Cost-Effectiveness Analysis of Difelikefalin for Patients with Chronic Kidney Disease-Associated Pruritus (CKD AP) Undergoing Haemodialysis in Italy

OBJECTIVES: Chronic kidney disease-associated pruritus (CKD-aP) is an impactful condition of CKD patients undergoing haemodialysis with increased morbidity/mortality, and worse health-related quality of life (HRQoL). Difelikefalin is the only drug approved in Europe for the treatment of moderate and severe CKD-aP in haemodialysis patients. Trials KALM 1-2 showed better efficacy of difelikefalin vs established clinical management (ECM), in terms of significant reductions in pruritus intensity and improvements in HRQoL, alongside good safety profile. The aim of this analysis was to estimate the Incremental Cost-Effectiveness Ratio (ICER) of difelikefalin compared to ECM from the perspective of the Italian National Health Service (INHS).

METHODS: A cohort model represented by four health states (No-itch, Mild, Moderate, and Severe) was recently published and adapted for the Italian setting. The model used data from KALM 1-2 trials for the efficacy, and 5-D Itch scores mapped to EQ-5D-5L to estimate utility parameters. Difelikefalin, consumption of one per patient/haemodialysis session, considered a price of €27 per vial. A recent Italian report on CKD-aP was used to input the cost of health states. The analysis was established over a 15-year time horizon, with a discount rate of 3% for health outcomes and costs; both deterministic univariate analysis and probabilistic multivariate sensitivity analysis (PSA) were developed. An acceptability threshold of 40,000 €/QALY was considered.

RESULTS: Difelikefalin showed greater efficacy (+0.373 QALY) which compensates for being more expensive (+€12,834) than ECM, with an ICER of €34,367/QALY. Sensitivity Analyses confirmed the robustness of the results. Remarkably difelikefalin was cost-effective in 57.3% of the PSA simulations.

CONCLUSIONS: Difelikefalin showed to be a cost-effective treatment for the INHS and, considering the lack of indicated effective treatments, these results support its reimbursement and the inclusion of difelikefalin in routine clinical practice for patients on haemodialysis with CKD-associated Pruritus in Italy.