Global Survey Examines Barriers to Optimal Lung Cancer Biomarker Testing

Matthew Smeltzer, PhD

Barriers preventing optimal biomarker testing among patients with early- or late-stage lung cancer were similar, and included cost, time, tissue sample quality, access, and awareness, according to a global survey presented at the 2024 IASLC World Conference on Lung Cancer.¹

The International Association for the Study of Lung Cancer conducted a biomarker testing survey in spring 2024, results of which were compared with a previous biomarker testing survey done in 2018. Results from the past survey revealed low adoption of biomarker testing because of cost, lack of quality and standards, access, awareness, and long turnaround times. Since this survey was conducted, several advances have been made in the early- and late-stage NSCLC treatment paradigms.

In the most recent survey, 63.4% of respondents ranked late-stage lung cancer, and 29.4% ranked early-stage lung cancer as highly important to perform biomarker testing. Moreover, 98.3% of respondents believed that biomarker testing significantly impacts outcomes and 91.2% claimed to have a clear understanding of who should receive biomarker testing.

“We asked a repeat question from 2018 which was, do you think more than half of individuals with lung cancer in your country are being tested? Last time, that was at 39%, and that went up to 67% this time, which was significantly greater [P < .0001]. So, there is the perception that things are improving,” Matthew Smeltzer, PhD, associate professor in the Division of Epidemiology, Biostatistics, and Environmental Health at The University of Memphis in Tennessee, said during a press conference on the survey. “But 43% said they sometimes often treat patients prior to receiving the biomarker results. This is not what we want to happen, and so this shows us that there’s still a gap in actually getting those results into the hands of people who need to make treatment decisions in time.”

Among the highest-ranked barriers that prevent optimal biomarker testing, were cost (27.2%), time (13.9%), tissue sample quality (13.8%), access (12.8%), and awareness (8.0%). An analysis of data from the focus group showed that cost represents a complex, multifactorial issue that varies by country. When respondents were asked what best described the reimbursement system for biomarker testing at their institution or health system, 25% reported having full reimbursements for all biomarker tests conducted, 37% said partial reimbursement based on specific criteria or guidelines, 18% said limited reimbursement or that it was challenging to offer comprehensive testing, and 13% reported having no reimbursement system for biomarker testing.

“Cost is a universal concern, and this is a multifaceted problem that we need to continue to try to solve,” Smeltzer said in the oral presentation. “The processes around testing our patients have inefficiencies, and we can’t really pinpoint exactly one thing, but the whole system could be more working more efficiently.”

When asked what potential solutions would help reduce biomarker testing costs in respondents’ countries, 63% said educating decision-makers on the cost-effectiveness of biomarker testing, 55% said working with policymakers to mandate or incentivize full reimbursement, 49% said having innovative cost-sharing agreements with diagnostic companies, 41% said having innovative cost-sharing agreements with payers, and 39% said increasing patient financial support programs.

“The complex issues, though, around making this happen really vary by region. Some things are pretty universal,” Smeltzer said during the press conference. “Some things are really specific to your practice or your region but universally, it seems that we still need more awareness on the value of biomarker testing and more education about why it’s important how to do it.”

Regarding the barrier of time, the turnaround time for tissue testing was a median of 14 working days. However, when asked what steps of the process most contribute to increased turnaround time for biomarker testing, respondents did not come to a consensus on a singular source of increased time. As possible solutions, nearly 700 respondents said the time from tissue sample processing to molecular analysis had the most opportunity for improvements to reduce turnaround time for biomarker testing.

Pathologists from the survey reported that insufficient tissue is the most significant reason why biomarker testing is not performed in late-stage lung cancer (48%), which led to sample quality as another barrier. For patients with unresectable, locally advanced, and metastatic lung cancer at diagnosis, having an insufficient amount of tumor cells provided by the biomarker test was more commonly reported. The same reason was reported for tissue re-biopsy requests for patients at diagnosis with resectable early-stage lung cancer.

“This spelled out as an area of potential opportunity. Sometimes the biopsy is insufficient, and we can’t actually run the test on the biopsy that was received,” Smeltzer explained. “We asked why that happens, and those who acquire the tissue said the most frequent reason is there’s an insufficient amount of tumor cells in the biopsy, followed by poor tissue quality.”

As a possible solution, Smeltzer said utilizing other tools, such as liquid biopsies when tissue biopsies are poor quality, can be helpful. “Liquid biopsy is another available tool when the tissue is not available,” he said. “I think any additional tools that we can develop to help us understand the disease better are going to be highly important, and we need to be open to new technology and figure out how to rigorously develop it.”

A final barrier was awareness, of which 54% of respondents’ institutions used the CAP-IASLC-AMP biomarker testing guidelines, 21% used other guidelines, and 26% were unaware of any guidelines. Furthermore, 68% said it is always necessary to help educate patients on biomarker testing after a diagnosis of lung cancer, 29% said it is somewhat necessary, and 3% said it is not necessary.

Of the total respondents from the survey, there were 1677 evaluable responses across 90 countries and 14 disciplines, some of which included medical oncologists, pathologists, thoracic surgeons, pulmonologists, and others.

“A major takeaway is we’ve really had a paradigm shift and how we should think about biomarker testing. It’s no longer something that’s nice to have for our patients, but it’s really a must-have for every patient with lung cancer,” Smeltzer concluded.

Reference

Smeltzer M, Connolly C, Lantuejoul S, et al. The 2024 International Association for the Study of Lung Cancer (IASLC) Global Survey on Biomarker Testing. Presented at: 2024 IASLC World Conference on Lung Cancer; September 7-10, 2024; San Diego, California. Abstract OA03.03.