Subject: Lumakras 4766-A SGM P2024
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
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.
B. Compendial Uses
1. Recurrent, advanced, or metastatic KRAS G12C-mutated NSCLC
2. Pancreatic adenocarcinoma
3. Colorectal cancer
4. Ampullary adenocarcinoma
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
A. Non-Small Cell Lung Cancer (NSCLC)
Authorization of 12 months may be granted for treatment of KRAS G12C-mutated recurrent,
advanced or metastatic NSCLC in members who have received at least one prior systemic
therapy, as a single agent.
B. Pancreatic Adenocarcinoma
Authorization of 12 months may be granted for treatment of recurrent, locally advanced or
metastatic pancreatic adenocarcinoma when all of the following criteria are met:
1. The tumor or plasma specimen is positive for the KRAS G12C mutation.
2. The member has an ECOG (Eastern Cooperative Oncology Group) performance status
of 0-2
3. The requested medication will be used as a single agent
C. Colorectal Cancer
Authorization of 12 months may be granted for treatment of advanced or metastatic
colorectal cancer, including appendiceal adenocarcinoma and anal adenocarcinoma, when
all of the following criteria are met:
1. The tumor or plasma specimen is positive for the KRAS G12C mutation.
2. The requested medication will be used as a single agent, or in combination with
cetuximab (Erbitux) or panitumumab (Vectibix).
3. The member previously received treatment with chemotherapy.
D. Ampullary Adenocarcinoma
Authorization of 12 months may be granted for treatment of progressive ampullary
adenocarcinoma when all of the following criteria are met:
1. The tumor or plasma specimen is positive for the KRAS G12C mutation.
2. The requested medication will be used 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:
- Lumakras [package insert]. Thousand Oaks, CA: Amgen Inc.; April 2023.
- The NCCN Drugs & Biologics Compendium® © 2024 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed March 5, 2024.
- NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines): Colon Cancer. Version 1.2024. Accessed March 5, 2024. https://www.nccn.org/professionals/physician_gls/pdf/colon.pdf
- NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines): Anal Carcinoma. Version 1.2024. Accessed March 5, 2024. https://www.nccn.org/professionals/physician_gls/pdf/anal.pdf
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
