Economic evaluations of genomic testing may have misleading conclusions

April 19, 2018, Yale University
Economic evaluations of genomic testing may have misleading conclusions
Oncotype DX. Credit: iStock Photo

Research led at the Yale School of Public Health have found that the majority of published papers analyzing the cost-effectiveness of a widely used test for breast cancer used a study design that can increase bias.

Oncotype DX, a gene-expression profiling test, is used in clinical care to guide chemotherapy decisions for patients with early stage breast cancer. Several cost-effectiveness analyses (CEAs) concluded that Oncotype DX is cost-effective, yet clinical guidelines suggest Oncotype DX testing for select rather than for all patients.

Lead author, Shi-Yi Wang, M.D., Ph.D., assistant professor at Yale School of Public Health and his co-authors were interested in why literature has yielded different conclusions. In the study, published in the Journal of Clinical Oncology, the research team conducted a of Oncotype DX CEAs and applied mathematical modeling to examine the extent to which the study designs and assumptions may influence their results. They also explored whether industry funding was associated with study designs that favor Oncotype DX.

"Reviewing 27 analyses, we identified eight issues that might compromise the accuracy and validity of the results. We also found that industry-funded studies tended to favor Oncotype DX," said Wang. "Our findings suggest that the majority of existing CEAs of Oncotype DX for women with early-stage have problematic issues that may result in misleading conclusions."

By combining systematic review with simulation modeling, Wang and his team identified factors that had large impact on CEA conclusions. For example, whether or not using prevalence information from population-based studies could lead to an opposite conclusion. An intervention with an incremental cost-effectiveness ratio less than $50,000 per quality adjusted life year is generally viewed as cost-effective. The incremental cost-effectiveness ratio of Oncotype DX is $42,000 per quality adjusted life year if using prevalence from a clinical trial (cost-effective), but is $167,600 per quality adjusted life year if using population-based prevalence data (cost-ineffective).

"As precision medicine is the mainstream for future practice, assessing the relationship between costs and benefits of expensive precision medicine gene tests is important.," said Cary Gross, M.D., professor of medicine and and the study's senior author. "Our results could provide critical insights for value-based frameworks, which rely on rigorous independent cost effectiveness analyses to help between high and low value clinical settings for specific tests.

Explore further: Gene test to predict breast cancer recurrence less cost effective in real world practice

More information: Shi-Yi Wang et al. Cost-Effectiveness Analyses of the 21-Gene Assay in Breast Cancer: Systematic Review and Critical Appraisal, Journal of Clinical Oncology (2018). DOI: 10.1200/JCO.2017.76.5941

Related Stories

Gene test to predict breast cancer recurrence less cost effective in real world practice

January 8, 2018
The most commonly used gene expression profile test used to help predict breast cancer recurrence may not be as cost-effective as once thought, say a team of researchers led by Georgetown Lombardi Comprehensive Cancer Center.

Common breast cancer test may not be worth the cost, study suggests

September 14, 2016
A new study by a UCLA researcher in collaboration with colleagues at Harvard and University of Texas Southwestern has found that a genomic test widely used to help determine whether women with a common form of breast cancer ...

First comparison of common breast cancer tests finds varied accuracy of predictions

February 15, 2018
Commercially-available prognostic breast cancer tests show significant variation in their abilities to predict disease recurrence, according to a study led by Queen Mary University of London of nearly 800 postmenopausal women.

New study could save breast cancer patients time, money and side effects

October 22, 2015
Most breast cancer patients with invasive lobular carcinoma could be treated with hormones alone and not with chemotherapy, according to a study by Virginia Piper Cancer Institute at Abbott Northwestern Hospital, part of ...

Industry-led oncology trials may inflate cost-effectiveness

December 11, 2015
(HealthDay)—Pharmaceutical industry-sponsored studies are more likely to report favorable estimates in cost-effectiveness analysis (CEA) of drugs used in breast cancer treatment, according to a research letter published ...

Diagnostic tool Oncotype DX associated with reduction in chemotherapy rates post-surgery in younger patients

December 11, 2014
In what's believed to be one of the largest population-based studies of Oncotype DX ever conducted, researchers at The University of Texas MD Anderson Cancer Center have found that the commercial diagnostic tool, Oncotype ...

Recommended for you

Mutant cells colonize our tissues over our lifetime

October 18, 2018
By the time we reach middle age, more than half of the oesophagus in healthy people has been taken over by cells carrying mutations in cancer genes, scientists have uncovered. By studying normal oesophagus tissue, scientists ...

Study involving hundreds of patient samples may reveal new treatment options of leukemia

October 17, 2018
After more than five years and 672 patient samples, an OHSU research team has published the largest cancer dataset of its kind for a form of leukemia. The study, "Functional Genomic Landscape of Acute Myeloid Leukemia", published ...

A 150-year-old drug might improve radiation therapy for cancer

October 17, 2018
A drug first identified 150 years ago and used as a smooth-muscle relaxant might make tumors more sensitive to radiation therapy, according to a recent study led by researchers at The Ohio State University Comprehensive Cancer ...

Loss of protein p53 helps cancer cells multiply in 'unfavourable' conditions

October 17, 2018
Researchers have discovered a novel consequence of loss of the tumour protein p53 that promotes cancer development, according to new findings in eLife.

New method uses just a drop of blood to monitor lung cancer treatment

October 17, 2018
Dr. Tasuku Honjo won the 2018 Nobel Prize in physiology or medicine for discovering the immune T-cell protein PD-1. This discovery led to a set of anti-cancer medications called checkpoint inhibitors, one of the first of ...

Researcher fighting breast cancer with light therapy

October 17, 2018
When treatment is working for a patient who is fighting cancer, the light at the end of the tunnel is easier to see.

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.