Subject: Alecensa 2150-A SGM P2022

Drug

ALECENSA  (alectinib)

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 as a single agent
                 2.  Brain metastases from ALK rearrangement-positive
                      NSCLC as a single agent
                 3.  Relapsed/refractory ALK+ anaplastic large cell
                      lymphoma as a single agent

             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 treatment
                 of relapsed/refractory ALK-positive ALCL 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.  Anaplastic Large Cell Lymphoma (ALCL)
                 Authorization of 12 months may be granted for continued
                 treatment in members requesting reauthorization 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^® © 2022 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed March 9, 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.

August 24, 2022