Subject: Copiktra 2754-A SGM P2023
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.
A. FDA-Approved Indications
Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic
Lymphoma (SLL)
Copiktra is indicated for the treatment of adult patients with
relapsed or refractory CLL or SLL after at least two prior
therapies.
B. Compendial Use
1. Chronic lymphocytic leukemia/small lymphocytic
lymphoma (CLL/SLL)
2. T-Cell lymphomas
a. Breast implant associated anaplastic large cell
lymphoma (ALCL)
b. Hepatosplenic T-Cell lymphoma
c. Peripheral T-cell lymphomas (PTCL)
All other indications are considered experimental/investigational
and not medically necessary.
II. CRITERIA FOR INITIAL APPROVAL
A. Chronic Lymphocytic Leukemia (CLL)/Small
Lymphocytic Lymphoma (SLL)
Authorization of 12 months may be granted for treatment of
relapsed or refractory CLL/SLL when the requested
medication is used as single agent.
B. T-Cell Lymphomas
Authorization of 12 months may be granted for treatment of
T-cell lymphomas with any of the following subtypes:
1. Breast implant-associated anaplastic large cell lymphoma
(ALCL) when all of the following are met:
i. The requested drug is used as subsequent therapy
for relapsed or refractory disease.
ii. The requested drug is used as a single agent
2. Hepatosplenic T-Cell lymphoma when all of the following
criteria are met:
i. The requested drug is used for refractory disease
after 2 first-line therapy regimens
ii. The requested drug is used as a single agent
3. Peripheral T-cell lymphoma (PTCL) [including the
following subtypes: peripheral T-cell lymphoma not
otherwise specified, enteropathy-associated T-cell
lymphoma (EATL), monomorphic epitheliotropic intestinal
T-cell lymphoma (MEITL), angioimmunoblastic T-cell
lymphoma (AITL), nodal peripheral T-cell lymphoma with
TFH phenotype (PTCL, TFH), follicular T-cell lymphoma
(FTCL), or anaplastic large cell lymphoma (ALCL) when all
of the following criteria are met:
i. The requested drug is used as palliative or
subsequent therapy for relapsed or refractory
disease
ii. The requested drug is used as a single agent
III. CONTINUATION OF THERAPY
Authorization of 12 months may be granted for continued
treatment in members requesting reauthorization for an
indication listed in Section II when there is no evidence of
unacceptable toxicity or disease progression while on the current
regimen.
Place of Service:
Outpatient
The above policy is based on the following references:
- Copiktra [package insert]. Las Vegas, NV: Secura Bio, Inc.; December 2021.
- The NCCN Drugs & Biologics Compendium® © 2023 National Comprehensive Cancer Network. The NCCN Drugs & Biologics Compendium. http://www.nccn.org. Accessed June 2, 2023.
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 09, 2023
