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

IF 4.8 3区 医学 Q1 CLINICAL NEUROLOGY
Neurology and Therapy Pub Date : 2025-08-01 Epub Date: 2025-06-04 DOI:10.1007/s40120-025-00761-7
Barbara Polistena, Anna Maria Provenzano, Caterina Rizzi, Elena Colombo, Roberto Bergamaschi
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引用次数: 0

Abstract

Introduction: Multiple 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.

Methods: A 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.

Results: The 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.

Conclusion: Cladribine 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.

Abstract Image

Abstract Image

Abstract Image

在意大利,克拉德滨片治疗高活性复发缓解型多发性硬化症的成本-后果
简介:多发性硬化(MS)是一种影响中枢神经系统的慢性自身免疫性疾病。高度活跃的复发缓解型MS (HA-RRMS)患者经常经历持续24小时以上的症状发作,随后是完全或部分无症状的缓解期。本研究旨在评估在意大利背景下,克拉德滨片治疗HA-RRMS患者的经济影响。方法:PRECISIONheor开发的马尔可夫模型用于模拟18岁以上HA-RRMS患者超过三条治疗线的治疗结果,适用于意大利国家卫生系统组织。该模型考虑了治疗和复发管理的直接成本,以及与不良事件和间接成本相关的成本。该模型采用社会视角,时间跨度为4年。通过确定性敏感性分析来解决不确定性。结果:该分析纳入了55,635名意大利HA-RRMS患者中的16,691名(30%)。与口腔疾病改善疗法(dmt)相比,克拉德滨片治疗将患者的反应期(无复发)从1.3个月(最坏情况)延长至1.4个月(最佳情况),与单克隆抗体dmt相比,从2.4个月延长至5.7个月。与口服dmt相比,克拉德里滨片剂的成本节约从69.9%到10.9%不等,与单克隆抗体dmt相比,成本节约从74.3%到33.0%不等。与口服dmt相比,反应期每月额外节省的成本从27,663.2欧元到4154.3欧元不等,与单克隆抗体dmt相比,每月额外节省的成本从16,224.5欧元到3035.3欧元不等。结论:在延长HA-RRMS患者的非复发期方面,克拉德里滨片具有益处,并且与所有其他dmt相比,可以节省大量的直接成本。我们的分析表明,采用克拉德滨片治疗HA-RRMS可以在4年的时间范围内获得临床效益,并为意大利社会节省资金。
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来源期刊
Neurology and Therapy
Neurology and Therapy CLINICAL NEUROLOGY-
CiteScore
5.40
自引率
8.10%
发文量
103
审稿时长
6 weeks
期刊介绍: Aims and Scope Neurology and Therapy aims to provide reliable and inclusive, rapid publication for all therapy related research for neurological indications, supporting the timely dissemination of research with a global reach, to help advance scientific discovery and support clinical practice. Neurology and Therapy is an international, open access, peer reviewed, rapid publication journal dedicated to the publication of high-quality clinical (all phases), observational, real-world and health outcomes research around the discovery, development, and use of neurological and psychiatric therapies, (also covering surgery and devices). Studies relating to diagnosis, pharmacoeconomics, public health, quality of life, and patient care, management, and education are also welcomed. The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, case reports, trial designs, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Neurology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research. Rapid Publication The journal’s rapid publication timelines aim for a peer review decision within 2 weeks of submission. If an article is accepted, it will be published online 3-4 weeks from acceptance. These rapid timelines are achieved through the combination of a dedicated in-house editorial team, who closely manage article workflow, and an extensive Editorial and Advisory Board who assist with rapid peer review. This allows the journal to support the rapid dissemination of research, whilst still providing robust peer review. Combined with the journal’s open access model, this allows for the rapid and efficient communication of the latest research and reviews to support scientific discovery and clinical practice. Open Access All articles published by Neurology and Therapy are open access. Personal Service The journal’s dedicated in-house editorial team offer a personal “concierge service” meaning that authors will always have a personal point of contact able to update them on the status of their manuscript. The editorial team check all manuscripts to ensure that articles conform to the most recent COPE and ICMJE publishing guidelines. This supports the publication of ethically sound and transparent research. We also encourage pre-submission enquiries and are always happy to provide a confidential assessment of manuscripts. Digital Features and Plain Language Summaries Neurology and Therapy offers a range of additional features designed to increase the visibility, readership and educational value of the journal’s content. Each article is accompanied by key summary points, giving a time-efficient overview of the content to a wide readership. Articles may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand the scientific content and overall implications of the article. The journal also provides the option to include various types of digital features including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations. All additional features are peer reviewed to the same high standard as the article itself. If you consider that your paper would benefit from the inclusion of a digital feature, please let us know. Our editorial team are able to create high-quality slide decks and infographics in-house, and video abstracts through our partner Research Square, and would be happy to assist in any way we can. For further information about digital features, please contact the journal editor (see ‘Contact the Journal’ for email address), and see the ‘Guidelines for digital features and plain language summaries’ document under ‘Submission guidelines’. For examples of digital features please visit our showcase page https://springerhealthcare.com/expertise/publishing-digital-features/ Publication Fees Upon acceptance of an article, authors will be required to pay the mandatory Rapid Service Fee of €5250/$6000/£4300. The journal will consider fee discounts and waivers for developing countries and this is decided on a case-by-case basis. Peer Review Process Upon submission, manuscripts are assessed by the editorial team to ensure they fit within the aims and scope of the journal and are also checked for plagiarism. All suitable submissions are then subject to a comprehensive single-blind peer review. Reviewers are selected based on their relevant expertise and publication history in the subject area. The journal has an extensive pool of editorial and advisory board members who have been selected to assist with peer review based on the afore-mentioned criteria. At least two extensive reviews are required to make the editorial decision, with the exception of some article types such as Commentaries, Editorials and Letters which are generally reviewed by one member of the Editorial Board. Where reviews conflict, an Editorial Board Member will be contacted for further advice and a presiding decision. Manuscripts are then either accepted, rejected or authors are required to make major or minor revisions (both reviewer comments and editorial comments may need to be addressed. Once a revised manuscript is re-submitted, it is assessed along with the responses to reviewer comments and if it has been adequately revised, it will be accepted for publication. Accepted manuscripts are then copyedited and typeset by the production team before online publication. Appeals against decisions following peer review are considered on a case-by-case basis and should be sent to the journal editor, and authors are welcome to make rebuttals against individual reviewer comments, if appropriate. Preprints We encourage posting of preprints of primary research manuscripts on preprint servers, authors'' or institutional websites, and open communications between researchers whether on community preprint servers or preprint commenting platforms. Posting of preprints is not considered prior publication and will not jeopardize consideration in our journals. Please see here for further information on preprint sharing: https://www.springer.com/gp/authors-editors/journal-author/journal-author-helpdesk/submission/1302#c16721550 Copyright Neurology and Therapy is published under the Creative Commons Attribution-Noncommercial License, which allows users to read, copy, distribute, and make derivative works for non-commercial purposes from the material, as long as the author of the original work is cited. The author assigns the exclusive right to any commercial use of the article to Springer. For more information about the Creative Commons Attribution-Noncommercial License, click here: http://creativecommons.org/licenses/by-nc/4.0. Contact For more information about the journal, including pre-submission enquiries, please contact managing editor Lydia Alborn at lydia.alborn@springer.com.
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