Subject: Krazati 5699-A SGM P2023a
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
Krazati is indicated for the treatment of adult patients with
Kirsten rat sarcoma (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. Non-small cell lung cancer
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
III. CRITERIA FOR INITIAL APPROVAL
A. NSCLC
Authorization of 12 months may be granted for treatment of
recurrent, advanced, or metastatic KRAS G12C mutation
positive NSCLC as a single agent when either of the following
criteria are met:
1. The member has received at least one prior systemic
therapy and has not experienced disease progression on
KRAS G12C-targeted therapy
2. The member has brain metastases
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. Member has an Eastern Cooperative Oncology Group
(ECOG) 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:
- Krazati [package insert]. San Diego, CA: Mirati Therapeutics, Inc.; December 2022.
- The NCCN Drugs & Biologics Compendium® © 2023 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed July 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.
February 06, 2024
