Pharmacy Prior Authorization Criteria

Krazati (adagrasib)

Indications for Prior Authorization

Krazati (adagrasib)

• For diagnosis of Non-small cell lung cancer (NSCLC)
  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.

  This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of a clinical benefit in a confirmatory trial(s).

• For diagnosis of Colorectal Cancer (CRC)
  Indicated in combination with cetuximab, for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic CRC, as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.

Criteria

Krazati

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Non-Small Cell Lung Cancer (NSCLC)

• Diagnosis of non-small cell lung cancer (NSCLC)
AND
• Disease is one of the following:
• Locally advanced
• Metastatic
AND
• Disease is KRAS G12C-mutated as detected by a U.S. Food and Drug Administration (FDA) -approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)
AND
• Patient has received at least one prior systemic therapy (e.g., chemotherapy, immunotherapy)

Krazati

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Colorectal Cancer (CRC)

• Diagnosis of colorectal cancer (CRC)
AND
• Disease is one of the following:
• Locally advanced
• Metastatic
AND
• Tumor is KRAS G12C-mutated as detected by a U.S. Food and Drug Administration (FDA) -approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)
AND
• Medication is used in combination with Erbitux (cetuximab)
AND
• Patient has received prior treatment with ALL of the following:
• fluoropyrimidine-based chemotherapy
• oxaliplatin-based chemotherapy
• irinotecan-based chemotherapy

Krazati

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of All Indications

• Patient does not show evidence of progressive disease while on therapy

P & T Revisions

2024-07-11, 2024-02-14, 2023-07-03, 2023-02-16

References

1. Krazati Prescribing Information. Mirati Therapeutics, Inc. San Diego, CA. June 2024.
2. ClinicalTrials.gov. Phase 1/2 Study of MRTX849 in Patients With Cancer Having a KRAS G12C Mutation KRYSTAL-1. Available at: https://clinicaltrials.gov/study/NCT03785249. Accessed July 8, 2024.
3. The NCCN Drugs and Biologics Compendium. Available at: https://www.nccn.org/professionals/physician_gls/pdf/colon.pdf. V 4.2024 – July 3, 2024. Accessed July 8, 2024.
4. The NCCN Drugs and Biologics Compendium. Available at: https://www.nccn.org/professionals/physician_gls/pdf/rectal.pdf. V 3.2024 – July 3, 2024. Accessed July 8, 2024.

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Revision History

• 2024-07-11: Update guideline for New Indication Colorectal Cancer
• 2024-02-14: 2024 Annual Review - no changes
• 2023-07-03: Removed specialist requirement
• 2023-02-16: New Program

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