KRAZATI (adagrasib)

KRAZATI (adagrasib)

Self-Administration – oral

Indications for Prior Authorization:

• Non-small cell lung cancer (NSCLC) - Treatment of adult patients with KRAS G12C- mutated locally advanced or metastatic non-small cell lung cancer, 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 confirmatory trials.

Coverage Criteria:

For diagnosis of non-small cell lung cancer (NSCLC):

• Dose does not exceed 600mg (three 200 mg tablets) orally twice daily; AND
• Patient is 18 years of age or older; AND
• Prescribed by or in consultation with an oncologist; AND
• Medical records document a diagnosis of locally advanced OR metastatic non-small cell lung cancer (NSCLC); AND 
• Disease is KRAS G12C-mutated as determined by an 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., Keytruda, Opdivo, Tecentriq, Alimta, Yervoy, Abraxane, bevacizumab, cisplatin, carboplatin, docetaxel, gemcitabine, paclitaxel, vinorelbine) 

Reauthorization Criteria:

For diagnosis of non-small cell lung cancer (NSCLC):

• Dose does not exceed 600mg (three 200 mg tablets) orally twice daily; AND
• Patient does not show evidence of progressive disease while on therapy

Coverage Duration:

• Initial: 1 year
• Reauthorization: 1 year

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information:

• Information on FDA-approved tests for the detection of a KRAS G12C mutation is available at: https://www.fda.gov/CompanionDiagnostics
• Per NCCN guidelines, not recommended to switch between Krazati and Lumakras at time of progression. 
• Dosage and administration:
  • Recommended dosing is 600 mg orally (three 200 mg tablets) twice daily until disease progression or unacceptable toxicity 
  • Do not chew, crush, or split tablets
• Drug interactions:
  • Strong CYP3A4 Inducers: avoid concomitant use
  • Strong CYP3A4 Inhibitors: avoid concomitant use until Krazati concentrations have reached steady state
  • Sensitive CYP3A4 Substrates: avoid concomitant use with sensitive CYP3A4 substrates
  • Sensitive CYP2C9 or CYP2D6 Substrates or P-gp Substrates: avoid concomitant use with sensitive CYP2C9 or CYP2D6 substrates or P-gp substrates where minimal concentration changes may lead to serious adverse reactions
  • Drugs that prolong QT Interval: avoid concomitant use with Krazati

Policy Updates:

• 06/01/2023 – New policy approved by P&T

References:

• Krazati Prescribing Information. Mirati Therapeutics, Inc. San Diego, CA. December 2022. 
• Food and Drug Administration. In vitro diagnostics: List of cleared or approved companion diagnostic devices (in vitro and imaging tools). Current as of January 4, 2023. FDA Web site. 
• National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology – Non-small cell lung cancer v1.2023. NCCN Web site