CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Krazati (adagrasib)

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyKrazati (adagrasib)

Policy CodePolicy N/A

Change TypeUpdated indications and template conversion

Effective Date

Next Review Date

Key ActionProvide documentation of KRAS G12C mutation detection by an FDA-approved test for approval.

SourceLink

POLICY UPDATE CHANGES

Updated colorectal cancer indication section (Nov 2025).

Converted to new Evolent guideline template and replaced prior UM ONC_1473 Krazati policy (Aug 2025).

Added colorectal cancer indication section (Aug 2024).

Updated exclusion criteria (Aug 2024).

2Covered Indications

5Exclusion Criteria Items

1Drug HCPCS Code

Coverage Summary

Defines accepted indications, continuation and exclusion criteria, coding, and applicable lines of business for coverage and utilization management of Krazati (adagrasib). Krazati is covered with criteria for use in non-small cell lung cancer (NSCLC) — monotherapy for adult members with KRAS G12C‑mutated recurrent, advanced, or metastatic disease after prior platinum‑containing therapy — and for colorectal cancer — combination therapy with cetuximab or panitumumab for adult members with KRAS G12C‑mutated locally advanced or metastatic disease after prior fluoropyrimidine-, oxaliplatin-, and irinotecan‑based chemotherapy. Evolent is responsible for processing all medication requests from network ordering providers and medications not authorized by Evolent may be deemed not approvable and not reimbursable.

Initial (New) Therapy Criteria

Non-Small Cell Lung Cancer (NSCLC) - Coverage Criteria

Krazati (adagrasib) may be used when ALL of the following are met:

Adult member with recurrent, advanced, or metastatic non-small cell lung cancer (NSCLC)
Tumor harbors KRAS G12C mutation
Member has received prior platinum-containing therapy, with or without immunotherapy
Krazati used as monotherapy

Colorectal Cancer - Coverage Criteria

Krazati (adagrasib) may be used when ALL of the following are met:

Adult member with locally advanced or metastatic colorectal cancer
Tumor harbors KRAS G12C mutation as determined by an FDA-approved test
Member has received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy
Krazati is used in combination with Erbitux (cetuximab) or Vectibix (panitumumab) as subsequent therapy

Continuation Therapy Criteria

Continuation Requests Exception

Continuation requests for a not-approvable medication shall be exempt provided

The member has not experienced disease progression on the requested medication
The requested medication was used within the last year without a lapse of more than 30 days of having an active authorization
Additional medication(s) are not being added to the continuation request

Documentation Required

Continuation documentation requirements

Continuation requests for a previously authorized medication may be exempt from this policy only when all of the following are met: the member has not experienced disease progression on the requested medication; the requested medication was used within the last year without a lapse of more than 30 days of having an active authorization; and no additional medication(s) are being added to the continuation request.

No lapse > 30 days in active authorization within the last year
No additional medications added to the continuation request
No disease progression on the requested medication

Exclusion / Not Approvable Criteria

Clinically meaningful outcomes follow ASCO‑recommended definitions (for example, hazard ratio < 0.80 and a recommended survival benefit for OS and PFS of at least 3 months). These definitions are applied when assessing whether reported study outcomes support an off‑label or investigational use. The policy’s exclusion criteria require that off‑label uses be supported by CMS‑recognized compendia or acceptable peer‑reviewed literature and state that investigational/off‑label requests may be denied when: patient or tumor characteristics and the administered regimen are not adequately represented in the published evidence; reported outcomes do not meet clinically meaningful thresholds; experimental design is inappropriate; evidence is limited to case reports or meeting abstracts without full peer‑reviewed articles; or overall evidence is insufficient per CMS standards.

Provider Actions / Prior Authorization

Prior Authorization

Authorization required via Evolent

Requests for this medication must be processed and authorized by Evolent. Medications that are not authorized by Evolent may be deemed not approvable and not reimbursable.

Documentation Required

Mutation test documentation required

Provide documentation confirming detection of the KRAS G12C mutation by an FDA-approved test as a condition for approval.

Billing Rule

Dose and quantity limits enforcement

Claims will be excluded/not approvable if they exceed the operational dose or quantity limits. The policy enforces a single-dose limit of 600 mg and a monthly tablet maximum of 180 (200 mg strength). The affected HCPCS/J-code is J8999 (adagrasib).

HCPCS/J-code: J8999
Single dose limit: 600 mg
Monthly tablet limit: 180 (200 mg strength)

Denial Risk

Prior progression or unsupported off-label use

Requests will be denied when there is documented disease progression while taking Krazati (adagrasib) or another KRAS G12C-targeted therapy, or when an off-label use is unsupported by CMS-recognized compendia or acceptable peer-reviewed literature.

Progression on Krazati or another KRAS G12C-targeted therapy (e.g., sotorasib)
Off-label use without support from CMS-recognized compendia or acceptable peer-reviewed literature

Clinical Evidence & References

Key evidence includes the pivotal NSCLC trial (Jänne PA et al., NEJM 2022), the colorectal cancer trial (Yaeger R et al., NEJM 2023) evaluating adagrasib with or without cetuximab, and the Manufacturer’s prescribing information (Krazati prescribing information, Bristol‑Myers Squibb, 2024). These references form the primary evidence base reviewed for the NSCLC and colorectal cancer indications and for implementation of the policy’s coverage criteria.

Quick-reference evidence citations

NSCLC trialJänne PA et al., NEJM 2022

Colorectal trialYaeger R et al., NEJM 2023

Manufacturer PIKrazati prescribing information, Bristol-Myers Squibb Company, 2024

Background

Adagrasib (Krazati) is accepted for specified indications: monotherapy for adult NSCLC with KRAS G12C mutation after prior platinum‑containing therapy, and combination therapy with cetuximab or panitumumab for adult KRAS G12C‑mutated locally advanced or metastatic colorectal cancer after prior standard chemotherapy. Approval requires supporting evidence from one of the following sources: FDA approved product labeling, CMS‑recognized compendia, NCCN, ASCO clinical guidelines, or acceptable peer‑reviewed literature that meets CMS Medicare Benefit Policy Manual standards. Evolent processes and must authorize medication requests from network providers; requests not authorized by Evolent may be considered not approvable and not reimbursable.

Revision History

August 2024added