Subject: Lumakras 4766-A SGM P2023b
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
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.
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.; January 2023.
- The NCCN Drugs & Biologics Compendium® © 2023 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed October 10, 2023.
- NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines): Colon Cancer. Version 3.2023. Accessed October 6, 2023. https://www.nccn.org/professionals/physician_gls/pdf/colon.pdf
- NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines): Anal Carcinoma. Version 3.2023. Accessed October 6, 2023. 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.
November 09, 2023
