Evidence map›Paper›PMID 40461934›Full record

ArticleNeurology and therapy2025

Cost-Consequences of Cladribine Tablets for the Treatment of Highly Active Relapsing-Remitting Multiple Sclerosis in Italy.

Barbara Polistena, Anna Maria Provenzano, Caterina Rizzi, Elena Colombo, Roberto Bergamaschi

Abstract read
In one paragraph

Article in Neurology and therapy, 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. Review
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

5 authors.

Barbara PolistenaUniversity of Rome Tor Vergata, C.R.E.A. Sanità, Rome, Italy. barbara.polistena@uniroma2.it.ORCID http://orcid.org/0000-0002-0138-0223
Anna Maria ProvenzanoMerck Serono S.p.A., Rome, Italy.
Caterina RizziMerck Serono S.p.A., Rome, Italy.
Elena ColomboMultiple Sclerosis Center, IRCCS Mondino Foundation, Pavia, Italy.
Roberto BergamaschiMultiple Sclerosis Center, IRCCS Mondino Foundation, Pavia, Italy.

Funding

Merck 10.13039/100009945
6 · The paper itself

Abstract

introductionMultiple sclerosis (MS) is a chronic autoimmune disease impacting the central nervous system. Individuals with highly active relapsing-remitting MS (HA-RRMS) frequently experience symptomatic episodes lasting more than 24 h, followed by a remission period completely or partially symptom free. This study aimed to assess the economic impact of cladribine tablets for the treatment of patients with HA-RRMS in the Italian context.

methodsA Markov model developed by PRECISIONheor for simulating treatment outcomes in patients with HA-RRMS aged over 18 years over three treatment lines was adapted to the Italian National Health System organization. The model considers direct costs of treatment and relapse management, as well as costs related to adverse events and indirect costs. The model adopts the societal perspective and a 4-year time horizon. Uncertainty was addressed through deterministic sensitivity analysis.

resultsThe analysis considered 16,691 out of 55,635 Italian patients with HA-RRMS (30%). Treatment with cladribine tablets extended the duration of patients' responsive stage (relapse free) from 1.3 months (worst scenario) to 1.4 months (best scenario) when compared to oral disease-modifying therapies (DMTs) and from 2.4 to 5.7 months when compared to monoclonal antibody DMTs. cladribine tablets were associated with cost savings ranging from 69.9% to 10.9% compared to oral DMTs and from 74.3% to 33.0% compared to monoclonal antibody DMTs. The cost savings per additional month in responsive stage ranged from € 27,663.2 to € 4154.3 vs oral DMTs and from € 16,224.5 to € 3035.3 vs monoclonal antibody DMTs.

conclusionCladribine tablets are associated with a benefit in terms of prolonging the non-relapsing phase in patients with HA-RRMS, as well as substantial direct cost savings in comparison with all other DMTs. Our analysis suggests that adopting cladribine tablets for HA-RRMS enables clinical benefits over a 4-year time horizon and savings for Italian society.

Indexed as

Cladribine tabletsCost-effectivenessMultiple sclerosis

Identifiers

PMID40461934
PMCPMC12255608

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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.