Pharmacy Prior Authorization Criteria

Lumakras (sotorasib)

For diagnosis of Non-Small Cell Lung Cancer (NSCLC)
Indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), 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 overall response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
For diagnosis of Metastatic Colorectal Cancer
Indicated in combination with panitumumab, for the treatment of adult patients with KRAS G12C-mutated metastatic colorectal cancer (mCRC), as determined by an FDA-approved test, who have received prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy.

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Non-Small Cell Lung Cancer (NSCLC)

AND

AND

Presence of KRAS G12C-mutation as detected by a U.S. Food and Drug Administration (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., chemotherapy, immunotherapy)

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Metastatic Colorectal Cancer

AND

Presence of KRAS G12C-mutation as detected by a U.S. Food and Drug Administration (FDA)-approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)

AND

Patient has received prior therapy with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy

AND

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of All indications listed above

2025-03-12, 2024-11-26, 2024-08-01, 2023-08-03, 2023-03-31, 2022-08-22, 2021-07-29

Lumakras [package insert]. Thousand Oaks, CA: Amgen, Inc; January 2025.
Skoulidis F, Li BT, Dy GK, et al. Sotorasib for lung cancers with KRAS p.G12C mutation. N Engl J Med 2021;384:2371-2381.

2025-03-12: Added new indication for metastatic colorectal cancer
2024-11-26: Added new 240 mg capsules to existing guideline
2024-08-01: 2024 Annual Review. No change to clinical intent. Updated verbiage relating to genetic mutation. Background updates
2023-08-03: Annual Review; update to examples and removal of specialist requirement
2023-03-31: Addition of new strength for Lumakras
2022-08-22: Annual Review - No criteria changes
2021-07-29: New UM Policy