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<p>Phage therapy is considered a&#xa0;promising approach for the targeted treatment of bacterial infections. It has not yet been approved as a&#xa0;regular form of medical therapy in Germany. This article examines the economic and reimbursement challenges of phage therapy as a&#xa0;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&#xa0;significant cost factor is also the diagnostics needed for the identification of bacterial pathogens, which requires additional investments.</p><p>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” (§&#xa0;137c&#xa0;SGB&#xa0;V) and emergency supply (§&#xa0;2 Abs.&#xa0;1a&#xa0;SGB&#xa0;V) allow for reimbursement under certain conditions, but require justifications and generate transaction costs.</p><p>This article provides recommendations for promoting phage therapy, including drawing parallels to the reimbursement of CAR-T&#xa0;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.</p>

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Kostenaspekte und erstattungsrechtliche Voraussetzungen der Phagentherapie

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2025年5月13日

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  • Dennis Häckl,
  • Jutta Dillschneider,
  • Christian Elsner

摘要

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.