Subject: Cystaran-Cystadrops 2090-A SGM P2024

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.


  IV.  CONTINUATION OF THERAPY

          Authorization of 12 months may be granted for continued treatment in members requesting
          reauthorization for an indication listed in Section III who are responding to therapy met by
          either of the following criteria:
          A.  Member has experienced a decrease in corneal cystine crystal accumulation; or
          B.  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: Leadiant Biosciences, Inc.; February 2022.

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 16, 2024