INDICATION

LUMAKRAS® is 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).
NSCLC
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LUMAKRAS® (sotorasib) has established broad coverage, with 93% of patients covered nationally1,*

*Includes 94% commercial, 84% Medicare, 95% managed Medicaid, and 96% state Medicaid coverage.1

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The median time for a patient to receive LUMAKRAS® is ~ 6 days2,†,‡

†Based on data from 8 specialty pharmacies that dispensed LUMAKRAS® from May 2021–December 2024.2

‡The time for a patient to receive LUMAKRAS® ranges from ~ 4 to 11 days.2

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Over 1,000,000 patients have been served by the Amgen SupportPlus programs3

For HCPs
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HCP Support Center

Our Amgen SupportPlus Representatives can assist with issues around patient coverage, prior authorizations, co-pay programs, and more.

Benefits verification

  • Verify patient’s insurance plan coverage details
  • Identify if there is a payer-mandated pharmacy for prescription fulfillment

Prior authorization requirements

  • Provide payer-specific prior authorization forms

Amgen SupportPlus customer portal

  • A tool for managing patient benefit corrected QT interval verifications and more
  • Submit, store, and retrieve benefit verifications electronically
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Field Reimbursement Specialists

A Reimbursement Specialist can provide live or virtual coverage and access resources to support your patients.

Contact your Reimbursement Specialist for live or virtual support that includes:

  • Help with navigating prior authorization, appeals, and fulfillment processes
  • Educating on payer requirements and necessary documentation for individual patient support
  • Guidance on general reimbursement questions, including product coding and billing information
  • Answers to general questions about Amgen SupportPlus programs and other available resources

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Financial support

Financial support

We know every patient has unique needs. And we’re here to provide financial support information and resources, regardless of their current financial situation or type of insurance they have.

Co-pay program

Co-pay program

The Amgen SupportPlus co-pay program may help eligible patients with private or commercial insurance lower their out of pocket costs.

  • Pay as little as $0 out of pocket for each dose
  • Can be applied to deductible, co-insurance, and co-payment*
  • No income eligibility requirement
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*Eligibility criteria and program maximums apply. See AmgenSupportPlus.com/Copay for full Terms and Conditions.

What if my patient doesn’t have private or commercial insurance?

Amgen SuppotPlus can provide information about resources that may help lower out-of-pocket costs.

Resources
Access guide

Contains dosing guidelines, coverage and co-pay details, and resources

Prior authorization guide

Information on navigating the payer approval process

Sample Letter of Medical Necessity

See how to craft a Letter of Medical Necessity for your patients

Sample letter of appeal

Example of how to appeal the denial of coverage for LUMAKRAS®

Pharmacy fact sheet

Includes product information, description, storage requirements, and contact information for coverage questions

LUMAKRAS® specialty pharmacy and distributors list

Contact information for the pharmacies in the LUMAKRAS® network

LUMAKRAS® dose modification fact sheet
Dosing flyer for your patients
Access roadmap for your patients
Patient profiles
Visit our patient site for more resources

IMPORTANT SAFETY INFORMATION

Hepatotoxicity

  • LUMAKRAS® can cause hepatotoxicity and increased ALT or AST which may lead to drug-induced liver injury and hepatitis.
  • In the pooled safety population of NSCLC patients who received single agent LUMAKRAS® 960 mg hepatotoxicity occurred in 27% of patients, of which 16% were Grade ≥ 3. Among patients with hepatotoxicity who required dosage modifications, 64% required treatment with corticosteroids.
  • In this pooled safety population of NSCLC patients who received single agent LUMAKRAS® 960 mg, 17% of patients who received LUMAKRAS® had increased alanine aminotransferase (ALT)/increased aspartate aminotransferase (AST); of which 9% were Grade ≥ 3. The median time to first onset of increased ALT/AST was 6.3 weeks (range: 0.4 to 42). Increased ALT/AST leading to dose interruption or reduction occurred in 9% of patients treated with LUMAKRAS®. LUMAKRAS® was permanently discontinued due to increased ALT/AST in 2.7% of patients. Drug-induced liver injury occurred in 1.6% (all grades) including 1.3% (Grade ≥ 3).
  • In this pooled safety population of NSCLC patients who received single agent LUMAKRAS® 960 mg, a total of 40% patients with recent (≤ 3 months) immunotherapy prior to starting LUMAKRAS® had an event of hepatotoxicity. An event of hepatotoxicity was observed in 18% of patients who started LUMAKRAS® more than 3 months after last dose of immunotherapy and in 17% of those who never received immunotherapy. Regardless of time from prior immunotherapy, 94% of hepatotoxicity events improved or resolved with dosage modification of LUMAKRAS®, with or without corticosteroid treatment.
  • Monitor liver function tests (ALT, AST, alkaline phosphatase, and total bilirubin) prior to the start of LUMAKRAS®, every 3 weeks for the first 3 months of treatment, then once a month or as clinically indicated, with more frequent testing in patients who develop transaminase and/or bilirubin elevations. Withhold, reduce the dose or permanently discontinue LUMAKRAS® based on severity of the adverse reaction. Consider administering systemic corticosteroids for the management of hepatotoxicity.

Interstitial Lung Disease (ILD)/Pneumonitis

  • LUMAKRAS® can cause ILD/pneumonitis that can be fatal.
  • In the pooled safety population of NSCLC patients who received single agent LUMAKRAS® 960 mg ILD/pneumonitis occurred in 2.2% of patients, of which 1.1% were Grade ≥ 3, and 1 case was fatal. The median time to first onset for ILD/pneumonitis was 8.6 weeks (range: 2.1 to 36.7 weeks). LUMAKRAS® was permanently discontinued due to ILD/pneumonitis in 1.3% of LUMAKRAS®-treated patients. Monitor patients for new or worsening pulmonary symptoms indicative of ILD/pneumonitis (e.g., dyspnea, cough, fever). Immediately withhold LUMAKRAS® in patients with suspected ILD/pneumonitis and permanently discontinue LUMAKRAS® if no other potential causes of ILD/pneumonitis are identified.

Most Common Adverse Reactions

  • The most common adverse reactions ≥ 20% were diarrhea, musculoskeletal pain, nausea, fatigue, hepatotoxicity, and cough.

Drug Interactions

  • Advise patients to inform their healthcare provider of all concomitant medications, including prescription medicines, over‑the‑counter drugs, vitamins, dietary and herbal products.
  • Inform patients to avoid proton pump inhibitors and H2 receptor antagonists while taking LUMAKRAS®.
  • If coadministration with an acid-reducing agent cannot be avoided, inform patients to take LUMAKRAS® 4 hours before or 10 hours after a locally acting antacid.

INDICATION

LUMAKRAS® is 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).

 

Please see full LUMAKRAS® Prescribing Information.

  • References: 1. Data on file, Amgen; [Payer mix]. 2. Data on file, Amgen; [Specialty Pharmacy Turnaround Time]. 3. Data on file, Amgen; [Amgen SupportPlus Patients and HCPs].