OBJECTIVES: For those living with a stoma, leakage outside the baseplate (LOB) is reported to negatively impact quality of life and increase health care resource use. The aim of the analysis was to assess the impact of a Digital Leakage Notification System (DLNS) on Health-Related Quality of Life (HRQoL) and health care resource utilization (HCRU) relating to LOB using recent UK study data.

METHODS: A cost-utility analysis (CUA) was conducted using a Markov model, to quantify the impact of a DLNS compared to standard of care (SoC) from a UK National Health Service (NHS) perspective. The CUA incorporated; (i) efficacy data quantifying the impact of a DLNS on LOB events, (ii) a UK-based Time Trade-off study, (iii) HCRU impacts from market research surveys, (iv) stoma appliance unit costs from Drug Tariff with costs weighted through market share data and (v) HCRU from the Unit Costs of Health and Social Care. The model outputs include costs, quality adjusted life years (QALYs) and incremental cost-effectiveness ratio (ICER). Sensitivity analyses were conducted to investigate the robustness of the results.

RESULTS: Estimated costs directly associated with LOB indicate an average cost to the health care system of £33.14 per event, while HRQoL impacts were 0.006 QALYs per LOB event. When results were extrapolated over 3 years, assuming no change in leakage risk, the DLNS reduced the number of LOB events by 49 per patient, leading to a potential LOB related saving of £1,578 and a gain of 0.306 QALY. Overall results were an incremental cost of £186 with an ICER of £608/QALY. Variables having the biggest impacts were cost of the DLNS and the associated reduction in LOB events.

CONCLUSIONS: The introduction of a DLNS could enable people living with a stoma to avoid LOB and improve their HRQoL at a minimal incremental cost to the NHS.