Subject: Copiktra 2754-A SGM P2022
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® © 2022 National Comprehensive Cancer Network. The NCCN Drugs & Biologics Compendium. 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 13, 2022
