OBJECTIVES: To estimate the cost-effectiveness of difelikefalin compared to the best supportive care (BSC) for the treatment of CKD-aP in adult patients receiving hemodialysis, from the Spanish NHS perspective.

METHODS: A Markov model was developed with seven health states: five health states representing levels of pruritus intensity over time (No, Mild, Moderate, Severe and Very severe CKD-aP) based on the data of difelikefalin clinical trials (KALM), and renal transplant and death as absorbing states. The model only includes patients with moderate, severe, and very severe CKD-aP at baseline, in line with difelikefalin approved indication. Costs and quality-adjusted life-years (QALYs) were discounted at a 3% annual rate with a lifetime horizon (36 years).

RESULTS: Difelikefalin treatment was associated with an increased number of QALYs (+0.49) and higher costs (+12,300€) compared to the BSC. Using a placeholder cost of 270.6€ per 28-days for difelikefalin, the incremental cost-utility ratio was 25,000€/QALY. The sensitivity analysis (DSA) confirms the robustness of the results. The probabilistic sensitivity analysis (PSA), undertaken using 1000 iterations, suggests a 48% probability of difelikefalin being cost effective at a WTP threshold of 25,000 €/QALY.

CONCLUSIONS: Difelikefalin could be a cost-effective option compared to BSC for the management of CKD-aP in hemodialysis patients in Spain. Considering the unmet medical needs, these results support the convenience of utilizing difelikefalin in routine clinical practice in Spain.