Retrospektive GKV-Versorgungsforschungsstudie über GnRH-Antagonisten/-Agonisten zur initialen Therapie des fortgeschrittenen Prostatakarzinoms – Verordnungsmuster und Krankenhauskosten in Deutschland

Zusammenfassung

Hintergrund Die Androgendeprivationstherapie (ADT) ist fester Therapiebestandteil des fortgeschrittenen oder metastasierten Prostatakarzinoms (PCa). Ziel der vorliegenden Versorgungsforschungsstudie war der Vergleich von Verordnungsmustern, Hospitalisierungsraten und Krankenhauskosten beim initialen Einsatz verschiedener GnRH-Agonisten und -Antagonisten (GnRHa).

Material und Methoden Anonymisierte GKV-Daten von > 70 Krankenkassen aus 2010 bis 2015 (n = 4 205 227) wurden analysiert (1 Jahr Vorbeobachtung, 1 Indexquartal mit initialer GnRHa-Verordnung, ≥ 2 Jahre Follow-Up (FU)).

Ergebnisse Die Studienpopulation umfasste 2382 PCa-Patienten im Alter von durchschnittlich 75 Jahren. Leuprorelin (Leu) wurde mit 56,6 % am häufigsten verordnet. Bei erstmaliger GnRHa-Anwendung hatten 70 % aller Patienten keine Lymph- oder Fernmetastasen. Nach der initialen Verordnung wurden bei 11,2 % die GnRHa abgesetzt, bei 17,6 % nach durchschnittlich 457 Tagen (Median: 399 Tage) umgestellt, in der Hybrid (Hyb)-Gruppe durchschnittlich 100 Tage schneller als bei den Agonisten (p = 0,016). Die Prävalenzrangfolge der häufigsten Komorbiditäten war über die Zeit gleichbleibend: Hypertonie, Hyperlipidämie, kardiovaskuläre Erkrankungen (CVD) und Diabetes. Die Hypertonieprävalenz zeigte einen signifikant höheren Anstieg unter Agonisten (16,4 %; vs. Antagonist 6,9 % p = 0,022; vs. Hybride 11,6 % p = 0,006). Bei der CVD gab es hinsichtlich der relativen Wachstumsraten zwischen den 3 zusammengefassten Therapieklassen keine signifikanten Unterschiede. Insgesamt waren 23,9 % aller Patienten nach 3 Jahren FU verstorben. Die Mortalitätsrate war am niedrigsten für Triptorelin (Trp, 22,1 %) und am höchsten für Goserelin (Gos, 29,4 %, n.s.). Im Indexquartal hatten 26,4 % der Patienten mind. einen Krankenhausaufenthalt [min; max: Trp 22,4 %; Gos 30,3 %] mit einer mittleren Krankenhausverweildauer/Patient von 3 Tagen [Trp 2,4; Gos 4,5]. Die jährliche Hospitalisierungsrate lag bei 36,2 – 40,7 %, die mittlere Krankenhausverweildauer im gesamten FU zwischen 17,6 (Trp) und 20,8 (Hyb) Tagen. Die Krankenhauskosten im Indexquartal betrugen ca. 1200 EUR [Trp 988; Gos 1803] und pro FU-Jahr ca. 3000 EUR. In der Trp-Kohorte lagen die Gesamtkosten (Indexquartal + 3 Jahre) mehr als 1000 EUR unter dem Durchschnitt von 9476 EUR [Trp 8116; Leu 9779; n.s.].

Schlussfolgerung Diese GKV-Versorgungsforschungsstudie beschreibt die Anwendung von GnRHa zur initialen Therapie beim fortgeschrittenen PCa in Deutschland und zeigt substanzabhängige Unterschiede in den Verordnungsmustern, Hospitalisierungsraten und Krankenhauskosten.

Abstract

Introduction: Androgen deprivation therapy (ADT) plays a pivotal role in the treatment of advanced or metastasised prostate cancer (PCa). The aim of this health services research was to compare real-world data on the initial use of different GnRH agonists and antagonists (GnRHa) with regard to prescription patterns, hospitalisation rates and costs.

Material and methods: Anonymised claims data from > 70 German health insurance funds between 2010 and 2015 (n = 4 205 227) were analysed (1 year pre-observation period, 1 index quarter with initial GnRHa prescription, ≥ 2 years of follow-up (FU)).

Results: The study population included 2382 PCa patients (mean age 75 years). Leuprolide (Leu) was prescribed most frequently (56.6 %). At initial GnRHa administration, 70 % of patients neither had lymph node nor distant metastases. Around 11.2 % of all patients stopped GnRHa treatment after the first prescription, 17.6 % switched their initial therapy to another substance after a mean of 457 days (median: 399 days); in the hybrid (hyb) group 100 days earlier on average than in the agonist group (p = 0.016). The prevalence ranking of the most common comorbidities was consistent over time: hypertension, hyperlipidaemia, cardiovascular disease (CVD) and diabetes. The prevalence of hypertension increased significantly in the agonist group (16.4 %) compared with the antagonist (6.9 %, p = 0.022) and hyb group (11.6 %, p = 0.006). With regard to CVD, there were no significant differences in the relative growth rate between the 3 combined therapy classes. In total, 23.9 % of all patients died within the 3-year FU. The mortality rate was lowest for triptorelin (Trp, 22.1 %) and highest for goserelin (Gos, 29.4 %, n.s.). In the index quarter, 26.4 % of patients had at least one inpatient hospitalisation [min-max: Trp 22.4 %; Gos 30.3 %], with an average length of hospital stay/patient of 3 days [Trp 2.4; Gos 4.5]. The annual hospitalisation rate was between 36.2 and 40.7 %, the average length of hospital stay in the entire FU was between 17.6 (Trp) and 20.8 days (hyb). The average hospital costs in the index quarter were approx. EUR 1200 [Trp 988; Gos 1803] and per FU year approx. EUR 3000. In the Trp cohort, total costs (index quarter + 3 years) were more than EUR 1000 below the average costs of EUR 9476 [Trp 8116; Leu 9779; n.s.].

Conclusion: This comparative retrospective analysis provides real-world information on initial GnRHa treatment for advanced prostate cancer, revealing differences in treatment patterns, hospitalisation rates and hospital costs in Germany.

Schlüsselwörter

fortgeschrittenes Prostatakarzinom - Versorgungsforschungsstudie - GnRH-Agonist - GnRH-Antagonist - Androgendeprivationstherapie

Keywords

advanced prostate cancer - retrospective health services research - GnRH agonist, GnRH antagonist - German claims database - androgen deprivation therapy

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