Evidence map›Paper›PMID 39514176›Full record

ArticleJournal of nephrology2025

Cost effectiveness of difelikefalin for the treatment of patients with chronic kidney disease-associated pruritus undergoing hemodialysis in Italy.

Lucio Manenti, Andrea Marcellusi, Eugenio Di Brino, Andrea Aiello, Asia Barugolo, Patrizia Berto, Marco Soro

Abstract read
In one paragraph

Article in Journal of nephrology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Lucio ManentiUOC Nefrologia e Dialisi. ASL 5 Liguria, La Spezia, Italy.ORCID 0000-0002-4144-2142
Andrea MarcellusiDepartment of Pharmaceutical Sciences - DISFARM, University of Milan, Milan, Italy.ORCID 0000-0002-3974-3798
Eugenio Di BrinoAltems Advisory, spin-off dell'Università Cattolica del Sacro Cuore, Rome, Italy.ORCID 0000-0001-7964-3348
Andrea AielloPharmaLex Italy, Milan, Italy. andrea.aiello@pharmalex.com.
Asia BarugoloPharmaLex Italy, Milan, Italy.
Patrizia BertoPharmaLex Italy, Milan, Italy.
Marco SoroGlobal Value Access & Policy, CSL Vifor, Glattbrugg, Switzerland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundChronic kidney disease (CKD)-associated pruritus is a condition that strongly impacts CKD patients and is associated with increased morbidity/mortality, and worse health-related quality of life (HRQoL). Difelikefalin is currently the only drug approved in Europe specifically for treating moderate to severe CKD-associated pruritus in patients undergoing hemodialysis. The KALM-1 and KALM-2 trials showed better efficacy of difelikefalin vs placebo and best supportive care. The aim of this study was to investigate the cost-effectiveness of difelikefalin according to the Italian National Health Service (NHS) perspective.

methodsA cohort model represented by four health states (No, Mild, Moderate, and Severe pruritus) was adapted to the Italian setting. The model used data from the KALM-1 and -2 trials for efficacy, integrated with other publications for HRQoL estimations. To assess the cost of disease management, a recent Italian publication on CKD-associated pruritus was used and a price of €27 per difelikefalin vial was assumed. The base case analysis over a 15-year time horizon, and an additional 10-year scenario analysis, were established. Additionally, both deterministic univariate analysis and probabilistic multivariate sensitivity analyses were developed. Discount rates of 3% were applied. An acceptability threshold of 40,000 €/quality-adjusted life-year (QALY) was considered.

resultsThe results show that difelikefalin plus best supportive care is cost-effective vs best supportive care alone, with an incremental cost-effectiveness ratio, in the base case, of €35,823/QALY. Both the scenario and sensitivity analyses confirmed the strength of the results.

conclusionsDifelikefalin was found to be a cost-effective treatment for the Italian NHS. These results support its reimbursement and its inclusion in routine clinical practice.

Indexed as

AntipruriticsDrug CostsPruritusRenal DialysisRenal Insufficiency, ChronicCost-Benefit AnalysisCost-Effectiveness AnalysisFemaleHumansItalyMaleMiddle AgedModels, EconomicMorphinansQuality-Adjusted Life YearsQuality of LifeAntipruriticsMorphinansSpiro CompoundsTRK 820CKD-aPCost-effectivenessDifelikefalinHemodialysisItaly

Identifiers

PMID39514176
PMCPMC11903552

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.