LUMAKRAS (sotorasib)

LUMAKRAS (sotorasib)

Self-Administration – oral

Indications for Prior Authorization:

• 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).

Coverage Criteria:

For diagnosis of non-small cell lung cancer (NSCLC):

• Dose does not exceed 960 mg (eight 120 mg tablets) orally once daily, AND
• Patient is 18 years of age or older, AND
• Prescribed by or in consultation with an oncologist, AND
• Medical records document a diagnosis of locally advanced or metastatic non-small cell lung cancer (NSCLC), AND
• The tumor is KRAS G12C-mutated 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., cisplatin/pemetrexed, atezolizumab, nivolumab, capmatinib)

Reauthorization Criteria:

For diagnosis of non-small cell lung cancer (NSCLC):

• Dose does not exceed 960 mg (eight 120 mg tablets) orally once daily, AND
• Prescribed by or in consultation with an oncologist, AND
• Patient does not show evidence of progressive disease while on therapy

Coverage Duration:

• Initial: 1 year
• Reauthorization: 1 year

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information:

• Recommended dose: 960 mg (eight 120 mg tablets) orally once daily until disease progression or unacceptable toxicity
• If adverse reactions occur, a maximum of two dose reductions are permitted. Discontinue Lumakras if patients are unable to tolerate the minimum dose of 240 mg once daily
• Warnings for hepatotoxicity and Interstitial Lung Disease (ILD)/ pneumonitis

Policy Updates:

• 10/19/2021 – New policy approved by P&T

References:

• Lumakras [package insert]. Thousand Oaks, CA: Amgen, Inc; May 2021.
• 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.