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The success story of biopharmaceuticals begins in 1982 and has continued since then. Every year, new biologics receive approval for the German market, thereby increasing the share of sales of all drugs - most recently to almost 18 percent. The growth is primarily due to the active ingredient group TNF-alpha inhibitors, which are used to treat inflammatory diseases such as rheumatoid arthritis, Crohn's disease or psoriasis. This study, carried out by INSIGHT Health, is intended to provide a brief overview of the development of biopharmaceuticals in the context of outpatient statutory health care. On the other hand, the second section focuses on the TNF-alpha inhibitors, which are by far the two highest-selling products in Germany.
28.05.2013
The panel discussion “Effects of AMNOG” was moderated by Prof. Dr. Reinhold Roski (publisher MVF) sums up the second lecture session. The speakers Prof. Dr. Wolfgang Greiner (Bielefeld University), Dr. André Kleinfeld (INSIGHT Health), Tim Steimle (Health Insurance Technician), Professor Dr. W. Dieter Paar (Sanofi-Aventis), Prof. Dr. also spoke up. Neugebauer (IFOM, Cologne) and Prof. Dr. Christian Franken (DocMorris).
28.05.2013
Over 20 years ago, Professor Dr. Bertram Häussler coined a term with his lecture "Health Services Research with Routine Data from Statutory Health Insurance in Germany" that has become indispensable in the healthcare landscape because—as Häussler explains—the population-based data processed by this subfield of health systems research "sometimes actually lead to findings that are relevant for medical research." Häussler, whose institute has conducted around 2,000 health services research projects to date—currently, 116 studies are running concurrently for 77 clients—explains when and when this is the case in the cover interview of "Monitor Health Services Research." In the interview, he calls for a public-use file containing all data relevant to health services research, which should be freely accessible to everyone, regardless of the research question.
28.05.2013
Prostate carcinoma is the most common cancer in men. It is estimated that around 68,000 men in Germany were diagnosed with prostate cancer in 2012. Although the mortality rate has been falling since 2003, according to the Robert Koch Institute, around 11,000 men still died of prostate cancer in 2008 [Robert Koch Institute 2012]. It becomes clear that prostate cancer is a disease that also has great health economic importance. With the development of new effective drugs, the survival of patients with metastatic castration-resistant prostate cancer has improved significantly. In a study recently presented by the Institute of Cancer Research, a patient group of 442 patients showed a median survival of 31 months, which is significantly longer than the overall survival that could be derived in previous studies and based on nomograms, which was 18 months (Halabi) and 21 months (Smaletz) (Fig. 1 [Omlin et al. 2013]). If one also looks at the estimated survival of 6 to 10 months for these patients in the therapeutic era before docetaxel was approved in 2005, one can see that survival has now more than doubled.
24.01.2013
The importance of holistic, cross-sector care concepts and the associated requirements for the daily work of medical and nursing service providers are in a continuous process of change. New forms of care, intersectoral cooperation and process optimization measures are a central component and at the same time the basis of modern patient care. A transfer of information and knowledge related to these circumstances thus becomes a critical factor for the final quality of the service provision and its maximum possible care efficiency [1]. Building on this, new, complex requirements for technical work tools and communication media are developing, which meaningfully complement existing supply structures or even take on a central cross-sectional function [2, 3]. The influence of electronic procedures increases exponentially as soon as sectoral boundaries are broken particularly frequently in a still fragmented care system, large spatial distances have to be overcome or intersectoral cooperation becomes particularly important in terms of treatment success [3, 4]. All of these factors are of central importance, especially for the design of new and information-intensive forms of care within the meaning of the Fifth Social Security Code (Table 1) [5]. Information and communication technology (ICT) solutions must demonstrate the potential here to better meet the current and future challenges in the healthcare system [6, 7] [8] and at the same time sustainably increase quality and cost-effectiveness [1, 3, 9]
24.01.2013
The Medicines Market Reorganization Act (AMNOG) has been in force since January 1, 2011. The introduction of this legal system represents a paradigm shift, comparable to the fixed price regulation introduced in 1989. The background to the AMNOG was the legislature's desire to counteract the “cost explosion” in the health system while at the same time ensuring an adequate supply of medicines. The implementation of the AMNOG regulations primarily means the implementation of the early benefit assessment in accordance with Section 35a SGB V. This system is based in particular on comparable models from the Scottish Medicine Consortium (SMC) and the English National Institute for Clinical Research (NICE).
24.01.2013
40 years ago, the WHO declared that at least 50 percent of diabetes cases worldwide could be prevented and - as can be read in the Diabetes Health Report 2013 (1, p. 23) - called for actions to prevent this disease. However, the call received little attention back then - much like it does today. Over these many years, the German healthcare system has invested billions to care for people with this disease. According to the CODE-2 study (2), the costs caused by patients with type 2 diabetes in Germany amounted to around 15.7 million euros in 1998 - which has since extrapolated to many hundreds of billions of euros. But: Despite this immense investment, why are there still deficits in diabetic care as one of the most cost-intensive chronic diseases? It is reasonable to assume that the fundamental problem of almost all “non-communicable diseases” - enabling the people affected to self-manage and motivating lifestyle changes - cannot be overcome with the current acute care approach alone.
24.01.2013
In 2011, 30 new agents were approved in the USA and 22 in Europe, including 8 and 7 for the treatment of oncological indications, respectively (1). This trend towards an increasing proportion of oncological drugs, which has already been observed for several years, is continuing in 2012, as current figures from the US Food and Drug Administration (FDA) show: one third – 13 of the 39 newly approved active substances – relate to oncological areas of application (2). Approval in oncology often takes place as part of accelerated approval procedures (“conditional marketing authorization” or “accelerated approval”) and/or as an “orphan drug” for rare diseases. The main reasons given for the significant increase in oncological active substances are: progress in the molecular-biological characterization of tumor growth, development of a large number of new "targeted" active substances, great need for more effective drug therapy options for advanced tumor diseases, demographic development, expiry of patents for blockbusters on Treatment of common diseases and a very lucrative market for oncological drugs.
24.01.2013
When discussing surrogates and endpoints, one quickly comes to the question of which treatment results and characteristics are actually relevant for the patient. The appropriate expression “patient-relevant endpoint” is anchored in the legal basis for early benefit assessment according to Section 35a SGB V.1 While in other places there is explicit talk of a “therapy-relevant higher benefit” or “therapy-relevant side effects” (cf. e.g. § 35 Para. 1b SGB V), is clearly aimed at the patient. In the associated dossier specifications for Section 35a SGB V, module 3.3.6 mentions patient preferences as a data source to be taken into account.2 Thus, the importance of patient-relevant endpoints and patient preferences has increased with the AMNOG (Law on the Reorganization of the Medicines Market), but what role they play in concrete terms plays is still to be clarified. Nevertheless, the IQWiG (Institute for Quality and Efficiency) commissioned pre-AMNOG for two pilot studies on preference measurement (Conjoint Analysis, Analytical Hierarchy Process), one of which has already been published. IQWiG also focuses on patient preferences in its current method paper (see IQWIG (2013); IQWIG (2010b); IQWIG (2011)).
24.01.2013
The German Medical Association defines health services research (1) as the scientific study of the provision of health-related products and services to individuals and the population (2) under everyday conditions. For this purpose, health services research examines how access to health and health care, how its quality and costs and ultimately how our health and well-being are influenced by the financing systems, by social and individual factors, by organizational structures and processes and by health technologies ( 3). The observation units include individuals, families, populations, organizations, institutions, municipalities, etc. In addition to this definition of content, the German Medical Association offers a methodological/functional definition of health services research, describes the general objective of health services research and names the systematics/components (input-throuput- Output-outcome) of health services research (1). In our article we would like to expand this characterization of health services research to include five further tasks: the distinction between care and research, the economic definition of over- and under-care, the description of the data and methods required for health services research, and the distinction between economically complete and incomplete health care analyses and ultimately the formal medical (in addition to the commercial) assessment of effort and return, including a method for identifying patient-relevant endpoints.