CurrentMass General Brigham Health PlanPolicy N/A

Cystaran (cysteamine) prior authorization for corneal cystine accumulation

Policy governs prior authorization and pharmacy benefit requirements for Cystaran (cysteamine) for Commercial/Exchange members, including specialty pharmacy dispensing and documentation for initiation and reauthorization.

Policy Summary

PayerMass General Brigham Health Plan

PolicyCystaran (cysteamine) prior authorization for corneal cystine accumulation

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJan 1, 2023

Next Review DateN/A

Key ActionObtain prior authorization and documentation demonstrating diagnosis and ophthalmologist involvement; provide physician documentation of improvement for reauthorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Commercial/Exchangeplan applicability

Specialty pharmacydispensing requirement

24 monthsauthorization duration

Physician docreauthorization

Coverage Criteria for Cystaran (cysteamine)

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Initial Therapy

Authorization may be granted when ALL of the following are met

Initial Authorization Criteria: The member has a diagnosis of corneal cystine accumulation with cystinosis.

Documentation must be provided.

Initial Authorization Criteria: The provider is an ophthalmologist or the drug is being used in consultation with an ophthalmologist.

Documentation must be provided.

Requests for members who are new to the plan but are currently receiving Cystaran may be reviewed on a case-by-case basis. This review does not apply to Cystaran obtained as samples or through the manufacturer’s patient assistance programs. Other exclusions are not specified in the policy.

Provider Actions, Documentation & Billing

Prior Authorization

Prior Authorization Required

Prior authorization is required for Commercial/Exchange members. Requests from members new to the plan who are currently receiving Cystaran may be reviewed on a case-by-case basis; prior therapy obtained as samples or via manufacturer patient assistance programs is excluded from this exception.

Commercial/Exchange members: prior authorization required
Members new to plan currently receiving Cystaran: case-by-case review; excludes samples or manufacturer patient assistance program supply

Step Therapy

No step therapy requirement is specified for this medication.

Documentation Required

Required clinical documentation

Documentation must show a diagnosis of corneal cystine accumulation with cystinosis and that the prescriber is an ophthalmologist or that the drug is being used in consultation with an ophthalmologist. For continuation/reauthorization, physician documentation must show improvement of the member's condition. This medication is designated specialty and must be filled at a contracted specialty pharmacy.

Diagnosis: corneal cystine accumulation with cystinosis
Provider: ophthalmologist or use in consultation with an ophthalmologist
Continuation: physician documentation of clinical improvement required
Specialty fill: must be dispensed at contracted specialty pharmacy

Denial Risk

Denial Triggers

Denial may occur if documentation does not support the required diagnosis or provider specialty/consultation, or if a member new to the plan lacks documentation of current treatment (except for supplies obtained only as samples or via manufacturer assistance). Failure to provide required continuation documentation demonstrating improvement may result in reauthorization denial.

Missing or insufficient documentation of diagnosis or ophthalmology involvement
Members new to plan: no documentation of current treatment → potential denial (excludes samples/PAP)
Lack of physician documentation of improvement on reauthorization

Definitions

Corneal cystine accumulation with cystinosis — definition and indication for Cystaran

DefinitionAn inherited defect of lysosomal transport causing corneal deposition of cystine crystals (corneal cystine accumulation with cystinosis).

Pathophysiology relevant to treatmentCysteamine converts cystine to cysteine and a cysteine-cysteamine mixed disulfide that can exit the lysosome, reducing corneal cystine crystal accumulation.

Indication for Cystaran (cysteamine ophthalmic solution)Treatment of corneal cystine accumulation in patients with cystinosis when the member has the diagnosis and therapy is prescribed by an ophthalmologist or in consultation with an ophthalmologist.

Required provider specialtyPrescriber must be an ophthalmologist or the drug must be used in consultation with an ophthalmologist.

Documentation noteDocumentation of the diagnosis and ophthalmology involvement must be provided with the authorization request.