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Economic analysis based on multinational studies: methods for adapting findings to national contexts
(2010)
Background: Health economic parameters are increasingly considered as variables in health care decisions, but decision makers are interested in country-specific evaluations. However, a large number of studies are performed in foreign countries or in a multinational setting, which limits the transferability to a single nation’s context.
Objective: The present analysis summarises several of the most common international methods for generating health economic analyses based on clinical studies from different settings.
Methods: A narrative literature review was performed to identify potential reasons for limited transferability of health economic evaluation results from one country to another. Based on these results, we searched the methodological literature for analytic approaches to handle the restrictions. Additionally we describe the possibility of transferring foreign economic study results to the country of interest by matching trial data with routine data of national databases.
Results: The main factors for limited transferability of health economic findings were found in country-specific differences in resource consumption and the resulting costs. These differences are affected by a number of influencing cofactors (demography, epidemiology and individual patient’s factors) and the overall health care system structures (e.g. payment systems, health provider incentives). However, despite the limitations country-specific health economic assessments could be realised using the pooled/split analyses approach, some statistical approaches and modelling approaches.
Conclusion: A variety of methods for identifying and adjusting country-specific differences in costs, effects and cost-effectiveness was established during the past decades. Multinational studies will continue to play a crucial role in the evaluation of cost-effectiveness at national levels. It seems likely that the growing interest in multinational studies will lead to continued developments in adaptation methods.
Peripheral arterial disease (PAD), a marker of elevated vascular risk, is highly prevalent in
general practice. We aimed to investigate patient characteristics and outcomes of PAD patients treated according to the guidelines versus those who were not.
Methods. PACE-PAD was a multicentre, cluster - randomised prospective, longitudinal cohort study of patients with PAD in primary care, who were followed-up for death or vascular events over 18 months. Guideline-orientation was assumed, if patients received anti¬coagu¬lant/antiplatelet therapy, exercise training, and (if applicable) advice for smoking cessation and therapy of
diabetes mellitus, hypertension, or hypercholesterolemia, respectively.
Results. The 5099 PAD patients (mean age 68.0 ± 9.0 years, 68.5% males) who were followed-up were in Fontaine stages I, IIa, IIb, III, and IV in 22.5%, 34.6%, 30.1%, 7.8%, and 3.5%
(1.5% not specified). Comprehensive guideline orientation was reported in 28.4% only, however, patients in lower Fontaine stages received more often guideline-oriented therapy (I: 30.3%; IIa: 31.6%, IIb: 29.1%, III: 9.8%, IV: 18.0%). During 18 months, 457 patients died (224 due to cerebrovascular or coronary deaths), 319 had instable angina pectoris, 116 myocardial infarction, and 140 an ischemic stroke event. In total, 24% of patients had experienced any vascular event (19.1% a first event). Event rates did not differ between patients treated according to guidelines, and those who were not.
Conclusion. The present PAD cohort was a high-risk sample with an unexpectedly high rate of deaths and vascular events. While physicians appear to focus on the treatment of individual risk factors, rates of comprehensive PAD management in line with guideline recommendations are still suboptimal. Factors contributing to the lacking difference between outcomes in the guideline-oriented and non-guideline-oriented groups may comprise low treatment intensity or other reasons for unsatisfactory effect of treatment, misclassification of events, patient's non-compliance with therapy.
We analyze risks and crises for healthcare providers and discuss the impact of cloud computing in such scenarios. The analysis is conducted in a holistic way, taking into account organizational and human aspects, clinical, IT-related, and utilities-related risks as well as incorporating the view of the overall risk management.
Ökonomische Faktoren spielen bei der Ausgestaltung des Betrieblichen Gesundheitsmanagements eine wichtige Rolle. Zahlreiche und regelmäßige Statistiken zu Absentismus und Präsentismus durch berufsbedingte Erkrankungen weisen auf die Notwendigkeit eines Betrieblichen Gesundheitsmanagements für Unternehmen hin. Doch die Auswirkungen gehen über die Konsequenzen für die Unternehmen weit hinaus. Diese Nutzen- und Kostenkonsequenzen eines Betrieblichen Gesundheitsmanagements für die betroffenen Patienten, die Gesellschaft und die Krankenkassen werden in gesundheitsökonomischen Analysen dargestellt. Trotz des hohen gesellschaftlichen Potenzials eines Betrieblichen Gesundheitsmanagements und der grundsätzlichen Eignung der methodischen Ansätze der Gesundheitsökonomie auch zur Untersuchung dieser Maßnahmen finden sich nur wenige Studien zur medizinischen Wirksamkeit und so gut wie keine gesundheitsökonomischen Evaluationen zu unternehmensbasierten Präventionskonzepten. Dieser Beitrag fasst die wesentlichen geeigneten methodischen Konzepte der Gesundheitsökonomie sowie den Stand der Literatur zu gesundheitsökonomischen Studien von Maßnahmen des Betrieblichen Gesundheitsmanagements zusammen.
A crucial attribute of genetically stratifying personalised medicine technologies is the combination of a biomarker test (or a set of more than one) and a therapeutic decision which is made according to the test results. The biomarker test – often called a ‘companion diagnostic’ – is an essential part of the personalised medicine treatment strategy. The US FDA (Food and Drug Administration) approval agency even stated in a recent reflection paper that it would not approve a new drug without the companion biomarker test if a marker is known (FDA, 2011).
According to drug manufacturers, the pharmaceutical industry is suffering from an ‘innovation crisis’. Nowadays, the development of new products requires significantly more investment than in the past. Most of the simple but useful chemical entities seem to have been discovered already. Moreover, many topselling drugs lose their patent protection (‘patent cliff ’) and, subsequently, prices and sales of the original drug are undermined by competing generics. Producers try to compensate for the loss of sales by launches of new molecular entities (Jimenez, 2012). However, the new compounds generate fewer sales. As market observers calculated, new products launched in the period from 2001 to 2005 achieved annual average sales of USD 208 million after three years. New products of the period from 2006 to 2010 reached only USD 143 million (Rockoff and Winslow, 2013). Development of a drug which yields more than a billion USD per year (‘blockbuster’) succeeds less often. Drugs combined with biomarker-based diagnostic tests, stratifying patients into groups characterised by different drug reactions, appear to be one way out of trouble, because a new generation of patented products seems attainable (Scollen and Phelan, 2014).
‘Personalised medicine’ (PM) has raised great hopes and expectations among researchers, patients, health-care providers and politicians in past years. Although the term ‘person’ in PM suggests an approach of medicine which takes into account psychosocial and value aspects of the patient as human being, most articles refer to PM as strategies limited to biological features of individuals which are used to stratify patient groups for the purposes of prevention, diagnosis and treatment of disease.
Beyond the proof of efficacy and safety for approval purposes health technology assessment (HTA) is a more comprehensive evaluation of all relevant short- and long-term consequences of the application of a specific medical technology. HTA is performed for the purpose of reimbursement decision making. It covers clinical, societal, economic, ethical and legal aspects based on the available scientific evidence.
Although there are some special issues to be considered all principles of HTA are equally valid for the evaluation of biomarker tests and personalized medicine technologies. All requirements of evidence-based medicine remain and causality should and could only be demonstrated with high-quality controlled studies, preferably with randomized design. The multimodality of the intervention and by tendency smaller sample sizes lead to an increased amount of uncertainty. Besides the test strategy, itself also questions of test or sample quality, laboratory size, or the platform used, and the specific technology must be taken into consideration.
Economic evaluations should also include these aspects.
In summary the fundamental principles of HTA and health economic evaluation are also valid and feasible for the evaluation of personalized medicine and genetic biomarker tests, but careful adaptations of the existing HTA and health economic guidelines are required.
Obwohl die Diskussion zur Arbeitsfähigkeit der Belegschaft bereits durch Trends wie den demografischen Wandel angeregt wurde, sind entsprechende unternehmerische oder politische Umsetzungen noch selten. Um ein ganzheitliches Betriebliches Gesundheitsmanagement umzusetzen, fehlt es häufig an praxistauglichen Modellen und Anregungen. Dieses Kapitel stellt zunächst Ilmarinens Work-Ability-Modell bzw. das empirische Werkzeug des Work-Ability-Index als mögliche Ansatzpunkte für ein Betriebliches Gesundheitsmanagement vor und zeigt weiterhin Praxisbeispiele auf, die sich mit den Dimensionen bzw. Zielbereichen des Modells assoziieren lassen.