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Cochrane postuliert, dass „the best available evidence“ (www.cochrane.org) die Basis für medizinische Entscheidungen sein muss und somit die Qualität des Studiendesigns entscheidend ist. Hieraus kann man schlussfolgern, dass neben Randomized Controlled Trials (RCT) grundsätzlich auch versorgungsnahe Daten herangezogen werden können. Fragestellungen zu besonders seltenen Erkrankungen, zu denen zunehmend auch immer kleinere Subgruppen häufiger Erkrankungen gehören (individualisierte Therapien, bspw. auf der Basis bestimmter genetischer Eigenschaften), wie auch zunehmend wichtige Endpunkte wie Patient-Reported Outcome Measures (PROMs) und Patient-Reported Experience Measures (PREMs) lassen sich nicht in einem RCT klären. Anstelle eines ganz bestimmten Studiendesigns sollte die Güte von Studien im Vordergrund stehen. Es geht also keinesfalls darum, Anforderungen zu schwächen, sondern konsequent die Qualität von Studien zu erhöhen, in die auch neue Datenquellen mit einbezogen werden können. Der nachfolgende Text stellt einerseits eine Reflexion zum Workshop „RWE – Fit-for-purpose“ auf dem MSD-Gesundheitsforum 2023 dar, andererseits sollen einige Gedanken zum undogmatischen Umgang mit Datenquellen anhand von Ideen aus der Managementlehre diskutiert werden.
04.12.2023
Basierend auf den Vorgaben des SGB V bildet Evidenzbasierte Medizin (EbM) die Grundlage für die Arbeit des Gemeinsamen Bundesausschusses (G-BA) sowie des Instituts für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG) bei deren medizinischen Bewertungen und Entscheidungen zur Konkretisierung von Versorgungsinhalten wie z. B. den Disease-Management-Programmen (DMP) sowie der von der Gesetzlichen Krankenversicherung (GKV) zu finanzierenden Leistungen. Die Bewertung vorliegender Evidenz ist somit direkt mit Preisbildung, Erstattung, aber auch mit Versorgungssteuerung verknüpft. Eine höhere Flexibilität im Umgang mit den Evidenzanforderungen wurde in der Vergangenheit zwar ausgeübt, allerdings ohne Konsistenz und durchaus auch dann, wenn eine Absenkung des Anforderungsniveaus zu einem finanziellen Vorteil für die Gesetzliche Krankenversicherung (GKV) führte. Zugleich existieren auch Beispiele, bei denen die klinische Relevanz einer Intervention so offensichtlich war, dass der G-BA Handlungsspielräume im Sinne der Versorgung nutzte.
04.12.2023
Das Konzept „Target Trial Emulation“ sowie propensity score-basierte Adjustierungsverfahren sind empfohlene Methoden, um in indirekten Vergleichen ohne Brückenkomparator systematische Verzerrung zu minimieren. Anhand des Vergleichs der einarmigen Evidenz für das CAR-T Ciltacel mit Daten der Studie LocoMMotion, die in der medizinischen Fachwelt als beste prospektive Studie zum Versorgungsstandard bei vielfach vorbehandeltem multiplem Myelom anerkannt wurde, wird die Anwendung des Konzepts im AMNOG vorgestellt. Der Vergleich und der damit gezeigte dramatische Überlebensvorteil unter Ciltacel, dessen Validität und klinische Bedeutung durch medizinische Experten bestätigt wird, stehen der vollständigen Ablehnung durch den G-BA gegenüber. Diese Diskrepanz lohnt einen Rückblick.
04.12.2023
Since 2003, hospital services have been reimbursed through the case-volume-dependent, flat-rate reimbursement system of the G-DRG (German Diagnosis Related Groups) (Section 17b (1) Sentence 1 KHG/Reimbursement Institute 2023). Diagnosis, severity of the illness, and the operations and procedures performed, along with other parameters if applicable, are entered into the patient classification system for grouping (Reimbursement Institute 2023). Although other countries, such as the United Kingdom, Finland, and the Netherlands, also use DRG systems, Germany has a strong performance and volume incentive compared to other countries1. Despite the additional refinancing of nursing care through the nursing budget introduced in 2020 (Reimbursement Institute 2023), there is no case-volume-independent refinancing of necessary provision (Federal Ministry of Health 2023).
04.12.2023
Patient safety is one of the highest goals of healthcare and, since 2022, the tenth national health goal in Germany. Care errors contribute significantly to temporary or permanent impairment, prolonged hospital stays, or even death of patients. Although the topic has received considerable attention in the USA since the publication of "To err is human" in 2000, there remains a significant need for action. Adverse events triggered in the treatment context cannot be completely prevented given the complexity of medical treatments and the range of patient pre-existing health conditions. Strategies to improve the quality of care therefore focus on preventing avoidable adverse events. These are defined as those that would not occur if current medical standards were adhered to. The Patient Safety Action Alliance (APS), an alliance of representatives of healthcare professions, institutions, associations, and patient organizations, has been committed to implementing strategies to prevent adverse events since its founding in 2005. Treatment errors usually occur within complex and collaborative contexts. Against this backdrop, the APS considers collaborative learning from mistakes to be the most important tool for improving patient safety [1]. To enable and successfully implement this, open communication is essential.
04.12.2023
Patient safety in healthcare has increasingly become the focus of global attention. It is defined as the "avoidance, prevention, and improvement of adverse events or injuries resulting from healthcare processes" (Campbell et al., 2020). At the 74th World Health Assembly (2021), the World Health Organization (WHO) presented a global action plan to prevent health threats and harm to patients arising from healthcare (World Health Organization, 2021). Strategic Goal 4 of this action plan explicitly calls for active patient involvement (PD) in the further development of healthcare. Given the continued significant number of preventable adverse events in medical healthcare, even in Germany, the tenth National Health Goal on Patient Safety was established in 2022 (Holtz & Jonitz, 2023). This goal also calls for the active involvement of patients, their relatives, or representatives, e.g., through the use of appropriate tools. B. by promoting patient safety competence and supporting patients in their active participation in the development of measures.
04.12.2023
“Transparency has to come. The transparency of which hospital is particularly good for which service, so that citizens can make an informed decision. The patients need that, we won't shake that, we won't move away from that." Federal Health Minister Prof. Karl Lauterbach explained this after the Federal Council voted with a narrow majority of 35 votes to refer his planned hospital transparency law to the mediation committee. This is “tends to be bad news for patients.” Because it costs valuable time.
27.11.2023
“A decision that sustains and strengthens Germany as a location” (Habeck); “A really good day for Germany” (Lauterbach). It is rare that two federal ministers - Prof. Dr. Karl Lauterbach (Health) and Dr. Robert Habeck (Economy and Vice Chancellor) appear together at a press conference for a pharmaceutical company. All that was missing was Bettina Stark-Watzinger, Federal Minister of Education and Research, to round out the triumvirate of ministries significantly involved in the topic. After all, the research-based pharmaceutical company Eli Lilly and Company in Berlin announced far-reaching investment plans in Germany: construction of a new high-tech production facility in Alzey is to begin in 2024 - subject to the approval of the state authorities - for 2.3 billion euros. Initially around 1,900 employees will work in the new production network, and after completion in 2027 around 1,000 employees will work.
18.11.2023
Comment series part 8: Dr. med. Christine Tretter, specialist in psychiatry, expert; Nutritional Psychiatry, Vienna
04.11.2023
With the Pharmaceutical Market Reorganization Act (AMNOG) in 2011, the German legislature enshrined the principle of benefit-based pricing in law. Since then, price negotiations have been largely based on the additional benefits of a medicine, in addition to the annual therapy costs of comparable medicines and retail prices in other EU countries. The aim of the law was to negotiate the price for new drugs with patent protection or new document protection following an additional benefit assessment. The benefit assessment is carried out compared to the appropriate comparator therapy (zVT). This determined additional benefit, together with the previously mentioned criteria, forms the basis for the reimbursement price negotiation, which is carried out between the pharmaceutical company and the umbrella association of health insurance companies (GKV-SV) on the basis of the resolution of the Federal Joint Committee (G-BA). The resulting price discount on the introductory price is the basis for calculating the AMNOG savings in accordance with Section 130b SGB V. These are calculated using the sales difference between the real sales considered (price corresponding to reimbursement amount negotiation x quantity) and a “fictitious” sales (price without Reimbursement amount negotiation x quantity) which would have been reimbursed without the AMNOG price negotiations.