Subject: Cystaran-Cystadrops 2090-A SGM P2023

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 corneal
          cystine crystal accumulation with cystinosis 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: Lediant Biosciences, Inc.; February 2022.
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 18, 2023