Subject: Cystaran-Cystadrops 2090-A SGM P2022

Drug

CYSTARAN  (cysteamine ophthalmic solution)

CYSTADROPS  (cysteamine ophthalmic solution)

Policy:

       I.  INDICATIONS

            The indications below including FDA-approved indications and
            compendial uses are considered a covered benefit provided
            that all the approval criteria are met and the member has no
            exclusions to the prescribed therapy.

            FDA-Approved Indications
            Cystaran
            Cystaran is indicated for the treatment of corneal cystine
            crystal accumulation in patients with cystinosis.

            Cystadrops
            Cystadrops is indicated for the treatment of corneal cystine
            crystal deposits in adults and children with cystinosis.

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

 
     II.  DOCUMENTATION

           Submission of the following information is necessary to initiate
           the prior authorization review: assay detecting increased
           cystine concentration in leukocytes or genetic testing results
           supporting the diagnosis.

 
   III.  CRITERIA FOR INITIAL APPROVAL

           Cystinosis
           Authorization of 12 months may be granted for treatment of
           corneal cystine crystal accumulation when all of the following
           criteria are met:
           A.  Diagnosis of cystinosis was confirmed by the presence of
                increased cystine concentration in leukocytes or by genetic
                testing; and
           B.  Member has corneal cystine crystal accumulation.

 

 

1. CONTINUATION OF THERAPY

Authorization of 12 months may be granted for continued treatment in members requesting reauthorization for corneal cystine crystal accumulation with cystinosis who are responding to therapy met by either of the following criteria:

1. Member has experienced a decrease in corneal cystine crystal accumulation; or
2. Member did not experience an increase in corneal cystine crystal accumulation.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Cystaran [package insert]. Gaithersburg, MD: Lediant Biosciences, Inc.; April 2020.
2. Cystadrops [package insert]. Lebanon, NJ: Recordati Rare Diseases Inc.; August 2020.
3. Ivanova E, De Leo MG, De Matteis MA, Levtchenko E. Cystinosis: clinical presentation, pathogenesis, and treatment. Pediatr Endocrinol Rev. 2014;12(1):176-184.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

June 26, 2022