Cost Benefit Associated with the Use of SITZMARKS® for the Diagnosis of Constipation in an Adult Population


Ibrahim K1, Salt II WB2, Magar R3
1AHRM Inc., Austin, TX, USA, 2IBS and Gut Microbiome Solutions, Dublin, OH, USA, 3AHRM Inc., Raleigh, NC, USA

OBJECTIVES: Constipation is a prevalent symptom-based disorder that disproportionately affects women and older adults and presents a significant economic problem in the US. By 2030, an estimated 1 in 5 Americans in be 65 and older, thus prevalence of constipation is expected to increase, and optimal diagnosis of constipation will prevent constipation related complications.

METHODS: A decision tree analysis was modeled using Treeage Pro 2021 Software to evaluate cost savings and net benefit of utilizing SITZMARKS versus other standard of care in the diagnosis of constipation in a hypothetical adult population. SITZMARKS capsule is a safe, non-invasive convenient tool used to detect blockage or colonic inertia in pediatric or adult patients with constipation. Sensitivity and specificity of each test included in this study (SITZMARKS, computed tomography, thyroid function tests, anorectal manometry, flexible sigmoidoscopy, balloon expulsion) were extracted from physician survey and literature. Direct medical costs (adjusted to 2021 dollars) were obtained from private payer reimbursement rates. Sensitivity analyses were performed to evaluate the robustness of the model parameters and variables with the greatest effect. Incremental cost effectiveness and other outcomes were reported.

RESULTS: The use of Sitzmarks dominated all standard of care with an expected value of US$3,734 (assuming an 80% test sensitivity). After SITZMARKS as a dominant strategy, computed tomography also emerged as a dominant strategy with an expected value of $9,391 and an incremental cost of $5,657. Sensitivity analysis results showed that SITZMARKS remained the least expensive option at 60% diagnostic yield. Untreated constipation was the most expensive option with an incremental cost of $31,775 followed by colonoscopy with an expected value of $19,904.

CONCLUSIONS: Constipation exacts a significant economic and humanistic burden on the US population, thus the use of SITZMARKS may improve diagnostic accuracy and consequently reduce the need for further testing which could result in significant cost savings.

Conference/Value in Health Info

2023-05, ISPOR 2023, Boston, MA, USA

Value in Health, Volume 26, Issue 6, S2 (June 2023)




Clinical Outcomes, Economic Evaluation, Medical Technologies, Methodological & Statistical Research

Topic Subcategory

Clinical Outcomes Assessment, Diagnostics & Imaging, Survey Methods


STA: Medical Devices

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