Blood-based MRD Test for Cancer Recurrence Can Generate Cost Savings in Colorectal Cancer Treatment, Finds Study in JAMA Health Forum

Rhea-AI Summary

A study published in JAMA Health Forum suggests that blood-based minimal residual disease (MRD) testing, specifically the Haystack MRD™ ctDNA test, can reduce healthcare costs in colorectal cancer treatment. Conducted by Quest Diagnostics and its subsidiary Haystack Oncology, the study found that testing half of eligible stage II colorectal cancer patients could cut costs by up to 21%. The study showed that ctDNA MRD tests could help identify patients who may safely skip chemotherapy, reducing both costs and adverse events. Results showed cost savings of $221,684 for commercial plans and $116,720 for Medicare Advantage plans, assuming 50% of eligible patients are tested. The findings are significant, considering that colorectal cancer is among the most diagnosed cancers in the U.S., with over 106,970 new cases projected in 2023.

Positive

• ctDNA MRD testing can reduce healthcare costs by up to 21% for commercial plans and 5% for Medicare Advantage plans.
• Testing half of eligible stage II colorectal cancer patients can save commercial plans $221,684 and Medicare Advantage plans $116,720.
• The study shows that ctDNA MRD tests can guide clinicians in making informed decisions on adjuvant chemotherapy (ACT), benefiting both patients and healthcare budgets.
• The DYNAMIC trial demonstrated a nearly 50% reduction in ACT use without compromising recurrence-free survival.
• Quest Diagnostics' acquisition of Haystack Oncology adds best-in-class ctDNA MRD technology to its oncology portfolio.

Negative

• The analysis did not consider costs related to potential disease recurrence and mortality.
• There is uncertainty in actual ACT use rates in real-world clinical practice.
• The study's hypothetical model may not fully reflect real-world clinical scenarios and patient adherence.

Insights

Medical Oncologist

The use of circulating tumor DNA (ctDNA) MRD tests in colorectal cancer treatment represents a significant advancement in personalized oncology. These tests enable the identification of patients who can safely forgo adjuvant chemotherapy (ACT) after surgery, reducing the adverse effects associated with chemotherapy. This approach aligns with the ongoing shift towards precision medicine, where treatments are tailored to individual patient profiles. The study in JAMA Health Forum suggests that ctDNA MRD testing can reduce the need for chemotherapy nearly by half without compromising recurrence-free survival. This is critical as it not only preserves the quality of life for patients but also decreases the financial burden of post-surgical cancer care. This method can be transformative for patients and healthcare systems alike, promoting more efficient and effective cancer management.

Financial Analyst

From a financial perspective, the implementation of ctDNA MRD testing in colorectal cancer treatment could result in substantial cost savings for health plans. The study highlights potential reductions of $221,684 for commercial health plan populations and $116,720 for Medicare Advantage populations. This reduction is attributed to a decrease in the utilization of adjuvant chemotherapy, which is costly and often associated with significant side effects. The analysis indicates that, when adopted broadly, ctDNA MRD testing can offer health plans budget-neutral or even cost-saving benefits, making it an attractive option for both payers and patients. The financial implications here are quite promising, suggesting a win-win scenario for reducing healthcare costs while maintaining effective patient care.

Market Research Analyst

The market implications for ctDNA MRD testing are significant. The ability to identify patients who can forgo chemotherapy could drive broader adoption of this technology across healthcare systems. Considering colorectal cancer is one of the most commonly diagnosed cancers in the U.S., with substantial patient populations eligible for this testing, the market potential is considerable. The study forecasts cost savings and better resource allocation, which can make this technology highly desirable for policy makers and healthcare providers. Furthermore, Quest Diagnostics' acquisition of Haystack Oncology augments its portfolio in oncology services, potentially increasing its market share and influence in the cancer diagnostics space. This market shift towards advanced diagnostics is likely to attract further investments and development, making it a sector to watch closely.

Circulating tumor DNA (ctDNA) testing for minimal residual disease (MRD) can reduce costs by up to 21% across health plan populations when half of eligible patients with stage II colorectal cancer are tested for treatment decisions

SECAUCUS, N.J. and BALTIMORE, May 31, 2024 /PRNewswire/ -- A blood test could help reduce costs for health plans by reliably identifying patients who might be able to safely forgo chemotherapy after surgery for stage II colorectal cancer, according to a study published today in JAMA Health Forum, a member of the JAMA Network. Researchers from Haystack Oncology, a Quest Diagnostics (NYSE: DGX) company and developer of the Haystack MRD™ tumor-informed ctDNA MRD technology, City of Hope and the Walter and Eliza Hall Institute of Medical Research conducted the study.

The analysis is the first of its kind published in a peer-reviewed journal to demonstrate the potential of circulating tumor DNA minimal residual disease (ctDNA MRD) tests to help reduce costs of adjuvant chemotherapy to U.S. health plans without compromising recurrence-free survival in patients with colorectal cancer.

ctDNA MRD tests are highly advanced blood or "liquid biopsy" tests that help identify early evidence of residual or recurrent cancer after surgical removal of a solid tumor.

"This study provides compelling evidence that health plans can reimburse for ctDNA MRD testing with neutral affect to their budgets while also gaining clinical insights into disease risk that other routine tests may not provide," said Afsaneh Barzi, MD, PhD, senior author of the study and a medical oncologist at Duarte Cancer Center in Duarte, California, specializing in the treatment of gastrointestinal cancers.

"We hope this latest data gives healthcare policy makers greater confidence to adopt tumor-informed ctDNA MRD testing as an economically and clinically valuable facet of colorectal cancer care," said co-author Jeanne Tie, MBChB, FRACP, MD, Medical Oncology Lead for the Lower Gastrointestinal tumor stream at Peter MacCallum Cancer Centre and a senior research fellow within the division of personalized oncology at the Walter and Eliza Hall Institute.

Building Evidence from the DYNAMIC Trial

In June 2022, a randomized clinical trial (DYNAMIC) demonstrated that a tumor-informed ctDNA MRD test performed on patients with stage II colorectal cancer reduced the application of adjuvant chemotherapy (ACT) by nearly half (15% vs. 28%) without compromising recurrence-free survival. While many patients can safely forgo ACT, physicians cannot reliably identify these patients with conventional pathological and clinical metrics. This information could help reduce the administration of ACT, thus decreasing the risk of adverse events and the related costs ($44,022 to $65,792 per patient). Results from the DYNAMIC study demonstrate that post-surgical evaluation with an appropriate ctDNA MRD test can significantly improve the identification of patients that stand to benefit from ACT.

"The DYNAMIC trial showed that testing with an appropriate tumor-informed ctDNA MRD approach more precisely identifies patients that stand to benefit from ACT," said Dan Edelstein, general manager and co-founder, Haystack Oncology. "This new study shows that the value of this new ctDNA information can help guide clinicians to make a more informed decision around ACT that benefits not only the individual patient but can also deliver broad economic benefit."

The Haystack ctDNA MRD technology is a highly optimized version of the Safe-SeqS chemistry used in the DYNAMIC study.

In the new analysis, hypothetical health plans with 1 million covered lives included 35 commercial health plan members and 102 Medicare Advantage members aged 75 years of age or younger with stage II colon cancer who were eligible for ctDNA MRD testing. The analysis compared standard clinical evaluation to a hypothetical treatment model in which 50% of patients are managed with tumor-informed ctDNA MRD testing.

Among the study's key findings:

• ctDNA MRD testing would reduce costs by 21% (1,068,040 vs. 846,356, a savings of $221,684 in total or $0.018 per member per month [PMPM]) for a commercial plan population and by 5% (2,550,029 vs. 2,433,309, a savings of $116,720 in total or $0.01 PMPM) for a Medicare Advantage plan population. Differences in cost savings between commercial and Medicare plans are related to differences in average age of plan members and associated clinical practice patterns.
• Using ctDNA MRD for greater than 50% of patients would produce even higher cost savings.
• The number-needed-to-test to avoid ACT use in one patient was estimated to be 4 in the commercial health plan population and 10 in the Medicare Advantage population.
• The budget-neutral cost for ctDNA testing was $16,202 for a commercial health plan and $5,793 for a Medicare Advantage payer. While the base-case model assumed 6 months of ACT, savings were also observed for a more conservative 3 months of therapy.

"The absolute reduction in ACT use in ctDNA-guided treatment vs. standard clinical evaluation-based treatment is expected to be the most significant factor affecting budget, based on our analysis," said lead author Yonghong Li, PhD, Director, Science and R&D, Quest Diagnostics. "If more than 50% of patients who are eligible are tested, cost savings may even be higher."

The analysis had several limitations, including lack of consideration for the costs of potential disease recurrence and mortality and uncertainty of actual ACT use rate in ctDNA-guided treatment in real-world clinical practice. Strengths included that the budget impact analysis was based on a landmark clinical trial showing the clinical utility of ctDNA testing in colon cancer and that model parameters were derived from large studies and claims in the U.S. population. This analysis provides a model where payers can input parameters observed in their health plans to estimate potential budget impact.

Quest acquired Haystack Oncology in June 2023, adding the best-in-class Haystack MRD™ tumor-informed ctDNA MRD test to its portfolio of oncology services. Quest Diagnostics and Haystack Oncology will also be exhibiting at this year's American Society of Clinical Oncology (ASCO) meeting in Chicago, IL, at booth #35145.

Colorectal cancer is among the most commonly diagnosed cancer in the United States. In 2023, an estimated 106,970 individuals were projected to be diagnosed with the disease, with up to 25% having stage II disease and 52,550 individuals succumbing to disease.¹

About Haystack Oncology
Haystack Oncology represents the culmination of over 20 years of collaboration to advance technical and clinical development in liquid biopsy technologies by cancer genomics pioneers at Johns Hopkins School of Medicine. The company, a wholly owned subsidiary of Quest Diagnostics, developed Haystack MRD™, a next generation tumor-informed approach for the measurement of minimal residual disease. Haystack MRD uses an error-corrected ctDNA technology to detect down to one ctDNA molecule in a million normal DNA molecules. Haystack Oncology works with biopharmaceutical companies to accelerate and better inform clinical development programs and advance important therapeutics to global markets, from early phase clinical development to companion diagnostics.

Haystack MRD was developed and validated in a CLIA-certified laboratory and is available for testing in clinical research in laboratories located in Baltimore, Maryland; Hamburg, Germany; and Helsinki, Finland. Quest Diagnostics is now offering the test to select providers through an early experience program and plans to launch a clinical version of the Haystack MRD™ test broadly in the U.S. later this year. Learn more at haystackmrd.com. 

About Quest Diagnostics
Quest Diagnostics works across the healthcare ecosystem to create a healthier world, one life at a time. We provide diagnostic insights from the results of our laboratory testing to empower people, physicians and organizations to take action to improve health outcomes. Derived from one of the world's largest databases of de-identifiable clinical lab results, Quest's diagnostic insights reveal new avenues to identify and treat disease, inspire healthy behaviors and improve healthcare management. Quest Diagnostics annually serves one in three adult Americans and half the physicians and hospitals in the United States, and our nearly 50,000 employees understand that, in the right hands and with the right context, our diagnostic insights can inspire actions that transform lives and create a healthier world. www.QuestDiagnostics.com.

¹ https://acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.21772

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SOURCE Quest Diagnostics

FAQ

How much cost savings can ctDNA MRD testing provide for colorectal cancer treatment?

The study suggests ctDNA MRD testing can reduce healthcare costs by up to 21% for commercial plans and 5% for Medicare Advantage plans.

What is the financial impact of testing stage II colorectal cancer patients with ctDNA MRD?

Testing half of eligible patients can save commercial plans $221,684 and Medicare Advantage plans $116,720.

How does ctDNA MRD testing affect adjuvant chemotherapy (ACT) use?

The DYNAMIC trial demonstrated that ctDNA MRD testing reduces ACT use by nearly half without compromising recurrence-free survival.

What are the limitations of the ctDNA MRD testing study?

The study did not account for costs related to potential disease recurrence and mortality and has uncertainties in real-world ACT use rates.

What are the key findings of the JAMA Health Forum study on ctDNA MRD testing?

The study found that ctDNA MRD testing could reduce healthcare costs, guide more informed ACT decisions, and improve patient outcomes.