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Abstract Background There has been an increase in 'risk sharing' schemes for pharmaceuticals between healthcare institutions and pharmaceutical companies in Europe in recent years as an additional approach to provide continued comprehensive and equitable healthcare. There is though confusion surrounding the terminology as well as concerns with existing schemes. Methods Aliterature review was undertaken to identify existing schemes supplemented with additional internal documents or web-based references known to the authors. This was combined with the extensive knowledge of health authority personnel from 14 different countries and locations involved with these schemes. Results and discussion A large number of 'risk sharing' schemes with pharmaceuticals are in existence incorporating both financial-based models and performance-based/outcomes-based models. In view of this, a new logical definition is proposed. This is "risk sharing' schemes should be considered as agreements concluded by payers and pharmaceutical companies to diminish the impact on payers' budgets for new and existing schemes brought about by uncertainty and/or the need to work within finite budgets". There are a number of concerns with existing schemes. These include potentially high administration costs, lack of transparency, conflicts of interest, and whether health authorities will end up funding an appreciable proportion of a new drug's development costs. In addition, there is a paucity of published evaluations of existing schemes with pharmaceuticals. Conclusion We believe there are only a limited number of situations where 'risk sharing' schemes should be considered as well as factors that should be considered by payers in advance of implementation. This includes their objective, appropriateness, the availability of competent staff to fully evaluate proposed schemes as well as access to IT support. This also includes whether systematic evaluations have been built into proposed schemes.

With finite resources, healthcare payers must make difficult choices regarding spending and the ethical distribution of funds. Here, we describe some of the ethical issues surrounding inequity in healthcare in nine major European countries, using cancer care as an example. To identify relevant studies, we conducted a systematic literature search. The results of the literature review suggest that although prevention, access to early diagnosis, and radiotherapy are key factors associated with good outcomes in oncology, public and political attention often focusses on the availability of pharmacological treatments. In some countries this focus may divert funding towards cancer drugs, for example through specific cancer drugs funds, leading to reduced expenditure on other areas of cancer care, including prevention, and potentially on other diseases. In addition, as highly effective, expensive agents are developed, the use of value-based approaches may lead to unacceptable impacts on health budgets, leading to a potential need to re-evaluate current cost-effectiveness thresholds. We anticipate that the question of how to fund new therapies equitably will become even more challenging in the future, with the advent of expensive, innovative, breakthrough treatments in other therapeutic areas.

Introduction: The appreciable growth in pharmaceutical expenditure has resulted in multiple initiatives across Europe to lower generic prices and enhance their utilization. However, considerable variation in their use and prices., Objective: Assess the influence of multiple supply and demand-side initiatives across Europe for established medicines to enhance prescribing efficiency before a decision to prescribe a particular medicine. Subsequently utilize the findings to suggest potential future initiatives that countries could consider., Method: An analysis of different methodologies involving cross national and single country retrospective observational studies on reimbursed use and expenditure of PPIs, statins, and renin-angiotensin inhibitor drugs among European countries., Results: Nature and intensity of the various initiatives appreciably influenced prescribing behavior and expenditure, e.g., multiple measures resulted in reimbursed expenditure for PPIs in Scotland in 2010 56% below 2001 levels despite a 3-fold increase in utilization and in the Netherlands, PPI expenditure fell by 58% in 2010 vs. 2000 despite a 3-fold increase in utilization. A similar picture was seen with prescribing restrictions, i.e., (i) more aggressive follow-up of prescribing restrictions for patented statins and ARBs resulted in a greater reduction in the utilization of patented statins in Austria vs. Norway and lower utilization of patented ARBs vs. generic ACEIs in Croatia than Austria. However, limited impact of restrictions on esomeprazole in Norway with the first prescription or recommendation in hospital where restrictions do not apply. Similar findings when generic losartan became available in Western Europe., Conclusions: Multiple demand-side measures are needed to influence prescribing patterns. When combined with supply-side measures, activities can realize appreciable savings. Health authorities cannot rely on a "spill over" effect between classes to affect changes in prescribing.

Background: There are potential conflicts between authorities and companies to fund new premium priced drugs especially where there are effectiveness, safety and/or budget concerns. Dabigatran, a new oral anticoagulant for the prevention of stroke in patients with non-valvular atrial fibrillation (AF), exemplifies this issue. Whilst new effective treatments are needed, there are issues in the elderly with dabigatran due to variable drug concentrations, no known antidote and dependence on renal elimination. Published studies showed dabigatran to be cost-effective but there are budget concerns given the prevalence of AF. These concerns resulted in extensive activities pre- to post-launch to manage its introduction., Objective: To (i) review authority activities across countries, (ii) use the findings to develop new models to better manage the entry of new drugs, and (iii) review the implications based on post-launch activities., Methodology: (i) Descriptive review and appraisal of activities regarding dabigatran, (ii) development of guidance for key stakeholder groups through an iterative process, (iii) refining guidance following post launch studies., Results: Plethora of activities to manage dabigatran including extensive pre-launch activities, risk sharing arrangements, prescribing restrictions and monitoring of prescribing post launch. Reimbursement has been denied in some countries due to concerns with its budget impact and/or excessive bleeding. Development of a new model and future guidance is proposed to better manage the entry of new drugs, centering on three pillars of pre-, peri-, and post-launch activities. Post-launch activities include increasing use of patient registries to monitor the safety and effectiveness of new drugs in clinical practice., Conclusion: Models for introducing new drugs are essential to optimize their prescribing especially where concerns. Without such models, new drugs may be withdrawn prematurely and/or struggle for funding.

Considerable variety in how patients respond to treatments, driven by differences in their geno- and/ or phenotypes, calls for a more tailored approach. This is already happening, and will accelerate with developments in personalized medicine. However, its promise has not always translated into improvements in patient care due to the complexities involved. There are also concerns that advice for tests has been reversed, current tests can be costly, there is fragmentation of funding of care, and companies may seek high prices for new targeted drugs. There is a need to integrate current knowledge from a payer's perspective to provide future guidance. Multiple findings including general considerations; influence of pharmacogenomics on response and toxicity of drug therapies; value of biomarker tests; limitations and costs of tests; and potentially high acquisition costs of new targeted therapies help to give guidance on potential ways forward for all stakeholder groups. Overall, personalized medicine has the potential to revolutionize care. However, current challenges and concerns need to be addressed to enhance its uptake and funding to benefit patients.

Background: There are potential conflicts between authorities and companies to fund new premium priced drugs especially where there are safety and/or budget concerns. Dabigatran, a new oral anticoagulant for the prevention of stroke in patients with non-valvular atrial fibrillation (AF), exemplifies this issue. Whilst new effective treatments are needed, there are issues in the elderly with dabigatran due to variable drug concentrations, no known antidote and dependence on renal elimination. Published studies have shown dabigatran to be cost-effective but there are budget concerns given the prevalence of AF. There are also issues with potentially re-designing anticoagulant services. This has resulted in activities across countries to better manage its use., Objective: To (i) review authority activities in over 30 countries and regions, (ii) use the findings to develop new models to better manage the entry of new drugs, and (iii) review the implications for all major stakeholder groups., Methodology: Descriptive review and appraisal of activities regarding dabigatran and the development of guidance for groups through an iterative process., Results: There has been a plethora of activities among authorities to manage the prescribing of dabigatran including extensive pre-launch activities, risk sharing arrangements, prescribing restrictions, and monitoring of prescribing post-launch. Reimbursement has been denied in some countries due to concerns with its budget impact and/or excessive bleeding. Development of a new model and future guidance is proposed to better manage the entry of new drugs, centering on three pillars of pre-, peri-, and post-launch activities., Conclusion: Models for introducing new drugs are essential to optimize their prescribing especially where there are concerns. Without such models, new drugs may be withdrawn prematurely and/or struggle for funding.

Introduction: European countries need to learn from each other to address unsustainable increases in pharmaceutical expenditures., Objective: To assess the influence of the many supply and demand-side initiatives introduced across Europe to enhance prescribing efficiency in ambulatory care. As a result provide future guidance to countries., Methods: Cross national retrospective observational study of utilization (DDDs - defined daily doses) and expenditure (Euros and local currency) of proton pump inhibitors (PPIs) and statins among 19 European countries and regions principally from 2001 to 2007. Demand-side measures categorized under the "4Es" - education engineering, economics, and enforcement., Results: Instigating supply side initiatives to lower the price of generics combined with demand-side measures to enhance their prescribing is important to maximize prescribing efficiency. Just addressing one component will limit potential efficiency gains. The influence of demand-side reforms appears additive, with multiple initiatives typically having a greater influence on increasing prescribing efficiency than single measures apart from potentially "enforcement." There are also appreciable differences in expenditure (€/1000 inhabitants/year) between countries. Countries that have not introduced multiple demand side measures to counteract commercial pressures to enhance the prescribing of generics have seen considerably higher expenditures than those that have instigated a range of measures., Conclusions: There are considerable opportunities for European countries to enhance their prescribing efficiency, with countries already learning from each other. The 4E methodology allows European countries to concisely capture the range of current demand-side measures and plan for the future knowing that initiatives can be additive to further enhance their prescribing efficiency.

Aim: The aim of this article was to evaluate the influence of different demand-side measures to enhance the prescribing of generics in ambulatory care based on cross-national comparisons., Methods: An observational retrospective study was conducted using administrative databases from across Europe, documenting changes in reimbursed utilization and expenditure of different proton pump inhibitors (PPIs) and statins between 2001 and 2007, alongside different reforms to enhance prescribing efficiency. Utilization was converted to defined daily doses (DDDs) and expenditures were converted to euros. Demand-side measures were collated under the '4 Es'--education, engineering, economics and enforcement--to enable comparisons on the nature and intensity of reforms between countries., Results: There were considerable differences in the utilization of generics and patent-protected PPIs and statins among Western European countries. Decreased utilization of omeprazole and simvastatin, alongside increased utilization of esomeprazole, atorvastatin and rosuvastatin, was seen in countries with limited demand-side measures to counteract commercial pressures. Prescribing restrictions, or a combination of education, prescribing targets and financial incentives, had the greatest influence on enhancing the utilization of omeprazole and simvastatin. For example, there was a threefold reduction in the utilization of atorvastatin in Austria following prescribing restrictions. Multiple demand-side interventions generally had a greater influence than single interventions, with the impact appearing additive. Multiple interventions coupled with initiatives to lower prices of generics considerably enhanced prescribing efficiency., Conclusion: This cross-national study has demonstrated considerable variation in the utilization and expenditure of PPIs and statins across Europe, providing opportunities to further improve prescribing efficiency. The '4 Es' do provide an understandable methodology to document and compare the influence of different demand-side measures, with the influence varying by their extent and intensity. Further reforms are essential given current financial pressures. Consequently, further research will concentrate on the potential to develop a scoring system to help predict the possible impact of different demand-side measures on future utilization patterns.

Background and Purpose: In 2004, German statutory health care funds were given the possibility to offer their insured a special general practitioner-( GP-)centered health care contract (HZV), since 2007 they are obliged to do so. The aim of these contracts is to strengthen the role of the GP as a coordinator in the health care system. Until now, the evidence regarding the GPs' view on these contracts is poor. A written survey was conducted in Hesse in order to learn how the participating GPs evaluate the regional HZV., Methods: In Apri 2008, a questionnaire was developed, tested and mailed to 2,815 GPs who were participating in the GP-centered health care contract at that time. All analyses where conducted with SPSS (version 15.0)., Results: A total of 686 questionnaires were returned (response rate 24.4%). Altogether, the GPs' feedback ranged from great approval to clear disapproval of the contract. However, 70.0% of the survey's participants evaluated the HZV in general to be positive, 60.1% felt it strengthens their role as a GP. Quality circles on good prescribing and GP-specific education, obligatory parts of the HZV, were evaluated to be especially positive (70.3% and 69.4%, respectively). Positive effects were also seen concerning coordination of care (53.3%) and cooperation with patients (36.3%). Improvements concerning cooperation with specialists and hospitals were reported less often (24.9% and 13.0%, respectively). Workload because of additional administration for the HZV was criticized., Conclusion: In future, special GP-centered health care contracts should focus on improvement of cooperation between GPs and other caregivers. Workload for additional administration should be reduced.

Chromosomal aberrations detected by fluorescence in situ hybridization (FISH) on interphase nuclei are important prognostic markers in chronic lymphocytic leukemia (CLL). Deletions in 13q14 and in 11q22.3 are two of the most frequent aberrations in this disease entity (55 and 18%, respectively) and are usually effected by interstitial deletions. Here, we report on the case of a 66-year-old woman with CLL who was analyzed by conventional metaphase cytogenetics as well as fluorescence in situ hybridization. Deletion-specific probes detected a homozygous loss of two anonymous loci in chromosomal band 13q14 in parallel with a heterozygous loss of the ATM gene located in chromosomal band 11q22.3. Karyotype analysis indicated reciprocal but unbalanced translocations involving chromosomes 3, 11, and 13. Deleted sites on 13q14 appeared to be located within the breakpoint regions of the translocations. We show that mechanisms other than interstitial deletions may lead to loss of critical chromosomal regions in CLL.

On behalf of the German Association of Cardiologists in Private Practice (BNK) the Steering Committee of the QuIK Registry reports on the results of the voluntary quality assurance in invasive cardiology in 2003-2005 and compares it to other data collections. In 2005 more than 70% of diagnostic (LHK) and 78% of therapeutic (PCI) cardiac catheterization procedures in private practice were entered into the registry. Altogether 229,462 LHK and 64,818 PCI were documented over the 3 years. In the reported period age of patients, percentage of acute coronary syndromes and three-vessel coronary artery disease increased in LHK as well as in PCI while consumption of contrast media and fluoroscopy time decreased. By implemented possibility of follow-up, a high rate of external auditing (monitoring) and certification QuIK remains a worldwide unique quality assurance project in cardiology. On a stable data basis over 10 years the QuIK Registry enables the implementation of quality indicators for future quality assurance purposes.

Statutory health insurance data are being increasingly used for secondary data research. Longitudinal data can be prepared for research in health care, epidemiology or demand planning, in particular through the person-related nature of the data which is a precondition for the creation of inter-sector and inter-period data sets. This application possibility was introduced in a method study "person-related sampling of statutory health insurance data" and is now translated into practice on a larger scale for the first time in the regional sample "Versichertenstichprobe AOK Hessen/KV Hessen". For the collection and use of these data, model procedures were designed which take account of organisational (data access, contractual agreement, advisory board), technical (sampling, collection and storage of data) and confidentiality (data protection concept, pseudonymisation) aspects. The insured person-related sample may thus serve as a basis for the data pool planned for the national health system (Social Security Regulation 303 a-SGB V).

The Society of German Cardiologists in private practice (BNK) reports about its project on quality assurance in invasive cardiology (QuIK). Results of a computerized data collection and analysis of cardiac catheterizations and interventions in the years 1999-2002 are presented. These results are compared with other registries. The QuIK-project is done voluntarily by 70% of the society's cardiologists who perform invasive methods. A total of 225,562 diagnostic and 64,895 interventional procedures are documented over the 4 years. Patient characteristics and procedural data kept unchanged. Complication rates were low (< 2%), MACE < 0.5%. There was a rising number of patients referred with acute myocardial infarction. Less time was used to complete procedures from 1 year to another. Two out of three of the centers underwent a monitoring/auditing process in 2002. The desirable post-interventional follow-up after discharge in all cases appears to be impossible to fulfill under the given economical circumstances.

In 2001, the Advisory Council for the Concerted Action in Health Care reported deficits of medical care in Germany and disclosed a potential for improvement in the quality and efficiency of care. The introduction and implementation of disease management programs counteracts these deficits by standardising medical care processes for defined patient groups in co-operation with participants from different sectors and professions. Thus, doctors are well advised to learn as much as possible about DMPs for two reasons: they both create and offer DMPs! And this gave rise to an initiative of the German Medical Association and the National Association of Statutory Health Insurance Physicians to create an advanced modularly constructed training program especially for doctors, which was first published on January 24th, 2003.