Klin Monbl Augenheilkd 2019; 236(02): 180-191
DOI: 10.1055/s-0043-125076
Experimentelle Studie
Georg Thieme Verlag KG Stuttgart · New York

Kostenvergleich zugelassener intravitrealer Therapien bei nicht ausreichend auf primäre Therapie ansprechendem diabetischem Makulaödem mit fovealer Beteiligung in Deutschland

Cost Comparison of Licensed Intravitreal Therapies for Insufficiently Anti-VEGF Responding Fovea Involving Diabetic Macular Edema in Germany
Aljoscha S. Neubauer
1   Praxis für Augenheilkunde und Institut für Gesundheitsökonomie (IfG), München
,
Christos Haritoglou
2   Augenklinik Herzog Carl Theodor, München
,
Michael W. Ulbig
3   Augenklinik, Klinikum rechts der Isar der Technischen Universität München
› Author Affiliations
Further Information

Publication History

eingereicht 09 March 2017

akzeptiert 01 December 2017

Publication Date:
16 February 2018 (online)

Zusammenfassung

Hintergrund Bei der Behandlung eines diabetischen Makulaödems mit fovealer Beteiligung kann es trotz intensiver und konsequenter initialer Therapie mit einem Anti-VEGF-Medikament zu einem unzureichenden Ansprechen kommen. Für eine weitere Therapie stehen derzeit ein Wechsel des Anti-VEGF-Präparates oder die intravitreale Gabe der Steroidimplantate Fluocinolonacetonid oder Dexamethason zur Verfügung. Es soll zum einen systematisch untersucht werden, welche Studiendaten evidenzbasiert zur Wirksamkeit einer zugelassenen Therapie nach vorangegangener Anti-VEGF-Therapie vorliegen, und zum anderen, welche Ausgaben für die Krankenversicherungen mit einer weiteren intravitrealen Therapie verbunden sind.

Material und Methoden Es erfolgte eine systematische Literatursuche (SLR) zu randomisierten, kontrollierten Studien (RCT) in Medline und Embase. Ein Kurzzeitkostenmodell in MS Excel mit 3 Jahren Zeithorizont wurde erstellt, um die zugelassenen Optionen Ranibizumab (Lucentis®), Aflibercept (Eylea®), Fluocinolonacetonid-Implantat (Iluvien®) und Dexamethason-Implantat (Ozurdex®) zu vergleichen. Kostenkomponenten sind Arzneimittel- und Injektionskosten, optische Kohärenztomografie (OCT) und unerwünschte Ereignisse wie Endophthalmitis, den Augeninnendruck senkende Medikation bzw. Eingriffe oder Kataraktoperationen.

Ergebnisse Es wurden 42 Publikationen zu 20 RCTs identifiziert, wobei keine eine Population nach vorangegangener Anti-VEGF-Therapie hatte, sodass kein direkter Vergleich der Wirksamkeit möglich war. Im Kostenmodell ergaben sich Kosten von 17 542 € für Ranibizumab, 15 896 € für Aflibercept, 10 826 € für das Fluocinolonacetonid-Implantat und 12 365 € für das Dexamethason-Implantat. Bei allen Therapien sind die Medikamentenkosten die bestimmende Kostenkomponente. In der uni- und multivariaten Sensitivitätsanalyse zeigten sich die Ergebnisse als robust gegen Veränderungen des Inputs.

Schlussfolgerung Zusammenfassend konnte in einem Kostenvergleichsmodell über 3 Jahre gezeigt werden, dass die Steroidimplantate in der Therapie des diabetischen Makulaödems nach vorangegangener Anti-VEGF-Gabe erhebliche Kosteneinsparungen im Vergleich zu einer weiteren In-Label-Anti-VEGF-Therapie liefern können. Dabei stellt eine einmalige Gabe des Steroidimplantats Fluocinolonacetonid die kostengünstigste zulassungskonforme Alternative dar.

Abstract

Background In the treatment of center-involving diabetic macular edema, despite initial therapy with an anti-VEGF compound, an insufficient response may occur. Further therapy options include a switch of anti-VEGF products or to corticosteroid implants, such as Fluocinolone acetonide or Dexamethasone.

Objectives Firstly, to investigate systematically which evidence-based study data are available describing the efficacy of in-label treatments after primary anti-VEGF treatment, secondly, to investigate which costs go along for the healthcare provider.

Methods A systematic literature review (SLR) for randomized controlled trials (RCT) was performed in Medline and Embase. A short-term cost-cost model was built in MS Excel with a 3 year time horizon to compare in-label intravitreal options Ranibizumab (Lucentis®), Aflibercept (Eylea®), Fluocinolone acetonide implant (Iluvien®), and Dexamethasone implant (Ozurdex®). Cost components comprised of drug and injection costs, optical coherence tomography (OCT) procedures, and adverse events such as endophthalmitis, IOP-lowering drugs and surgery and cataract surgery.

Results A total of 42 publications of 20 RCTs were identified. No study had a clearly defined population after first line anti-VEGF treatment, thus no direct efficacy comparison was possible. In the short-term cost-cost model total costs were 17,542 € for Ranibizumab, 15,896 € for Aflibercept, 10,826 € for Fluocinolone acetonide implant and 12,365 € for Dexamethasone implant. For all treatment regimens, drug costs were the predominant cost component, followed by injection costs (with variations dependent on the specific drug) and OCT costs. In the uni- and multivariate sensitivity analyses, the results obtained were robust to changes of model inputs.

Conclusions In summary, the short-term cost-cost comparison demonstrates that steroid implants can provide significant cost savings versus in-label anti-VEGF treatment for center-involving diabetic macular edema. Single application of the long-lasting Fluocinolone acetonide implant is the most cost-efficient in-label treatment option.

 
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