Cost-savings and potential cost-savings through the distribution of generic antiretroviral drugs within the statutory health insurance market of Germany between January 2017 and June 2019

Background: Recent patent losses for antiretroviral drugs (ARV) have led to the debate of cost-saving through the replacement of patented drugs with generic drugs. The split of recommended single-tablet regimens (STR) into their single substance partners is one of the considerations mentioned in said debate. Particularly, generic tenofovir disoproxil/emtricitabine (TDF/FTC) is expected to hold untapped cost-saving potential, which may curb increasing overall expenditures for combined antiretroviral therapy (cART) within the statutory health insurance (SHI) of Germany. Methods: Data of ARV reimbursed by the SHI were used to describe the trends of defined daily doses (DDD) as well as the revenue within the German ARV market. They were also used to determine the cost-savings of moving to generic drugs. The time period observed was between January 2017 and June 2019. The potential cost-savings were determined with following assumption in mind: the maximum possible use of generic ARV, including 1) the split of STR and replacing all substance partners with generic ones, and 2) replacing patented tenofovir alafenamide/emtricit- abine (TAF/FTC) with generic TDF/FTC. Results: Throughout the observation period, the DDD of generic ARV increased nearly five-fold while their revenue increased more than four-fold. Total cost-saving showed a sharp increase over the same period, with generic TDF/FTC accounting for a share of around 70%. The largest potential cost-saving could have been achieved through replacing patented TAF/FTC with generic TDF/FTC, peaking at nearly 10% of total revenue, but showing decreasing trends in general. Conclusion: The progressive distribution of generic ARV ensured increasing cost-savings, but consequently curbed the potential cost-savings. Unique price reductions of generic TDF/FTC have played a pivotal role for these effects. In any case, substituting with generic ARV should not fail to adhere to the treatment guidelines and continue to con- sider the medical requirements for the treatment.Peer Reviewe

Prognosemodelle zur Steuerung von intensivmedizinischen COVID-19-Kapazitäten in Deutschland

Hintergrund: Zeitdynamische Prognosemodelle spielen eine zentrale Rolle zur Steuerung von intensivmedizinischen COVID-19-Kapazitäten im Pandemiegeschehen. Ein wichtiger Vorhersagewert (Prädiktor) für die zukünftige intensivmedizinische (ITS-)COVID-19-Bettenbelegungen ist die Anzahl der SARS-CoV-2-Neuinfektionen in der Bevölkerung, die wiederum stark von Schwankungen im Wochenverlauf, Meldeverzug, regionalen Unterschieden, Dunkelziffer, zeitabhängiger Ansteckungsrate, Impfungen, SARS-CoV-2-Virusvarianten sowie von nichtpharmazeutischen Eindämmungsmaßnahmen abhängt. Darüber hinaus wird die aktuelle und auch zukünftige COVID-ITS-Belegung maßgeblich von den intensivmedizinischen Entlassungs- und Sterberaten beeinflusst. Methode: Sowohl die Anzahl der SARS-CoV-2-Neuinfektionen in der Bevölkerung als auch die intensivmedizinischen COVID-19-Bettenbelegungen werden bundesweit flächendeckend erfasst. Diese Daten werden tagesaktuell mit epidemischen SEIR-Modellen aus gewöhnlichen Differenzialgleichungen und multiplen Regressionsmodellen statistisch analysiert. Ergebnisse: Die Prognoseergebnisse der unmittelbaren Entwicklung (20-Tage-Vorhersage) der ITS-Belegung durch COVID-19-Patienten*innen werden Entscheidungsträgern auf verschiedenen überregionalen Ebenen zur Verfügung gestellt. Schlussfolgerung: Die Prognosen werden der Entwicklung von betreibbaren intensivmedizinischen Bettenkapazitäten gegenübergestellt, um frühzeitig Kapazitätsengpässe zu erkennen und kurzfristig reaktive Handlungssteuerungen, wie etwa überregionale Verlegungen, zu ermöglichen.Background: Time-series forecasting models play a central role in guiding intensive care coronavirus disease 2019 (COVID-19) bed capacity in a pandemic. A key predictor of future intensive care unit (ICU) COVID-19 bed occupancy is the number of new severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections in the general population, which in turn is highly associated with week-to-week variability, reporting delays, regional differences, number of unknown cases, time-dependent infection rates, vaccinations, SARS-CoV‑2 virus variants, and nonpharmaceutical containment measures. Furthermore, current and also future COVID ICU occupancy is significantly influenced by ICU discharge and mortality rates. Methods: Both the number of new SARS-CoV‑2 infections in the general population and intensive care COVID-19 bed occupancy rates are recorded in Germany. These data are statistically analyzed on a daily basis using epidemic SEIR (susceptible, exposed, infection, recovered) models using ordinary differential equations and multiple regression models. Results: Forecast results of the immediate trend (20-day forecast) of ICU occupancy by COVID-19 patients are made available to decision makers at various levels throughout the country. Conclusion: The forecasts are compared with the development of available ICU bed capacities in order to identify capacity limitations at an early stage and to enable short-term solutions to be made, such as supraregional transfers.Peer Reviewe

Retrospektive Evaluation eines Prognosemodells für die Bettenbelegung durch COVID-19-Patientinnen und -Patienten auf deutschen Intensivstationen

Während der COVID-19-Pandemie waren bundesweite Daten zu den Kapazitäten der Gesundheits-versorgung und Krankenhäuser eine wichtige Orientierungshilfe für ressourcenstrategische und politische Entscheidungen. Im vorliegenden Beitrag wird die Leistungsfähigkeit eines Prognosemodells für die Bettenbelegung durch COVID-19-Patienten und -Patientinnen auf deut-schen Intensivstationen am Beispiel der fünf „Kleeblatt“-Regionen Deutschlands (Nord, Ost, Süd, Süd-West, West) im Zeitraum vom 1.7.2021 bis zum 2.1.2023 retrospektiv evaluiert. Außerdem werden Zeiträume mit außergewöhnlichen Abweichungen von prognostizierten und tatsächlichen Werten visualisiert und diskutiert.Peer Reviewe

A Federated and Distributed Data Management Infrastructure to Enable Public Health Surveillance from Intensive Care Unit Data

The Robert Koch Institute (RKI) monitors the actual number of COVID-19 patients requiring intensive care from aggregated data reported by hospitals in Germany. So far, there is no infrastructure to make use of individual patient-level data from intensive care units for public health surveillance. Adopting concepts and components of the already established AKTIN Emergency Department Data registry, we implemented the prototype of a federated and distributed research infrastructure giving the RKI access to patient-level intensive care data.Peer Reviewe

Untersuchung von SARS-CoV-2-Ausbrüchen in Deutschland durch Feldteams des Robert Koch-Instituts, Februar–Oktober 2020

The Robert Koch Institute (RKI) offers advice and assistance to local public health agencies on the investigation and management of outbreaks of infectious diseases. Specially trained experts conduct field investigations. During the COVID-19 pandemic, RKI experts participated in the investigation of outbreaks in residential buildings, physicians' offices, nursing homes, hospitals, and asylum seekers' facilities as well as at a night club and on a cruise ship.This report describes some of the field investigations conducted in Germany during the COVID-19 pandemic between February and October 2020. The investigations provided information on the properties of SARS-CoV‑2 and its transmission as a basis for the recommendations on suitable prevention measures. The practical examples demonstrate the variety of support given as well as the opportunities to gather epidemiological evidence.In September 2020, the RKI established a new unit called the 'Focal Point for the Public Health Service,' which now coordinates and is expanding field support. In order to further support the public health system to improve its capability to react to and investigate outbreaks of infectious diseases, interdisciplinary training shall be intensified

Das Lagemanagement des Robert Koch-Instituts während der COVID-19-Pandemie und der Austausch zwischen Bund und Ländern

The Robert Koch Institute (RKI) plays a central role in Germany in the management of health hazards of biological origin. The RKI's crisis management aims to contribute to protecting the health of the population in Germany in significant epidemic situations and to maintain the RKI's working ability over a long period of time even under high load. This article illustrates the crisis management of the RKI in general as well as during the COVID-19 pandemic. The generic RKI crisis management structures and the setup of the RKI emergency operations centre (EOC), their operationalisation in the context of the COVID-19 pandemic and the resulting challenges as of 31 October 2020 are described in this paper. The exchange between the federal and state governments during the pandemic is also described.The COVID-19 pandemic has led to extraordinary circumstances. During the epidemic situation, good communication and coordination has been essential, both within the RKI and with other federal or state authorities and expert groups. Under great pressure, the RKI produces and regularly updates recommendations, statements and assessments on various topics. To provide operational support for all COVID-19 related activities, an EOC was activated at the RKI. During the COVID-19 pandemic, there are various challenges regarding personnel and structures. It became apparent that good preparation (e.g. existing task descriptions and premises) has an important positive impact on crisis management