ModifiedUnitedHealthcarePolicy 2024 P 1404-3

Krazati (adagrasib) prior authorization / notification criteria

UnitedHealthcare prior authorization/notification program for Krazati (adagrasib) defining initial authorization and reauthorization clinical criteria across multiple tumor types (NSCLC, colorectal, ampullary, pancreatic, biliary tract and NCCN-recommended uses), authorization duration, and notes on state mandates and automated approval processes.

Policy Summary

PayerUnitedHealthcare

PolicyKrazati (adagrasib) prior authorization / notification criteria

Policy CodePolicy 2024 P 1404-3

Change TypeAdded and revised clinical criteria (2/2024, 8/2024)

Effective DateNov 1, 2024

Next Review Date

Key ActionObtain prior authorization; document KRAS G12C mutation and prior systemic therapy for initial approvals and absence of progression for reauthorization.

POLICY UPDATE CHANGES

Added criteria for NCCN recommended use of Krazati in colon cancer, rectal cancer, ampullary adenocarcinoma and pancreatic adenocarcinoma (2/2024).

Combined criteria for colon and rectal cancer into one Colorectal Cancer section and added criteria for biliary tract cancer (8/2024).

P&T reviews and approvals updated 2/2023, 2/2024, 8/2024.

MultipleCovered Indications

12 moAuthorization Duration

KRAS G12CRequired Biomarker

Coverage Summary

UnitedHealthcare prior authorization/notification program for Krazati (adagrasib) establishes coverage with criteria across multiple tumor types including non‑small cell lung cancer (NSCLC), colorectal cancer (CRC), ampullary adenocarcinoma, pancreatic adenocarcinoma, biliary tract cancers, and NCCN‑recommended uses. Coverage requires documentation of the KRAS G12C biomarker. Initial authorizations and reauthorizations are issued for 12 months. The program notes that state mandates, federal requirements, and automated approval processes may affect coverage and that members under age 19 process automatically without coverage review.

Initial Therapy Criteria

NSCLC - Initial Authorization

Covered when ALL of the following are met:

ALL of the following

Diagnosis of non-small cell lung cancer (NSCLC)
Presence of KRAS G12C mutation
Disease stage
- Recurrent
- Advanced
- Metastatic
Patient has received at least one prior systemic therapy

Colorectal Cancer (CRC) - Initial Authorization

Covered when ALL of the following are met:

ALL of the following

Diagnosis of colorectal cancer
Presence of KRAS G12C mutation
Disease stage
- Recurrent
- Advanced
- Metastatic

Ampullary Adenocarcinoma - Initial Authorization

Covered when ALL of the following are met:

ALL of the following

Diagnosis of ampullary adenocarcinoma
Presence of KRAS G12C mutation
Disease stage
- Recurrent
- Advanced
- Metastatic

Pancreatic Adenocarcinoma - Initial Authorization

Covered when ALL of the following are met:

ALL of the following

Diagnosis of pancreatic adenocarcinoma
Presence of KRAS G12C mutation
Disease stage
- Recurrent
- Advanced
- Metastatic

Biliary Tract Cancers - Initial Authorization

Covered when ALL of the following are met:

ALL of the following

Diagnosis
- Gallbladder cancer
- Intrahepatic cholangiocarcinoma
- Extrahepatic cholangiocarcinoma
Presence of KRAS G12C mutation
Disease status

NCCN Recommended Regimens

Authorization for NCCN-recognized regimens with Category 1, 2A, or 2B; approvals issued for 12 months.

Use is recognized by the NCCN Drugs and Biologics Compendium with Category of Evidence and Consensus of 1, 2A, or 2B

Patients under 19 years

Authorization for members under age 19 processes automatically without coverage review; approvals issued for 12 months.

ALL of the following

Patient is less than 19 years of age