Expert Calls for Standardized Reflexive Biomarker Testing to Address Treatment Delays in Lung Cancer
Key Insights
Dr. Robert Kratzke from the University of Minnesota warns that delays in molecular testing for non-small cell lung cancer patients can lead to treatment lags that cost lives.
The expert advocates for making reflexive biomarker testing standard of care, requiring pathologists to automatically send lung cancer biopsy samples for genomic testing and immunohistochemistry.
Policy changes at the American College of Pathology level and insurer requirements are needed to ensure every NSCLC patient receives comprehensive biomarker testing regardless of geographic location.
Delays in molecular testing for patients with non-small cell lung cancer (NSCLC) can lead to treatment lags that cost lives, according to Robert Kratzke, MD, professor of medicine and head of medical oncology at the University of Minnesota. In recent interviews, Kratzke called for systematic changes to ensure reflexive biomarker testing becomes standard practice across all healthcare settings.
Current Testing Gaps Create Treatment Barriers
Kratzke emphasized that the failure to reflexively test biopsy samples for biomarkers represents a significant impediment to care, particularly affecting patients in rural areas. "The fact that this is not always reflexively done delays treatment for our patients," he explained during a recent Institute for Value-Based Medicine event focused on precision medicine in lung cancer.
The expert stressed that efficient biomarker testing serves dual purposes: "Efficient biomarker testing saves money and it saves lives both, and there's no particular reason why this shouldn't be done efficiently and quickly for all of our patients with lung cancer."
Standardizing Reflexive Testing Protocols
Given the expanding landscape of biomarker-driven therapies in lung cancer, Kratzke advocates for making reflexive testing mandatory. "If a biopsy sample says lung cancer, the pathologists are more or less required to send that for genomic testing, and that there's not a delay," he stated.
The oncologist drew parallels to the breast cancer community's experience with HER2 (search) testing decades ago, noting that systematic implementation required both professional society mandates and insurer requirements. "Finally, my understanding is that the American College of Pathology said, 'You have to do this,' and insurers started to say, 'You have to do this,' because once again, these therapies worked—they saved lives and they saved money."
Addressing Implementation Challenges
Kratzke acknowledged that pathology departments often view additional testing as an extra burden without direct benefit. "Quite often, in my experience, the impediment there is that the pathology department doesn't necessarily benefit from it. It's just an extra task, and we have to streamline it such that it's really just what has to be done."
He emphasized the need for comprehensive testing protocols: "We should make standard testing for doing next-generation sequencing testing on all NSCLC samples and aggressively standardize immunohistochemistry for targets such as HER2 (search) and now MET, since there are antibody-drug conjugates for those targets."
Technology Integration and Health Equity
The expert highlighted the potential role of artificial intelligence and electronic health records in reducing disparities. "The electronic medical record should, in my opinion, level that playing field dramatically" for providers in small towns, inner cities, and Native American reservations who may lack access to the most recent treatments.
Kratzke noted his positive experience with AI tools, stating that when given precise instructions, systems like ChatGPT provided accurate answers. He advocated for provider education to overcome resistance: "The electronic medical record is not our enemy; AI is not our enemy. If we let it, it would really help us and help our patients dramatically."
Value-Based Care Considerations
Addressing concerns about value-based reimbursement models, Kratzke urged insurers to consider long-term benefits even when only a subset of patients responds to treatment. He cited examples where biomarker-driven therapies can extend lives by 3-5 years for 20-30% of patients.
"If something really benefits 20% of the patients, that may not seem all that valuable. But if you're in that 20% and living 5 years, it's very, very valuable, obviously," he explained, referencing lessons learned from trastuzumab (Herceptin) in breast cancer treatment.
Real-World Data Applications
Kratzke emphasized the importance of real-world data in justifying coverage for new therapies, including antibody-drug conjugates in NSCLC. "Real-world data are critical in allowing us to see who benefits and how much the benefit in longer lives or even lives saved can be," he stated.
He noted that such data can help identify both beneficial and potentially harmful effects: "What therapies may be more harmful than we originally thought, that many of the antibody-drug conjugates do have significant toxicities."
Policy Recommendations
The expert called for policy changes at multiple levels to ensure equitable access to precision oncology. He suggested that either the American College of Pathology certification requirements or insurance provider mandates should ensure comprehensive testing across all healthcare settings.
"Somebody somewhere has to, in my opinion, make sure that every patient with NSCLC in the US has their sample tested at the DNA level and at the appropriate immunohistochemistry level for targeted changes and mutations," Kratzke concluded.