Subject: Lumakras 4766-A SGM P2022

Drug

LUMAKRAS  (sotorasib)

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.

            FDA-Approved Indications
            Lumakras is indicated for the treatment of adult patients with
            KRAS G12C-mutated locally advanced or metastatic non-small
            cell lung cancer (NSCLC), as determined by an FDA-approved
            test, who have received at least one prior systemic therapy

            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: Documentation of the presence
           of KRAS G12C mutation in tumor or plasma specimens.

 

    III.  CRITERIA FOR INITIAL APPROVAL

            Non-Small Cell Lung Cancer (NSCLC)
            Authorization of 12 months may be granted for treatment of
            KRAS G12C-mutated locally advanced or metastatic NSCLC in
            members who have received at least one prior systemic
            therapy, as a single agent.  

 
     IV.  CONTINUATION OF THERAPY

            Authorization of 12 months may be granted for continued
            treatment in members requesting reauthorization for an
            indication 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. Lumakras [package insert]. Thousand Oaks, CA: Amgen Inc.; May 2021.

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