Healthcare Resource Utilization of Stage 3 & Stage 4 Pressure Ulcer (PU) and Diabetic Foot Ulcer (DFU) Patients Treated Early with Clostridial Collagenase Ointment (CCO) - A Payer’s Perspective

Introduction: CCO is the only FDA approved enzymatic agent indicated for debriding chronic dermal ulcers. The objective of this study was to estimate healthcare resource utilization in the early initiation versus late initiation of CCO in PU and DFU patients in the US from a commercially-managed payer perspective.

Methods: Humana administrative claims databases contained within the PearlDiver research tool were retrospectively reviewed to identify PU and DFU patients using ICD-9-CM and ICD-10-CM codes between 2007 and 2016. CCO early initiation was defined as patient’s receiving CCO within 30 days after index diagnosis date and CCO late initiation was defined as patient’s receiving CCO between 31 days and 90 days. Patients included in the study were continuously enrolled in the health plan for 12 months; >20 years of age; and did not receive CCO before the study period. 1:1 matched cohorts on patient demographic characteristics were used to calculate all-cause and disease-related healthcare resource utilization.  Multivariate regression analysis was conducted.

Results: There were 580 PU patients and 1,714 DFU treated with CCO identified after matching in the study period. All-cause healthcare costs for late CCO initiation were 51% ($51,106 vs $76,963) higher in PU patients and 28% higher ($52,762 vs $67,544) in DFU patients while disease-related healthcare costs were 91% ($12,938 vs $24,677) higher in PU patients and 20% higher ($14,158 vs $17,048) in DFU patients within the 12 month follow-up period. Multivariate regression analysis demonstrated all-cause and disease-related healthcare costs were decreased by $24,270 and $9,241, respectively for PU patients and decreased by $14,359 and $2755, respectively for DFU patients.

Conclusion: Early treatment initiation with CCO provides a clear overall and disease-related cost benefit to payers managing PU and DFU patients. Payers should consider mechanisms to encourage the early use of CCO in PU and DFU patients to lower costs