

Prior Authorization Required

Documentation Required

Prescriber Specialty Requirement

This medication must be prescribed by or in consultation with an ophthalmologist or a physician who specializes in the treatment of metabolic disease and/or lysosomal storage disorders.

Billing Rule

Authorization Duration

Authorizations, both initial and for continuation, may be granted for a duration of 12 months.

Clinical Evidence

Evidence references: Reference - Cystaran package insert (Leadiant Biosciences, Inc.; February 2022); Reference - Cystadrops package insert (Recordati Rare Diseases Inc.; August 2020).

Definition

TermCorneal cystine crystal accumulation/deposits

DefinitionDeposition of cystine crystals in the cornea associated with cystinosis; clinical target of topical cysteamine therapy.

Background

Cystaran and Cystadrops are cysteamine ophthalmic solutions indicated for the treatment of corneal cystine crystal accumulation/deposits in patients with cystinosis. Only the FDA‑approved/compendial uses listed are covered; all other uses are considered experimental/investigational and not medically necessary.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyCystaran and Cystadrops (cysteamine ophthalmic solution) coverage

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionPrior authorization is required; submission must include assay detecting increased cystine concentration in leukocytes or genetic testing results supporting the diagnosis.

On This Page

OpenPayer

Cystaran and Cystadrops (cysteamine ophthalmic solution) coverage

Coverage Summary

Initial Therapy Criteria

Continuation Therapy Criteria

Unproven / Exclusions

Applicable Codes

Provider Actions

Clinical Evidence

Background