The Voice

Why People with Lung Cancer Need Biomarker Testing – and Why They Aren’t Getting It

Over the past decade, there has been renewed hope for cancer treatment with the introduction of precision medicine. The practice of precision medicine is just as it sounds: using aspects of a patient’s tumor, often genomic changes in that tumor, to guide a specific therapeutic treatment plan. The application of precision medicine has led to better outcomes and longer survival for certain patients with advanced cancers, including metastatic non-small cell lung cancer (NSCLC).

In the U.S., there are several approved therapies that target known alterations in the gene alterations present in NSCLC. However, despite the availability of these therapies, data shows that nearly half of patients with advanced NSCLC don’t get their tumors assessed through genomic biomarker testing, which are tests that allow your healthcare team to better understand your cancer’s DNA. This means patients are not getting the important opportunity to try therapies that target their specific kind of cancer early in treatment — or ever.

Biomarker Testing Barriers

The use of comprehensive and high-quality biomarker testing at the time of diagnosis and early in the treatment journey can allow patients and their doctors to have better conversations about treatment options. But many people with NSCLC are not receiving a biomarker test, often due to operational and financial challenges that prevent them from accessing it.

From an operational standpoint, biomarker testing takes many steps that can occur at different institutions and even in different states, making continuity of care and the testing itself difficult. First, the interventional radiologist gets the tumor tissue sample, a pathologist makes the diagnosis slides, and the oncologist orders the test. Then, a laboratory does the testing and sends the results, and ultimately, the oncologist and patient determine a treatment plan based on the findings.

On the financial side, despite the decreasing cost of genomic testing in recent years, testing prices remain high, and out-of-pocket costs are a barrier for many. Insurance coverage of comprehensive biomarker testing is variable and often based on metrics that don’t reflect the comprehensiveness of tests (the most important part) — only the number of biomarkers tested.

Moving Forward

As a molecular pathologist, an employee of an oncology company advancing precision medicines, and the son of a father whom we lost too soon to cancer, I am amazed by the progress we have made as a field in oncology, thanks to targeted therapies and the diagnostic testing that informs their use. And we as physicians, patients, and caregivers must strive to make sure that financial and operational barriers don’t stand in the way of accessing life-enhancing medicine.

People living with lung cancer, caregivers, and advocacy organizations can continue to push for broader insurance coverage policies to allow for more timely access to biomarker testing and ensure appropriate, effective therapies are prescribed. Oncologists and pathologists can work to understand which diagnostic test is most appropriate for their patients, and patients can elevate these conversations by asking whether the testing for their tumor is comprehensive and relevant to NSCLC.

Finally, from an institutional perspective, we must build systems and processes to solve operational and financial problems and get patients tested with the right test at the right time. This is what we’re trying to do at Loxo@Lilly, the oncology unit of Eli Lilly and Company, an institution that is working to open the door for better treatment of NSCLC with our Tempus Sponsored Testing Program, a program that offers no-cost, comprehensive next-generation sequencing (NGS) for eligible advanced NSCLC patients.
To hear more about overcoming barriers to biomarker testing, tune into Have You Heard of Biomarker Testing? of the Backstage @ Upstage podcast.

Guest Author Bio:

Anthony Sireci, MD, clinical pathologist

Anthony Sireci, M.D. is a board-certified clinical pathologist and a practicing molecular pathologist. Prior to joining Loxo, he was an assistant professor of pathology and cell biology at Columbia University and a medical director in the Laboratory of Personalized Genomic Medicine at Columbia Medical Center. He is an active member of the Association for Molecular Pathology (AMP), where he serves as the vice chair for new codes and pricing on the Economic Affairs Committee. He is also a member of the Pathology Coding Caucus in the College of American Pathologists (CAP) and the Molecular Pathology Advisory Group in the American Medical Association (AMA). Dr. Sireci received a B.A. in chemistry from New York University and an M.D. from the Johns Hopkins University School of Medicine. He completed his residency training in Clinical Pathology at the New York Presbyterian Hospital-Columbia University Medical Center, where he also served as chief resident. During this residency, he also received an MSc in biostatistics from the Mailman School of Public Health at Columbia.