Lumakras (sotorasib)
Indications for Prior Authorization
Lumakras (sotorasib)
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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).
Criteria
Lumakras
Prior Authorization (Initial Authorization)
Length of Approval: 12 Month(s)
- Diagnosis of non-small cell lung cancer (NSCLC) AND
- Disease is one of the following:
- Locally advanced
- Metastatic
- 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)
Lumakras
Prior Authorization (Reauthorization)
Length of Approval: 12 Month(s)
- Patient does not show evidence of progressive disease while on therapy
P & T Revisions
2024-11-26, 2024-08-01, 2023-08-03, 2023-03-31, 2022-08-22, 2021-07-29
References
- Lumakras [package insert]. Thousand Oaks, CA: Amgen, Inc; June 2024.
- 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.
Revision History
- 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
HEALTHY LIVING