Subject: Specialty Quantity Limit Copiktra 2759-H P2022

Drug

COPIKTRA  (duvelisib)

Policy:

I.   PROGRAM DESCRIPTION 

The standard limit is designed to allow a quantity sufficient for the most common uses of the medication. If the member’s plan allows a quantity limit exception review for the requested medication, coverage of an additional quantity may be provided up to the exception limit with prior authorization.

 

II.  COVERED QUANTITIES 

Medication	Standard Limit	Exception Limit*	FDA-recommended dosing
Copiktra (duvelisib) 15 mg capsules	56 per 28 days	Not applicable	Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic  Lymphoma (SLL): 25 mg twice daily   Dose modification may be made for toxicity or drug  interactions.
Copiktra (duvelisib) 25 mg capsules	56 per 28 days	168 per 28 days for up to two 28-day cycles

* Coverage up to the exception limits to address Peripheral T-Cell Lymphoma may be provided with prior authorization via the Specialty Post Limit Quantity Exception Criteria for approval.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Copiktra [package insert]. Las Vegas, NV: Secura Bio, Inc.; December 2021.
2. The NCCN Clinical Practice Guidelines in Oncology: T-Cell Lymphomas. Version 2.2022. National Comprehensive Cancer Network, Inc. Available at: http://www.nccn.org. Accessed May 25, 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.

December 29, 2022