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Peristomal skin complications (PSCs) have a significant impact on quality of life and ostomy treatment costs. This study aimed to assess the healthcare resource use for patients with an ileostomy and PSCs symptoms. Two surveys were developed and, after validation by healthcare professionals and patients, data were collected on healthcare resource use while not experiencing any PSCs symptoms and while experiencing complications of various severities, as defined by the modified Ostomy Skin Tool. Costs applied to resource use were assigned from relevant United Kingdom sources. Additional healthcare resource use associated with PSCs, relative to no complications, was estimated to result in a total cost per instance of £258, £383, and £505 for mild, moderate, or severe PSC, respectively. The average estimated total cost per complication instance, weighted across mild, moderate, and severe PSCs, was £349. Severe‐level PSCs were associated with the highest cost, because of the treatment‐level required and the longer duration of symptoms. There is potential for clinical benefits and economising in stoma care if interventions are implemented that reduce the incidence and/or severity of PSCs.

Background: Leakage of stomal effluent outside the baseplate that soils clothes or bedsheets is a common problem for many people with a stoma and significantly impacts their quality of life. Aim: To understand behavioural changes for people experiencing faecal leakage outside the baseplate regarding the usage of pouching systems, supporting products and interactions with health professionals. Methods: Retrospective, self-reported questionnaire. Findings: Respondents on average experienced 1.1 incidents of faecal leakage outside the baseplate per fortnight. In periods with issues of leakage, 21% of respondents had been in contact with health professionals, 40% increased their use of pouching systems, 25% increased their use of existing supporting products, and 21% included additional supporting products to their change routine. The increased use of healthcare resources was estimated to cost £32.47 in the 3 weeks following a leakage incident. Conclusion: Incidents of leakage outside the baseplate lead to increased use of healthcare resources.

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Objectives: Medical devices are typically reimbursed through distinct pathways vs. pharmaceuticals due to their relatively greater number, lower cost, shorter life-cycles, and greater difficulties in conducting randomized trials. National Health Technology Assessments typically inform public reimbursement of drugs and not devices. However, in Canada the remit of CADTH includes both drugs and devices. This research aimed to elucidate the rate of submission and reimbursement approval of medical devices versus drugs in Canada. Methods: A retrospective analysis of Canadian HTA records was conducted using CADTH CDR, CADTH pCODR, and OHTAC. These online sources were used to (a) identify CADTH HTA submissions of all drugs and medical devices made between January 1, 2013, and December 30, 2018, and (b) further classify the assessments into those that were approved for reimbursement in Canada, and those that were not. Results: A total of 372 HTA submissions were identified, 7% (26/372) for medical devices and 93% (346/372) for drugs. Overall, 77% medical devices were approved for reimbursement (90% unconditionally) compared to 82% of drugs (29% unconditionally). Cardiovascular devices accounted for 31% of all medical device submissions, followed by genitourinary devices (27%) whereas for drugs, oncology (30%) and hepatic (7%) were the most common indications. Conclusions: Medical device HTA submission numbers are low (n=26) and this does not represent the number of devices that are currently available in the healthcare industry. However, this subset has a HTA approval rate similar to that of drugs. The decision to publically fund a medical device is often driven by cost-effectiveness, as is true for most drug approvals. Additionally, a positive outcome is often without caveat, which is not usually the case with drugs, especially oncology drugs. Evidence presented here suggests manufacturers should be reassured that public funding is available for devices that address unmet medical needs, especially when costeffective.