Kosten einer leitliniengerechten Versorgung von Hepatitis-C-Patienten im Zeitalter Interferon-freier Therapien

Zusammenfassung

Die Therapie der chronischen Hepatitis-C-Infektion hat sich mit der Zulassung neuer direkt antiviral wirkender Substanzen grundlegend verändert. Sie erlauben Heilungsraten von über 90 %, weisen ein akzeptables Nebenwirkungsprofil auf und ermöglichen eine erhebliche Verkürzung der Therapiedauer. Daher empfehlen auch die aktuellen deutschen Leitlinienergänzungen ausschließlich den Einsatz dieser neuen Interferon-freien Therapien. Die Fortschritte in der Therapie wurden jedoch von einem erheblichen Anstieg der Therapiekosten begleitet, was sowohl national als auch international zu Diskussionen geführt hat. Ziel der Arbeit war die systematische Kostenanalyse für die nach aktueller Leitlinienergänzung empfohlenen Therapieregime sowie die Ableitung der durchschnittlichen Kosten pro Therapieerfolg. Die Kostenkalkulation wurde nach Genotyp, Behandlungs- (naiv/erfahren) und Zirrhosestatus des Patienten stratifiziert. Dabei erfolgte eine Unterteilung in (1.) basisdiagnostische Maßnahmen, (2.) Monitoring und (3.) Arzneimittel. Die Kostenbewertung wurde aus Perspektive der gesetzlichen Krankenversicherung vorgenommen. Für therapienaive nicht zirrhotische Genotyp-1-Patienten wurden mittlere Kosten von 41 766 €/SVR für die Therapie mit SOF/LDV ermittelt (PTV/r/OMV+DSV: 53 129 €/SVR). Für zirrhotische Patienten ergaben sich Kosten von 60 323 €/SVR (SOF/LDV+RBV) bzw. 80 604 €/SVR (PTV/r/OMV+DSV+RBV). Für therapieerfahrene nicht zirrhotische Genotyp-1-Patienten wurden Kosten von 60 366 €/SVR für SOF/LDV bzw. 53 134 €/SVR für PTV/r/OMV+DSV±RBV ermittelt (zirrhotische Patienten: 62 208 €/SVR für SOF/LDV+RBV; 80 824 €/SVR für PTV/r/OMV+DSV+RBV). Für therapienaive Genotyp 1-Patienten lagen die Kosten pro geheiltem Patienten im Bereich der bisherigen Therapien, bei therapieerfahrenen Patienten noch darunter. Für die anderen Genotypen lagen sowohl die Kosten als auch die Kosten pro SVR über denen der bisherigen Standardtherapie. Erste internationale langfristige Kosten-Effektivitäts-Analysen zeigen jedoch, dass die Therapien als kosteneffektiv angesehen werden können.

Abstract

The treatment of chronic hepatitis C has considerably changed with the introduction of recent direct acting antivirals. These antivirals have sustained virologic response (SVR) rates above 90 % as well as reduced toxicity and treatment duration. Therefore, current German guidelines recommend these interferon-free regimens as first-choice treatment. Nevertheless, recent developments were accompanied by a significant increase in treatment costs, which led to extensive discussions on reasonable pharmaceutical prices. The aim of the current study was to analyze the average treatment costs and costs per patient cured for guideline treatment recommendations. Analyses were stratified according to genotype, treatment status (naive/experienced), and presence/absence of cirrhosis. Costs were separated in (1.) basic diagnostic procedures, (2.) monitoring, and (3.) pharmaceuticals. The calculation is based on a remuneration scheme in the statutory health insurance system. In treatment-naïve non-cirrhotic patients, the average cost is 41 766 €/SVR for the treatment with SOF/LDV calculated (PTV/r/OMV+DSV: 53 129 €/SVR). In treatment-naive cirrhotic patients, costs were 60 323 €/SVR (SOF/LDV+RBV) and 80 604 €/SVR (PTV/r/OMV+DSV+RBV). Treatment-experienced genotype 1 patients had average costs of 60 366 €/SVR for SOF/LDV treatment as well as 53 134 €/SVR for PTV/r/OMV+DSV±RBV treatment (cirrhotic patients: 62 208 €/SVR for SOF/LDV+RBV; 80 824 €/SVR for PTV/r/OMV+DSV+RBV). The average treatment costs per SVR in treatment-naive genotype 1 patients are comparable to previous standard of care treatments and lower in treatment-experienced patients. In other genotypes, treatment costs and costs per cure are significantly higher compared to previous standard of care. However, long-term modelling studies show that new regimens are cost-effective.

Schlüsselwörter

Hepatitis C - Leitlinie - Kosten - Kosten pro SVR - Kosteneffektivität

Key words

hepatitis C - guideline - costs - costs per SVR - cost effectiveness

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