Coverage Policies, Team Protocols Could Boost Spotty Uptake of Biomarker Testing in NSCLC

Research presented at the 2024 World Conference on Lung Cancer described exciting advances in targeted therapies that are designed to treat specific genetic mutations in patients with lung cancer. However, uptake of the biomarker testing that determines eligibility for these targeted treatments is frustratingly inconsistent, according to other findings presented at the conference.

Biomarker testing is critical for determining optimal therapy early in the NSCLC treatment process, but research shows uneven insurance coverage of these tests and inconsistent uptake in cancer centers. | Image Credit: © syhin_stas - stock.adobe.com

FDA approvals for therapies targeting biomarkers like EGFR, ALK, and PD-L1 have transformed the landscape of treatment for non–small cell lung cancer (NSCLC), but disparities in access to testing persist and threaten to worsen patient outcomes, according to one poster.¹ The investigators aimed to assess existing state legislation that mandates insurance coverage for biomarker testing in NSCLC. Only 13 states have enacted policies mandating such coverage, with 15 more expected to introduce legislation this year. However, a coverage law doesn’t necessarily guarantee receipt of biomarker testing, as some states’ policies allow for prior authorization or other utilization management controls, and not all of them specify any requirements for the cost-sharing structure.

For instance, Arizona’s HB 2144, which requires coverage of biomarker testing with clinical utility, mandates a timely response to authorization requests and specifies that deductibles and co-pays must be consistent with the rest of the plan’s coverage. The comparable laws in California and Nevada don’t include any provisions relating to cost.

“Without mandating affordable co-pays, insurance companies retain discretion over cost sharing, potentially exacerbating disparities,” the authors wrote.

Presenting author Goetz Kloecker, MD, MBA, MSPH, of University of Louisville Health, told The American Journal of Managed Care^® that his home state of Kentucky provides a successful example of how oncologists and other clinicians can make the case to legislators that these laws are necessary to eliminate hurdles to biomarker testing.

“The Kentucky Society of Clinical Oncology, KYSCO, which is part of ASCO, the American Society of Clinical Oncology, had an advocacy team, and we approached the legislation, so the chairwoman of the health cabinet, and presented the issue that there is effective treatment and insurances make it sometimes difficult to get tests to allow us to treat the patients for oncogenes. And then, with this effort, the law was proposed and voted on and was implemented one and a half years ago, and since then, I personally have not had any more peer-to-peer questions on why we order a genomic workup in a patient with lung cancer,” Kloecker said.

The oncologists, pulmonologists, and other professionals who treat cancer are powerful messengers in advocating for legislative change because they are most familiar with the need for biomarker testing and can best explain it to policy makers.

“We had also very good legislators who had some understanding about the medical need in Kentucky. Kentucky, as you know, has a big lung cancer problem, and when we told them the data [show] that maybe a third or 50% of lung cancer patients don’t get these tests, and it would prolong life by years and years, they understood it,” Kloecker said.

Zooming in from the state policy level to individual clinics, another group of researchers reported results of a quality improvement initiative to boost biomarker testing rates at 3 cancer centers.² They assessed baseline data, analyzed root causes of barriers to testing, and held multidisciplinary workshops to brainstorm solutions. The baseline data showed room for improvement in biomarker testing, as the 3 centers performed PD-L1 testing in 55%, 95%, and 80% of cases but EGFR testing in 55%, 45%, and 80% of cases. At center 3, 90% of cases were discussed by a multidisciplinary tumor board, but at the first 2 clinics these rates were just 65% and 62%.

The investigators proposed a pathology-driven reflex biomarker testing protocol for patients newly diagnosed with NSCLC, which could help address the current variations in what tests are ordered and when. They also noted the impact of complex reimbursement regulations, as test orders may be delayed if the patient is hospitalized due to the inpatient Medicare 14-day rule.

“Updated guidelines for biomarker testing are not sufficient to drive process change in cancer centers,” the investigators wrote. “A concentrated, multidisciplinary team effort is critical to ensuring equitable, efficient testing and optimized comprehensive care delivery.”

References

1. Kalantri S, Singh R, Singh I, Kolesar J, Kloecker G. Review of state legislation mandating biomarker coverage in cancer care. Presented at: 2024 World Conference on Lung Cancer; September 7-10, 2024; San Diego, CA. Accessed September 9, 2024. https://cattendee.abstractsonline.com/meeting/20598/Session/309

2. Smeltzer M, Kim J, Alvarez B, et al. A quality improvement initiative to address biomarker testing and quality of care delivery for early-stage NSCLC at 3 cancer centers in the US. Presented at: 2024 World Conference on Lung Cancer; September 7-10, 2024; San Diego, CA. Accessed September 9, 2024. https://cattendee.abstractsonline.com/meeting/20598/Session/323