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Exploratory analysis of factors influencing patient population estimates in early benefit assessment dossiers

The effects of certain factors evaluated in the benefit assessment process on price negotiations have been examined in other studies (Theidel & Graf von derschulenburg, 2016). The biggest influencing factor in price negotiations is the additional benefit. In this respect, G-BA decisions are stricter than the decisions of other countries regarding the same drugs and indications (Fischer, Heisser, & Stargardt, 2016). A measurement system was proposed to predict G-BA decisions regarding the additional benefit of medicines (Schwandera, Banz, Kaier, & Walzer, 2014). Since clinical data serve as the basis for deciding on the added value of drugs in benefit dossiers, this study focuses on the second important factor that can influence price negotiations: the number of patients in the target populations with a therapeutically significant additional benefit. Particularly in cases where there are multiple patient subgroups and the negotiations are based on a mixed price model, the influence of the submitted patient populations per target group is more pronounced.

04.04.2019
Transfer of knowledge from research into routine lung cancer care

Lung cancer is one of the most common tumor diseases and the most common cause of cancer death in Germany.1,2 Only about 1/3 of non-small cell lung carcinomas (NSCLC), which is present in 80% of all lung cancer cases, is operable when initially diagnosed.3 For patients with advanced or In NSCLC that cannot be treated curatively, only marginal improvements in response and survival have been achieved over decades with systemic therapy, usually with chemotherapy. With the discovery that the growth of some tumors is driven by an activating mutation of the tyrosine kinase and that these can be specifically inhibited, there have been significant advances in the treatment of lung cancer in the field of precision medicine, also known as personalized medicine, for around ten years .4 This means that around 30% of all NSCLC patients in advanced stages can now be treated in a personalized or targeted manner.4 In randomized studies, patients with NSCLC and mutations in the EGF receptors have higher response rates, longer progression-free survival and lower rates when treated with a TKI Side effects compared to cytotoxic chemotherapy.8 In addition, several treatment cohorts worldwide have shown an improvement in overall survival with personalized medicine for lung cancer.9 The patients recorded in the Cologne Network for Genomic Medicine (NGM) showed lung cancer compared to a historical control group with the relevant driver mutations a significant increase in overall survival of a median of 21.9 months in EGFR-positive and 12 months in ALK-positive NSCLC patients.10

04.04.2019
On the economic efficiency of the care situation for patients with spastic movement disorder

Spastic movement disorder (SB) occurs as a result of damage to the central nervous system. Accordingly, SB is a symptom of numerous underlying diseases, including stroke, multiple sclerosis and infantile cerebral palsy [1, 2]. A current extrapolation from data from the Leipzig forums suggests that around 530,000 patients are affected by SB that requires treatment. A lack of care or inadequate care can have a significant impact on the quality of life of those affected. In addition to sometimes severe impairments in everyday life, contractures, ulcerations and pain can occur as accompanying illnesses. This often results in a higher need for care or a higher level of care classification [2, 3]. SB cannot be cured, but its severity and comorbidities can be reduced. Suitable therapeutic procedures are described in the specialist literature and the corresponding guidelines [4-8]. However, it can be assumed that the reality of care in Germany shows a different picture. A survey should therefore clarify what the treatment of those affected is like [9]. A total of 109 general practitioners from Germany were surveyed by post about their patient clientele with SB and their care. Since the treatment decision of the respective doctor should not be interfered with, a non-interventional, retrospective study design was chosen. The questionnaire sent out included a total of 26 questions on general information about the patient clientele, non-invasive and drug therapy and collaboration with other specialist disciplines. On average, each GP provides care to approximately 24 patients with SB.

04.04.2019
Prescription-based prevalence of biologic therapy in patients with psoriasis, rheumatoid arthritis, and inflammatory bowel disease

The body's native and adaptive immune system plays an important role in a variety of diseases such as psoriasis (PSO) [1], inflammatory bowel disease (CD/CU) [2] and rheumatoid arthritis (RA) [3]. These autoimmune diseases result from disruption of pro-inflammatory and anti-inflammatory responses, leading to an immune-mediated attack on the host tissue [4]. Recent decades have seen an increase in the incidence and prevalence of autoimmune diseases, highlighting the importance of appropriate treatment of these diseases [5]. Biologic drugs are treatments aimed at altering the course of autoimmune diseases and represent an important alternative to conventional treatments [6]. The main targets of biological drugs are cytokines (e.g. tumor necrosis factor-α [TNF-α], interleukin-1 [IL-1] or -6 [IL-6]), B cells and costimulation molecules (e.g. T- Cell surface protein CD28 or cytotoxic T lymphocyte-associated antigen-4 [CTLA-4]) [7]. Biological medicines have several advantages such as: B. an established long-term effect, a high selectivity for target molecules, positive cardiovascular effects, their suitability for patients with impaired kidney or liver function and maximum adherence to intake [8].

04.04.2019
Health care research needs three-dimensional standards for describing health services – Part 2

In the first part of the article, under the title “Connection between digitalization and health care research,” we discussed the requirements that must exist in order to be able to depict everyday care in the health system (1). Metaphorically speaking, the function of a digital information highway and that of health services research are similar: functional highways are worthless if the exits are geographically poorly laid out and the vehicles used are only partially suitable for driving or transporting. An information highway is a necessary, but not sufficient, condition for improving healthcare. It is suitable for improving healthcare if it contributes to improving the health of citizens, rather than just a surrogate parameter, such as compliance with medical prescriptions. And health services research only has a future if it manages to prove its benefit to society. To do this, it needs instruments that are actually able to observe and measure effects under everyday conditions, i.e. it needs a three-dimensional standard for describing complex health services.

04.04.2019
“Change of perspective for chronic illnesses”

The Chronic Care Congress, organized by MedEcon Ruhr, will take place in Bochum from June 12th to 13th, 2019. MedEcon Ruhr is the central hub for the healthcare industry in Germany's largest metropolitan area, comprising over 160 institutions from the hospital and healthcare sectors. The congress aims to raise public awareness of chronic care and identify areas where political reform is needed. Furthermore, the exchange between professionals, patient advocacy groups, researchers, and the healthcare industry is intended to stimulate initiatives and models, particularly within the region.

01.04.2019
“Consider social benefits”

Hagen Pfundner is a pharmacist, industrial manager, board member of the Federation of German Industries (BDI) and the Association of Research-Based Drug Manufacturers (VFA) and honorary professor at the University of Freiburg im Breisgau. Having worked in the pharmaceutical industry for over a quarter of a century, he is expressly committed to a technology offensive that ranges from molecular diagnostics to “red biotechnology” and genetic engineering to networked, digitized and therefore personalized medicine. This requires, he says in the title interview with “Monitor Healthcare Research”, “a common strategy, a collaborative approach by all those involved in the healthcare system, which takes social benefits into account beyond particular interests”.

04.02.2019
Health Services Research – Using Potential & Ensuring Quality!

In the lead-up to the 17th Congress for Health Services Research, held from October 10-12, 2018, the German Network for Health Services Research (DNVF) is presenting an updated position paper. A total of twelve measures are recommended to improve and ensure the long-term quality of health services research in Germany, as well as to increase the transfer of research findings into practice and thus the benefits of health services research. In this context, transparency, a focus on research goals and knowledge transfer, and the creation of research infrastructures are called for.

04.06.2018
“I expressly wish for the necessary evidence”

As Senator and President of the Authority for Health and Consumer Protection of the Free and Hanseatic City of Hamburg, as Deputy Member of the Federal Council for the Free and Hanseatic City of Hamburg, as a member of the Health Committee and the Federal-State Working Group, Cornelia Prufer-Storcks relies on the results of health services research. As an experienced health politician, she says in the cover interview with “Monitor Health Care Research”: “I am glad that we can rely on the results of health care research in many areas - especially on the deficits of our system.” In many, that means not in all. That's why she brought an extensive wish list with her to this year's German Congress for Health Services Research, of which she was patron.

04.06.2018
Nagel: “The expectations have no measure”

This is the first German congress on oversupply, a speaker praised the organizers, WINEG and TK on the one hand, and the INgef research institute from spectrumK on the other hand, which jointly organized the “Practice Health Services Research” forum in Berlin under the title “A lot helps not always much - On the way to the right care”. About “patient autonomy at the end of life” (Prof. Dr. mult. Eckhard Nagel, University of Bayreuth) about analyzes of “chemotherapies at the end of life” by Prof. Dr. Roland Linder (WINEG) and “Incorrect care and its effects on the patient” by Dr. Jochen Walker (InGef), “Overtherapy at the end of life” (author Dr. Matthias Thöns) and “Therapy goals for advanced cancer” by Dr. Johannes Bruns (German Cancer Society) led the discussion on “Use of antibiotics in primary care” with the question “Individual benefit vs. collective harm?” by Prof. Dr. Attila Altiner (University of Rostock), “Medicinal therapy for multimorbidity”, combined with the question “Where does the net benefit end?” (Prof. Dr. Petra A. Thürmann, University of Witten/Herdecke) to a comprehensive editorial on the topic “Together clever: Doctor-patient communication as the key to participation” by Prof. Dr. Norbert Schmacke (University of Bremen), which can be read in full from page 39.

04.06.2018

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