Subject: Alecensa 2150-A SGM P2024a
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
1. Alecensa is indicated as adjuvant treatment in adult patients following tumor resection of
anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) (tumors
≥ 4 cm or node positive), as detected by an FDA-approved test.
2. 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. 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)
1. 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.
2. Authorization of 12 months may be granted for the adjuvant treatment of ALK-positive
NSCLC (tumors ≥ 4 cm or node positive) following complete tumor resection 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. Inflammatory Myofibroblastic Tumor (IMT)
Authorization of 12 months may be granted for treatment of ALK-positive IMT as a single
agent when either of the following criteria is met:
1. The member has uterine sarcoma and the disease is advanced, recurrent, metastatic, or
inoperable
2. The member has a soft tissue sarcoma (not including uterine sarcoma)
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)
1. Authorization of 12 months may be granted for continued treatment in members
requesting reauthorization for recurrent, advanced, or metastatic NSCLC when there is
no evidence of unacceptable toxicity while on the current regimen.
2. Authorization of 12 months (up to a maximum duration of 2 years) may be granted for
continued treatment in members requesting reauthorization for adjuvant treatment of
NSCLC when there is no evidence of unacceptable toxicity or disease recurrence 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:
- Alecensa [package insert]. South San Francisco, CA: Genentech USA, Inc.; September 2021.
- The NCCN Drugs & Biologics Compendium® © 2024 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed March 14, 2024.
- NCCN Clinical Practice Guidelines in Oncology® Non-Small Cell Lung Cancer (Version 5.2024). © 2024 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed April 23, 2024.
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, 2024
