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ZusammenfassungHintergrund Personen mit injizierendem Drogenkonsum werden häufig nicht von Angeboten zur Hepatitis-C-Testung und -Behandlung erreicht. Um die Verfügbarkeit von Testangeboten zu erhöhen, wurde 2020 § 24 des Infektionsschutzgesetzes dahingehend umformuliert, dass nunmehr u. a. Hepatitis-C-Schnelltests auch von nicht-ärztlichem Personal in niedrigschwelligen Einrichtungen durchgeführt werden können. Diese Studie untersucht die Akzeptanz der Gesetzesänderung in den Einrichtungen der Aids- und Drogenhilfe auf der Ebene der dort tätigen Fachkräfte.Methoden Im Rahmen der Studie wurden deutschlandweit Einrichtungen der Aids- und Drogenhilfe (n=88) per Fragebogen befragt und Experteninterviews durchgeführt (n=4). Die Analyse der Akzeptanz der Gesetzesänderung erfolgte anhand eines theoriegeleiteten Modells zur Akzeptanzmessung entlang des Technologieakzeptanzmodells nach Davis et al. (1989).Ergebnisse Die Ergebnisse zeigen, dass die befragten Einrichtungen die Gesetzesänderung grundsätzlich positiv bewerten. 13,6% der Einrichtungen implementierten Schnelltests durch nicht-ärztliches Personal für den Nachweis des Hepatitis-C-Virus und 31,1% planten die Einführung eines Hepatitis-C-Schnelltestangebots. Die Experteninterviews bestätigten die Akzeptanz der Gesetzesänderung.Schlussfolgerung Angesichts der kurzen Zeitspanne seit Inkrafttreten der Gesetzesänderung kann die Umsetzungsrate als relativ hoch eingestuft werden. Es wird jedoch vermutet, dass hier eine Verzerrung in Richtung der Überschätzung vorliegt (positive Selbstselektion der teilnehmenden Einrichtungen, hohe Aufgeschlossenheit und Handlungsabsicht, institutioneller Mut). Der frühe Trend wird sich somit nicht linear fortsetzen. Flankierende Unterstützungsmaßnahmen zur Ausweitung der Umsetzung sowie ggf. Aufrechterhaltung des Schnelltestangebots sind deshalb notwendig. Langfristig angelegte Begleitforschung hierzu wird empfohlen.

Laura Kulik,1 Leonardo G da Fonseca,2 Aiwu Ruth He,3 Jordi Rimola,4 Andrea Wilson Woods,5 York F Zöllner,6 Peter R Galle7 1Northwestern University, Chicago, IL, USA; 2Clinical Oncology, Instituto do Cancer do Estado de São Paulo, São Paulo, Brazil; 3Georgetown University, Washington, DC, USA; 4Radiology Department, Hospital Clínic de Barcelona, Barcelona, Catalonia, Spain; 5Blue Faery: The Adrienne Wilson Liver Cancer Association, Birmingham, AL, USA; 6Hamburg University of Applied Sciences, Competence Center Health, Hamburg, Germany; 7University Medical Centre Mainz, Mainz, GermanyCorrespondence: Peter R GalleUniversity Medical Centre Mainz, Mainz, GermanyTel +49 6131 177275Email Peter.Galle@unimedizin-mainz.deAbstract: A virtual expert roundtable was convened on April 16, 2020, to discuss the evolving landscape of care for treating patients with advanced hepatocellular carcinoma (HCC) and discuss questions related to patient care and treatment selection. This commentary presents highlights from this discussion and provides an expert opinion about approaches to treatment for HCC in the Americas and the European Union. We anticipate that atezolizumab plus bevacizumab will become the standard of care for advanced HCC patients. However, this approach will make decisions regarding the sequencing of treatments for second-line therapies and beyond more challenging. Therapy will require individualization based on patient characteristics and preferences, while insurance coverage decisions and requirements may also impact the options that patients can access. Additional research regarding prognostic and predictive biomarkers is needed to help better identify optimal treatment approaches for specific patient populations. Multidisciplinary tumor boards will continue to play a critical role in guiding treatment selection for individual patients. Atezolizumab plus bevacizumab offers a promising new first-line therapeutic option for patients with advanced HCC, but more research is needed to optimize and individualize patient therapy.Keywords: hepatocellular carcinoma, immuno-oncologics, biomarkers, patient-reported outcomes

Introduction Cartilage defects in the knee can be caused by injury, various types of arthritis, or degeneration. As a long-term consequence of cartilage defects, osteoarthritis can develop over time, often leading to the need for a total knee replacement (TKR). The treatment alternatives of chondral defects include, among others, microfracture, and matrix-associated autologous chondrocyte implantation (M-ACI). The purpose of this study was to determine cost-effectiveness of M-ACI in Germany with available mid- and long-term outcome data, with special focus on the avoidance of TKR. Materials and methods We developed a discrete-event simulation (DES) that follows up individuals with cartilage defects of the knee over their lifetimes. The DES was conducted with a status-quo scenario in which M-ACI is available and a comparison scenario with no M-ACI available. The model included 10,000 patients with articular cartilage defects. We assumed Weibull distributions for short- and long-term effects for implant failures. Model outcomes were costs, number of TKRs, and quality-adjusted life years (QALYs). All analyses were performed from the perspective of the German statutory health insurance. Results The majority of patients was under 45 years old, with defect sizes between 2 and 7 cm2 (mean: 4.5 cm2); average modeled lifetime was 48 years. In the scenario without M-ACI, 26.4% of patients required a TKR over their lifetime. In the M-ACI scenario, this was the case in only 5.5% of cases. Thus, in the modeled cohort of 10,000 patients, 2700 TKRs, including revisions, could be avoided. Patients treated with M-ACI experienced improved quality of life (22.53 vs. 21.21 QALYs) at higher treatment-related costs (18,589 vs. 14,134 € /patient) compared to those treated without M-ACI, yielding an incremental cost‐effectiveness ratio (ICER) of 3376 € /QALY. Conclusion M-ACI is projected to be a highly cost‐effective treatment for chondral defects of the knee in the German healthcare setting.

Zum Auftakt der 11. Jahrestagung der Deutschen Gesellschaft für Gesundheitsökonomie am 18. März 2019 in Augsburg hatte der Ausschuss „Krankenversicherung“ der dggö vier Experten eingeladen, um das Motto „Der Innovationsfonds an der Schwelle zur Regelversorgung (?)“ zu diskutieren. In diesem Artikel werden die Ergebnisse aus den Vorträgen der vier Experten und die anschließende Podiumsdiskussion zusammengefasst.

Purpose Most metastatic colorectal cancer (mCRC) patients are elderly. This systematic review identifies and describes observational studies evaluating the influence of age on first-line treatment effectiveness in real-world practice. Methods Medline and EMBASE were searched up to May 2016. The included studies were those that investigated first-line treatment of mCRC and reported age groups and overall survival (OS), progression-free survival (PFS) or overall response rate (ORR) were included. Studies published before 2008 were excluded. Study quality was assessed using the Newcastle–Ottawa Scale. Data were evaluated by age group (

OBJECTIVE Antineutrophil cytoplasmic antibody-associated vasculitis (AAV) is considered a chronic, relapsing condition. To date, no studies have investigated multimorbidity in AAV nationally. This study was undertaken to characterize temporal trends in multimorbidity and report excess health care expenditures associated with multimorbidities in a national AAV cohort from Scotland. METHODS Eligible patients with AAV were diagnosed between 1997 and 2017. Each patient was matched with up to 5 general population controls. Linked morbidity and health care expenditure data were retrieved from a Scottish national hospitalization repository and from published national cost data. Multimorbidity was defined as the development of ≥2 disorders. Prespecified morbidities, individually and together, were analyzed for risks and associations over time using modified Poisson regression, discrete interval analysis, and chi-square test for trend. The relationship between multimorbidities and health care expenditure was investigated using multivariate linear regression. RESULTS In total, 543 patients with AAV (median age 58.7 years [range 48.9-68.0 years]; 53.6% male) and 2,672 general population controls (median age 58.7 years [range 48.9-68.0 years]; 53.7% male) were matched and followed up for a median of 5.1 years. AAV patients were more likely to develop individual morbidities at all time points, but especially

Als Health Technology Assessment (HTA) wird eine systematische, transdisziplinare Bewertung der Auswirkungen und direkte und indirekte Konsequenzen fur bestimmte Nutzungsgruppen von Gesundheitstechnologien bezeichnet. Inhalte umfassen klassischerweise die klinische und auserklinische Wirksamkeit, gesundheitsokonomische, ethische, rechtliche, soziale und organisatorische Aspekte. Die Methode wird schon seit den 1970er-Jahren in den USA eingesetzt. In Deutschland etablierte sich HTA mit dem GKV-Modernisierungsgesetz 2004. Das IQWiG ist in Deutschland die primare HTA Agentur und wird vom G-BA beauftragt. Zusatzlich kann uber das Internetportal „ThemenCheck Medizin“ jedermann Vorschlage fur HTA einreichen. Health Technology Assessment ist auch fur Medizinprodukte mit der Erprobungsregelung und Nutzenbewertung nach § 137h SGB V gesetzlich verankert. Die Umsetzung erfordert eine fruhzeitige Planung, um z. B. gesundheitsokonomische Fragestellungen an klinische Studien anzuheften und ein entsprechendes Studiendesign zu wahlen. Medizintechnikhersteller sollten zudem die europaischen HTA-Harmonisierungsverfahren im Blick haben fur einen zukunftig erfolgreichen Marktzugang.

An increasingly competitive environment, reduced drug pipelines, multiple patent expiries and payers’ increasing demands for outcomes-based evidence are all factors currently presenting challenges to the pharmaceutical industry. Offering value-added services alongside products, as a means to improve health outcomes and provide a competitive advantage, is a strategy currently being explored by many pharmaceutical companies to confront these challenges. The aim of this study is to analyse to what extent such service strategies are and will be integrated into the pharmaceutical business model. The scope of the study is global and concentrates on pharmaceutical companies manufacturing branded products. In all, 59 experts working for the pharmaceutical industry were asked for their perceptions on current and future service strategies within the industry. Most respondents believed that service strategies are becoming increasingly important. However, there are still multiple challenges to overcome. Legal restric...

Background: Most patients with type 1 diabetes (T1D) administer insulin by multiple daily injections (MDI). However, continuous subcutaneous insulin infusion (CSII) therapy has been shown to improve glycemic control compared with MDI. Objective: The objective was to determine the key medical event and cost offsets generated over a 4-year period by introducing CSII to T1D patients who have inadequately controlled glucose metabolism on MDI in Germany. Methods: A decision-analytic budget impact model, simulating a treatment switch scenario, was developed. In the base case, all T1D patients received MDI, while in the switch scenario, 20% of the eligible T1D population, randomly selected, moved to CSII. The model focused on 2 medical endpoints and their corresponding cost offsets: severe hypoglycemic events requiring hospitalization (SHEH) and complication-borne diabetic events (CDEs) avoided. Event rates and costs were taken from the literature and official sources, adopting a health insurance perspective. Results: Compared with the base case, treating 20% of patients with CSII in the switch scenario resulted in 47 864 fewer SHEH and 5543 fewer CDEs. This led to total cost offsets of €183 085 281 within the 4-year time horizon. Of these, 92% were driven by avoided SHEH. Compared to an expected budget impact (cost increase) of 83%, only treatment costs considered, the total impact of the switch scenario amounted merely to a 24.5% increase in costs (reduction by 58.5% points; a factor of 3.4). Conclusion: The use of CSII resulted in fewer SHEH and CDEs compared to MDI. The incurred CSII implementation costs are hence offset to a substantial degree by cost savings in complication treatment.

Purpose There is currently a lack of detailed information concerning drug related problems in the outpatient treatment of Parkinson's disease. Methods Problems associated with drug treatment communicated anonymously in Parkinson's disease online forums were therefore retrospectively searched and documented for 1 year. Results Based on postings concerning 12 drugs for the treatment of Parkinson's disease, a total of 238 drug related problems were identified and categorised using the Problem Intervention Documentation (PI-Doc). Of these, 153 were adverse drug reactions. Adverse drug reactions associated with the skin were relatively common, but central effects such as cognitive or psychiatric changes, effects on the sleep/waking system and other problems like headache and dizziness accounted for the highest percentage of adverse events. A comparison with data from scientific literature revealed a number of differences. This means that an analysis of online forums detected a number of drug related problems that were otherwise largely invisible. These were mainly associated with the qualitative aspects of treatment such as medication handling, dosage and individual problems concerning adverse events. In addition, the described method of identifying and classifying drug related problems in Internet forums may also be seen as a contribution to the international discussion about consumer reports and pharmacovigilance. The information about adverse drug reactions given by Internet users can be seen as a valuable adjunct to clinical trial data and as being very timely with regard to the event itself. Conclusion Online forums may be considered as a suitable source of observational information to complement data from randomised clinical trials. Copyright © 2007 John Wiley & Sons, Ltd.

Although vaccination is one of the most cost-effective health care interventions, under-vaccination and variation in coverage rates lower than policy targets is rising in developed countries, partly due to concerns about vaccination value and benefits. By merging various antigens into a single product, combination vaccines represent a valuable tool to mitigate the burden associated with the numerous injections needed to protect against vaccine preventable infectious diseases and increase coverage rate, possibly through various behavioral mechanisms which have yet to be fully explored. Beyond their cost-effectiveness in protecting against more diseases with fewer injections, combination vaccines also have several other benefits, for children, their parents/carers, as well as for the health system and the population as a whole. The objectives of this review are to identify and illustrate the value of combination vaccines for childhood immunization. Evidence was classified into 2 groups: benefits for society and benefits for public health and healthcare systems. This article also highlights the value of innovation and challenges of combination vaccine development as well as the need for an increased number of suppliers to mitigate the impact of any potential vaccine shortage. Increasing public confidence in vaccines and combination vaccines is also critical to fully exploit their benefits.

Vaccination has made an important contribution to the decreased incidence of numerous infectious diseases and associated mortality. In 2013, it was estimated that 103 million cases of childhood diseases in the United States had been prevented by the use of vaccines since 1924. These health effects translate into positive economic results, as vaccination can provide significant savings by avoiding the direct and indirect costs associated with treating the disease and possible long-term disability. A recent US study estimated that every dollar spent on childhood vaccination could save US$3 from a payer perspective and US$10 from a societal perspective. The first vaccines set a high standard from a public health ‘return on investment’ perspective, because they are highly cost-saving. Today, however, where only a few healthcare interventions are considered to be cost-saving, the challenge that decision-makers typically face is to identify such healthcare interventions that are deemed cost-effective, that is, provide extra benefit at a reasonable extra cost. Some of the newer vaccines provide a solution to some of today’s important health issues, such as cervical cancers with human papillomavirus vaccines, or debilitating diseases with herpes zoster vaccines. These recent, more expensive vaccines have been shown to be cost-effective in several economic analyses. Overall, vaccination can still be regarded as one of the most cost-effective healthcare interventions. Keywords: vaccination; economic analysis; cost-effectiveness; cost-saving; public health (Published: 12 August 2015) Citation: Journal of Market Access & Health Policy 2015, 3: 27041 - http://dx.doi.org/10.3402/jmahp.v3.27041

OBJECTIVE: Exocrine pancreatic insufficiency (EPI) is frequent in patients with chronic pancreatitis (CP). This 1-year, prospective, multicenter, observational, disease management study aimed to assess symptom improvement and quality of life in patients with CP with EPI who were receiving pancreatic enzyme replacement. METHODS: Patients with CP and chronic EPI were either assigned to cohort 1 that consisted of patients already taking pancreatin (Kreon; Abbott Arzneimittel GmbH, Hannover, Germany) or cohort 2 that consisted of patients with newly diagnosed EPI without prior pancreatic enzyme treatment. Symptoms were documented, and quality of life was assessed using the gastrointestinal quality of life index (GIQLI) at baseline, 6 months, and 1 year. RESULTS: A total of 294 patients were evaluated (cohort 1, n = 206; cohort 2, n = 88). The proportion of patients experiencing gastrointestinal symptoms and recurrent pain after 1 year was significantly reduced in both cohorts (P < 0.001). The alleviation of symptoms was reflected in GIQLI score improvements at 1 year in both cohorts (P < 0.001), independent of CP severity and etiology. Improvements in GIQLI score were more pronounced in cohort 2 (P < 0.001). CONCLUSIONS: Pancreatin demonstrated symptom relief and improvement in quality of life in patients with CP-related EPI in this disease management study.

Little is known about the relationship between specific subtypes of treatment-associated motor complications and different domains of health-related Quality of Life (QoL) in patients with Parkinson's disease (PD). Larger studies that investigate these aspects within a cross-cultural setting are scarce.To assess QoL and its association with on-off fluctuations, peak-dose dyskinesias, biphasic dyskinesias, and off-dystonias in PD patients from five European countries.Data from 817 PD patients were collected cross-sectionally in France, Germany, Italy, Spain, and the UK. QoL was measured with the generic EuroQoL 5-Dimension questionnaire (EQ-5D) and the disease-specific Parkinson's Disease Questionnaire-39 (PDQ-39). Multivariable linear regression analyses were performed to test the associations of motor complication subtypes with QoL.Thirty-three percent of the patients (varying from 23% in Italy to 58% in France) suffered from motor complications, either a single subtype or a combination of different subtypes. On-off fluctuations were associated with a 7.1 percentage point decrease in the EQ-5D (p0.001) and a 3.6 percentage point deterioration in the PDQ-39 (p = 0.01). Dyskinesias were not seen to affect global QoL scores, but had detrimental effects on the PDQ-39 dimensions activities of daily living, cognitions, stigma, and bodily discomfort. Patients from Spain, Italy, and France had lower global QoL scores in the multivariable analyses than patients from Germany and the UK.Motor complications, primarily on-off fluctuations, may impact QoL in PD patients. This substantiates the importance of clinical strategies targeting the prevention, delay of onset, and management of motor complications in PD patients.

Implementation of guidelines can improve clinical practice. The aim in this study was to investigate whether neurologists in Germany adhered to the national Parkinson’s disease guideline. Data were obtained from a cross-sectional survey of 60 neurologists. Analyses were performed on 320 patients with idiopathic Parkinson’s disease with either low grades of functional impairment (Hoehn and Yahr stage I) or higher grades of functional impairment (stage II–V) but without motor complications. The sample was divided into four groups depending on age and grade of functional impairment. For each group, a biometric parameter on the use of dopamine agonists and L-dopa was defined based on the guideline. In patients aged

Objective: To investigate the cost-utility of eprosartan versus enalapril (primary prevention) and versus nitrendipine (secondary prevention) on the basis of head-to-head evidence from randomized controlled trials. Methods: The HEALTH model (Health Economic Assessment of Life with Teveten® for Hypertension) is an object-oriented probabilistic Monte Carlo simulation model. It combines a Framingham-based risk calculation with a systolic blood pressure approach to estimate the relative risk reduction of cardiovascular and cerebrovascular events based on recent meta-analyses. In secondary prevention, an additional risk reduction is modeled for eprosartan according to the results of the MOSES study ("Morbidity and Mortality after Stroke - Eprosartan Compared to Nitrendipine for Secondary Prevention"). Costs and utilities were derived from published estimates considering European country-specific health-care payer perspectives. Results: Comparing eprosartan to enalapril in a primary prevention setting the mean costs per quality adjusted life year (QALY) gained were highest in Germany (24,036) followed by Belgium (17,863), the UK (16,364), Norway ( 13,834), Sweden ( 11,691) and Spain ( 7918). In a secondary prevention setting (eprosartan vs. nitrendipine) the highest costs per QALY gained have been observed in Germany (9136) followed by the UK (6008), Norway (1695), Sweden (907), Spain (-2054) and Belgium (-5767). Conclusions: Considering a 30,000 willingness-to-pay threshold per QALY gained, eprosartan is cost-effective as compared to enalapril in primary prevention (patients 50 years old and a systolic blood pressure 160 mm Hg) and cost-effective as compared to nitrendipine in secondary prevention (all investigated patients). © 2009, International Society for Pharmacoeconomics and Outcomes Research (ISPOR).