BackgroundHealth care decision-makers have begun to realize that medical nutrition plays an important role in the delivery of care, and it needs to be seen as a sole category within the overall health care reimbursement system to establish the value for money. Indeed, improving health through improving patients’ nutrition may contribute to the cost-effectiveness and financial sustainability of health care systems. Medical nutrition is regulated by a specific bill either in Europe or in the United States, which offers specific legislations and guidelines (as provided to patients with special nutritional needs) and indications for nutritional support. Given that the efficacy of medical nutrition has been proven, one can wonder whether the heterogeneous nature of its coverage/reimbursement across countries might be due to the lack of health-related economic evidence or value-for-money of nutritional interventions. This paper aims to address this knowledge gap by performing a systematic literature review on health economics evidence regarding medical nutrition, and by summarizing the results of these publications related to the value for money of medical nutrition interventions.MethodsA systematic literature search was initiated and executed based on a predefined search protocol following the population, intervention, comparison, and outcomes (PICO) criteria. Following the systematic literature search of recently published literature on health economics evidence regarding medical nutrition, this study aims to summarize the results of those publications that are related to the value for money of medical nutrition interventions. The evaluations were conducted by analyzing different medical nutrition according to their indications, the economic methodology or perspective adopted, the cost source and utility measures, selected efficiency measures, as well as the incremental cost-effectiveness ratio.ResultsA total of 225 abstracts were identified for the detailed review, and the data were entered into a data extraction sheet. For the abstracts that finally met the predefined inclusion criteria (n=53), full-text publications were obtained via PubMed, subito, or directly via each journal’s Webpage for further assessment. After a detailed review of the full text articles, 34 publications have been qualified for a thorough data extraction procedure. When differentiating the resulting articles in terms of their settings, 20 studies covered inpatients, whereas 14 articles covered outpatients, including patients in community centers. When reviewing the value-for-money evaluations, the indications showed that the different results were mostly impacted by the different perspectives adopted and the comparisons that were made. In order to draw comprehensive conclusions, the results were split according to the main indications and diseases.DiscussionThe systematic literature search has shown that there is not only an interest in health economics and its application in medical nutrition, but that there is a lot of ongoing research in ...

BackgroundMedical nutrition is a specific nutrition category either covering specific dietary needs and/or nutrient deficiency in patients or feeding patients unable to eat normally. Medical nutrition is regulated by a specific bill in Europe and in the US, with specific legislation and guidelines, and is provided to patients with special nutritional needs and indications for nutrition support. Therefore, medical nutrition products are delivered by medical prescription and supervised by health care professionals. Although these products have existed for more than 2 decades, health economic evidence of medical nutrition interventions is scarce. This research assesses the current published health economic evidence for medical nutrition by performing a systematic literature review related to health economic analysis of medical nutrition.MethodsA systematic literature search was done using standard literature databases, including PubMed, the Health Technology Assessment Database, and the National Health Service Economic Evaluation Database. Additionally, a free web-based search was conducted using the same search terms utilized in the systematic database search. The clinical background and basis of the analysis, health economic design, and results were extracted from the papers finally selected. The Drummond checklist was used to validate the quality of health economic modeling studies and the AMSTAR (A Measurement Tool to Assess Systematic Reviews) checklist was used for published systematic reviews.ResultsFifty-three papers were identified and obtained via PubMed, or directly via journal webpages for further assessment. Thirty-two papers were finally included in a thorough data extraction procedure, including those identified by a “gray literature search” utilizing the Google search engine and cross-reference searches. Results regarding content of the studies showed that malnutrition was the underlying clinical condition in most cases (32%). In addition, gastrointestinal disorders (eg, surgery, cancer) were often analyzed. In terms of settings, 56% of papers covered inpatients, whereas 14 papers (44%) captured outpatients, including patients in community centers. Interestingly, in comparison with the papers identified overall, very few health economic models were found. Most of the articles were modeling analyses and economic trials in different design settings. Overall, only eight health economic models were published and were validated applying the Drummond checklist. In summary, most of the models included were carried out to quite a high standard, although some areas were identified for further improvement. Of the two systematic health economic reviews identified, one achieved the highest quality score when applying the AMSTAR checklist.ConclusionThe reasons for finding only a few modeling studies but quite a large number of clinical trials with health economic endpoints, might be different. Until recently, health economics has not been required for reimbursement or coverage decisions concerning medical nutriti...

Objectives: In 2004 the German health legislation invented a couple of new and innovative care models in order to increase a more competitive care market and to improve the quality and efficiency of care provisions. More than ten years after invention the market share of this new models still only are about 1% of the total health care marked volume. To put the stalled project back on track last year's legislation abolished major bureaucratic hurdles, improved contracting conditions and invented a funding for innovative care concepts and care research on existing care models -the Innovations fund at G-BA. MethOds: Analysis of the first three waves of applications to the Innovation fund regarding timing, process, quantity and quality of applications, funding volume and period. Results: Germany's Joint Federal Committee (G-BA) grants 300 Million Euro per year for innovative care concepts (225 Million Euro) and care research (75 Million Euro). In a first round of applications for care research funding, 296 concepts for research projects, aiming the knowledge production on the advancement of care provisions have been submitted. One third (93) has been open-topic and two third (203) topic-specific proposals. The majority of the topic-specific proposals targeting the topic of "quality assurance and patient safety in health care" followed by the topic on "Application of routine data for the improvement of care provisions". The exceedingly fewest proposals focused on the topics "Innovative concepts of patient oriented nursing" and "administrative and bureaucratic requirements in healthcare". Other topic-specific themes addressed have been -"Needs-based justice and/or efficiency of care in social health insurance funding" and "Tools for measuring Quality of life". cOnclusiOns: Currently two further waves on innovative care concepts are ongoing (due July5th and 19th) that will reveal further knowledge on the new topics funded by Innovation fund and will be presented in the final poster.

Zusammenfassung Ziel Das vorliegende gesundheitsökonomische Modell wurde entwickelt, um in Deutschland standardmäßig Therapien im Bereich chronische Wunden systematisch und vergleichend zu analysieren. In der zugrunde liegenden Analyse wurden die gesundheitsökonomischen Parameter von Patienten mit einem Ulcus cruris venosum/mixtum, die zusätzlich zur Standardversorgung (SV) mit einer azellulären synthetischen Matrix (ASM) behandelt wurden, berechnet und mit denen von Patienten verglichen, die nur eine Standardversorgung erhalten haben. Methodik Zunächst wurde in den (Standard-)Literaturdatenbanken systematisch nach einem gesundheitsökonomischen Modell gesucht. Die Ergebnisse dieser Literatursuche werden in einer anderen Publikation zur Methodik und Modellbeschreibung ausführlich diskutiert. Angesichts des Fehlens eines publizierten, akzeptierten und für Deutschland adäquaten Modells wurde in Form eines Discrete-Event-Simulations-Modells (DES-Modell) ein neues gesundheitsökonomisches Modell für den Bereich chronische Wunden entwickelt. Auf Basis des DES-Modells wurde eine Kosteneffektivitätsanalyse aus Sicht der Gesetzlichen Krankenversicherung (GKV) durchgeführt. Für die Kostendaten wurden GKV-Routinedaten genutzt. Patienten aus dem Deutschen Register chronischer Wunden (DRCW), die nur mit der SV behandelt wurden und ähnliche Patientencharakteristika aufwiesen, wurden mit Patienten aus einer einarmigen multizentrischen Phase-II-Studie einer azellulären synthetischen Matrix (ASM) verglichen. Die Wirksamkeit der Behandlung (1-Jahres-Vorhersage) wurde mittels Kaplan-Meier-Kurven für die 12-Wochen-Heilungszeit der SV + ASM im Vergleich zur alleinigen Behandlung mit der SV berechnet. Die Modellergebnisse wurden mittels einer probabilistischen Sensitivitätsanalyse für ulzerationsfreie Tage validiert und die Ergebnisse jeweils in einem Scatterplot der geschätzten gemeinsamen Dichte der inkrementellen Kosten und der inkrementellen Effekte der SV versus der SV + ASM sowie in einer Kosteneffektivitäts-Akzeptanz-Kurve dargestellt. Ergebnisse Die Kosteneffektivitätsanalyse zeigte, dass eine auf SV + ASM basierende Therapie gemäß dem Modell effektiver (0,008 inkrementeller Effekt ambulant; −0,045 inkrementeller Effekt stationär) und kostensparender (−321,14 €) ist und somit aus gesundheitsökonomischer Sicht als dominant gegenüber der SV angesehen werden kann. Zusätzlich zeigten sich die Therapien in der Versorgungssäule Facharzt gegenüber denen in der Versorgungssäule Hausarzt als zumindest gleich effektiv und kosteneinsparend und somit dominant. Bei Berücksichtigung der ambulanten Pflege in Verbindung mit dem jeweiligen Arzt war die hausärztliche Versorgung zwar gleich effektiv, aber kostensparender (129,40 € vs. 187,20 € = −57,80 €) als die fachärztliche Versorgung und somit dominant. Die Dominanz nach Hausarzt und Facharzt sowie mit ambulanter Pflege war konsistent zu der, die sich aus der Kosteneffektivität ergibt. Schlussfolgerung Die azelluläre synthetische Matrix (ASM) bestätigte in einer klinischen Studie ihre signifikanten Heilungschancen, die in das gesundheitsökonomische Modell zur chronischen Wunde eingeflossen sind. Unter den zugrunde liegenden Modellannahmen bekräftigt das Modell angesichts von Kosteneinsparungen in allen Behandlungspfaden eines Ulcus cruris venosum/mixtum die Wirtschaftlichkeit einer möglichen Verordnung der ASM im deutschen Kontext.

Objectives: In response to greater health budget restrictions and the rise in costly new treatments, manufacturers and payers have increasing interest in performancebased risk-sharing arrangements (PBRSAs) that address uncertainty and accelerate access to medicines. Our objectives were to review guidelines for PBRSA implementation and the use of PBRSAs in the UK, Italy, and the Netherlands. MethOds: A non-systematic review was undertaken using PubMed to identify guidance on PBRSA implementation. Appropriate governmental and agency websites in the UK, Italy, and the Netherlands were also reviewed to identify PBRSA examples. Key considerations for PBRSA implementation and its historical application in the UK, Italy and the Netherlands were evaluated. Results: Several key considerations for PBRSA implementation were identified from published guidelines. The approach to PBRSA implementation varies between countries with regards to: evidence collection, governance, reporting, and evaluation. While PBRSAs have been applied in the UK, simple cost-sharing arrangements are now encouraged due to difficulties with the implementation and evaluation of PBRSAs. In Italy, AIFA makes extensive use of online monitoring registries to inform their PBRSAs. However, there is no established process for implementation. Currently, in the Netherlands all inpatient drugs with a budget impact > € 0.6 million and an unacceptable level of uncertainty can be granted access via coverage with evidence development arrangements. Both national and international registry data are used in the re-evaluation of reimbursement decisions. cOnclusiOns: The approach to PBRSA implementation varied across the three countries reviewed, although the objectives for their use were similar across the analysed countries. Manufacturers need to consider country-specific factors for implementation and key PBRSA considerations identified via our research offer guidance for applying PBRSAs in these markets.Objectives: Risk Share Agreements (RSAs) are defined as agreements between a payer and a manufacturer where the price level is related to the actual future performance of the product. In the last years RSAs were introduced and applied in various jurisdictions. MethOds: RSAs in Australia, Canada, Italy, Spain, UK and the US were systematically searched for. They were clustered into the type of RSA per country and compared to each other. Results: In Australia the main RSA types were annual sales caps, indication-wide caps, label caps, price-volume agreements, comparator rebates. The details of deeds of agreements/RSAs are generally not publicly available. In Canada the final formulary inclusion decisions are made by each province separately where confidential contracting with direct discounts are preferred. In Italy different contracting mechanisms evolved to payments-by-results in the last years with the AIFA patient registry supporting the implementation of RSAs. Even though payment-by-results was the main type of RSA, cost sharing, cost ceiling, risk sharing and com...