Subject: Specialty Quantity Limit Cystaran-Cystadrops 2908-H P2024

Drug

CYSTARAN  (cysteamine ophthalmic solution)

CYSTADROPS  (cysteamine ophthalmic solution)

Policy:

I.  PROGRAM DESCRIPTION

The standard limit is designed to allow a quantity sufficient for the most common uses of the medication. The recommended dosing parameters for all FDA-approved indications fall within the standard limits. Coverage of an additional quantity may be reviewed on a case-by-case basis upon request.


II.   COVERED QUANTITIES

Medication	Standard Limit	FDA-recommended dosing
Cystaran (cysteamine ophthalmic solution) 0.44% 15mL bottle	4 bottles per 28 days	Instill one drop in each eye, every waking hour   Discard after 1 week of use
Cystadrops (cysteamine ophthalmic solution) 0.37% 5mL   solution (in 10mL bottle)	4 bottles per 28 days	Instill one drop in each eye, four times a day during waking hours   Discard after 1 week of use

 

Place of Service:

Outpatient

The above policy is based on the following references:

1. Cystaran [package insert]. Gaithersburg, MD: Leadiant Biosciences, Inc.; February 2022.
2. Cystadrops [package insert]. Lebanon, NJ: Recordati Rare Diseases Inc.; August 2020.

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