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Cost-Effectiveness of Immunotherapy in the Treatment of Seasonal Allergic Rhinitis: Identifying Product-Specific Parameters of Relevance for Health Care Decision-Makers and Clinicians

机译:免疫疗法在季节性变应性鼻炎治疗中的成本效益:确定与医疗保健决策者和临床医生相关的特定产品参数

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摘要

Pharmacotherapy is widely used to manage allergic rhinitis (AR), but often does not adequately control symptoms. Allergy immunotherapy (AIT) should be considered for patients who are not adequately controlled on symptomatic treatment. AIT is gaining attention because of its potential to improve symptom relief and quality of life, and to provide sustained effect after the end of treatment by modifying the course of disease. However, evidence of efficacy needs to be shown for each individual AIT product, based on stateof-the-art studies. The majority of products cannot truly claim efficacy and disease-modifying potential, as evidence of such an effect from robust randomized double-blind, placebo -controlled long-term trials is lacking. The potential of a specific immunotherapy product should be evaluated against four levels of benefit defined by the European Medicines Agency (EMA) guideline on clinical development of AIT products. These clearly distinguish between efficacy of symptom relief in the first year, efficacy over 2-3 treatment years, sustained efficacy and disease modification treatment ends, and sustained absence of allergic symptoms in posttreatment years. The clinician's choice of a specific AIT product should take the level of evidence and risk/benefit into account, as the patient's quality of life and the product's potential long-term effect are important components of its overall cost-effectiveness. Without evidence of maintained clinical benefit and disease modification after the end of treatment, claims of long-term economic benefit of specific AIT products cannot be justified. This paper discusses the evidence that is essential for critical evaluation of product claims in health economic analysis comparing AIT products. (C) 2016 S. Karger AG, Basel
机译:药物疗法被广泛用于治疗变应性鼻炎(AR),但通常不能充分控制症状。对于对症治疗未得到充分控制的患者,应考虑使用过敏免疫疗法(AIT)。 AIT可以改善症状缓解和生活质量,并在治疗结束后通过改变病程提供持续的效果,因此受到关注。但是,基于最新研究,需要针对每种AIT产品显示功效证据。大多数产品不能真正声称具有疗效和疾病缓解潜力,因为缺乏强有力的随机双盲,安慰剂对照长期试验的证据。应根据欧洲药品管理局(EMA)在AIT产品临床开发指南中定义的四个益处水平评估特定免疫疗法产品的潜力。这些明确区分了第一年症状缓解的功效,2-3个治疗年的功效,持续的功效和疾病修饰治疗的结束以及治疗后几年持续没有过敏症状的情况。临床医生在选择特定AIT产品时应考虑证据水平和风险/收益,因为患者的生活质量和该产品的潜在长期影响是其整体成本效益的重要组成部分。如果没有证据表明在治疗结束后仍保持临床益处和疾病改变,则无法证明特定AIT产品具有长期经济利益的主张。本文讨论了在比较AIT产品的健康经济分析中对产品声明进行严格评估所必需的证据。 (C)2016 S.Karger AG,巴塞尔

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