Difelikefalin Treatment in Chronic Kidney Disease-Associated Pruritus: Modelling Infection-Related Hospitalisation Cost Offsets Using Trial and Real-World Data Across Seven European Countries.

INTRODUCTION: We estimated cost offsets from treating moderate-to-severe chronic kidney disease-associated pruritus (CKD-aP) with difelikefalin, through reduced infection-related hospitalisations (IRHs). METHODS: Using Stockholm CREAtinine Measurements study data, IRH rates were estimated for patients who developed incident CKD-aP while on maintenance haemodialysis (2006-2021). Real-world IRH rates were applied to the time patients spent with resolved (mild/none) or persistent (moderate/severe) CKD-aP, based on randomised controlled trials of difelikefalin. Two-year national cost offsets of difelikefalin treatment were estimated using country-specific costs, the proportion of patients on haemodialysis, and established CKD-aP prevalence data for France, Italy, Portugal, Spain, Sweden, Switzerland, and the UK. Scenario analyses using alternative sources of CKD-aP prevalence and catheter infection rates were also conducted. RESULTS: Of 2329 patients free from CKD-aP at baseline, 17.6% developed CKD-aP during follow-up. IRH rates were 1.5-fold higher with incident CKD-aP versus those who remained CKD-aP free [incidence rate ratio 1.48 (95% confidence interval 1.19-1.83); P < 0.001]. Combining incidence rates with trial data, over 2 years, patients on difelikefalin were projected to have 61.7 weeks free of CKD-aP, versus 38.1 weeks with placebo. Estimated IRH-associated 2-year offsets through difelikefalin treatment were: €2-6.4 million in France, €1.2-3.5 million in Spain, €1.1-2.6 million in Italy, €1-3 million in the UK, €0.5-1.4 million in Portugal, €0.25-0.73 million in Switzerland, and €0.23-0.66 million in Sweden. CONCLUSION: Modelling difelikefalin's clinical benefits on real-world IRH-associated costs projected substantial potential cost offsets nationally, indicating how CKD-aP management may offer economic value in patients undergoing haemodialysis.