The FDA has approved around 100 targeted therapies for different types of cancer, with many more in the pipeline. Current agents for non-small cell lung cancer (NSCLC), for example, target about 10 different biomarkers, and more than 70% of people with the condition have alterations in their tumors that are tied to available treatments. But a recent study found that due to practice gaps in the precision oncology pathway, just more than one-third of patients with biomarkers that could be treated with an FDA-approved therapy are actually benefiting from those drugs.
Lung cancer is one of the most common types of cancer, and NSCLC makes up the bulk of the cases. Many of the agents approved for NSCLC are targeted therapies that are indicated for specific subsets of the disease, and numerous tests are available to help providers determine the best treatment for a patient.
As detailed in a recent article in JCO Precision Oncology, researchers from Diaceutics and the Personalized Medicine Coalition (PMC) sought to determine whether people with NSCLC actually are receiving the most effective treatment based on their biomarkers.
Researchers analyzed commercial and Medicare claims and laboratory data from more than 500,000 people with NSCLC in the U.S. via Diaceutics’ proprietary DXRX Data Repository. Those were then whittled down to claims and data for 38,068 Medicare patients with advanced NSCLC who were newly diagnosed and actively managed in 2019.
That data was analyzed to determine which patients could have benefited — but did not — from a personalized therapy. Researchers focused on seven steps of the precision oncology pathway, starting with biopsy referral to treatment decision, to see where practice gaps existed. After normalizing the data to a patient population of 1,000, an analysis found the following:
For every 1,000 patients, 66 did not have a biopsy performed.
Of the remaining 934 patients, 136 had an insufficient data collection during the biopsy.
Of the remaining 798 patients, 14 had overestimation of the biospecimen tumor cell content, which impeded testing and the tests’ accuracy.
Of the remaining 784 patients, 142 did not have biomarker testing ordered for them or began treatment before such testing was ordered.
Of the remaining 642 patients, a test was inconclusive or provided false negative results for 118 patients.
Of the remaining 524 patients, 21 had lab delays, resulting in decisions about treatment being made that did not take into account the test results.
Of the remaining 503 patients, 147 did not receive the appropriate treatment for a variety of reasons.
So only 356 of every 1,000 patients eligible for precision oncology treatments — about 36% — are benefiting from the appropriate care, concluded the study authors.
For the Managed Care Oncology Index: Q1 2021, from March 4, 2022, to April 19, 2022, Zitter Insights polled 34 commercial payers covering 116.0 million lives and 26 Medicare payers representing 38.7 million lives about their management of NSCLC. Payers with just slightly more than half of commercial lives said that they covered companion diagnostics, although those with 79% of lives required results from these tests before members could have access to a treatment (see chart).
Zitter Insights and AIS Health are both MMIT companies.
“Addressing practice gaps can lead to improved clinical care associated with a precision oncology approach,” concluded the study authors. “Attention to practice gaps may also help to decrease health care costs through enhanced systemic efficiency and potentially reduced downstream spending on hospitalizations and health resource expenditures necessitated by suboptimal earlier care. An increased understanding of the impact of practice gaps can thus inform strategies to deliver more fully on the promise of personalized medicine.”
“This study reminds us that personalized medicine will not occur just because the science suggests it should,” said PMC President Edward Abrahams in a statement. “Only standardized test processing, broader educational initiatives, and additional studies to demonstrate the clinical and economic benefits of personalized medicine will deliver its promise to patients.”
For more information on the Zitter Insights data, contact Jill Brown Kettler at firstname.lastname@example.org.