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* = Presenting author

P702 F-calprotectin use in inflammatory bowel disease is characterized by improved diagnostic accuracy, less patient harm and decreased costs, compared with conventional serological markers and colonoscopy. A cost-effectiveness study in Italy

Mascialino B.*1, Vora A.2

1Thermo Fisher Scientific, ImmunoDiagnostics, Uppsala, Sweden 2Thermo Fisher Scientific, ImmunoDiagnostics, San Francisco, United States

Background

Gastrointestinal disorders may exhibit overlapping symptoms making diagnosis difficult in primary and specialty care. Inflammatory bowel disease (IBD), prevalence <0.5% in the general population, is characterized by chronic inflammation of the gastrointestinal tract, non-specific elevation of inflammatory markers such as ESR and CRP and may present with extra-intestinal manifestations. Irritable bowel syndrome (IBS) is a functional disorder without gastrointestinal inflammation and with an estimated prevalence of 10–20%.

Endoscopy is the gold standard for detecting IBD vs. IBS, but due to the low prevalence of IBD, is negative in the majority of cases. Furthermore, it is invasive, expensive, and uncomfortable for the patient and not without risks. Moreover, inadequate bowel preparation prior to colonoscopy is known to increase the burden of disease from both the clinical and the economic perspective: shorter intervals between repeated procedures, higher missed rates, patient inconvenience, and increased risk of complications are reported in the scientific literature.

F-Calprotectin (FC) is a fecal marker of intestinal inflammation; IBD patients exhibit FC levels higher than the general population; IBS patients have FC levels higher than controls, but lower than IBD patients. Therefore, FC can be used as a pre-endoscopic test to differentiate between IBD and IBS.

This study evaluates the cost-effectiveness (CE) of FC compared to CRP+ESR, and to colonoscopy to rule out IBD in Italy.

Methods

A Markov model was developed for each diagnostic strategy, simulating 1000 patients presenting to primary care with unspecific gastrointestinal symptoms. In the model, 1.6% of the colonoscopies brought about complications (Rabasinghe, 2016), resulting in Emergency Room visits/surgery. Inadequate colon preparation (23%-Kilgore, 2011) and repeated colonoscopies (30.3%-Hendry, 2006) were included in the calculations.

Outcomes include cost savings, cost per corrected IBD diagnosed, colonoscopy reduction.

Results

FC is CE when compared to CRP+ESR, and to colonoscopy.

Table 1. Clinical and economic results of the simulation model

F-CalprotectinCRP+ESRColonoscopy
Total costs (EUR)66 08868 796111 807
Average cost/patient (EUR)66.168.8111.8
N colonoscopies avoided736722
Colonoscopy – costs avoided (EUR)75 25774 233
N correctly diagnosed IBS683657
N correctly diagnosed IBS9835
Colonoscopy – complication costs (EUR)2 6673 0718 548
Colonoscopy – inadequate colon preparation costs (EUR)2 1712 4906 928

It results in more correctly IBD diagnoses at a lower price; it reduces the unnecessary endoscopies, increasing the number of correctly diagnosed IBD (63) and IBS (26) patients.

Conclusion

Results show that the as pre-endoscopic tool FC is associated with fewer colonoscopies and correctly identifies more disease while decreasing costs compared to the alternatives. FC demonstrates superior value both from patient and payer perspective, while simultaneously increasing diagnostic efficacy.