Subject: Alecensa 2150-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 Indication
Alecensa is indicated for the treatment of patients with
anaplastic lymphoma kinase (ALK)-positive, metastatic non-
small cell lung cancer (NSCLC) as detected by an FDA-
approved test.
B. Compendial Uses
1. Recurrent or advanced NSCLC, ALK rearrangement-
positive
2. Brain metastases from ALK rearrangement-positive
NSCLC
3. ALK+ anaplastic large cell lymphoma
4. ALK+ large B-cell lymphoma
5. Uterine Sarcoma - Inflammatory myofibroblastic tumor
(IMT) with ALK translocation
6. Erdheim-Chester Disease with ALK fusion
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: ALK mutation status
III. CRITERIA FOR INITIAL APPROVAL
A. Non-Small Cell Lung Cancer (NSCLC)
Authorization of 12 months may be granted for treatment of
recurrent, advanced or metastatic ALK-positive NSCLC
(including brain metastases from NSCLC) as a single agent.
B. Anaplastic Large Cell Lymphoma (ALCL)
Authorization of 12 months may be granted for initial
palliative therapy or treatment of relapsed/refractory ALK-
positive ALCL as a single agent.
C. Large B-Cell Lymphoma (LBCL)
Authorization of 12 months may be granted for treatment of
relapsed/refractory ALK-positive large B-cell lymphoma.
D. Uterine Inflammatory Myofibroblastic Tumor (IMT)
Authorization of 12 months may be granted for treatment of
uterine inflammatory myofibroblastic tumor (IMT) when all of
the following criteria are met:
1. The disease is advanced, recurrent, metastatic, or
inoperable
2. The disease is ALK-positive
3. The requested medication will be used as a single agent
E. Erdheim-Chester Disease (ECD)
Authorization of 12 months may be granted for treatment of
symptomatic or relapsed/refractory ALK-positive Erdheim-
Chester Disease as a single agent.
IV. CONTINUATION OF THERAPY
A. Non-Small Cell Lung Cancer (NSCLC)
Authorization of 12 months may be granted for continued
treatment in members requesting reauthorization when there
is no evidence of unacceptable toxicity while on the current
regimen.
B. All Other Indications
Authorization of 12 months may be granted for continued
treatment in members requesting reauthorization for all
other indications listed in Section III 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:
1. Alecensa [package insert]. South San Francisco, CA: Genentech USA,
Inc.; September 2021.
2. The NCCN Drugs & Biologics Compendium® © 2023 National
Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed
February 27, 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.
August 18, 2023
