Original article
Based on the statements on the GSAV, it can be seen that, among other actors, the medical profession in particular has expressed considerable criticism of the planned regulation on the interchangeability of biosimilars. The National Association of Statutory Health Insurance Physicians (KBV) points out that biosimilars cannot “automatically be substituted by the pharmacist without close monitoring by the doctor” [2]. The Federal Council also expressed clear reservations about the change in the law and stated that there is currently a “lack of valid data to assess the effects of substitution on adherence and therapy results”. At the same time, the Federal Council warns of “a significant risk to the success of a therapy and patient safety” that can be associated with an aut-idem substitution of biosimilars [3]. The National Association of Statutory Health Insurance Funds, on the other hand, expressly welcomes the proposed regulation and regrets the delayed entry into force, which the association finds “also incomprehensible in terms of content” [4]. The present report is intended to contribute to the health policy discussion about the requirements for the underlying evidence for the possible interchangeability of biosimilars.
04.04.2020
The group of people under 60 years of age may already have osteoporotic fractures. The changes in bone density and structure can be ideopathic, postmenopausal, or caused by harmful medication as well as other secondary causes such as hormonal disorders (hyperthyroidism, hyperparathyroidism, hypogonadism, diabetes) (Torner 2015). To date, there have been few separate studies on the frequency of osteoporotic fractures, specifically in middle age (between 50 and 64 years). Against the background of epidemiological information, previous and current work focuses primarily on geriatric clients in the derivation of preventive interventions, for example in secondary prophylaxis (Conley et al. 2019). However, there is little literature on the relevance of health promotion and prevention for working-age patients. In particular, the risk factors known for osteoporosis, drug use, vitamin D and calcium deficiency or psychosocial stress and lack of exercise (DVO; DiPietro et al. 2019; Follis et al. 2019) could play a role in this population. The aim of the present work is to describe the frequency of hospital-diagnosed osteoporotic fractures within the middle age between 50 and 64 years in Germany. Furthermore, the relevance and type of possible preventative measures in this phase of life should be discussed.
04.04.2020
“Rare diseases” are not “rare” at all, but extremely common. After all, around four million people in Germany suffer from a chronic “rare disease” (SE). In Europe, a disease is defined as rare if it affects fewer than 5 in 10,000 people. Of the 30,000 currently known diseases, around 7,000 to 8,000 are classified as “rare”. Despite the small number of patients per disease, the impact of SE can be profound not only for patients and their families but also for society. Rare diseases therefore pose particular challenges for all those involved in the healthcare system. A special case among “rare diseases” are those that are treated with biotherapeutics. These include defects in the immune system, autoimmune disorders or chronic inflammatory diseases of the nervous system. Preparations obtained from plasma are vital for the treatment of these diseases. The uniqueness of the raw material plasma as a starting material for the production of vital medicines must therefore be given special consideration. Immunoglobulins (IG) obtained from human plasma are of particular importance in the treatment of immune defects. IG preparations are highly complex biological medicines that cannot be produced synthetically but are obtained exclusively from voluntary blood/plasma donations. Raising awareness of and improving the diagnosis of immune defects as well as an expansion of immunomodulatory indications are causing the need for plasma to continue to rise. At the same time, however, the number of potential donors is decreasing due to demographic developments and also due to a lack of willingness to donate. This development can lead to bottlenecks in the plasma supply in the long term.
04.04.2020
For years it has been reported worldwide that antibiotics from the fluoroquinolones group are associated with serious and sometimes irreversible risks for patients. In comparison, these antibiotics in particular are prescribed very frequently in Germany. According to calculations by the AOK Scientific Institute (WIdO) based on prescription data from AOK insured persons, these drugs were prescribed to 3.3 million patients in Germany in 2018 alone - still too often given the fact that fluoroquinolones are are reserve antibiotics. For many indications, highly effective and at the same time lower-risk substances are available. In the case of minor illnesses such as uncomplicated urinary tract or simple respiratory tract infections, the use of antibiotics can be avoided entirely. Fluoroquinolones are antibiotics whose active ingredient name ends in “-floxacin”, such as ciprofloxacin (trade name, e.g. “Ciprobay”) or levofloxacin (trade name, e.g. “Tavanic”). They have antibacterial properties and can cure serious, life-threatening infections. However, in a few cases they cause serious and long-lasting side effects such as tendon ruptures or psychological disorders such as depression and anxiety. Therefore, these reserve antibiotics should only be used after a thorough benefit-risk assessment and only as a last-line treatment option (so-called last-line use). Patients must be intensively informed about the dangers and alternatives of these medications and receive targeted support in the event of damage.
04.04.2020
Legislators have opened the door to application-related data collection for the benefit assessment of new drugs. This presents an opportunity for real-world evidence. However, the requirements under discussion are demanding. Can clinical registries in Germany currently meet these requirements? And could these requirements even be achieved with a reasonable amount of effort? A recent study takes stock of the situation.
02.04.2020
“We want to make our contribution to making medicine a little better.” That’s what Prof. Dr. med. Jörg F. Debatin MBA, Chairman of the health innovation hub (hih), in the cover interview with “Monitor Healthcare Research”. Among other things, Debatin and his team, which he has gathered around him in a very multi-professional manner, want to help ensure that the “digitalization that is quite theoretically anchored in the law actually reaches the patient”. That makes hih, as Debatin explains in the interview, “very free in our ideas and not obligated to anyone else.” And since the end of hih's business activities is already certain at the end of 2021, there is no need to worry about follow-up orders, extensions or the like.
02.04.2020
In Germany, a heated debate has quickly developed regarding access to innovative medicines and their reimbursement. With this contribution, we aim to introduce a proposal for improvement into the discussion, one that utilizes methods of so-called artificial intelligence, although the underlying principles are quite simple to understand.
02.04.2020
The Tübingen Institute for Occupational Medicine began its work in January 1965, but had the first chair holder, Prof. Dr. med. Heinz Weichardt, a toxicological orientation. However, in 1977, a socio-medical department was added under the direction of Prof. Schmahl, which also led to the expansion of the institute's name. Thanks to institutional funding, the continued existence of the institute was contractually secured in 2003 - at a time when similar facilities were being closed at many other faculties in Germany. The third expansion brought Prof. Dr. med. Monika A. Rieger, who has been teaching and researching as medical director of the Institute for Occupational Medicine, Social Medicine and Health Care Research at the University Hospital of Tübingen since 2009.
02.04.2020
„As the German Association for Managed Care (BMC), we don’t believe in one supposedly optimal form of care or management, but rather in the constant pursuit of better, alternative solutions.“ This is what the BMC wrote in the foreword to its annual congress, which, held in January shortly before the outbreak of the COVID-19 pandemic, once again drew well over 600 attendees. They came not only to celebrate the tenth anniversary of what is arguably the most important (and, given the pandemic, perhaps the only one this year) industry congress, but also to discuss the topics chosen by the BMC – cooperation, coordination, and digitalization for patient-centered care – in depth. Since it is impossible to even begin to document the diverse range of forums, panel discussions, and sessions, which covered topics from digital care approaches and patient interests in care concepts to business models and intersectoral care solutions in the healthcare system, you will find only a few highlights here.
02.04.2020
“We want to make our contribution to making medicine a little better.” That’s what Prof. Dr. med. Jörg F. Debatin MBA, Chairman of the health innovation hub (hih), in the cover interview with “Monitor Healthcare Research”. Among other things, Debatin and his team, which he has gathered around him in a very multi-professional manner, want to help ensure that the “digitalization that is quite theoretically anchored in the law actually reaches the patient”. That makes hih, as Debatin explains in the interview, “very free in our ideas and not obligated to anyone else.” And since the end of hih's business activities is already certain at the end of 2021, there is no need to worry about follow-up orders, extensions or the like.