Parkinson Network Eastern Saxony (PANOS): Reaching Consensus for a Regional Intersectoral Integrated Care Concept for Patients with Parkinson's Disease in the Region of Eastern Saxony, Germany.

As integrated care is recognized as crucial to meet the challenges of chronic conditions such as Parkinson's disease (PD), integrated care networks have emerged internationally and throughout Germany. One of these networks is the Parkinson Network Eastern Saxony (PANOS). PANOS aims to deliver timely and equal care to PD patients with a collaborative intersectoral structured care pathway. Additional components encompass personalized case management, an electronic health record, and communicative and educative measures. To reach an intersectoral consensus of the future collaboration in PANOS, a structured consensus process was conducted in three sequential workshops. Community-based physicians, PD specialists, therapists, scientists and representatives of regulatory authorities and statutory health insurances were asked to rate core pathway-elements and supporting technological, personal and communicative measures. For the majority of core elements/planned measures, a consensus was reached, defined as an agreement by >75% of participants. Additionally, six representatives from all partners involved in the network-design independently assessed PANOS based on the Development Model for Integrated Care (DMIC), a validated model addressing the comprehensiveness and maturity of integrated care concepts. The results show that PANOS is currently in an early maturation state but has the potential to comprehensively represent the DMIC if all planned activities are implemented successfully. Despite the favorable high level of consensus regarding the PANOS concept and despite its potential to become a balanced integrated care concept according to the DMIC, its full implementation remains a considerable challenge.

"Market withdrawals" of medicines in Germany after AMNOG: a comparison of HTA ratings and clinical guideline recommendations.

BACKGROUND: According to the AMNOG act, the German Federal Joint Committee (G-BA) determines the additional benefit of new medicines as a basis for subsequent price negotiations. Pharmaceutical companies may withdraw their medications from the market at any time during the process. This analysis aims to compare recommendations in clinical guidelines and HTA appraisals of medicines that were withdrawn from the German market since the introduction of AMNOG in 2011. METHODS: Medications withdrawn from the German market between January 2011 and June 2016 following benefit assessment were categorized as opt-outs (max. 2 weeks after start of price negotiations) or supply terminations (during or after further price negotiations). Related guidelines were systematically analyzed. For all withdrawals, therapeutic area, additional benefit rating and recommendation status in relevant clinical guidelines were assessed. RESULTS: Among 139 medications, 10 opt-outs and 12 supply terminations were identified. Twenty-one out of 22 withdrawn medicines (95%) received 'no additional benefit' appraisal by the G-BA (average 'no additional benefit' rating for all AMNOG products: 47%). Of the 22 medicines, 15 (68%) were recommended by at least one guideline at the time of benefit assessment and 18 (82%) on 1 June 2016. Heterogeneity among guidelines was high. Acceptance of clinical trial endpoints was different between G-BA appraisals and clinical guidelines. CONCLUSION: Our analysis revealed considerable differences across clinical guidelines as well as between clinical guidelines and HTA appraisals of the medicines that were withdrawn from the German market. Better alignment of the clinical perspective and close collaboration between all involved parties is required to achieve and maintain optimization of patient care.

Effect of Crossover in Oncology Clinical Trials on Evidence Levels in Early Benefit Assessment in Germany.

BACKGROUND: In oncology clinical trials, crossover is used frequently but may lead to uncertainties regarding treatment effects. OBJECTIVE: To investigate the handling of evidence from crossover trials by the European Medicines Agency (EMA) and the German Federal Joint Committee (G-BA). METHODS: For oncology medicines with early benefit assessments before January 2015, presence of crossover, clinical data, EMA requests for additional data, and G-BA benefit ratings/evidence levels were analyzed from manufacturers' dossiers, G-BA appraisals, European Public Assessment Reports, and original publications. RESULTS: Eleven of 21 benefit assessments included crossover trials. Significant intergroup differences (P < 0.05) in overall survival (OS) were noted in 7 of 11 trials with and 7 of 10 without crossover. For 6 of 11 medicines with crossover, these were demonstrated before crossover. Treatment effects generally worsened with increasing proportions of crossover. The EMA requested additional data more frequently if crossover was performed, particularly if no OS data were available before crossover. The G-BA granted a considerable benefit to 73% of medicines with crossover and 40% of those without. Evidence levels were intermediate for 50% and 75%, respectively. None of the medicines received the highest evidence level. CONCLUSIONS: In G-BA appraisals, oncology medicines with crossover received better additional benefit ratings, but were assigned lower evidence levels, than those without. The five medicines with crossover after progression were assigned lower evidence levels than the six medicines with crossover after demonstration of superior OS, indicating that the way in which crossover is implemented may be one factor influencing the assignment of evidence levels by the G-BA.

Contract Design: Risk Management and Evaluation.

INTRODUCTION: Effective risk adjustment is an aspect that is more and more given weight on the background of competitive health insurance systems and vital healthcare systems. The risk structure of the providers plays a vital role in Pay for Performance. A prerequisite for optimal incentive-based service models is a (partial) dependence of the agent's returns on the provider's gain level. Integrated care systems as well as accountable care organisations (ACOs) in the US and similar concepts in other countries are advocated as an effective method of improving the performance of healthcare systems. These systems outline a payment and care delivery model that intends to tie provider reimbursements to predefined quality metrics. By this the total costs of care shall be reduced. METHODS: Little is known about the contractual design and the main challenges of delegating "accountability" to these new kinds of organisations and/or contracts. The costs of market utilisation are highly relevant for the conception of healthcare contracts; furthermore information asymmetries and contract-specific investments are an obstacle to the efficient operation of ACOs. A comprehensive literature review on methods of designing contracts in Integrated Care was conducted. The research question in this article focuses on how reimbursement strategies, evaluation of measures and methods of risk adjustment can best be integrated in healthcare contracting. RESULTS: Each integrated care contract includes challenges for both payers and providers without having sufficient empirical data on both sides. These challenges are clinical, administrative or financial nature. Risk adjusted contracts ensure that the reimbursement roughly matches the true costs resulting from the morbidity of a population. If reimbursement of care provider corresponds to the actual expenses for an individual/population the problem of risk selection is greatly reduced. The currently used methods of risk adjustment have widely differing model and forecast accuracy. For this reason, it is necessary to clearly regulate the method of risk adjustment in the integrated care contract. CONCLUSIONS AND DISCUSSION: The series of three articles on contract design has shown that coordination and motivation problems in designing healthcare contracts cannot be solved at no-costs. Moreover, it became clear, that complete contracts in healthcare are unrealistic and that contracts do always include certain uncertainties. These are based on the risk of random, and no contracting party can control these risks completely. It is also not possible to fully integrate these risks in the contract or to eliminate these risks by the parties.

Contract Design: The problem of information asymmetry.

INTRODUCTION: Integrated care systems are advocated as an effective method of improving the performance of healthcare systems. These systems outline a payment and care delivery model that intends to tie provider reimbursements to predefined quality metrics. Little is known about the contractual design and the main challenges of delegating "accountability" to these new kinds of organisations and/or contracts. The research question in this article focuses on how healthcare contracts can look like and which possible problems arise in designing such contracts. In this a special interest is placed on information asymmetries. METHODS: A comprehensive literature review on methods of designing contracts in Integrated Care was conducted. This article is the first in a row of three that all contribute to a specific issue in designing healthcare contracts. Starting with the organisation of contracts and information asymmetries, part 2 focusses on financial options and risks and part 3 finally concludes with the question of risk management and evaluation. RESULTS: Healthcare contracting between providers and payers will have a major impact on the overall design of future healthcare systems. If Integrated care systems or any other similar concept of care delivery are to be contracted directly by payers to manage the continuum of care the costs of market utilisation play an essential role. Transaction costs also arise in the course of the negotiation and implementation of contracts. These costs are the reason why it is generally not possible to conclude perfect (complete) contracts. Problems with asymmetric distribution of information can relate to the situation before a contract is concluded (adverse selection) and after conclusion of a contract (moral hazard). DISCUSSION AND CONCLUSIONS: Information asymmetries are seen as a major obstacle to the efficient operation of integrated care programmes. Coordination and motivation problems cannot be solved at no-costs. The presented problems in the design of selective individual contracts represent a necessary but not a sufficient condition for further government intervention. A state or political failures have to be assumed continuously.

Contract Design: Financial Options and Risk.

INTRODUCTION: Integrated care systems as well as accountable care organisations (ACOs) in the US and similar concepts in other countries are advocated as an effective method of improving the performance of healthcare systems. These systems outline a payment and care delivery model that intends to tie provider reimbursements to predefined quality metrics. By this the total costs of care shall be reduced. When designing healthcare options contractors are faced with a variety of financial options. The costs of market utilisation are highly relevant for the conception of healthcare contracts; furthermore contract-specific investments are an obstacle to the efficient operation of ACOs. METHODS: A comprehensive literature review on methods of designing contracts in Integrated Care was conducted. This article is the second in a row of three that are all published in this issue and contribute to a specific issue in designing healthcare contracts. The first dealt with the organisation of contracts and information asymmetries, while part 3 concludes with the question of risk management and evaluation. The specific research question of this second article focusses on the financial options and reimbursement schemes that are available to define healthcare contracts. RESULTS: A healthcare contract is a relational contract, which determines the level of reimbursement, the scope of services and the quality between service providers and payers, taking account of the risks relating to population and performance. A relational contract is an agreement based upon assumption of a longer timeframe. A major obstacle to the practical implementation of healthcare contracts is the prognosis of the inflows and outflows due to the actuarial risks of the insured population. Financing conditions and reimbursement arrangements that are based on a prospectively determined fixed price, have a significant drawback: it is very difficult to take the differences in health status and the utilisation of distinct insured clientele (panel) into account. DISCUSSION AND CONCLUSION: The first two articles of this series on contract design have shown that complete contracts in healthcare are unrealistic. Healthcare reimbursement contracts are incomplete contracts with a high degree of uncertainty. In incomplete contracts specific contractual regulations are not made for any eventuality. For this reason it is important that the parties agree on the prevention of endogenous risks (asymmetric information after the conclusion of the contract) and on the procedure in the case of unforeseen circumstances (the risks of random, parameter risk and change risks to the healthcare program).

[Assessing the benefits of digital health solutions in the societal reimbursement context]. / Nutzenbewertung von digitalen Gesundheitsprodukten (Digital Health) im gesellschaftlichen Erstattungskontext.

For a number of reasons, achieving reimbursability for digital health products has so far proven difficult. Demonstrating the benefits of the technology is the main hurdle in this context. The generally accepted evaluation processes, especially parallel group comparisons in randomized controlled trials (RCTs) for (clinical) benefit assessment, are primarily intended to deal with questions of (added) medical benefit. In contrast to drugs or classical medical devices, users of digital health solutions often profit from gaining autonomy, increased awareness and mindfulness, better transparency in the provision of care, and improved comfort, although there are also digital solutions with an interventional character targeting clinical outcomes (e. g. for indications such as anorexia, depression). Commonly accepted methods for evaluating (clinical) benefits primarily rely on medical outcomes, such as morbidity and mortality, but do not adequately consider additional benefits unique to digital health. The challenge is therefore to develop evaluation designs that respect the particularities of digital health without reducing the validity of the evaluations (especially with respect to safety). There is an increasing need for concepts that include both continuous feedback loops for adapting and improving an application while at the same time generate sufficient evidence for complex benefit assessments. This approach may help improve risk benefit ratio assessments of digital health when it comes to implementing digital innovations in healthcare.

Patients' preferences for primary health care - a systematic literature review of discrete choice experiments.

BACKGROUND: Primary care is a key element of health care systems and addresses the main health problems of the population. Due to the demographic change, primary care even gains in importance. The knowledge of the patients' preferences can help policy makers as well as physicians to set priorities in their effort to make health care delivery more responsive to patients' needs. Our objective was to describe which aspects of primary care were included in preference studies and which of them were the most preferred aspects. METHODS: In order to elicit the preferences for primary care, a systematic literature search was conducted. Two researchers searched three electronic databases (PubMed, Scopus, and PsycINFO) and conducted a narrative synthesis. Inclusion criteria were: focus on primary health care delivery, discrete choice experiment as elicitation method, and studies published between 2006 and 2015 in English language. RESULTS: We identified 18 studies that elicited either the patients' or the population's preferences for primary care based on a discrete choice experiment. Altogether the studies used 16 structure attributes, ten process attributes and four outcome attributes. The most commonly applied structure attribute was "Waiting time till appointment", the most frequently used process attribute was "Shared decision making / professional's attention paid to your views". "Receiving the 'best' treatment" was the most commonly applied outcome attribute. Process attributes were most often the ones of highest importance for patients or the population. The attributes and attribute levels used in the discrete choice experiments were identified by literature research, qualitative research, expert interviews, or the analysis of policy documents. CONCLUSIONS: The results of the DCE studies show different preferences for primary health care. The diversity of the results may have several reasons, such as the method of analysis, the selection procedure of the attributes and their levels or the specific research question of the study. As the results of discrete choice experiments depend on many different factors, it is important for a better comprehensibility of the studies to transparently report the steps undertaken in a study as well as the interim results regarding the identification of attributes and levels.

High resource utilization in liver transplantation-how strongly differ costs between the care sectors and what are the main cost drivers?: a retrospective study.

To control treatment pathways of transplant patients across healthcare sectors, a profound knowledge of the underlying cost structure is necessary. The aim of this study was to analyze the resource utilization of patients undergoing liver transplantation. Data on resource utilization for 182 liver-transplanted patients was investigated retrospectively. The observational period started with the entry on the waiting list and ended up to 3 years after transplantation. Median treatment cost was 144 424€. During waiting time, median costs amounted to 9466€; 72% of costs were attributed to inpatient care, 3% to outpatient care, and 26% to pharmaceuticals. During the first year after transplantation, median costs of 105 566€ were calculated; 83% were allocated for inpatient and 1% outpatient care, 14% for drugs, and 1% for rehabilitative care. During follow-up after the first year of transplantation, median costs amounted to 20 115€; 75% of these were caused by pharmaceuticals, 21% by inpatient, 4% by outpatient, and <1% by rehabilitative services. Subgroup analyses (e.g., for labMELD scores) were done. Costs incurred by inpatient care and pharmaceuticals are the dominating cost factors. These findings encourage a debate on challenges and improvements for cost-efficient clinical management between different healthcare sectors.

Inconsistent approaches of the G-BA regarding acceptance of primary study endpoints as being relevant to patients - an analysis of three disease areas: oncological, metabolic, and infectious diseases.

BACKGROUND: Previous evaluations of oncological medicines in the German early benefit assessment (EBA) procedure have demonstrated inconsistent acceptance of endpoints by regulatory authorities and the Federal Joint Committee (G-BA). Accepted standard endpoints for regulatory purposes are frequently not considered as patient-relevant in the German EBA system. In this study the acceptance of clinically acknowledged primary endpoints (PEPs) from regulatory trials in EBAs conducted by the G-BA was evaluated across three therapeutic areas. METHODS: Medicines for oncological, metabolic and infectious diseases with EBAs finalised before 25 January 2016 were evaluated. Respective manufacturer's dossiers, regulatory assessments, G-BA appraisals and oral hearing minutes were reviewed, and PEPs were examined to determine whether they were considered relevant to patients by the G-BA. Furthermore, the acceptance of symptomatic vs asymptomatic PEPs was also analysed. RESULTS: A total of 65 EBAs were evaluated. Mortality PEPs were widely accepted as patient-relevant but were only used in a minority of EBAs and exclusively in oncological diseases. Morbidity PEPs constituted around 72 % of assessed PEPs, but were excluded from the EBA in over half of the corresponding assessments as they were not considered patient-relevant. Symptomatic endpoints were largely deemed patient-relevant, whereas acceptance of asymptomatic endpoints varied between therapeutic areas. CONCLUSIONS: This evaluation identified inconsistencies in patient relevance of morbidity-related PEPs as well as in acceptance of asymptomatic endpoints by the G-BA in all three disease areas examined. Better harmonisation between the regulatory authorities and the G-BA is still required after 5 years of AMNOG health technology assessment in Germany.

German community pastors' contact with palliative care patients and collaboration with health care professionals.

The current level of palliative care in Germany is unsatisfactory. Health care professionals view the psychosocial support of patients and families and the collaboration amongst the different care providers as the main deficiencies. In this context little is known about the viewpoints of community pastors who might have an important role in providing psychosocial and spiritual care for patients at home. In order to study their perspectives we performed 76 standardized telephone interviews with Protestant and Catholic pastors and examined how much contact pastors had with palliative care patients; their views of the collaboration with health care professionals; and how the pastors assessed their own skills in palliative care. Forty-one percent of respondents had no contact with any palliative care patients. The majority perceived collaboration with family doctors to be insufficient. The pastors assessed their own skills concerning palliative care predominantly as "satisfactory". Our findings suggest that community pastors' participation in the delivery of palliative care in Germany might be encouraged by specialized training and intensified contact with health care professionals.

Job satisfaction and motivation among physicians in academic medical centers: insights from a cross-national study.

Our study assesses how work-related monetary and nonmonetary factors affect physicians' job satisfaction at three academic medical centers in Germany and the United States, two countries whose differing health care systems experience similar problems in maintaining their physician workforce. We used descriptive statistics and factor and correlation analyses to evaluate physicians' responses to a self-administered questionnaire. Our study revealed that German physician respondents were less satisfied overall than their U.S. counterparts. In both countries, participation in decision making that may affect physicians' work was an important correlate of satisfaction. In Germany other important factors were opportunities for continuing education, job security, extent of administrative work, collegial relationships, and access to specialized technology. In the U.S. sample, job security, financial incentives, interaction with colleagues, and cooperative working relationships with colleagues and management were important predictors of overall job satisfaction. The implications of these findings for the development of policies and management tactics to increase physician job satisfaction in German and U.S. academic medical centers are discussed.

Discrepancies in the viewpoints of different German health care providers on palliative care.

In many countries with highly developed health care systems, significant improvements in end-of-life care are strongly recommended. Up to the present, the assessment of perceived deficits predominantly reflects the point of view of experts in the palliative and hospice movement, with very little being known about the perspective of other professionals. The aim of this study was to assess the points of view of a wide range of different health care providers who treated or interacted with palliative care patients. The authors subsequently performed 597 semistructured telephone interviews with a wide range of German health care professionals. Overall, the assessment of the current situation was better than expected, although statistically significant differences existed among the groups surveyed. However, there is an unquestionable need for improvement, although opinions regarding the extent of these deficits depend significantly on the individual respondents' roles and professional orientation.