CurrentColorado Rocky Mountain Health PlansPolicy N/A

Krazati (adagrasib) prior authorization

Defines prior authorization/notification criteria for coverage of Krazati (adagrasib) for various KRAS G12C-mutated cancers and specifies authorization durations and reauthorization requirements; applies to members of the payer plan.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyKrazati (adagrasib) prior authorization

Policy CodePolicy N/A

Change TypeAnnual reviewprior material adds and revisions

Effective Date11/1/2025

Next Review Date

Key ActionObtain prior authorization for Krazati and document KRAS G12C mutation and prior systemic therapy when required.

SourceLink

POLICY UPDATE CHANGES

Added criteria for NCCN recommended use of Krazati in colon cancer, rectal cancer, ampullary adenocarcinoma and pancreatic adenocarcinoma.

Combined criteria for colon and rectal cancer in one section - Colorectal Cancer and added criteria for biliary tract cancer.

Annual review with updated background and references; no changes to coverage criteria in 8/2025.

12 monthsstandard authorization period

KRAS G12Crequired mutation

At least 1prior systemic therapy required

Includes <19pediatric auto-approve

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Coverage Criteria for Krazati (adagrasib)

Patients less than 19 years of age

Pediatric auto-approval

Pediatric approval: Patient is less than 19 years of age

Authorization issued for 12 months

NSCLC - Initial Therapy

Initial authorization for NSCLC

NSCLC initial: Diagnosis of non-small cell lung cancer (NSCLC) AND presence of KRAS G12C mutation AND disease is recurrent, advanced, or metastatic AND patient has received at least one prior systemic therapy

Authorization issued for 12 months

NSCLC - Reauthorization

Reauthorization for NSCLC

NSCLC reauth: Patient does not show evidence of progressive disease while on Krazati therapy

Authorization issued for 12 months

Colorectal Cancer - Initial Therapy

Initial authorization for Colorectal Cancer

CRC initial: Diagnosis of colorectal cancer AND presence of KRAS G12C mutation AND disease is recurrent, advanced, or metastatic AND patient has received at least one prior systemic therapy

Authorization issued for 12 months

Colorectal Cancer - Reauthorization

Reauthorization for Colorectal Cancer

CRC reauth: Patient does not show evidence of progressive disease while on Krazati therapy

Authorization issued for 12 months

Ampullary Adenocarcinoma - Initial Therapy

Initial authorization for Ampullary adenocarcinoma

Ampullary initial: Diagnosis of ampullary adenocarcinoma AND presence of KRAS G12C mutation AND disease is recurrent, advanced, or metastatic AND patient has received at least one prior systemic therapy

Authorization issued for 12 months

Ampullary - Reauthorization

Reauthorization for Ampullary adenocarcinoma

Ampullary reauth: Patient does not show evidence of progressive disease while on Krazati therapy

Authorization issued for 12 months

Pancreatic Adenocarcinoma - Initial Therapy

Initial authorization for Pancreatic adenocarcinoma

Pancreatic initial: Diagnosis of pancreatic adenocarcinoma AND presence of KRAS G12C mutation AND disease is recurrent, advanced, or metastatic AND patient has received at least one prior systemic therapy

Authorization issued for 12 months

Pancreatic - Reauthorization

Reauthorization for Pancreatic adenocarcinoma

Pancreatic reauth: Patient does not show evidence of progressive disease while on Krazati therapy

Authorization issued for 12 months

Biliary Tract Cancers - Initial Therapy

Initial authorization for Biliary Tract Cancers

Biliary initial: Diagnosis of gallbladder cancer, intrahepatic cholangiocarcinoma, or extrahepatic cholangiocarcinoma AND presence of KRAS G12C mutation AND disease is unresectable, resected gross residual (R2), or metastatic AND patient has received at least one prior systemic therapy

Authorization issued for 12 months

Biliary Tract Cancers - Reauthorization

Reauthorization for Biliary Tract Cancers

Biliary reauth: Patient does not show evidence of progressive disease while on Krazati therapy

Authorization issued for 12 months

NCCN Recommended Regimens

NCCN recommended uses

NCCN recognized: Drug recognized by NCCN Drugs and Biologics Compendium with Category of Evidence and Consensus 1, 2A, or 2B

Used to support coverage in additional indications as specified

Coverage decisions for Krazati (adagrasib) are based on the criteria in this document. Members under 19 years of age will have prescriptions automatically processed without a coverage review; in these cases authorization is issued for 12 months per the policy’s pediatric auto-approval provision.

State law and member-specific plan benefits may supersede the criteria in this document. Where a state mandate requires coverage for an off‑label use (or specifies use of particular compendia), that mandate takes precedence over the provisions in this policy and may alter coverage determinations for individual members.

Initial Therapy Criteria (by Indication)

Initial Therapy Criteria

Initial authorization criteria by cancer type

Initial therapy general: Diagnosis of specified cancer AND presence of KRAS G12C mutation AND disease status (recurrent/advanced/metastatic or specific disease state) AND prior systemic therapy where required

Authorization issued for 12 months

Continuation / Reauthorization Criteria

Continuation/Reauthorization

Reauthorization rules

Continuation therapy: Patient does not show evidence of progressive disease while on Krazati therapy

Authorization renewed for 12 months

Provider Actions, Documentation, and Denial Triggers

Prior Authorization

Prior Authorization Required

Prior authorization required for adults with documented KRAS G12C–mutated cancers listed in the clinical criteria. Authorization is typically issued for up to 12 months when initial criteria are met. Requests may be approved via prior authorization processes and automated review when program rules permit.

Authorization period: 12 months (when criteria met)
Applicable diagnoses include NSCLC, colorectal cancer, ampullary adenocarcinoma, pancreatic adenocarcinoma, biliary tract cancers (gallbladder, intrahepatic and extrahepatic cholangiocarcinoma)

Documentation Required

Required Documentation

Documentation must support the diagnosis and presence of a KRAS G12C mutation, current disease status (recurrent, advanced, or metastatic when specified), and prior systemic therapies when required by the indication. Include pathology or molecular testing reports showing the KRAS G12C mutation and relevant treatment history (dates and agents).

Key Definitions

Drug — Krazati (adagrasib) identification

Generic nameadagrasib

Brand nameKrazati

Drug classRAS GTPase inhibitor

Indicated adult uses (selected)Monotherapy for KRAS G12C‑mutated locally advanced or metastatic NSCLC after ≥1 prior systemic therapy; in combination with cetuximab for KRAS G12C‑mutated locally advanced or metastatic colorectal cancer after prior fluoropyrimidine-, oxaliplatin-, and irinotecan‑based chemotherapy

Typical authorization period12 months when criteria met

Biomarker required for covered indications — KRAS G12C mutation

Background and Drug Information

Krazati (adagrasib) is a RAS GTPase family inhibitor used for treatment of tumors harboring the KRAS G12C mutation. It is indicated as monotherapy for adults with KRAS G12C‑mutated locally advanced or metastatic non‑small cell lung cancer after prior systemic therapy, and in combination with cetuximab for KRAS G12C‑mutated metastatic colorectal cancer following specified prior chemotherapies. The NCCN Drugs and Biologics Compendium also recognizes additional uses that may support coverage in other KRAS G12C‑mutated indications.

For authorization purposes in covered indications, documentation must confirm the specific cancer diagnosis, presence of the KRAS G12C mutation, disease status (recurrent, advanced, unresectable, or metastatic as applicable), and prior systemic therapy history when required. When criteria are met, authorizations are generally issued for 12 months.

Step Therapy and Supply Limits

Step	Requirement / Note
1	Supply limits and/or step therapy may be in place per program; the policy document does not specify specific step therapy rules or failure criteria
2	Automated approval or prior-authorization processes may vary by program; prior medication history, diagnosis codes, or claim logic could be used for approval where applicable

Policy Revision History

02/2024material addition

Added criteria for NCCN‑recommended use of Krazati in colon cancer, rectal cancer, ampullary adenocarcinoma, and pancreatic adenocarcinoma; updated background and references.

08/2024material revision

Combined criteria for colon and rectal cancer into a single 'Colorectal Cancer' section and added criteria for biliary tract cancer; updated background and references.

08/2025annual reviewLatest

Annual review with updated background and references; no changes to coverage criteria.