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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