CurrentMass General Brigham Health PlanPolicy N/A

Cystaran (cysteamine) ophthalmic therapy — Coverage Criteria

Policy governing prior authorization, specialty dispensing, and coverage criteria for Cystaran eye drops for treatment of corneal cystine accumulation in members with cystinosis across Mass General Brigham Health Plan products.

Policy Summary

PayerMass General Brigham Health Plan

PolicyCystaran (cysteamine) ophthalmic therapy — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJan 1, 2023

Next Review Date

Key ActionObtain prior authorization with documentation of diagnosis and ensure an ophthalmologist is the provider or consultant.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

24 monthsmaximum authorization duration

Specialty onlydesignated dispensing requirement

Ophthalmologist requiredprovider specialty requirement

Case-by-casecontinuation rule

Coverage Criteria for Cystaran (cysteamine) Ophthalmic Solution

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Initial Authorization

Authorization may be granted when ALL of the following are met and documentation is provided:

Initial Authorization Requirements: Member has a diagnosis of corneal cystine accumulation with cystinosis; the provider is an ophthalmologist or the drug is being used in consultation with an ophthalmologist; documentation is provided.

Authorization may be reviewed case-by-case for members new to the plan who are currently receiving treatment, excluding products obtained as samples or via manufacturer patient assistance programs.

Continuation of Therapy

Reauthorization will be considered when ALL of the following are met:

Reauthorization Requirements: Physician documentation demonstrating improvement in the member's condition is provided.

Authorizations will be approved for up to 24 months. Products obtained as samples or via manufacturer patient assistance programs are excluded from the case-by-case continuation review process for members new to the plan.

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required. Requests will be reviewed case-by-case for members new to the plan who are currently receiving Cystaran. Authorizations, when approved, are valid for 24 months.

Authorization review may consider members currently receiving treatment (excludes samples or manufacturer patient assistance program supply)
Authorization duration: 24 months

Step Therapy

Step therapy: No step therapy requirements apply for Cystaran beyond the plan's specialty designation and prior authorization requirements.

Medication designated as specialty — must be filled at a contracted specialty pharmacy
No additional step edits required before authorization

Documentation Required

Required Clinical Documentation

Required clinical documentation for initial request and reauthorization. Submit documentation that supports the diagnosis, treating provider specialty, and clinical response for continuation of therapy.

Initial request: clinical records confirming diagnosis of corneal cystine accumulation with cystinosis
Initial request: documentation that prescribing provider is an ophthalmologist or that treatment is being provided in consultation with an ophthalmologist
Reauthorization: physician documentation demonstrating improvement in the member's condition or clinical response to therapy

Denial Risk

Clinical Diagnosis and Provider Specialty Required

Clinical diagnosis and provider specialty required. Denial is likely if the medical record does not document the diagnosis of corneal cystine accumulation with cystinosis or if the prescribing provider is not an ophthalmologist and no ophthalmology consultation is documented.

Required: documentation of diagnosis — corneal cystine accumulation with cystinosis
Required: treating provider is an ophthalmologist or documentation of consultation with an ophthalmologist
Denial risk if diagnosis or ophthalmologist involvement is not documented

Definitions

Cystinosis / corneal cystine accumulation — definition

DefinitionCystinosis: an inherited defect of lysosomal transport resulting in accumulation of cystine crystals in the cornea (corneal cystine accumulation).

PathophysiologyIntracellular cystine accumulates in lysosomes due to defective transport, forming corneal cystine crystals.

Mechanism relevant to therapyCysteamine converts lysosomal cystine to cysteine and a cysteine–cysteamine mixed disulfide that can exit the lysosome, reducing corneal crystal burden.