Subject: Krazati SGM 5699-A P2024_R

Drug

KRAZATI  (adagrasib)

Policy:

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

• Krazati is indicated as a single agent 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.
• Krazati is indicated in combination with cetuximab for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic colorectal cancer (CRC), as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.

Compendial Uses

• Non-small cell lung cancer
• Pancreatic adenocarcinoma
• Colorectal cancer
• Ampullary adenocarcinoma
• Biliary tract cancers

All other indications are considered experimental/investigational and not medically necessary.

Documentation

Submission of the following information is necessary to initiate the prior authorization review:

Documentation of the presence of KRAS G12C mutation

Coverage Criteria

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:

• The member has received at least one prior systemic therapy and has not experienced disease progression on KRAS G12C-targeted therapy
• The member has brain metastases

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:

• The tumor or plasma specimen is positive for the KRAS G12C mutation
• Member has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
• The requested medication will be used as a single agent.

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:

• The tumor or plasma specimen is positive for the KRAS G12C mutation.
• The requested medication will be used as a single agent, or in combination with cetuximab (Erbitux) or panitumumab (Vectibix).
• The member previously received treatment with chemotherapy.

Ampullary Adenocarcinoma

Authorization of 12 months may be granted for treatment of progressive ampullary adenocarcinoma when both of the following criteria are met:

• The requested medication will be used as a single agent.
• The tumor or plasma specimen is positive for the KRAS G12C mutation.

Biliary Tract Cancers

Authorization of 12 months may be granted for subsequent treatment of unresectable, resected gross residual (R2), or metastatic biliary tract cancers (including intrahepatic and extrahepatic cholangiocarcinoma and gallbladder cancer), when both of the following criteria are met:

• The requested medication will be used as a single agent.
• The tumor or plasma specimen is positive for the KRAS G12C mutation.

Continuation of Therapy

Authorization of 12 months may be granted for continued treatment in members requesting reauthorization for an indication listed in the coverage criteria section 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. Krazati [package insert]. San Diego, CA: Mirati Therapeutics, Inc.; June 2024.
2. The NCCN Drugs & Biologics Compendium® © 2024 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed July 8, 2024.
3. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines): Colon Cancer. Version 4.2024. Accessed July 8, 2024. https://www.nccn.org/professionals/physician_gls/pdf/colon.pdf
4. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines): Anal Carcinoma. Version 1.2024. Accessed July 8, 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.

January 01, 2025