CurrentmhnPolicy CP.PHAR.605

KRAZATI (PDF)

Defines medical necessity criteria, prior authorization requirements, and approval durations for adagrasib (Krazati) for NSCLC, colorectal cancer, and specified NCCN compendium off-label indications across Commercial, HIM, and Medicaid lines of business.

Policy Summary

Payermhn

PolicyKRAZATI (PDF)

Policy CodePolicy CP.PHAR.605

Change TypeMultiple material updates (FDA CRC indication, NCCN off-label additions, redirection/step therapy changes, approval duration update)

Effective DateMar 1, 2023

Next Review Date

Key ActionProvider must submit documentation supporting that member meets all approval criteria and request prior authorization per the policy requirements.

SourceLink

POLICY UPDATE CHANGES

Added new FDA-approved indication for the treatment of colorectal cancer (CRC).

For NSCLC removed 'locally' from 'locally advanced' option and added monotherapy criterion and brain metastases as exception to prior therapy requirement.

Added multiple off-label NCCN compendium indications including pancreatic adenocarcinoma, ampullary adenocarcinoma, biliary tract cancers, small bowel adenocarcinoma, and appendiceal neoplasms.

Added generic redirection for initial and continued therapy and added step therapy bypass for IL HIM per IL HB 5395.

Revised initial approval durations for Medicaid/HIM to 12 months.

Added state IN to Appendix D for states with regulations against redirections in cancer.

3FDA-approved indications listed

5+NCCN compendium/off-label indications included

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1200 mg/dayMaximum daily dose (mg)

12 monthsTypical approval duration (Medicaid/HIM)

Coverage Summary

This policy defines medical necessity criteria, prior authorization requirements, and approval durations for adagrasib (Krazati) across Commercial, HIM, and Medicaid. Coverage stance: covered_with_criteria. Indications summarized: FDA‑approved for KRAS G12C‑mutated advanced/metastatic non‑small cell lung cancer (NSCLC) as monotherapy, and FDA‑approved in combination with cetuximab for KRAS G12C‑mutated locally advanced or metastatic colorectal cancer (CRC) after prior fluoropyrimidine‑, oxaliplatin‑, and irinotecan‑based chemotherapy; additional NCCN compendium off‑label indications (e.g., pancreatic, biliary, small bowel, appendiceal neoplasms) may be authorized with criteria. Policy includes redirection/step‑therapy to Lumakras (sotorasib) for many requests unless contraindicated, clinically significant adverse effects occur, or state regulations prohibit redirection; IL HIM step‑therapy bypass effective 1/1/2026. Approval durations: Medicaid/HIM – 12 months; Commercial – 12 months or duration of request, whichever is less.

Surface thresholds

Maximum daily dose1,200 mg/day (6 tablets of 200 mg)

Age≥ 18 years

Minimum prior use for continued therapyMember has received Krazati for at least 30 days

Standard dosing regimen600 mg PO twice daily (total 1,200 mg/day)

Product strengthTablet: 200 mg

Initial Therapy Criteria — NSCLC (Krasati monotherapy)

Initial Therapy Criteria — Colorectal Cancer (CRC)

Initial Therapy Criteria — NCCN Compendium / Off‑Label Indications

Continuation Therapy Criteria

Unapproved Indications & Policy Routing

Applicable Codes & Product Availability

Relevant drug product availabilityNDC

Tablet: 200 mg

Product availability listed as 200 mg tablet

HCPCS/J-codes and other billing codesmixed

No codes listed

Provider Actions & Authorization Requirements

Prior Authorization

Prior authorization required with criteria

Prior authorization required; approval is contingent on meeting the specified diagnosis, KRAS G12C positive status (FDA‑approved test), oncologist involvement, prior therapy requirements or exceptions (including redirection to Lumakras when applicable), dosing limits (maximum 1,200 mg/day), and evidence for off‑label regimens when applicable.

Documentation Required

Submit supporting documentation

Provider must submit documentation supporting that the member meets all approval criteria. Examples of supporting documentation include office chart notes, laboratory test results, and the KRAS G12C test result (FDA‑approved test).

Office notes
Lab results
KRAS G12C test result

Clinical Evidence & References

1200Maximum daily dose (mg)

12Typical approval duration (Medicaid/HIM) (months)

Evidence sources referenced in the policy include: Krazati Prescribing Information (Mirati Therapeutics; July 2024) (FDA prescribing information) and the key clinical trial Jänne PA et al., N Engl J Med. 2022; Adagrasib in non‑small‑cell lung cancer harboring a KRAS G12C mutation. The policy also notes that NCCN Drugs and Biologics Compendium guidance supports the off‑label NCCN compendium indications included in this policy.

Background & Definitions

Background: Adagrasib (Krazati) is a KRAS G12C inhibitor indicated for KRAS G12C‑mutated advanced/metastatic NSCLC and, in combination with cetuximab, for KRAS G12C‑mutated advanced/metastatic CRC after prior chemotherapy; additional off‑label NCCN compendium indications are included per the policy. The policy implements redirection/step therapy to Lumakras (sotorasib) for certain indications unless contraindicated or clinically significant adverse effects occur, with state‑level exceptions listed in Appendix D (states with prohibitions against redirections in cancer care; IL HIM exception effective 1/1/2026). Definitions: CRC = Colorectal cancer; EGFR = Epidermal growth factor receptor.

Revision History

06.27.24added

RT4: Added new FDA‑approved indication for colorectal cancer (CRC) and updated Appendix B. (Material change)

10.26.23revised

1Q2024 annual review: For NSCLC added monotherapy criterion and added brain metastases as exception to prior therapy requirement; added off‑label criteria for pancreatic adenocarcinoma and colorectal cancer. (Material change)

12.02.24revised

Policy Summary

Payermhn

PolicyKRAZATI (PDF)

Policy CodePolicy CP.PHAR.605

Change TypeMultiple material updates (FDA CRC indication, NCCN off-label additions, redirection/step therapy changes, approval duration update)

Effective DateMar 1, 2023

Next Review Date

Key ActionProvider must submit documentation supporting that member meets all approval criteria and request prior authorization per the policy requirements.

SourceLink

On This Page

Step Therapy

Step therapy/redirection to Lumakras

Policy redirects to Lumakras (sotorasib) for certain indications unless contraindicated or clinically significant adverse effects are experienced. Exceptions apply for states with regulations against redirections in cancer (see Appendix D). For Illinois HIM, the step therapy/ redirection requirements do not apply effective 2026-01-01 per IL HB 5395.

Redirection to Lumakras unless contraindicated or adverse effects
State exceptions per Appendix D (states listed in Appendix D prohibit redirections)
Illinois HIM bypass effective 2026-01-01 (IL HB 5395)

Billing Rule

Approval durations

Approval durations: Medicaid and HIM approvals are 12 months. Commercial approvals are 12 months or the duration of the request, whichever is less.

Medicaid/HIM — 12 months
Commercial — 12 months or duration of request, whichever is less

1Q2025 annual review / December SDC: Removed 'locally' from 'locally advanced' NSCLC option; added redirection to Lumakras for members without brain metastases and generic redirection language for initial and continued therapy. Also removed requirement that member has not received prior treatment with Lumakras. (Material change)

06.09.25clarified

Per SDC for CRC, added redirection to Lumakras; added step therapy bypass for Illinois HIM per IL HB 5395 effective 1/1/2026. (Material change / clarification)

10.21.25revised

1Q2026 annual review: Added small bowel adenocarcinoma and appendiceal neoplasms to NCCN compendium off‑label indications; revised initial approval durations for Medicaid/HIM to 12 months. (Material change)

04.09.26addedLatest

April 2026 update: Added state IN to Appendix D for states with regulations against redirections in cancer. (Non‑material change)