False-positive breast biopsies in the United States cost the healthcare system more than $2 billion per year, according to findings released from a new study in ClinicoEconomics and Outcomes Research, conducted by a team of health outcomes research scientists at IBM Watson Health in collaboration with Seno Medical's Chief Medical Officer, A. Thomas Stavros, MD.1
The study analyzed recent data focusing on diagnostic breast imaging, biopsies, and other diagnostic procedures performed for patients recalled for follow-up after suspicious findings from initial screening mammography or breast examination. Such follow-up procedures are ordered by clinicians largely because current tools often cannot provide diagnostic certainty in identifying cancerous breast masses. The study looked at how often the follow-up procedures were performed, on what volume of patients, the most common sequences in which the procedures were performed, and the associated costs.
Data was collected from a nationally representative sample of 875,000 adult women using real-world encounters from healthcare claims data from 2011 to 2015, and then projected nationally to estimate that more than 12 million women in the US received follow-up exams each year after suspicious findings. Based on actual payer claims for the women studied, 53.3 percent of such patients received diagnostic mammograms, 42.4 percent received diagnostic breast ultrasounds, and 10.3 percent received biopsies after initial diagnostic procedures. Total costs for these procedures were projected at:
• $3.05 billion for diagnostic mammograms (average cost $349)
• $0.92 billion for diagnostic breast ultrasounds (average cost $132)
• $3.07 billion for biopsies (average cost $1,938)
Combined with other follow-up imaging procedures (e.g., tomosynthesis, MRI, others), the data totals nearly $8 billion spent annually for follow-up breast diagnostic procedures.
Breast cancer is the most common malignancy among women worldwide and the second leading cause of cancer-related deaths in females, and it is estimated that 266,120 new cases of invasive breast cancer will be diagnosed in women in 2018.2 Survival rates have increased steadily over recent decades as earlier detection enables treatment at earlier stages when treatment is more effective and less costly. However, many organizations differ on timing (annually, bi-annually) and ages for screening (to begin at age 40 or 50 years, screening after age 74 years), with varying opinions on how to best balance breast cancer screening costs with rates of detection, rates of false-positives or over diagnoses, and reduction in mortality.1
The study authors stressed the critical need for follow-up with patients who present with abnormal results on a screening mammogram. Standards of care and practice guidelines require further imaging studies before an invasive procedure such as breast biopsy, when the screening mammogram uncovers something suspicious.
They further recognized unmet medical need for highly effective exam tools that could exclude patients whose suspicious breast masses are benign before they are subjected to invasive diagnostic procedures. Breast biopsies have been found to show a false-positive rate following diagnostic screening procedures as high as 71 percent in the United States according to the National Cancer Institute3, translating to an annual cost of $2.18 billion in biopsy procedures that might have been avoided.
"The costs to the healthcare system are secondary to the psychological impact on women who are told that their mammogram and ultrasound were inconclusive, and that a biopsy is required to rule out cancer," says A. Thomas Stavros, MD, FACR, professor specialist, Department of Radiology University of Texas Health Sciences Center and chief medical officer of Seno Medical, San Antonio, Texas.
"Conscientious clinicians rightly want to confirm that a mass is not malignant, so the guidelines and clinical practice aren't at fault. It's simply that technology—as advanced as it has become—still needs further refinement to provide better specificity without sacrificing sensitivity and to engender increased diagnostic confidence for the clinician. There are significant volumes and costs of procedures required to reach a definitive, 'yes,' that breast cancer does or does not exist."
"Our findings bring a national spotlight on the current diagnostic procedure journey faced by patients and providers in order to have confidence in the evidence of a woman's risk of breast cancer," says Jay Margolis, PharmD, senior research scientist at IBM Watson Health and senior author for the study. "Recalling a woman for subsequent imaging procedures that may not be truly needed places significant burdens on the patient, her family, and her career, with substantial costs to the healthcare system."