[噬菌体治疗的费用方面和报销要求]。

IF 1.7 4区 医学 Q3 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH
Dennis Häckl, Jutta Dillschneider, Christian Elsner
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引用次数: 0

摘要

噬菌体治疗被认为是一种很有前途的靶向治疗细菌感染的方法。在德国,它尚未被批准作为一种常规的医疗形式。本文探讨了噬菌体治疗作为细菌感染的靶向治疗选择的经济和报销挑战。有两种不同的生产方法。一方面,独立于患者的标准化噬菌体疗法的工业化生产可以通过规模经济潜在地降低成本,但由于固定成本、良好生产规范(GMP)要求和宿主特异性活性,存在不确定性。另一方面,(医院)药房的个别生产可以通过地方配药实现患者特异性噬菌体混合物,但需要生产、后勤工作和质量管理。鉴定细菌性病原体所需的诊断也是一个重要的成本因素,这需要额外的投资。德国目前的情况表明,噬菌体疗法迄今仅作为个人治疗尝试的一部分被处方和报销;它们既不是常规药品,也不是一线疗法。例外情况,如“潜在方法” (SGB V第137c条)和紧急供应(SGB V第2 Abs. 1a条)允许在某些条件下报销,但需要证明理由并产生交易成本。本文提供了促进噬菌体治疗的建议,包括将CAR-T细胞治疗的报销与患者特异性治疗的额外费用相提并论;对于即用型产品,讨论了基于结果的报销模型和基于证据的评估。为了创造经济激励,需要国家融资工具。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
[Cost aspects and reimbursement requirements of phage therapy].

Phage therapy is considered a promising approach for the targeted treatment of bacterial infections. It has not yet been approved as a regular form of medical therapy in Germany. This article examines the economic and reimbursement challenges of phage therapy as a targeted treatment option for bacterial infections. Two production approaches are distinguished. On the one hand, patient-independent, industrial production of standardized phage therapies could potentially lower costs through economies of scale, yet is associated with uncertainties due to fixed costs, requirements for Good Manufacturing Practice (GMP), and host-specific activity. On the other hand, individual production in (hospital) pharmacies enables patient-specific phage mixtures via magistral compounding but requires production, logistical efforts, and quality management. A significant cost factor is also the diagnostics needed for the identification of bacterial pathogens, which requires additional investments.The current situation in Germany shows that phage therapeutics are so far prescribed and reimbursed only as part of individual treatment attempts; they are neither established as regular medicinal products nor as first-line therapy. Exceptions such as the "Potential Method" (§ 137c SGB V) and emergency supply (§ 2 Abs. 1a SGB V) allow for reimbursement under certain conditions, but require justifications and generate transaction costs.This article provides recommendations for promoting phage therapy, including drawing parallels to the reimbursement of CAR-T cell therapy with additional fees for patient-specific therapeutics; for ready-to-use products, outcome-based reimbursement models and evidence-based assessments are discussed. To create economic incentives, state funding instruments are needed.

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来源期刊
Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz
Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz 医学-公共卫生、环境卫生与职业卫生
CiteScore
3.30
自引率
5.90%
发文量
145
审稿时长
3-8 weeks
期刊介绍: Die Monatszeitschrift Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz - umfasst alle Fragestellungen und Bereiche, mit denen sich das öffentliche Gesundheitswesen und die staatliche Gesundheitspolitik auseinandersetzen. Ziel ist es, zum einen über wesentliche Entwicklungen in der biologisch-medizinischen Grundlagenforschung auf dem Laufenden zu halten und zum anderen über konkrete Maßnahmen zum Gesundheitsschutz, über Konzepte der Prävention, Risikoabwehr und Gesundheitsförderung zu informieren. Wichtige Themengebiete sind die Epidemiologie übertragbarer und nicht übertragbarer Krankheiten, der umweltbezogene Gesundheitsschutz sowie gesundheitsökonomische, medizinethische und -rechtliche Fragestellungen.
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