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Prof. Dr. med. Wolf-Dieter Ludwig, chief physician at the Clinic for Hematology, Oncology and Tumor Immunology, HELIOS Klinikum Berlin-Buch, member of the Management Board of the EMA, Chairman of the AkdÄ and, among other things, member of the scientific advisory board of “Monitor Healthcare Research” (“MVF”), takes a strong stand for greater transparency regarding clinical trial data: It calls for public access to all clinical trial data. Direct access to detailed reports on clinical studies, such as in the form of a link in the European Assessment Report (EPAR) on an active ingredient after its approval, is essential “in order to be able to assess the effectiveness and harm of new drugs in a methodologically unbiased manner,” as stated in the article him with the published independent information sheet “The Medicines Letter” (46/2012).
28.05.2013
The debate about access to clinical trial data is currently at a critical point. The debate over data access is not new, nor are the efforts of scientific organizations such as the Cochrane Collaboration and the European Medicines Agency (EMA) for absolute data transparency. But the pharmaceutical industry is resisting the release and publication of clinical trial data. The ECJ's court rulings in the AbbVie and InterMune cases could decide whether the EMA can maintain its commitment to transparency in the long term or has to give in. The pharmaceutical companies' lawsuits are a novelty in that it is the first time that legal action has been taken against the EMA's transparency policy.
28.05.2013
It wasn't that long ago that the German health system served as a role model for other European countries. But things seem to have changed since 2006, when Germany was still way ahead in terms of quality - for the worse. Seven years ago, the European quality index EHCI confirmed that Germany was in third place in a European comparison, but in 2012 it was only in 14th place. Above all, the quality of medical treatment still leaves room for improvement. But how does this happen when health care spending has constantly increased in recent years? The auditing firm KPMG AG investigated this paradox and uncovered weak points.
28.05.2013
Medical progress on the one hand, patient dissatisfaction on the other, this is the common picture of our healthcare system. But how can this contradiction be explained? The variety of therapies seems to be enabling more and more people to live longer. At the same time, however, there are also complaints about deficits in the German healthcare system - long waiting times, for example. However, in the public discussion, the voice of patients is neglected, write the authors of the “Patient Wishes” study, who tried to close this gap with a large-scale survey and came to a surprising result: the patients are apparently not that dissatisfied.
28.05.2013
Discount agreements, which were initially established primarily in the generics segment, are increasingly being used throughout the entire pharmaceutical market. The 16th AMG amendment also brought about a partial reorganization of the contract constellations. Since May 1, 2013, discount contracts have been advertised publicly. This led to numerous terminations of old contracts and a flood of new tenders.
28.05.2013
In a joint statement, five major medical societies have drawn up suggestions for improvements to the process of assessing the benefits of medications in accordance with the Medicines Market Reorganization Act (AMNOG). You should contact the Institute for Quality and Efficiency in Health Care (IQWiG) and the Federal Joint Committee (G-BA), which carry out this benefit assessment. The specialist societies want to use their suggestions to help avoid unnecessary disputes and misjudgments. “At the same time, a more transparent process should increase the political acceptance of the results among legislators, payers, service providers and especially among patients and relatives,” the statement says.
28.05.2013
Zur initialen medikamentösen Therapie von Patienten mit einer venösen Thromboembolie bzw. Lungenembolie (VTE) sind in Deutschland niedermolekulare und unfraktionierte Heparine (NMH und UFH), Fondaparinux oder neue orale Antikoagulanzien (NOACs) zugelassen. Leiden die Betroffenen gleichzeitig unter einer schweren Einschränkung ihrer Nierenfunktion, besteht zumindest bei einigen Wirkstoffen das Risiko einer Akkumulation mit einem daraus folgenden höheren Blutungsrisiko. In Leitlinien und Fachinformationen wird das Problem adressiert - die Umsetzung im Klinikalltag war bisher allerdings nicht untersucht. „Monitor Versorgungsforschung“ sprach mit Professor Dr. Thomas Wilke, dessen Institut (www.ipam-wismar.de) sich dem Thema im Rahmen der nichtinterventionellen Studie „A-TRIP“ unter Unterstützung des Unternehmens Leo Pharma angenommen hatte. Leo Pharma bietet das NMH Tinzaparin („innohep“) an. Wilke beschreibt im Interview einen Zwischenstand der Studie, deren Ergebnisse noch 2013 publiziert werden sollen.
28.05.2013
The drug therapy for type 2 diabetes mellitus is being put to the test again with the stock market call on April 1, 2013. As early as 2011, every second euro of oral antidiabetic drugs (OADs) was spent on DPP-IV inhibitors (cf. Bensing/Kleinfeld 2012), and this share has now increased to almost 63 percent. The significant increases in expenditure (according to list prices) for OAD tend to be offset by constant prescription quantities.
28.05.2013
Opportunities through telematics for patient self-control (TzP) arise first and foremost for the patient. However, before we talk about the benefits of TzP for patients, we should briefly clarify what such benefits can actually consist of. Patients are sick by definition, so one benefit category is: less illness due to TtP, or – according to the Brockhaus definition of illness – fewer disorders of physical, mental and social well-being. But patients are also citizens and especially insured people, so there is a different category of benefits: lower costs for health and disease treatment, lower or less rapidly rising health insurance contributions.
28.05.2013
Gerhard Stein, board member and deputy chairman of the Deutsche BKK since October 2011, also worked for health insurance companies for some time as a human resources manager in clinics in southern Germany: He therefore knows the inpatient system and how it works when he says very carefully that the DRG The system is certainly complicated, but the service providers are trying to optimize the income side. A pension fund like Deutsche BKK, which with its high proportion of pensioners is not exactly one of the winners of the M-RSA system, is basically trying to do something similar - on both the income and expenditure side, which is why its central demand is: “The M-RSA must better reflect the real supply.”