Precision medicine incorporates the use of biomarkers found in tumors to assist in cancer diagnosis and prognosis along with targeted therapy selection and monitoring. Patient outcomes are improved with precision medicine, with research demonstrating improved progression-free survival and overall survival in patients with cancer when targeted therapy is used to treat cancer. In a 2017 study of patients with non–small-cell lung cancer (NSCLC), those patients treated with targeted therapy lived 1.4 years longer than patients treated with traditional chemotherapy.1
Blood, body fluids, or tumor biopsy samples are evaluated to identify tumor biomarkers, which are proteins or gene mutations, rearrangements, or fusions. This is an essential step in precision medicine. However, many patients with cancer are not tested for biomarkers for a variety of reasons. For some cancers there are no reliable or valid tests available, or insurance providers may not cover the costs of available tests. Healthcare providers may not be current on testing protocols or clinical treatment guidelines, and institutions may not be capable of performing tests. To help create uniformity, the American Cancer Society Cancer Action Network (ACS CAN) recently released recommendations for improving access to biomarker testing for providers and institutions.
Insurance coverage of biomarker tests varies across the US healthcare system, with payers’ approaches to decision-making based on a number of factors, including FDA labeling, clinical utility of tests, National Comprehensive Cancer Network (NCCN) guidelines, and clinical trials/cohort trials.2 Single-panel tests are more likely to be reimbursed while multipanel tests are less likely to be reimbursed, as they are often considered experimental or investigational.2 ACS CAN recommends that payers should provide coverage for the NCCN guideline–indicated biomarker tests and FDA-approved or -cleared companion or complementary diagnostics. Coverage is also recommended for appropriate interpretation services of biomarker tests.2
Most cancer patients are treated in community oncology practices, but there is an underutilization of guideline testing.2 This underutilization of guideline-recommended testing occurs across all practice types, including private, community, and academic practices. Barriers to this lag include the rapidly evolving nature of precision medicine, creating difficulties in staying abreast of new developments, limited tissue availability for multiple testing panels, and limitations of electronic health records in processing and interpreting precision medicine data.2 ACS CAN recommends that providers and institutes be equipped with the tools, resources, and training for proper test selection, administration, and interpretation.2 In addition, there should be institutional, high-quality biomarker testing guidelines and evidence-based clinical guidelines in place, along with continuing education requirements, to encourage healthcare providers to stay current on biomarker testing guidelines.2
ACS CAN also provides recommendations for patient involvement. Results of testing should be used to inform patients of eligibility for relevant clinical trials. An involved patient needs accurate information to fully participate in both their healthcare decisions and precision medicine so that they have enough information to seek appropriate testing.
Incorporation of ACS CAN recommendations will help institutions and healthcare providers improve patient outcomes for those with NSCLC.
- Gutierrez ME, Choi K, Lanman RB, et al. Genomic profiling of advanced non-small cell lung cancer in community settings: gaps and opportunities. Clin Lung Cancer. 2017;18:651-659.
- American Cancer Society Cancer Action Network. Improving access to biomarker testing: advancing precision medicine in cancer care. Published September 28, 2020. www.fightcancer.org/sites/default/files/Improving%20Access%20to%20Biomarker%20Testing.pdf. Accessed May 22, 2021.