An economic analysis of Chemo Mouthpiece^® versus supportive care for the reduction of oral mucositis incidence in patients receiving chemotherapy

Aim: Oral mucositis (OM) is a common, burdensome complication of chemotherapy (CT), associated with pain, weight loss and increased infection risk. OM can result in CT dose reductions or delay subsequent cycles, compromising treatment efficacy. Current guidelines recommend oral cryotherapy with basic multiagent oral care for prevention of CT-induced OM. Chemo Mouthpiece^® (CMP) is a cryotherapy medical device with FDA 510(k) marketing clearance. A randomized controlled trial demonstrated that CMP effectively reduced the incidence and severity of OM caused by long or short half-life CT regimens in adults, compared with basic supportive oral care (BSOC) alone. The objective of this study was to estimate OM-related clinical and cost impacts associated with reductions in CT-induced OM from use of CMP. Materials & methods: A model was developed to simulate 1000 adult patients undergoing stomatotoxic CT from a US healthcare payer perspective under two scenarios: optimal practice: 100% using CMP plus best supportive oral care (BSOC); and current practice: 100% using BSOC. Clinical outcomes and costs were modeled to estimate the incremental difference between the two scenarios. Two different time horizons were tested in the model: conservative base case (single CT cycle) and real-world base case (six CT cycles). Additional sensitivity analyses were also conducted. Results: The cost of CMP in optimal practice was offset by cost savings from other sources, for a net total cost savings. In the conservative base case, optimal practice with CMP use for a single CT cycle was associated with over one million dollars in cost savings compared with current practice ($20,094,565 vs $21,260,470), largely attributed to reduced hospitalization length of stay. Use of CMP in optimal practice was associated with $1166 total cost savings per patient. Of note, substantially greater cost savings were estimated in the real-world base case with a time horizon of six CT cycles (additional savings of $2846 per patient each subsequent CT cycle). Three of the four sensitivity analyses were also found to result in net cost savings. Conclusion: Adoption of CMP was projected to be associated with reduced OM-associated clinical events and healthcare resource use. For 1000 adults using CMP for one CT cycle, cost savings accumulated to over one million dollars, amounting to $1166 per patient. Results of the real-world base case indicated that the value of CMP is likely underestimated, with cost savings over 15 million dollars, amounting to $15,395 per patient.