CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Ophthalmic Cysteamine (Cystaran, Cystadrops) — Coverage Criteria

Covers prior authorization, documentation, initial and continuation authorization criteria for ophthalmic cysteamine (Cystaran and Cystadrops) to treat corneal cystine crystal accumulation in members with cystinosis.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyOphthalmic Cysteamine (Cystaran, Cystadrops) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit leukocyte cystine assay or genetic testing results to initiate prior authorization for up to 12 months when criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization period for initial and continuation approvals

2brand products referenced

1required diagnostic proof

Coverage Criteria for Ophthalmic Cysteamine

Initial Therapy

Authorization of 12 months may be granted when ALL of the following are met:

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Continuation Therapy

Authorization of 12 months may be granted for continued treatment when ANY of the following are met:

Continuation Authorization for Members Responding to Therapy: A. Member has experienced a decrease in corneal cystine crystal accumulation; or B. Member did not experience an increase in corneal cystine crystal accumulation.

All indications for Cystaran or Cystadrops beyond treatment of corneal cystine crystal deposits or accumulation in patients with cystinosis are considered experimental/investigational and therefore not covered. Coverage is limited to the labeled ophthalmic indication for management of corneal cystine crystal accumulation in members with a confirmed diagnosis of cystinosis.

Provider Requirements and Authorization Details

Prior Authorization

12-month Prior Authorization

Authorization of up to 12 months may be granted for initial and continuation treatment when criteria are met for treatment of corneal cystine crystal accumulation in cystinosis. Submit documentation of diagnosis to support prior authorization.

Prior authorization duration: up to 12 months for initial and continuation therapy
Required diagnostic documentation: leukocyte cystine assay OR genetic testing results
Continuation criteria: decrease in corneal cystine crystals OR no increase in corneal cystine crystals

Documentation Required

Required Diagnostic Documentation

Submit leukocyte cystine assay results showing increased cystine concentration or genetic testing results supporting a diagnosis of cystinosis with corneal cystine crystal accumulation as part of the prior authorization request.

Acceptable diagnostic evidence: increased cystine concentration in leukocytes OR genetic testing confirming cystinosis
Include documentation of corneal cystine crystal accumulation

Denial Risk

Unsupported Indications

All indications other than treatment of corneal cystine crystal deposits/accumulation in cystinosis are considered experimental/investigational and are NOT covered.

Not covered: any use other than corneal cystine crystal deposits/accumulation in cystinosis

Note

(Provider Action)

Provider-action highlight (reserved).

Background and Clinical Context

Cystinosis is a systemic metabolic disorder that results in accumulation of cystine crystals in multiple tissues, including the cornea, which can cause progressive ocular morbidity. Topical ophthalmic cysteamine formulations such as Cystaran and Cystadrops are indicated to treat corneal cystine crystal deposits/accumulation in patients with cystinosis and are intended to reduce or prevent corneal crystal burden.

Product Definitions

Cystaran — definition and indication

ProductCystaran (cysteamine ophthalmic solution)

IndicationTreatment of corneal cystine crystal accumulation in patients with cystinosis.

Patient populationPatients with cystinosis who have corneal cystine crystal accumulation.

Cystadrops — definition and indication

ProductCystadrops (cysteamine ophthalmic solution)

IndicationTreatment of corneal cystine crystal deposits in adults and children with cystinosis.

LimitationsAll other indications are considered experimental/investigational and not medically necessary.