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Digital Health Company Baysient Announces CDS/HCEI Software to Reduce Healthcare Cost in the Biosimilar Market

Baysient LLC’s founder, Diane Mould, announces the release of the iDose software technology platform version 1.0 for infliximab (an anti-inflammatory biologic drug), just before presenting Biologics and Precision Medicine in IBD at Canadian Digestive Disease Week (CDDW), February 28 – March 1. The presentation will include results from a 12-month clinical validation study (NCT02453776) demonstrating (p = 0.017) the potential to reduce “switching” from lower cost infliximab to more expensive biologics by 66%. Similar studies are ongoing in 9 countries on 3 continents (> 300 patients).

The results to be presented in Montreal were originally presented by the investigators at European Crohn’s and Colitis Organization (ECCO, CopenhagenMarch 2019) and Digestive Disease Week (DDW, San DiegoMay 2019). Approximately 30% of all patients treated with anti-inflammatory biologics need to switch drugs within the first year. Typical switching from infliximab (biosimilar) to another biologic (not infliximab, not biosimilar) increases drug cost by $11,000 per patient per year (U.S. average retail costs, January 9, 2020). Healthcare professionals using the iDose software’s clinical decision support (CDS) information have the potential to reduce drug costs in this typical scenario by $726,000 per 100 patients failing therapy. Clinical Decision Support (CDS) information from the iDose software keeps 66 of these patients on average from failing and having to switch. The relatively low cost of the iDose software was not subtracted from the savings in this scenario. The Baysient pipeline includes CDS for 25 other FDA approved anti-inflammatory biologics.

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The iDose algorithm combines scientifically appropriate pharmacokinetic (PK) modeling with statistically sound Bayesian learning (non-AI machine learning) and forecasting. Information from the iDose software helps physicians understand how to keep the amount of drug in a patient’s body from falling below the physician-selected target therapeutic level.

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Reimbursement codes (ICD and CPT) for therapeutic drug monitoring, other long term (current) drug therapy, or chronic care management may be applicable.

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Patented iDose functionality is offered as a business-to-business, cloud-based software as a service (SaaS) and is HIPAA-compliant and compatible with electronic medical records (EMRs). It is currently offered in the U.S. and Canada.

When used by, or under the supervision of healthcare professionals, the iDose software is exempted from FDA clearance requirements. Drug companies must meet FDA requirements prior to associating the iDose software with their products. Healthcare payor firms may use information obtained from the iDose software as healthcare economic information (HCEI) after internal review.

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