A health economic analysis has indicated potential cost savings associated with the use of the diagnostic blood panel IBSchek for patients suffering from diarrhea-predominant irritable bowel syndrome (IBS-D), according to Commonwealth Laboratories, LLC. 

The study, published in Clinical Therapeutics, utilized a cost-minimization decision tree model, a budget impact analysis, as well as physician surveys to compare the economic values.

IBSchek is a simple blood test designed to help physicians diagnose IBS, the most common gastrointestinal disorder in the U.S., which affects approximately 40 million Americans. IBSchek identifies the presence of two antibodies in a blood specimen – anti-CdtB and anti-vinculin. Elevated levels of either of these antibodies can confirm a diagnosis of diarrhea-predominant IBS (IBS-D) or IBS-Mixed (IBS-M).

The blood test uses a well-established immunoassay method called ELISA that can be conducted on a specimen collected via a standard blood draw. Results are reported to the physician 24 hours after the patient’s blood specimen is received by Commonwealth for analysis.

The results of the study showed that using the IBSchek diagnostic blood panel may result in both greater efficiencies in diagnosing IBS as well as cost savings to the healthcare system. A budget impact analysis estimates that, when the cost savings are amortized over one million lives, the blood panel will save healthcare payers more than $3.5 million annually.  

A cost-minimization decision tree model predicts an estimated $509 cost savings versus the exclusionary diagnostic pathway, which is the current standard of care. Additionally, the exclusionary diagnostic pathway was estimated conservatively in this study, according to Commonwealth. It did not consider repeated investigations (i.e., multiple colonoscopies), the potential for more invasive studies stemming from false-positive results of the investigations, or the cost of pathology assessments. 

“The financial and emotional toll of diagnosing IBS is substantial – diagnosis takes an average of 6.6 years, and patients typically consult with more than four healthcare providers about their symptoms, which adds up to many physician visits, tests and suffering,” Mark Pimentel, MD, director of the Pimentel Laboratory at Cedars-Sinai, said in a press statement. “IBSchek can help diagnose IBS patients earlier so physical symptoms may be treated, resulting in a reduction of the financial burden of IBS on both patients and the healthcare system.”

Traditionally, a diagnosis of IBS was made only after excluding other gastrointestinal conditions, such as Crohn’s disease and ulcerative colitis. This exclusionary process takes time and often requires patients to undergo costly and invasive medical procedures, such as colonoscopies, computed tomography scans, and endoscopies, among others. The invasive diagnostic procedures may have risks for patients, who can experience complications such as bacterial infection, hemorrhage and bowel perforation. 

Several methods were utilized in the study to estimate the potential cost savings of using the IBSchek diagnostic blood panel, including:

• A cost-minimization decision tree model for gastroenterology practices in the United States was constructed to compare two differing diagnostic strategies. This model predicts that use of the novel IBS diagnostic blood panel may result in an estimated cost savings of $509 [per patient], by allowing patients to proceed to treatment earlier, thereby avoiding unnecessary testing. The cost savings are dependent on the probability a test result would lead to treatment.
   
• A budget impact analysis was performed for a hypothetical health plan with one million covered lives. The prevalence of IBS was estimated from medical literature with analysis performed for the U.S. population aged 18-64. Analysis computes the difference in net costs for two scenarios: 1) 100 percent of eligible patients are diagnosed with the exclusionary pathways; 2) 50 percent of eligible patients are diagnosed with the IBS diagnostic blood panel pathway.
   
• Two surveys were developed and completed by nine expert gastroenterologists from primarily academic centers in the United States. The first survey looked at physician and patient characteristics (e.g., insurance type, patient distribution by subtype, time to diagnosis, etc.). The second survey addressed the same variables in the first survey, but in a more detailed manner.

Researchers disclosed several limitations when interpreting the study data, including the wide range of response in the surveys and survey sample size, the potential for physicians to initiate treatment before conducting testing, and that the decision to send a patient for treatment is affected by individual biomarker outcomes.